ISOSORBIDE MONONITRATE TABLETS 20 MG - patient leaflet, side effects, dosage

Patient leaflet - ISOSORBIDE MONONITRATE TABLETS 20 MG

Isosorbide Mononitrate 10mg, 20mg and 40mg tablets

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.

What is in this leaflet:

J What Isosorbide Mononitrate tablets are and what they are used for

What you need to know before you take Isosorbide Mononitrate tablets

_3l How to take Isosorbide Mononitrate tablets

Possible side effects

How to store Isosorbide Mononitrate tablets

Contents of the pack and other information

"H What Isosorbide Mononitrate tablets are and what they are used for Isosorbide Mononitrate belongs 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 may be used to: relieve the pain and frequency of angina attacks. help control certain types of heart failure.

What you need to know before you take Isosorbide Mononitrate tablets

Do not take Isosorbide Mononitrate tablets if you:

are allergic to isosorbide-5-mononitrate, isosorbide dinitrate or any of the other ingredients of this medicine (listed in section 6) have marked low blood pressure (systolic blood pressure 90 mmHg)
suffer from circulatory collapse or shock
suffer from cardiogenic shock
have had a heart attack
have been diagnosed with any of the following: – hypertrophic obstructive cardiomyopathy (a thickened heart muscle)
- constrictive pericarditis (an inflammation of the heart sac)
- cardiac tamponade (accumulation of fluid around the heart)
- low cardiac filling pressures
- aortic/mitral valve stenosis (narrowing of heart valves)

sufferfrom severe anaemia (low level of red blood cells)
sufferfrom closed angle glaucoma (high pressure in the eye)
suffer from conditions associated with raised pressure on the brain (e.g. following head trauma and cerebral haemorrhage)
sufferfrom severe hypovolaemia (decreased blood volume)
are taking sildenafil, vardenafil or tadalafil used in the treatment of male erectile dysfunction (when you cannot get an erection).

Warnings and precautions

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

suffer from hypothyroidism (your thyroid gland does not produce sufficient amounts of thyroid hormone)
suffer from malnutrition
have severe problems with your liver or kidneys
have low body temperature (hypothermia)
have recent history of myocardial infarction (heart attach
are already taking medicine to lower blood pressure
are taking any other medication
are pregnant or breast-feeding

Isosorbide Mononitrate tablets are used to stop angina attacks from happening. It is not intended to treat a sudden attack of angina. The lowest effective dose should be used. Do not stop taking Isosorbide Mononitrate tablets suddenly. It should be withdrawn gradually.

A low blood pressure caused by nitrates may occur with paradoxical bradycardia (slowing of the heart rate) and worsening of the symptoms of angina.

Taking Isosorbide Mononitrate tablets may cause transient hypoxaemia (an abnormally low level of oxygen in the blood). This happens because blood flow in your body is redistributed with an increase in perfusion of poorly ventilated areas of the lung.

This may cause ischaemia (not enough blood going to your heart muscle) if you have coronary heart disease.

Increasing doses and/or changes in intervals between doses can lead to this medicine not working with the effect that it should or not work at all.

Other medicines and Isosorbide Mononitrate tablets

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines:

other vasodilatators,
antihypertensives (medicines to treat high blood pressure) such as ACE-inhibitors, angiotensin- II-receptor antagonists, beta-blockers, calcium antagonists and diuretics,
neuroleptics (used to treat psychiatric disorders)
sapropterin (used to lower phenylalanine levels in the blood of patients with phenylketonuria)
alprostadil (for male erection problems)
aldesleukin (for cancer treatment)
sildenafil , tadalafil and vardenafil, used to treat male erection dysfunction. Treatments for erectile dysfunction can cause a severe and dangerous fall in blood pressure when taken together with Isosorbide Mononitrate tablets. This can be fatal.

Isosorbide Mononitrate tablets and alcohol

Do not to drink alcohol with this medicine as it may increase the blood pressure lowering effect of the tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine.

Driving and using machines

Isosorbide mononitrate tablets may make you feel dizzy or light headed. You may experience blurred vision. If you experience such symptoms you should not drive or operate machinery.

Isosorbide Mononitrate tablets contain lactose

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

"3

How to take Isosorbide Mononitrate tablets

Always take Isosorbide Mononitrate tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets with water after meals.

The recommended doses are:

Adults

Angina: Initially 20mg two or three times a day, then a maintenance dose of between 20–120mg a day.
Congestive heart failure: 20mg two or three times a day depending on your condition. Your doctor may also be treating you with other drugs.

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: Not recommended

If you take more Isosorbide Mononitrate tablets than you should

If you (or someone else) swallows a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include nausea, vomiting, restlessness, warm flushed skin, blurred vision, headache, fainting, tachycardia (a fast heartbeat), low blood pressure, strong or irregular heartbeat, bluish discoloration of the skin, shortness of breath, rapid shallow breathing and increased pressure within the skull.

If you forget to take Isosorbide Mononitrate tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Isosorbide Mononitrate tablets

You may feel unwell if you suddenly stop taking isosorbide mononitrate tablets. Do not stop taking the tablets without talking to your doctor and follow their advice.

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

_4

Possible side effects

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

Contact your doctor at once if you experience:

Uncommon (may affect up to 1 in 100 people)

Symptoms of an 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.

Continued top of next column

50989937 BBBA8209

Significant drop in blood pressure may lead to an increase in chest pain (exacerbation of angina pectoris symptoms), states of collapse, sometimes with bradyarrhythmias (slowing of the heartbeat)

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

Severe inflammatory skin disease (exfoliative dermatitis)

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

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

Particularly at the start of treatment, a temporary “nitrate headache” may occur which normally subsides after some days of continued treatment.

Common (may affect up to 1 in 10 people)

Low blood pressure (hypotension) and/or drop in blood pressure when standing up or move suddenly (postural hypotension), especially at the beginning of treatment, which may be accompanied by a fast heartbeat (tachycardia), slight states of dizziness or feeling weak
Gastro-intestinal symptoms (feeling or being sick), especially when first taken

Uncommon (may affect up to 1 in 100 people)

Syncope (fainting), skin flushing

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

Heartburn
Formation of methaemoglobin, in particular in susceptible patients (e.g. those with methaemoglobin reductase deficiency, diaphorase deficiency or abnormal haemoglobin structure), which can cause bluish discolouration of the skin, shortness of breath and rapid shallow breathing.
Low blood pressure causing feeling or being sick, restlessness, pale skin and excessive sweating

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

^1 how to store isosorbide mononitrate tablets

Keep this medicine out of the sight and reach of children.

Store below 25o C in a dry place.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. Do not throw away 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.

_6i contents of the pack and other information what isosorbide mononitrate tablets contain

The active substance is isosorbide mononitrate. Each tablet contains either 10mg, 20mg or 40mg of the active ingredient.
The other ingredients are crospovidone, lactose, magnesium stearate, maize starch, povidone and E460 —

What Isosorbide Mononitrate tablets look like and contents of the pack

Isosorbide Mononitrate tablets are white to off-white, circular, biconvex uncoated tablets impressed “C" on one face and on the reverse, the identifying letters “IO" (10mg), “IS" (20mg, on either side of division line), “IV" (40mg).

Pack sizes are 56 tablets

Marketing Authorisation holder and Manufacturer

Accord, Barnstaple, EX32 8NS, UK

This leaflet was last revised in June 2020