Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Isosorbide mononitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
e Isosorbide Mononitrate Tablets Do not take Isosorbide Mononitrate Tablets if:
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.
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
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Isosorbide Mononitrate Tablets
Isosorbide Mononitrate Tablets 10 mg comes as tablet containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Isosorbide Mononitrate Tablets 10 mg is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: ISMO 10, 10 mg, tablets, Isosorbide Mononitrate 10 mg Tablet. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Isosorbide Mononitrate Tablets 10 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Isosorbide Mononitrate Tablets is indicated for the prophylaxis of angina pectoris.
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 20 mg twice a day.
The maintenance dose in individual patients is usually between 20- 120 mg 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 10 mg 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.
Isosorbide Mononitrate Tablets 10 mg 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 10 mg 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 10 mg.
Co-administration with riociguat (see section 4.5).
Isosorbide Mononitrate Tablets 10 mg 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).
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.
The use of isosorbide mononitrate with riociguat, a stimulator of soluble guanylate cyclase, is contra-indicated (see section 4.3), since concomitant use can cause hypotension.
The safety and efficacy of Isosorbide Mononitrate Tablets during pregnancy or lactation has not been established.
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.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Ask anything about Isosorbide Mononitrate Tablets 10 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.