1. NAME OF THE MEDICINAL PRODUCT

Isosorbide Mononitrate Sustained-Release Capsules 50mg Capsules Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

    a) Each Sustained Release Capsule contains:
    Isosorbide Mononitrate                     50mg
    Excipients                                             q.s.

Excipients with known effect:
Each 50mg capsule contains:
Lactose (150mg/capsule)
Sucrose (48.15 mg/capsule)
For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Sustained -release capsule, hard.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Isosorbide Mononitrate Sustained Release Capsules 50mg capsules are indicated in adults for the prophylactic treatment of angina pectoris.

4.2 Posology and method of administration

Posology

Adults:

One capsule once daily given in the morning. The dose may be increased up to 120 mg.

The product must not be given in divided doses as a daily nitrate free period is required in order to prevent the development of tolerance. Thus, if more than one capsule is needed they must be taken simultaneously.

The dose can be titrated to minimise the possibility of headache by initiating treatment by a lower dose for the first two to four days.

Paediatric population

The safety and efficacy of Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules in children have not been established.

Elderly:

There is no need for routine dose adjustment in the elderly, but care may be needed in those patients with increased susceptibility to hypotension, and in those with marked hepatic or renal insufficiency.

The lowest effective dose should be used.

There is a risk of tolerance developing to Sustained -release preparations. In such patients, intermittent therapy may be more appropriate (see section 4.4).

As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing longterm treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored (see section 4.4).

Method of administration

For oral administration

The capsules may be taken with or without food.

The capsules should be swallowed whole with half a glass of fluid and they should not be chewed or crushed to avoid damage to the Sustained -release characteristics of the microgranules.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

This product should not be given to patients with a known sensitivity to nitrates.

Acute myocardial infarction with low filling pressures, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, aortic/mitral stenosis and severe anaemia, hypovolaemia, conditions causing raised intracranial pressure (e.g. cerebral haemorrhage, head trauma) and closed-angle glaucoma. Severe cerebrovascular insufficiency or hypotension are contraindications to use.

Phosphodiesterase type-5 inhibitors (e.g. sildenafil) have been shown to potentiate the hypotensive effects of nitrates, their co-administration with nitrates or nitric oxide donors is therefore contraindicated.

4.4 Special warnings and precautions for use

The lowest effective dose should be used.

There is a risk of tolerance developing to modified release preparations. In such patients intermittent therapy may be more appropriate.

Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see section 4.2).

Symptoms of circulatory collapse may arise after the first dose, particularly in patients with labile circulation.

Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.

Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol.

Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules are not indicated for relief of acute anginal attacks: in the event of an acute attack, glyceryl trinitrate should be used.

The administration of isosorbide mononitrate causes a decrease of effective renal plasma flow (eRPF) in cirrhotic patients and should be used with caution.

Caution should be used in patients who have a recent history of myocardial infarction and in patients suffering from hypothyroidism, hypothermia, malnutrition, and severe liver or renal disease. Oral nitrates should also be used with caution in patients with angina due to other causes, or pre-existing hyperdynamic conditions.

Since oral nitrates can cause venous dilatation, they should not be used in patients with increased intracranial pressure.

Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

The hypotensive effect of nitrates will be increased if used together with phosphodiesterase type-5 inhibitors (e.g. sildenafil). This might lead to life threatening cardiovascular complications.

Any medication which may cause hypotension may have its hypotensive effects potentiated by concurrent administration of Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules (e.g. alcohol, antihypertensives, vasodilators, calcium channel blockers, and diuretics).

Reports suggest that concomitant administration of isosorbide mononitrate may increase the blood level of dihydroergotamine and its hypertensive effect.

Alcohol can attenuate cerebral ischaemia associated with postural hypotension.

Isosorbide mononitrate can act as a physiological antagonist to noradrenaline, acetylcholine and histamine.

Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules should not be taken at the same time as alcohol. In vitro data suggests that in combination with Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules, alcohol may increase the rate of in vivo release of the product from the Sustained  release preparation. Alcohol may increase dose-dependent effects and lead to potential adverse pharmacodynamic interactions.

Alcohol use could therefore increase the rate and seriousness of isosorbide mononitrate adverse drug reactions such as vasodilatory related events.

There is no evidence of interaction with food.

4.6 Fertility, pregnancy and lactation

Pregnancy

The safety and efficacy of Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules during pregnancy in humans has not been established. Animal studies have shown reproductive toxicity (see section 5.3). Isosorbide mononitrate should only be used in pregnancy if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.

Breast-feeding

The safety and efficacy of Isosorbide Mononitrate Sustained Release Capsules 50mg Capsules during lactation in humans has not been established. It is not known whether nitrates are excreted in human milk and therefore caution should be exercised when administered to nursing women. Isosorbide mononitrate should only be used during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.

4.7 Effects on ability to drive and use machines

The patient should be warned not to drive or operate machinery if hypotension or dizziness occurs. These effects may be increased by alcohol.

4.8 Undesirable effects

Most of the adverse reactions are pharmacodynamically mediated and dose dependent.

The frequency of possible side effects listed below is defined using the following convention:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1000), Not known (cannot be estimated from available data).

System Organ ClassVery commonCommonUncommonRareNot Known
Nervous system disordersHeadache1Restlessness,

Somnolence,

Pituitary haemorrhage

Cardiac disordersTachycardia2

Paroxysmal bradycardia2

Vascular disordersHypotension3,

Light-headedness in the upright position (orthostatic hypotension)

(may be associated with flushing, dizziness, drowsiness, tachycardia, feeling of weakness).

Collapse4
Respiratory, thoracic and mediastinal disordersHypoxia
Gastrointestinal disordersNausea

Vomiting

Heartburn5

Diarrhoea
Skin and subcutaneous tissue disordersHyperhidrosisPruritus

Exfoliative dermatitis

Allergic skin reaction (e.g. rash)

Musculoskeletal and connective tissue disordersMyalgia
General disorders and administration site conditionsAsthenia

1 The incidence of headache usually disappears after 1-2 weeks of treatment. (see section 4.2)

2 These symptoms generally disappear during long-term treatment.

3 Severe hypotensive responses have been reported with organic nitrates with nausea, vomiting, restlessness, pallor, and excessive perspiration. Uncommonly, severe hypotension may lead to enhanced angina pectoris symptom (see section 4.4)

4 Sometimes accompanied by bradyarrhythmia, bradycardia and syncope

5 Most likely due to a nitrate-induced sphincter relaxation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms and signs

Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur.

Methaemoglobinaemia (cyanosis, hypoxaemia, change in mental status, respiratory depression, convulsions, cardiac arrhythmias, circulatory failure and raised intracranial pressure) occurs rarely.

Management

Induction of emesis, activated charcoal.

In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary, fluids should be administrated intravenously.

Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hour. Observe for at least 12 hours after the overdose. Monitor blood pressure and pulse.

If methaemoglobinaemia occurs seek expert advice. Treat with supplemental oxygen and methylene blue. In cases not responding to methylene blue or where methylene blue is contraindicated consider exchange transfusion or red blood cell concentrates. In case of cerebral convulsions, consider diazepam or clonazepam IV or, if therapy fails, phenobarbital, phenytoin or propofol anaesthesia.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vasodilator used in cardiac diseases

Mechanism of action

Organic nitrates (including glyceryl trinitrate, isosorbide dinitrate and isosorbide mononitrate) are potent relaxers of smooth muscle. They have a powerful effect on vascular smooth muscle with less effect on bronchiolar, gastrointestinal, ureteral and uterine smooth muscle. Low concentrations dilate both arteries and veins.

Venous dilatation pools blood in the periphery leading to a decrease in venous return, central blood volume, and ventricular filling volumes and pressures. Cardiac output may remain unchanged or it may decline as a result of the decrease in venous return. Arterial blood pressure usually declines secondary to a decrease in cardiac output or arteriolar vasodilatation, or both. A modest reflex increase in heart rate results from the decrease in arterial blood pressure. Nitrates can dilate epicardial coronary arteries including atherosclerotic stenoses.

Pharmacodynamic effects

The cellular mechanism of nitrate-induced smooth muscle relaxation has become apparent in recent years. Nitrates enter the smooth muscle cell and are cleaved to inorganic nitrate and eventually to nitric oxide. This cleavage requires the presence of sulphydryl groups, which apparently come from the amino acid cysteine. Nitric oxide undergoes further reduction to nitrosothiol by further interaction with sulphydryl groups.

Nitrosothiol activates guanylate cyclase in the vascular smooth muscle cells, thereby generating cyclic guanosine monophosphate (cGMP). It is this latter compound, cGMP, that produces smooth muscle relaxation by accelerating the release of calcium from these cells.

5.2 Pharmacokinetic properties

This product has all the pharmacokinetic characteristics of a true modified release dosage form.

Compared with an immediate-release dosage form, the peak plasma concentration obtained is lower and occurs later, while the apparent elimination half-life is unchanged. Thus, compared to ordinary capsules, the absorption phase is Sustained  and the duration of effect is extended.

The clinical effects of nitrates may be reduced following repeated administration due to too high and / or constant plasma levels. This can be avoided by allowing low plasma levels for a certain period between doses.

The slow continuous diffusion of the active ingredient from the modified-release microgranules makes it possible, at steady state, to maintain plasma concentrations above the putative effective level of 100ng/ml for a period of about 16 hours for the 40mg capsules and 20 hours for the 60mg capsules. Thus, no development of tolerance should be seen with isosorbide mononitrate SR capsules when they are taken in accordance with the recommended dosage regime.

Absorption

In man, isosorbide mononitrate is absorbed completely and rapidly following oral administration. There is no effect of food on bioavailability.

Distribution

Isosorbide mononitrate has a volume of distribution of about 40 litres and is not significantly protein bound.

Biotransformation

Isosorbide mononitrate is extensively metabolised to nitric oxide (NO-which is the active ingredient) and isosorbide (inactive). Unlike isosorbide dinitrate, isosorbide mononitrate does not undergo first pass hepatic metabolism and provides a low degree of inter-individual variation of blood levels, leading to predictable and reproducible clinical effects.

Elimination

Most of isosorbide mononitrate is excreted unchanged in the urine.

In patients with cirrhotic disease or cardiac failure or renal failure, parameters were similar to those obtained in healthy volunteers.

5.3 Preclinical safety data

High concentrations of isosorbide mononitrate in rats is associated with Sustained  gestation and parturition, stillbirths and deaths.

After chronic administration at high doses (60mg/kg), signs of toxicity have been detected in canine liver and kidneys. Tests conducted have shown no evidence of a teratogenic or mutagenic potential.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule content:

Lactose monohydrate, Sugar spheres (containing sucrose and maize starch),

Bleached dewaxed shellac, Dewaxed shellac, Copolymer of methacrylic acid and methyl methacrylate (1:1), Copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate chloride (1:2:0.1), Talc

Capsule shell (50mg): Gelatin, Titanium dioxide

Black printing ink: Shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

The capsules are packed in in blister packs (20 μm aluminium/250 μm PVC) and boxed in cardboard cartons containing 28, 30, 56 or 60 capsules.

Sample blister pack of 8 capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

  1. MANUFACTURED IN INDIA BY:


TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

ISOSORBIDE MONONITRATE SUSTAINED RELEASE CAPSULES 50MG TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Isosorbide mononitrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Please keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

  1. What Isosorbide Mononitrate Sustained-Release Capsules 50mg Taj Pharma are and what they are used for.
  2. What you need to know before you take Isosorbide Mononitrate Sustained-Release Capsules 50mg Taj Pharma.
  3. How to take Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma.
  4. Possible side effects.
  5. How to store Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma.
  6. Contents of the pack and other information.

 

  1. WHAT ISOSORBIDE MONONITRATE SUSTAINED RELEASE CAPSULES 50MG TAJ PHARMA ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma. The active ingredient is isosorbide mononitrate. Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma belongs to a group of medicines called nitrates.

They are called Sustained-release capsules because they are manufactured in a way that allows the isosorbide mononitrate to be released and slowly absorbed by your body over a period of several hours.

Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma is used in adults to prevent angina (chest pain) and work by opening up blood vessels and reducing the pain.

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOSORBIDE MONONITRATE SUSTAINED RELEASE CAPSULES 50MG TAJ PHARMA

Do not take Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma if you:

  • are under 18 years of age;
  • are allergic to isosorbide mononitrate or any other medicines known as nitrates (glyceryl trinitrate, isosorbide dinitrate), or any of the other ingredients of Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);
  • have any inflammation of the heart such as pericarditis;
  • have been diagnosed with any of the following heart conditions
    • Low cardiac filling pressure,
    • Cardiac tamponade,
    • Hypertrophic obstructive cardiomyopathy;
  • have had any serious damage to your heart, such as cardiomyopathy or have narrow heart valves;
  • suffer from severe anaemia (low levels of red blood cells in the blood);
  • have a low volume of blood in your body (hypovolaemia);
  • have a head injury or bleeding of the brain;
  • have closed-angle glaucoma (high pressure in the eyes);
  • have low blood pressure (hypotension);
  • have decreased blood supply to the brain (cerebrovascular insufficiency);
  • are taking a medicine called Viagra (sildenafil) used for male erectile dysfunction.

Warnings and precautions

Talk to your doctor or pharmacist before taking Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma if you:

  • have recently had a heart attack;
  • have an underactive thyroid gland (hypothyroidism);
  • have angina due to other causes (such as a large heart muscle), or have an increased circulatory volume;
  • have a head injury or bleeding of the brain;
  • develop low blood pressure (hypotension), a slow heart rate (bradycardia), or worsening your angina;
  • are at risk of having a stroke;
  • have liver or kidney problems, especially if you are elderly;
  • have cirrhosis of the liver;
  • have a poor diet;
  • have poor circulation;
  • have consumed alcohol as this may lead to low blood pressure (hypotension);
  • feel that you are developing a tolerance to Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma;
  • have a very low body temperature (hypothermia).

If you have an attack of angina whilst taking Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma, do not stop taking your Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma. Your doctor will provide another medicine to treat your condition.

Children

Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma are not suitable for use in children.

Other medicines and Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma

Tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines, including medicines obtained without a prescription.

It is especially important to tell your doctor if you are taking:

  • medicines used to treat high blood pressure (e.g. propranolol, furosemide);
  • medicines used to treat heart failure (e.g. nifedipine, ramipril);
  • medicines used in the treatment of erectile dysfunction (e.g. sildenafil);
  • any medication which may cause a lowering of your blood pressure (e.g. causing dizziness or light-headedness, especially on standing);
  • medicines such as noradrenaline, which are used to treat high blood pressure or a heart attack;
  • acetylcholine, which is used during some operations;
  • medicines such as histamine, which is used to treat allergic reactions;
  • medicines used to treat migraines (e.g. ergotamine).

Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma with food, drink and alcohol

Do not take Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma at the same time as an alcoholic drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The safety of Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma during pregnancy or whilst breastfeeding has not been established.

Driving and using machines

You can drive while taking Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma but do not drive until you know how the capsules affect you. They may give you low blood pressure or make you feel dizzy, if they affect you in this way, do not drive or operate any machinery.

Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma contain lactose and sucrose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  1. HOW TO TAKE ISOSORBIDE MONONITRATE SUSTAINED RELEASE CAPSULES 50MG TAJ PHARMA

Always take Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 40mg or 60mg a day, taken in the morning. Your doctor may increase this dose to 120mg, to be taken as a single dose.

You can take your medicine with or without food.

A lower dose may be prescribed for the first 2-4 days. The capsules should be swallowed whole with a glass of water. Do not crush or chew the capsules.

If Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma are taken frequently and for long periods the effectiveness of the drug may decrease. If you notice that your capsules are no longer working as well at relieving the pain as they have done before, consult your doctor.

If you are elderly and suffer from low blood pressure, liver or kidney disease, your doctor may prescribe a lower dose for you to take.

Use in children

Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma is NOT recommended for children under 18 years of age.

If you take more Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma than you should

If you take more Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma than you should contact your doctor or nearest hospital emergency department immediately. Take this leaflet and any remaining capsules with you.

Symptoms of overdose include headache, feeling over-excited, flushing, cold perspiration, feeling sick, being sick, feeling dizzy, fainting, a fast heart beat, low blood pressure, confusion, shortness of breath and consciousness.

If you forget to take Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma

If you remember within 8 hours take the forgotten dose immediately.

If you remember after 8 hours take the dose at the usual time.

If you stop taking Isosorbide Mononitrate Sustained-Release Capsules 50mg Taj Pharma

Ask your doctor before stopping treatment with Isosorbide Mononitrate Sustained-Release Capsules 50mg Taj Pharma, as treatment should be reduced gradually over several days and you must be monitored carefully by your doctor.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Isosorbide Mononitrate Sustained-Release Capsules 50mg Taj Pharma can cause side effects, although not everyone gets them.

If you experience the following side effects, you should STOP taking your medicine and tell your doctor IMMEDIATELY or go to your nearest casualty department.

  • skin troubles such as rash or itching;
  • wheezing or shortness of breath.

These may be signs of an allergic reaction.

Very Common (may affect more than 1 in 10 people):

  • headache, which may be throbbing – this usually becomes less after a few days of treatment.

Common (may affect up to 1 in 10 people):

  • dizziness;
  • lowered blood pressure (feeling light-headed, dizzy and a speeding up of the heart rate when standing up.
    Also feeling of weakness, drowsiness or increased heart rate).

Uncommon (may affect up to 1 in 100 people):

  • nausea, vomiting;
  • flushing;
  • skin rashes;
  • heartburn;
  • paleness, sweating and restlessness – if your blood pressure drops severely, leading to passing out (collapse). Worsening of angina symptoms can occur if blood pressure drops severely.

Rare (may affect up to 1 in 1,000 people):

  • increase in your heart rate (tachycardia).
  • decrease in your heart rate (paroxysmal bradycardia).

These symptoms generally disappear during long-term treatment.

Not known (frequency cannot be estimated from the available data):

  • muscle pain;
  • weakness;
  • inadequate supply of oxygen in the body (hypoxia);
  • restlessness;
  • sleepiness;
  • pituitary haemorrhage;
  • itching and allergic dermatitis;
  • skin peeling;

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

If Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma are taken frequently and for long periods the effectiveness of the drug may decrease. If you notice that your capsules are no longer working as well at relieving the pain as they have done before, consult your doctor.

  1. HOW TO STORE ISOSORBIDE MONONITRATE SUSTAINED RELEASE CAPSULES 50MG TAJ PHARMA

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma contains:
a) Each Sustained Release Capsule contains:
Isosorbide Mononitrate                     50mg
Excipients                                             q.s.

The other ingredients are: lactose monohydrate, sugar spheres (containing sucrose and maize starch), bleached dewaxed shellac, dewaxed shellac, talc, copolymer of methacrylic acid and methyl methacrylate (1:1) and copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate chloride (1:2:0:1) and the capsule shells are made of gelatin and also contain the colouring titanium dioxide.

What Isosorbide Mononitrate Sustained Release Capsules 50mg Taj Pharma look like and contents of the pack
They are packaged in blister packs of 28, 30, 56 or 60 capsules.
Not all pack sizes may be marketed.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com