Isosorbide Mononitrate Tablets 20mg Taj Pharma

NAME OF THE MEDICINAL PRODUCT

Isosorbide Mononitrate Tablets 10mg Taj Pharma
Isosorbide Mononitrate Tablets 20mg Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each tablet contains:
Isosorbide Mononitrate                     10mg
Excipients                                             q.s.
b) Each tablet contains:
Isosorbide Mononitrate                      20mg
Excipients                                              q.s.

Excipients with a known effect:

Each tablet contains approximately 109 mg of lactose and approximately 59 mg sucrose.

For the full list of excipients, see Section 6.1.

PHARMACEUTICAL FORM

Tablets

CLINICAL PARTICULARS

4.1 Therapeutic indications

Isosorbide Mononitrate Tablets is indicated for the prophylaxis of angina pectoris.

4.2 Posology and method of administration

Posology

Dosage should be reduced in patients with renal or hepatic impairment.

Adults

One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. Patients already accustomed to prophylactic nitrate therapy may normally be transferred directly to a therapeutic dose of isosorbide mononitrate. For patients not already receiving prophylactic nitrate therapy it is recommended that the initial dose be one tablet of Isosorbide Mononitrate Tablets 10mg / 20mg twice a day.

The maintenance dose in individual patients is usually between 20- 110mg / 20mg daily.

The lowest effective dose should be used.

Elderly

No evidence of a need for routine dosage adjustment in older people has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.

Children

The safety and efficacy of Isosorbide Mononitrate Tablets 10mg / 20mg has yet to be established in children.

Treatment with Isosorbide Mononitrate Tablets, as with any other nitrates, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.4)

Method of administration

It is recommended that the tablets should be swallowed whole with a drink of water.

4.3 Contraindications

Isosorbide Mononitrate Tablets 10mg / 20mg should not be used in cases of acute myocardial infarction with low filling pressures, acute circulatory failure (shock, vascular collapse), or very low blood pressure, hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage.

This product should not be given to patients with a known hypersensitivity to isosorbide dinitrate or mononitrate, to other nitrates or to any of the excipients.

Isosorbide Mononitrate Tablets 10mg / 20mg should not be used in patients with marked anaemia, sever hypotension, closed angle glaucoma, toxic pulmonary oedema or hypovolaemia.

Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil, tadalafil, vardenafil) have been shown to potentiate the hypotensive effects of nitrates and their co-administration with nitrates or nitric oxide donors is therefore contraindicated (see section 4.5).

Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of Isosorbide Mononitrate Tablets 10mg / 20mg.

4.4 Special warnings and precautions for use

Isosorbide Mononitrate Tablets 10mg / 20mg should be used with caution in patients who have a recent history of myocardial infarction, or who are suffering from closed-angle glaucoma, hypothyroidism, hypothermia, malnutrition and sever liver or renal disease.

Symptoms of circulatory collapse may arise after first dose in patients with labile circulation and in patients already taking ACE inhibitors.

This product may give rise to postural hypotension and syncope in some patients. Severe postural hypotension with light headedness and dizziness is frequently observed after the consumption of alcohol, therefore alcohol should be avoided during treatment. Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.

In the event of an acute angina attack, sublingual treatment such as a GTN spray or tablet should be used instead of isosorbide mononitrate tablets.

Isosorbide Mononitrate Tablets contain sucrose and lactose and therefore patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, sucrase-isomaltase insufficiency glucose-galactose malabsorption should not take this medicine.

If the tablets are not taken as indicated (see section 4.2) tolerance to the medication and cross-tolerance to other nitrates may occur. The lowest effective dose should be used.

Treatment with isosorbide mononitrate tablets, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.2).

4.5 Interaction with other medicinal products and other forms of interaction

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

Concurrent administration of drugs with blood pressure lowering properties, e.g, beta-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, angiotensin II receptor antagonist, ACE inhibitors etc. may potentiate the hypotensive effect of Isosorbide Mononitrate Tablets. This may also occur with neuroleptics and tricyclic antidepressants.

Alcohol can accentuate cerebral ischaemia associated with postural hypotension.

Any blood pressure lowering effect of Isosorbide Mononitrate Tablets will be increased if used together with phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil and verdenafil) which are used for erectile dysfunction (see special warnings and contraindications). This might lead to life threatening cardiovascular complications. Patients who are on Isosorbide Mononitrate Tablets therapy therefore must not use phosphodiesterase type-5 inhibitors.

Reports suggest that concomitant administration of Isosorbide Mononitrate Tablets may increase the blood level of dihydroergotamine and its hypertensive effect.

4.6 Fertility, pregnancy and lactation

The safety and efficacy of Isosorbide Mononitrate Tablets during pregnancy or lactation has not been established.

4.7 Effects on ability to drive and use machines

Dizziness, tiredness or blurred vision might occur at the start of treatment. The patients should therefore be advised that if affected, they should not drive or operate machinery. This effect may be increased by alcohol.

4.8 Undesirable effects

A very common (>10% of patients) adverse reaction to Isosorbide Mononitrate Tablets is throbbing headache. The incidence of headache diminishes gradually or disappears after 1-3 weeks and optimum dosage of isosorbide mononitrate may be achieved.

At the At the start of therapy or when the dosage is increased, hypotension and/or light headedness in the upright position are commonly observed (i.e in 1-10% of patients). These symptoms may be associated with cutaneous vasodilatation with flushing, dizziness, drowsiness, reflex tachycardia and occasionally unexplained bradycardia and a feeling of weakness.

Infrequently (i.e. in less than 1% of patients) nausea, vomiting, flushing and allergic skin reaction (e.g. rash) may occur sometimes severely. In single cases exfoliative dermatitis may occur.

Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration. Uncommonly collapse may occur (sometimes accompanied by bradyarrhythmia and syncope). Uncommonly severe hypotension may lead to enhanced angina symptoms.

Very rarely (i.e. in less than 0.01%) myalgia may occur.

A few reports of heartburn most likely due to a nitrate induced sphincter relaxation have been recorded.

Tachycardia and paroxysmal bradycardia have been reported.

Nitrate-induced pituitary apoplexy has been reported in patients with undiagnosed pituitary tumours.

Reporting suspected adverse reactions

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

4.9 Overdose

Symptoms and signs:

Pulsing headache, hypotension, nausea, vomiting, flushing, cold perspiration, sweating, tachycardia, vertigo, restlessness, excitation, warm flushed skin, blurred vision and syncope. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur. Methaemoglobinaemia (cyanosis, hypoxaemia, restlessness, respiratory depression, convulsions, cardiac arrhythmias, circulatory failure, raised intracranial pressure) occurs rarely.

Management:

Induction of emesis, 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. Correct hypotension by raising the foot of the bed and/or by expanding the intravascular volume. Other measures as indicated by the patient’s clinical condition. If severe hypotension persists despite the above measures consider use of inotropes or intravenous administration of fluid.

If methaemoglobinaemia (symptoms or > 30% methaemoglobin), IV administration of methylene blue 1-2 mg/kg body weight. If therapy fails with second dose after 1 hour or contraindicated, consider red blood cell concentrates or exchange transfusion. In case of cerebral convulsions, diazepam or clonazepam IV, or if therapy fails, phenobarbital, phenytoin or propofol anaesthesia.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vasodilators used in cardiovascular disease (organic nitrates).

The principal pharmacological action of isosorbide mononitrate, an active metabolite of isosorbide dinitrate, is relaxation of vascular smooth muscle, producing vasodilation of both arteries and veins with the latter effect predominating. The effect of the treatment is dependent on the dose. Low plasma concentrations lead to venous dilatation, resulting in peripheral pooling of blood, decreased venous return and reduction in left ventricular end-diastolic pressure (preload). High plasma concentrations also dilate the arteries reducing systemic vascular resistance and arterial pressure leading to a reduction in cardiac afterload. Isosorbide mononitrate may also have a direct dilatory effect on the coronary arteries. By reducing the end diastolic pressure and volume, the preparation lowers the intramural pressure, thereby leading to an improvement in the subendocardial blood flow.

The net effect when administering isosorbide mononitrate is therefore a reduced workload of the heart and an improved oxygen supply/demand balance in the myocardium.

5.2 Pharmacokinetic properties

Isosorbide-5-mononitrate is rapidly absorbed and peak plasma levels occur approx. 1 hour following oral dosing.

Isosorbide-5-mononitrate is completely bioavailable after oral doses and is not subjected to pre-systemic elimination processes.Isosorbide-5-mononitrate is eliminated from the plasma with half-life of about 5.1 hours. It is metabolized to Isosorbide-5MN-2-glucoronide, which has a half-life of approximately 2.5 hours. As well as being excreted unchanged in the urine.

After multiple oral dosing plasma concentrations are similar to those that can be predicted from single dose kinetic parameters.

5.3 Preclinical safety data

The accessible data indicate that isosorbide mononitrate has expected pharmacodynamic properties of an organic nitrate ester, has simple pharmacokinetic properties, and is devoid of toxic, mutagenic or oncogenic effects.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate, Compressible sugar, Sodium starch glycollate, Magnesium stearate, Silica colloidal anhydrous.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

Store in a dry place, below 25°C.

6.5 Nature and contents of container

Aluminium foil/UPVC blister packs: 28, 50, 56, 60 or 100 tablets.

Recloseable polyethylene jars: 100, 500 tablets.

6.6 Special precautions for disposal and other handling

No specific statement.

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 TABLETS 10MG / 20MG

PACKAGE LEAFLET: INFORMATION FOR THE USER

Isosorbide Mononitrate Tablets 10mg

Isosorbide Mononitrate Tablets 20mg

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse.

WHAT IS IN THIS LEAFLET

What Isosorbide Mononitrate Tablets are and what they are used for
What you need to know before you take Isosorbide Mononitrate Tablets
How to take Isosorbide Mononitrate Tablets
Possible side effects
How to store Isosorbide Mononitrate Tablets
Content of the pack and other information

WHAT ISOSORBIDE MONONITRATE TABLETS ARE AND WHAT THEY ARE USED FOR

Isosorbide Mononitrate Tablets belong to a group of medicines called nitrate vasodilators. These work by relaxing the blood vessels of the heart, reducing the strain on the heart making it easier to pump blood.

Isosorbide Mononitrate Tablets are used to prevent angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOSORBIDE MONONITRATE TABLETS

Do not take Isosorbide Mononitrate Tablets if:

you are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate or any of the other ingredients of Isosorbide Mononitrate Tablets (see section 6). An allergic reaction may include a rash, itching or difficulty breathing
you have severe anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness).
you are having a heart attack (myocardial infarction)
you have ever had a stroke.
you have a low blood volume (hypovolaemia), very low blood pressure
your blood has stopped circulating around your body properly (circulation failure).
you take sildenafil, tadalafil and vardenafil or any other phosphodiesterase inhibitor (used for male impotence). See the section “Other medicines and Isosorbide mononitrate”.
you are suffering from “shock” or vascular collapse.
you have an eye disease called glaucoma (increased pressure in the eye).
you have been diagnosed with any of the following heart conditions: hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis.
you have diseases associated with raised head pressure e.g. brain haemorrhage (bleeding); head injury (trauma).

Do not take Isosorbide Mononitrate Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Isosorbide Mononitrate Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Isosorbide Mononitrate Tablets if you:

have an underactive thyroid gland
are undernourished as a result of a poor diet
have severe liver or kidney problems
suffer from hypothermia (very low body temperature)
suffer from very poor circulation
had any serious damage to your heart, such as a heart attack
have an eye disease called glaucoma (increased pressure in the eye)

Do not take Isosorbide Mononitrate Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Isosorbide Mononitrate Tablets.

Other medicines and Isosorbide Mononitrate Tablets: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Isosorbide Mononitrate Tablets can affect the way some medicines work and some medicines can have an effect on Isosorbide Mononitrate Tablets.

Do not take Isosorbide Mononitrate Tablets if you are taking the following medicines:

Sildenafil, tadalafil and vardenafil used to treat male erection dysfunction, should not be taken if taking nitrate preparations such as Isosorbide Mononitrate Tablets because a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal. You must not stop taking Isosorbide Mononitrate Tablets to take sildenafil, tadalafil or vardenafil as this will increase your chances of having an angina attack.
Noradrenalin (norepinephrine) to treat sharp and severe drop in blood pressure
Acetylcholine used in some operations
Medicines to treat high blood pressure such as ACE inhibitors, beta blockers, alpha blockers, angiotensin-II receptor agonists, clonidine, diazoxide, diuretics (water tablets), methyldopa, moxonidine
Histamine (used mostly as a diagnostic agent in some medical conditions)
Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety)
Dihydorergotamine used for migraine

Do not take Isosorbide Mononitrate Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Isosorbide Mononitrate Tablets.

Isosorbide Mononitrate Tablets and alcohol: Do not drink alcohol. It could increase the effect of Isosorbide Mononitrate Tablets and lower your blood pressure too much. If this happens, you may feel dizzy or faint.

Pregnancy, breast-feeding and fertility: 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.

Driving and using machines: Isosorbide Mononitrate Tablets may give you headache, blurred vision or make you feel dizzy or tired, make sure you are not affected before you drive or operate machinery.

Isosorbide Mononitrate Tablets contains lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

HOW TO TAKE ISOSORBIDE MONONITRATE TABLETS

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

Take the tablets with a drink of water.
Isosorbide Mononitrate Tablets 10mg and 20mg can be divided into equal doses.

How much to take

Adults

The initial dose recommended, for patients not already accustomed to nitrate therapy to prevent angina pectoris, is one tablet twice a day.
The usual adult dose is 20mg tablet two or three times a day, then a maintenance dose of between 20-120 mg a day.
You will need to have a period of time (usually when you are sleeping) when no tablets are taken. This is called a “nitrate low” period and is needed to make sure your medicine remains effective.

You must not take Isosorbide Mononitrate Tablets for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label).

Patients with kidney or liver disease: A lower dose may be given.

Elderly: Dose should be reduced especially in patients with kidney or liver disease.

Children: Do not give these tablets to children. e

If you take more Isosorbide Mononitrate Tablets than you should: If you tak more Isosorbide Mononitrate tablets than you should, take to a doctor or go to a hospital straight away. Take the medicine pack with you so the tablets can be identified.

Signs of an overdose: pulsing headache, over excited, flushing, feeling or being sick, cold sweats, sweating, feeling dizzy or spinning sensation, restlessness, warm flushed skin, blurred vision fainting or passing out, fast heart beat or fall in blood pressure. Increase pressure in the brain with confusion and neurological deficits can sometimes occur. Methaemoglobinaemia, which manifests in symptoms such as bluish discoloration of the skin and mucous membranes (cyanosis); respiratory depression; seizures; irregular heart rate or rhythm.

If you forget to take Isosorbide Mononitrate Tablets

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Isosorbide Mononitrate Tablets: Do not stop taking Isosorbide Mononitrate Tablets without first talking to your doctor. You should keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the tablets your condition may get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Headaches
Feeling sick (nausea)
Feeling dizzy

The above problems usually disappear with time.

Other possible side effects:

Seek immediate medical help if you have any of the following symptoms:

Fainting or collapse
Allergic reaction-skin rash, swelling of the skin of the extremities or face, swelling of lips, tongue or the mucous membranes in mouth, throat or airways resulting in shortness of breath or difficulty to swallow

Very common side effects (may affect up to 1 in 10 people):

Mild headaches at the start of treatment. Usually they get better after 1-3 weeks of treatment.

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

Low blood pressure and/or light-headed on standing up
Tiredness, drowsiness, feeling weak
Fast or slow heart rate
Headache
Flushing
Dizziness

They may occur for the first few days of treatment or after your dosage has been increased.

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

Fainting or collapse
Skin rashes, looking pale
Feeling sick or being sick (nausea and/or vomiting), diarrhoea
Excessive sweating
Restlessness
Worse angina

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

Fainting
Rash
Itchy skin

Very rare side effects (may affect up to 1 in 10,000 people):

Heartburn
Red or scaly skin (exfoliative dermatitis)
Muscular pain (myalgia)

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.

HOW TO STORE ISOSORBIDE MONONITRATE TABLETS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a dry place, below 25°C.

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

CONTENT OF THE PACK AND FURTHER INFORMATION

What Isosorbide Mononitrate Tablets contain:

a) Each tablet contains:
Isosorbide Mononitrate 10mg
Excipients q.s.

b) Each tablet contains:
Isosorbide Mononitrate 20mg
Excipients q.s.

The other ingredients are lactose monohydrate, compressible sugar, sodium starch glycollate, magnesium stearate and colloidal silicon dioxide.

What Isosorbide Mononitrate Tablets look like and content of the pack

Isosorbide Mononitrate Tablets 10mg are white round tablets, Isosorbide Mononitrate Tablets 10mg/20mg are white round tablets, Pack sizes are 28, 50, 56, 60, 100 or 500 tablets. Not all pack sizes may be marketed.