Lomont 70mg / 5ml Oral Suspension

1. Name Of The Medicinal Product

Lomont 70mg/5ml Oral Suspension

2. Qualitative And Quantitative Composition

Active Ingredient	Per 5ml
Lofepramine Hydrochloride,	76.1mg
(equivalent to Lofepramine base)	70mg

3. Pharmaceutical Form

A white to pale yellow/orange suspension with odour of Cherry.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of symptoms of depressive illness.

4.2 Posology And Method Of Administration

Adults: The usual dose 70mg twice daily (140mg) or three times daily (210mg) depending upon patient response.

Elderly: Elderly patients may respond to lower doses in some cases.

Children: Not recommended

4.3 Contraindications

Lofepramine should not be used in patients hypersensitive to dibenzazepines, in mania, severe liver impairment and/or severe renal impairment, heart block, cardiac arrhythmias, or during the recovery phase following a myocardial infarction.

Lofepramine should not be administered with or within 2 weeks of cessation of therapy with monoamine oxidase inhibitors (see Section 4.5).

Use of lofepramine with amiodarone should be avoided (see Section 4.5).

Use of lofepramine with terfenadine should be avoided (see Section 4.5).

4.4 Special Warnings And Precautions For Use

It should be remembered that severely depressed patients are at risk of suicide. An improvement in depression may not occur immediately upon initiation of treatment, therefore the patient should be closely monitored until symptoms improve.

Lofepramine may lower the convulsion threshold, therefore it should be used with extreme caution in patients with a history of epilepsy or recent convulsions or other predisposing factors, or during withdrawal from alcohol or other drugs with anticonvulsant properties.

Concurrent electroconvulsive therapy should only be undertaken with careful supervision.

Lofepramine should be used with caution where there is a history of mania. Psychotic symptoms may be aggravated. There have also been reports of hypomanic or manic episodes during a depressive phase in patients with cyclic affective disorders receiving tricyclic antidepressants.

Lofepramine should be used with caution in patients with cardiovascular disease, impaired liver or renal function, narrow angle glaucoma, symptoms suggestive of prostatic hypertrophy, blood dyscrasias or porphyria.

Caution is needed in patients with hyperthyroidism, or during concomitant treatment with thyroid preparations, since aggravation of unwanted cardiac effects may occur.

In chronic constipation, tricyclic antidepressants may cause paralytic ileus, particularly in elderly and bedridden patients.

Care should be exercised in patients with tumours of the adrenal medulla (eg phaeochromocytoma, neuroblastoma) in whom tricyclic antidepressants may provoke hypertensive crises.

Blood pressure should be checked before initiating treatment because individuals with hypertension, or an unstable circulation, may react to lofepramine with a fall in blood pressure.

Anaesthetics may increase the risks of arrhythmias and hypotension (see Interactions), therefore before local or general anaesthesia, the anaesthetist should be informed that the patient has been taking lofepramine.

Hyponatraemia (usually in the elderly and possibly due to inappropriate secretion of antidiuretic hormone) has been associated with all types of antidepressants and should be considered in all patients who develop drowsiness, confusion or convulsions while taking lofepramine.

Abrupt withdrawal of lofepramine should be avoided if possible.

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide

Patients with a history of suicide

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Excipient Warnings

This product contains 10%v/v ethanol, i.e. up to 395mg per dose equivalent to 10ml of beer or 4ml of wine per dose. It is harmful for those suffering from alcoholism. It should be taken into account in pregnant or lactating women, children and high-risk groups such as patients with liver disease or epilepsy. It may modify or increase the effect of other medicines. The amount of alcohol in this product may impair the ability to drive or use machines.

This product also contains liquid maltitol and sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lofepramine should not be administered concurrently with or within 2 weeks of cessation of therapy of monamine oxidase inhibitors. It should then be introduced cautiously using a low initial dosage.

SSRI Inhibitors: co-medication may lead to additive effects on the serotonergic system. Fluvoxamine and fluoxetine may also increase plasma concentrations of lofepramine resulting in a lowered convulsion threshold and seizures.

Anti-arrhythmic drugs: There is an increased risk of ventricular arrhythmias if lofepramine is given with drugs which prolong the Q-T interval e.g. disopyramide, procainamide, propafenone, quinidine and amiodarone. Concomitant use with amiodarone should be avoided (See Section 4.3)

Neuroleptics: There is an increased risk of arrhythmias; there may be an increased plasma level of the tricyclic antidepressant, a lowered convulsion threshold and seizures.

Lofepramine should not be given with sympathomimetic agents (cardiovascular effects may be potentiated), central nervous depressants including alcohol or thyroid hormone therapy since its effects may be potentiated.

Lofepramine may decrease the antihypertensive effect of adrenergic neurone-blocking drugs; it is therefore advisable to review this form of antihypertensive therapy during treatment.

Anaesthetics given during tricyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. If surgery is necessary, the anaesthetist should be informed that a patient is being so treated. Barbiturates may increase the rate of metabolism.

Possible interactions between lofepramine and warfarin, leading to an enhancement of anticoagulant effect, have been reported rarely. Careful monitoring of plasma prothrombin is advised.

Anti-cholinergic agents: Lofepramine may potentiate the effects of these drugs (e.g. phenothiazine, antiparkinson agents, antihistamines, atropine, beperiden) on the central nervous system, eye, bowel and bladder.

Analgesics: There is an increased risk of ventricular arrhythmias.

Anti-epileptics: Antagonism can lead to a lowering of the convulsive threshold. Plasma levels of some tricyclic antidepressants, and therefore the therapeutic effect, may be reduced.

Calcium channel blockers: diltiazem and verapamil increase the plasma concentration of lofepramine.

Diuretics: There is an increased risk of postural hypotension.

Terfenadine: There is an increased risk of ventricular arrhythmias therefore concomitant use should be avoided.

Rifampicin: The metabolism of lofepramine is accelerated by rifampicin leading to a reduced plasma concentration

Digitalis glycosides: With digitalis glycosides there is a higher risk of arrhythmias.

Sotalol: The risk of ventricular arrhythmias associated with sotalol is increased.

Cimetidine: Cimetidine can increase the plasma concentration of lofepramine.

Clonidine: The effect of antihypertensive agents of the clonidine type can be weakened.

Altretamine: There is a risk of severe postural hypotension when co-administered with tricyclic antidepressants

Disulfiram and alprazolam: Co-medication with either disulfiram or alprazolam may require a reduction in the dose of lofepramine.

Nitrates: The effectiveness of sublingual nitrates may be reduced where the tricyclic antidepressant's anticholinergic effect has lead to dryness of the mouth.

Ritonavir: There may be an increased plasma concentration of lofepramine.

Oral contraceptives: Oestrogens and progestogens may antagonise the therapeutic effect of tricyclic antidepressants whilst the latter's side effects may be exacerbated due to an increased plasma concentration.

4.6 Pregnancy And Lactation

The safety of Lofepramine for use during pregnancy has not been established and there is evidence of harmful effects in pregnancy in animals when high doses are given. Lofepramine has been shown to be excreted in breast milk. The administration of Lofepramine in pregnancy and during breast feeding therefore, is not advised unless there are compelling medical reasons.

Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers have taken tricyclic antidepressants during the last trimester of pregnancy.

4.7 Effects On Ability To Drive And Use Machines

Ability to drive a car and operate machinery may be affected. Therefore caution should be exercised initially until the individual reaction to treatment is known.

4.8 Undesirable Effects

Lofepramine has been shown to be well tolerated and side-effects, when they occur, tend to be mild. Comparative clinical trials have shown that Lofepramine is associated with a low incidence of anticholinergic side effects. The following side effects have been reported with Lofepramine:

Cardiovascular: Hypotension, tachycardia, cardiac conduction disorders, increase in cardiac insufficiency, arrhythmias.

CNS and Neuromuscular: Dizziness, sleep disturbances, agitation, confusion, headache, malaise, paraesthesia; rarely, drowsiness, hypomania and convulsions (See section 4.4 Special Warnings and Precautions for Use); very rarely, uncoordinated movement.

Anticholinergic: Dryness of mouth, constipation, disturbances of accommodation, urinary hesitancy, urinary retention, sweating and tremor, induction of glaucoma; rarely, impairment of the sense of taste; very rarely, tinnitus.

Urinogenital: Testicular disorders e.g. pain.

Allergic: Skin rash, allergic skin reactions, photosensitivity reactions, facial oedema; rarely, cutaneous bleeding, inflammation of mucosal membranes.

Gastro-intestinal: Nausea, vomiting

Endocrine: Rarely, hyponatraemia (inappropriate secretion of antidiuretic hormone), interference with sexual function, changes of blood sugar level, gynaecomastia, galactorrhoea.

Haematological/ biochemical: Rarely, bone marrow depression including isolated report of: agranulocytosis, eosinophilia, granuloctyopenia, leucopenia, pancytopenia, thrombocytopenia. Increases in liver enzymes, sometimes progressing to clinical hepatitis and jaundice, have been observed in some patients, usually occurring within the first three months of starting therapy. There have been a small number of reports of jaundice. These reactions are reversible on cessation of therapy.

The following adverse effects have been encountered in patients under treatment with tricyclic antidepressants and should therefore be considered as theoretical hazards of Lofepramine even in the absence of substantiation: psychotic manifestations including mania and paranoid delusions may be exacerbated during treatment with tricyclic antidepressants; withdrawal symptoms may occur on abrupt cessation of therapy and include insomnia, irritability and excessive perspiration; adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers have taken tricyclic antidepressants during the last trimester of pregnancy.

Cases of suicidal ideation and suicidal behaviours have been reported during lofepramine therapy or early after treatment discontinuation (see section 4.4).

4.9 Overdose

Treatment of overdosage is symptomatic and supportive. It should include immediate gastric lavage and routine close monitoring of cardiac function. Reports of overdosage with Lofepramine, with quantities ranging from 0.7g up to 6.72g, have shown no serious sequelae directly attributable to the drug.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lofepramine inhibits the re-uptake of monoamines in peripheral adrenergic nerves. Lofepramine produces a lesser increase in heart rate than that produced by Amitriptyline when administered to normal individuals.

5.2 Pharmacokinetic Properties

Lofepramine is rapidly absorbed with peak plasma concentration being reached within 1 hour and having a plasma half-life of 5 hours. In common with Imipramine, Lofepramine appears to undergo significant presystemic metabolism.

Plasma protein binding is approximately 99%. After oral administration higher concentrations of Lofepramine and its metabolites can be found in blood, lungs, liver, kidney and brain.

Almost all of the drug is metabolized before excretion, which is mainly in the urine and in faeces. Lofepramine is metabolized by N-dealkylation, hydroxylation and glucuronidation. It is extensively metabolized to its principal metabolite, desmethylimipramine, on first pass through the liver. During chronic administration, the plasma level of desmethylimipramine is typically three times greater than that of lofepramine, except in the first few hours following administration of each dose, during which time the plasma level of the parent drug can exceed that of its metabolite. Desipramine, which is also an antidepressant is converted to 2-hydroxydesipramine in the liver. Both compounds are excreted mainly in the urine as glucuronides, but also by biliary excretion in the faeces. Less than 5% is excreted unchanged in the urine over 24 hours.

Neither renal disease or old age has any appreciable effect on the kinetics of desipramine. Elimination may be reduced and bioavailability increased in hepatic disease.

5.3 Preclinical Safety Data

Lofepramine Hydrochloride is a well established active substance.

Lofepramine, like other tricyclic antidepressants, has been shown to inhibit the neuronal uptake of noradrenaline and to potentiate serotonergic transmission.

The safety of Lofepramine for use during pregnancy has not been established and there is evidence of harmful effects in pregnancy in animals when high doses are given. Lofepramine has been shown to be excreted in breast milk. The administration of Lofepramine in pregnancy and breast feeding therefore, is not advised unless there are compelling medical reasons.

Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers have taken tricyclic antidepressants during the last trimester of pregnancy.

The toxological data available in the published literature on lofepramine have not revealed any hazards, which are likely to occur at the usual oral therapeutic dosage. The excipients in the formulation would not be anticipated to influence the pharmacology or toxicology of the drug.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water, sodium ascorbate, sorbitol solution 70% (non-crystallising), liquid maltitol, methyl hydroxybenzoate, propyl hydroxybenzoate, propylene glycol, ethanol (absolute), colloidal silicon dioxide (aerosil) and cherry flavour 28T7704.

6.2 Incompatibilities

None known

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store between 4°C and 25°C. Protect from light.

6.5 Nature And Contents Of Container

150ml, 200ml or 300ml amber (type III) glass bottles

Closures: - 1) Aluminium, EPE wadded, roll-on, pilfer-proof, or 2) HDPE, EPE wadded, tamper evident or 3) HDPE EPE wadded, tamper evident child resistant.

6.6 Special Precautions For Disposal And Other Handling

Keep out of the reach of children. Shake before use.

Administrative Data

7. Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

8. Marketing Authorisation Number(S)

0427/0094

9. Date Of First Authorisation/Renewal Of The Authorisation

1 February 1996

10. Date Of Revision Of The Text

02 February 2009

Vermox

Generic Name: mebendazole (Oral route)

me-BEN-da-zole

Commonly used brand name(s)

In the U.S.

• Vermox

Available Dosage Forms:

• Suspension


• Tablet, Chewable

Therapeutic Class: Anthelmintic

Chemical Class: Benzimidazole

Uses For Vermox

Mebendazole belongs to the family of medicines called anthelmintics. Anthelmintics are medicines used in the treatment of worm infections.

Mebendazole is used to treat:

• Common roundworms (ascariasis);


• Hookworm infections (uncinariasis);


• Pinworms (enterobiasis; oxyuriasis);


• Whipworms (trichuriasis); and


• More than one worm infection at a time.

This medicine may also be used for other worm infections as determined by your doctor.

Mebendazole works by keeping the worm from absorbing sugar (glucose). This gradually causes loss of energy and death of the worm.

Mebendazole is available only with your doctor's prescription.

Before Using Vermox

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in a limited number of children 2 years of age or older and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mebendazole in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Crohn's disease or


• Liver disease or


• Ulcerative colitis—Patients with these diseases may have an increased chance of side effects from mebendazole

Proper Use of Vermox

Mebendazole usually comes with patient directions. Read them carefully before using this medicine.

No special preparations or other steps (for example, special diets, fasting, other medicines, laxatives, or enemas) are necessary before, during, or immediately after taking mebendazole.

Mebendazole tablets may be chewed, swallowed whole, or crushed and mixed with food.

For patients taking mebendazole for hookworms, roundworms, or whipworms:

• To help clear up your infection completely, take this medicine exactly as directed by your doctor for the full time of treatment. In some patients a second course of this medicine may be required to clear up the infection completely. Do not miss any doses.

For patients taking mebendazole for pinworms:

• To help clear up your infection completely, take this medicine exactly as directed by your doctor. A second course of this medicine is usually required to clear up the infection completely.


• Pinworms may be easily passed from one person to another, especially in a household. Therefore, all household members may have to be treated at the same time. This helps to prevent infection or reinfection of other household members. Also, all household members may have to be treated again in 2 to 3 weeks to clear up the infection completely.

For patients taking mebendazole for infections in which high doses are needed:

• Mebendazole is best taken with meals, especially fatty ones (for example, meals that include whole milk or ice cream). This helps to clear up the infection by helping your body absorb the medicine better. However, if you are on a low-fat diet, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (chewable tablets):
  
  • For common roundworms, hookworms, and whipworms:
    
    • Adults and children 2 years of age and over—100 milligrams (mg) two times a day, morning and evening, for three days. Treatment may need to be repeated in two to three weeks.
    
    
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For pinworms:
    
    • Adults and children 2 years of age and over—100 mg once a day for one day. Treatment may need to be repeated in two to three weeks.
    
    
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For more than one worm infection at a time:
    
    • Adults and children 2 years of age and over—100 mg two times a day, morning and evening, for three days.
    
    
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Vermox

It is important that your doctor check your progress at regular visits, especially in infections in which high doses are needed. This is to make sure that the infection is cleared up completely and to allow your doctor to check for any unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

For patients taking mebendazole for pinworms:

• In some patients, pinworms may return after treatment with mebendazole. Washing (not shaking) all bedding and nightclothes (pajamas) after treatment may help to prevent this.


• Some doctors may also recommend other measures to help keep your infection from returning. If you have any questions about this, check with your doctor.

For patients taking mebendazole for hookworms or whipworms :

• In hookworm and whipworm infections anemia may occur. Therefore, your doctor may want you to take iron supplements to help clear up the anemia. If so, it is important to take iron every day while you are being treated for hookworms or whipworms; do not miss any doses. Your doctor may also want you to keep taking iron supplements for up to 6 months after you stop taking mebendazole. If you have any questions about this, check with your doctor.

Vermox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Fever


• skin rash or itching


• sore throat and fever


• unusual tiredness and weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abdominal or stomach pain or upset


• diarrhea


• nausea or vomiting

Rare

• Dizziness


• hair loss


• headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vermox side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Vermox resources

• Vermox Side Effects (in more detail)
• Vermox Use in Pregnancy & Breastfeeding
• Drug Images
• Vermox Drug Interactions
• Vermox Support Group
• 0 Reviews for Vermox - Add your own review/rating

• Vermox Consumer Overview


• Mebendazole Prescribing Information (FDA)


• Mebendazole Professional Patient Advice (Wolters Kluwer)


• Mebendazole Monograph (AHFS DI)


• Mebendazole MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Vermox with other medications

• Angiostrongylosis
• Ascariasis
• Capillariasis
• Dracunculiasis
• Echinococcus
• Filariasis, Elephantiasis
• Hookworm Infection, Necator or Ancylostoma
• Hydatid Disease
• Pinworm Infection, Enterobius vermicularis
• Trichinosis
• Trichostrongylosis
• Visceral Larva Migrans, Toxicariasis
• Whipworm Infection

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Simvastatin ratiopharm may be available in the countries listed below.

Ingredient matches for Simvastatin ratiopharm

Simvastatin

Simvastatin is reported as an ingredient of Simvastatin ratiopharm in the following countries:

• Austria


• Czech Republic


• Denmark


• Estonia


• Finland


• Germany


• Hungary


• Lithuania


• Slovakia


• Sweden

International Drug Name Search

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Ingredient matches for BetaCreme Lichtenstein

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of BetaCreme Lichtenstein in the following countries:

• Germany

International Drug Name Search

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Minoset may be available in the countries listed below.

Ingredient matches for Minoset

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Paracetamol is reported as an ingredient of Minoset in the following countries:

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International Drug Name Search

Duomax

Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX

What is Duomax (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Duomax (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Duomax (guaifenesin and phenylephrine)?

You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  circulation problems;

  
  


• 
  

  glaucoma;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  enlarged prostate or problems with urination.

  
  

It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Duomax (guaifenesin and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.

What should I avoid while taking Duomax (guaifenesin and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Duomax (guaifenesin and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  vomiting, upset stomach;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless (especially in children);

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  headache; or

  
  


• 
  

  dizziness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Duomax (guaifenesin and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with guaifenesin and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Duomax resources

• Duomax Side Effects (in more detail)
• Duomax Use in Pregnancy & Breastfeeding
• Duomax Drug Interactions
• Duomax Support Group
• 0 Reviews for Duomax - Add your own review/rating

• Crantex Prescribing Information (FDA)


• Despec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex LA Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Gentex LA Sustained-Release Tablets (12 Hour) MedFacts Consumer Leaflet (Wolters Kluwer)


• Guiatex PE Prescribing Information (FDA)


• Lusonex Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rescon-GG Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Sina-12X Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Duomax with other medications

• Cough and Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Duomax side effects (in more detail)

Alcis

Alcis may be available in the countries listed below.

Ingredient matches for Alcis

Estradiol

Estradiol is reported as an ingredient of Alcis in the following countries:

• Spain

International Drug Name Search

Versed

Generic Name: midazolam (Oral route)

MID-ay-zoe-lam

Oral route(Syrup)

Midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. Use only in settings that can provide for continuous monitoring of respiratory and cardiac function .

Commonly used brand name(s)

In the U.S.

• Versed

Available Dosage Forms:

• Tablet


• Syrup


• Solution

Therapeutic Class: Anesthetic Adjunct

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Uses For Versed

Midazolam is used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures. Midazolam is also given to produce amnesia (loss of memory) so that the patient will not remember any discomfort or undesirable effects that may occur after a surgery or procedure.

Midazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is given only by or under the immediate supervision of a doctor trained to use this medicine.

Before Using Versed

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of midazolam in children below 6 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of midazolam in the geriatric population. Safety and efficacy have not been established.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir


• Atazanavir


• Boceprevir


• Darunavir


• Delavirdine


• Efavirenz


• Fosamprenavir


• Indinavir


• Itraconazole


• Lopinavir


• Nelfinavir


• Ritonavir


• Saquinavir


• Telaprevir


• Tipranavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil


• Amobarbital


• Anileridine


• Aprobarbital


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlorzoxazone


• Codeine


• Conivaptan


• Dantrolene


• Ethchlorvynol


• Fentanyl


• Fospropofol


• Hydrocodone


• Hydromorphone


• Ketoconazole


• Levorphanol


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Morphine


• Morphine Sulfate Liposome


• Nilotinib


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenobarbital


• Posaconazole


• Primidone


• Propoxyphene


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Thiopental


• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant


• Armodafinil


• Carbamazepine


• Cimetidine


• Clarithromycin


• Crizotinib


• Cyclosporine


• Dalfopristin


• Deferasirox


• Diltiazem


• Echinacea


• Erythromycin


• Fluconazole


• Fluvoxamine


• Fosaprepitant


• Fosphenytoin


• Ginkgo Biloba


• Goldenseal


• Halothane


• Lurasidone


• Mitotane


• Phenytoin


• Quinupristin


• Roxithromycin


• St John's Wort


• Telithromycin


• Theophylline


• Vemurafenib


• Verapamil


• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Apnea (temporary stopping of breathing) or


• Heart disease or


• Hypoventilation (slow breathing) or


• Infections or


• Lung disease, severe or


• Lung or airway blockage—Use with caution. May increase risks for more serious side effects.

• Congestive heart failure or


• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Glaucoma, acute narrow-angle—Should not be used in patients with this condition.

Proper Use of Versed

Midazolam will be given to you or to your child in a hospital or clinic by a doctor trained to use this medicine. If you or your child will be receiving midazolam during surgery, your doctor or anesthesiologist will give you the medicine.

After you receive midazolam, you or your child will be watched closely to make sure this medicine is working. Your breathing, blood pressure, nervous system, and heart will also be watched closely to make sure the medicine is not causing unwanted side effects.

Precautions While Using Versed

If you will be receiving midazolam before surgery, your doctor will give you the medicine and closely follow your progress, to make sure this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

For patients going home within 24 hours after receiving midazolam:

• Midazolam may cause some people to feel drowsy, tired, or weak for 1 or 2 days after it has been given. It may also cause problems with coordination and one's ability to think. Therefore, do not drive, use machines, or do anything else that could be dangerous if you are not alert until the effects of the medicine have disappeared or until the day after you receive midazolam, whichever period of time is longer.


• Do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received midazolam, unless otherwise directed by your doctor. To do so may add to the effects of the medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; other sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures; and muscle relaxants.

Do not drink grapefruit juice or eat grapefruit while you are using this medicine. Also, do not take this medicine if you have allergies to cherries.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Versed Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Anxiety


• chest pain or discomfort


• choking


• confusion


• difficult or troubled breathing


• drowsiness


• dry mouth


• fast heartbeat


• hyperventilation


• irregular heartbeats


• irregular, fast or slow, or shallow breathing


• irritability


• lightheadedness, dizziness, or fainting


• nausea


• nervousness


• noisy breathing


• pale or blue lips, fingernails, or skin


• restlessness


• shaking


• shortness of breath


• slow or irregular heartbeat


• tightness in the chest


• trouble sleeping


• unable to speak


• unusual tiredness


• weakness


• wheezing

Rare

• Attack, assault, or force


• changes in patterns and rhythms of speech


• feeling of constant movement of self or surroundings


• headache


• lack or loss of self-control


• loss of balance


• mood swings


• noisy breathing


• not breathing


• restlessness


• seeing, hearing, or feeling things that are not there


• sensation of spinning


• shakiness and unsteady walk


• sleepiness


• slow to respond


• slurred speech


• trouble in speaking


• unconsciousness


• unsteadiness, trembling, or other problems with muscle control or coordination

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness


• difficulty with coordination


• loss of consciousness


• sleepiness or unusual drowsiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Vomiting

Less common

• Rash

Rare

• Blurred vision


• double vision


• gagging


• hiccups


• seeing double


• watering of mouth and drooling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Versed side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Versed resources

• Versed Side Effects (in more detail)
• Versed Use in Pregnancy & Breastfeeding
• Versed Drug Interactions
• Versed Support Group
• 4 Reviews for Versed - Add your own review/rating

• Midazolam MedFacts Consumer Leaflet (Wolters Kluwer)


• Midazolam Hydrochloride Monograph (AHFS DI)

Compare Versed with other medications

• ICU Agitation
• Light Anesthesia
• Light Sedation

Furosémide

Furosémide may be available in the countries listed below.

Ingredient matches for Furosémide

Furosemide

Furosémide is known as Furosemide in the US.

International Drug Name Search

Glossary

Click for further information on drug naming conventions and International Nonproprietary Names.

Caltrate 600 with D

Generic Name: calcium and vitamin D combination (KAL see um and VYE ta min D)

Brand Names: Calcarb with D, Calcet, Calcio Del Mar, Calcitrate with D, Calcium 600+D, Caltrate 600 with D, Caltrate 600 with D Plus Soy, Caltrate Colon Health, Citracal + D, Citracal 250 mg + D, Citracal Creamy Bites, Citracal Maximum + D, Citracal Petites, Citrus Calcium with Vitamin D, Dical-D, Os-Cal 250 with D, Os-Cal 500 + D, Os-Cal with D, Oysco 500 with D, Oysco D, Oyst-Cal-D, Oyster Shell Calcium with Vitamin D, Oyster-D, Oystercal-D, Posture-D H/P, Risacal-D

What is Caltrate 600 with D (calcium and vitamin D combination)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance.

Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcium and vitamin D combination is used to prevent or to treat a calcium deficiency.

Calcium and vitamin D combination may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Caltrate 600 with D (calcium and vitamin D combination)?

Before you take calcium and vitamin D combination, tell your doctor if you have kidney disease, past or present kidney stones, heart disease, circulation problems, a parathyroid disorder, or if you are pregnant or breast-feeding.

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Before taking calcium and vitamin D combination, tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I tell my healthcare provider before taking Caltrate 600 with D (calcium and vitamin D combination)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take calcium and vitamin D combination, tell your doctor if you have:

• kidney disease;


• past or present kidney stones;


• 
  

  heart disease;

  
  


• 
  

  circulation problems; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium and vitamin D combination if you are pregnant. Talk to your doctor before taking calcium and vitamin D combination if you are breast-feeding.

How should I take Caltrate 600 with D (calcium and vitamin D combination)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the calcium and vitamin D regular tablet with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Store calcium and vitamin D combination at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include irregular heartbeat, stomach pain, nausea, vomiting, dry mouth, a metallic taste in your mouth, confusion, loss of appetite, constipation, weakness, headache, confusion, or fainting.

What should I avoid while taking Caltrate 600 with D (calcium and vitamin D combination)?

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Caltrate 600 with D (calcium and vitamin D combination) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  an irregular heartbeat;

  
  


• 
  

  nausea, vomiting, or decreased appetite;

  
  


• 
  

  dry mouth;

  
  


• 
  

  constipation;

  
  


• 
  

  weakness;

  
  


• 
  

  headache;

  
  


• 
  

  a metallic taste;

  
  


• 
  

  muscle or bone pain; or

  
  


• 
  

  drowsiness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Caltrate 600 with D (calcium and vitamin D combination)?

Before taking calcium and vitamin D combination, tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids containing calcium, aluminum, or magnesium;

  
  


• 
  

  other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or other vitamin D supplements; or

  
  


• 
  

  a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and there may be other drugs that can interact with calcium and vitamin D combination. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Caltrate 600 with D resources

• Caltrate 600 with D Side Effects (in more detail)
• Caltrate 600 with D Use in Pregnancy & Breastfeeding
• Caltrate 600 with D Drug Interactions
• Caltrate 600 with D Support Group
• 0 Reviews for Caltrate 600 with D - Add your own review/rating

Compare Caltrate 600 with D with other medications

• Dietary Supplementation
• Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about calcium and vitamin D combination.

See also: Caltrate 600 with D side effects (in more detail)

PASS natrija sals

PASS natrija sals may be available in the countries listed below.

Ingredient matches for PASS natrija sals

Aminosalicylic Acid

Aminosalicylic Acid sodium (a derivative of Aminosalicylic Acid) is reported as an ingredient of PASS natrija sals in the following countries:

• Latvia

International Drug Name Search

Optipred

Optipred may be available in the countries listed below.

Ingredient matches for Optipred

Prednisolone

Prednisolone 21-acetate (a derivative of Prednisolone) is reported as an ingredient of Optipred in the following countries:

• Oman

International Drug Name Search

Formucare Allergy Relief

loratadine

Dosage Form: tablet
Access Business Group International LLC Allergy Relief Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• do not use if printed foil under cap is broken or missing


• store at 20°-25°C (68°-77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Original Prescription Strength

Relief of:

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

24 Hour

Actual Size

*When taken as directed. See Drug Facts Panel.

Allergy Relief Carton

Formucare Allergy Relief  loratadine  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10056-612 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains

Packaging # NDC Package Description Multilevel Packaging 1 10056-612-75 1 BOTTLE In 1 CARTON contains a BOTTLE 1 90 TABLET In 1 BOTTLE This package is contained within the CARTON (10056-612-75)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	01/27/2005

Labeler - Access Business Group International LLC (609682641)

Revised: 09/2009Access Business Group International LLC

More Formucare Allergy Relief resources

• Formucare Allergy Relief Side Effects (in more detail)
• Formucare Allergy Relief Dosage
• Formucare Allergy Relief Use in Pregnancy & Breastfeeding
• Formucare Allergy Relief Drug Interactions
• 0 Reviews for Formucare Allergy Relief - Add your own review/rating

Compare Formucare Allergy Relief with other medications

• Hay Fever
• Urticaria

Votrient

Generic Name: pazopanib (Oral route)

paz-OH-pa-nib

Oral route(Tablet)

Severe and fatal hepatotoxicity has been observed in clinical studies. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended .

Commonly used brand name(s)

In the U.S.

• Votrient

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Votrient

Pazopanib is an anticancer medicine that is used to treat adults with kidney cancer (advanced renal cell carcinoma).

Pazopanib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by pazopanib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with pazopanib, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Before Using Votrient

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pazopanib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pazopanib in the elderly. However, elderly patients may be more sensitive to the effects of pazopanib than younger adults, and are more likely to have age-related liver problems, which may require caution for patients receiving pazopanib.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride


• Dronedarone


• Mesoridazine


• Pimozide


• Posaconazole


• Sparfloxacin


• Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil


• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Atazanavir


• Azithromycin


• Carbamazepine


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Cyclosporine


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Ergotamine


• Erythromycin


• Fentanyl


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Indinavir


• Itraconazole


• Ketoconazole


• Lapatinib


• Levofloxacin


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nefazodone


• Nelfinavir


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paclitaxel


• Paliperidone


• Perflutren Lipid Microsphere


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Rifampin


• Ritonavir


• Salmeterol


• Saquinavir


• Sirolimus


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tacrolimus


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• food


• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain), history of or


• Gilbert's syndrome (a genetic liver disease) or


• Heart attack, history of or


• Heart disease or


• Heart rhythm problems (e.g., QT prolongation), history of or


• Hypertension (high blood pressure) or


• Hypothyroidism (underactive thyroid) or


• Stomach or bowel problems (e.g., fistula, perforation, tear) or


• Stroke, history of—Use with caution. May make these conditions worse.

• Bleeding problems or


• Hemoptysis (coughing up of blood), history of or


• Stomach bleeding (last 6 months)—It is not known if pazopanib will work in patients with these conditions.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Votrient

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine on an empty stomach, at least one hour before or 2 hours after a meal.

Swallow the tablets whole. Do not break, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For late-stage kidney cancer:
    
    • Adults—800 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use it, and it is less than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Votrient

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine may increase your chance of bleeding. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; trouble breathing; heartburn; indigestion; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Grapefruits and grapefruit juice may increase the effects of pazopanib by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Votrient Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain or tenderness


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• blurred vision


• chest pain


• chills


• clay colored stools


• cloudy urine


• constipation


• cough


• coughing up blood


• dark urine


• decreased appetite


• depressed mood


• difficulty with breathing or swallowing


• dizziness


• dry skin and hair


• feeling cold


• fever


• hair loss


• headache


• hoarseness or husky voice


• increased menstrual flow or vaginal bleeding


• itching


• loss of appetite


• lower back or side pain


• muscle cramps and stiffness


• nausea and vomiting


• nervousness


• nosebleeds


• painful or difficult urination


• pale skin


• paralysis


• pinpoint red spots on the skin


• pounding in the ears


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• redness, swelling, or pain of the skin


• scaling of the skin on the hands and feet


• shortness of breath


• skin rash


• slow or fast heartbeat


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swelling of the feet or lower legs


• swollen glands


• tingling of the hands and feet


• ulceration of the skin


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain


• yellow eyes or skin

Less common

• Bleeding from rectum or bloody stools


• blood in the urine


• bloody nose


• chest pain or discomfort


• confusion


• coughing or spitting up blood


• fainting


• irregular heartbeat


• irregular or slow heart rate


• numbness or tingling in the face, arms, or legs


• pain or discomfort in the shoulders, arms, jaw, back, or neck


• sweating


• swelling or puffiness of the face


• trouble speaking, thinking, or walking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change in hair color


• change in taste


• decreased weight


• diarrhea


• hair loss


• lack or loss of strength


• loss of taste


• thinning of the hair


• weight loss

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Votrient side effects (in more detail)

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More Votrient resources

• Votrient Side Effects (in more detail)
• Votrient Use in Pregnancy & Breastfeeding
• Votrient Drug Interactions
• Votrient Support Group
• 7 Reviews for Votrient - Add your own review/rating

• Votrient Prescribing Information (FDA)


• Votrient Consumer Overview


• Votrient Monograph (AHFS DI)


• Votrient MedFacts Consumer Leaflet (Wolters Kluwer)


• Pazopanib Professional Patient Advice (Wolters Kluwer)

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