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 dinitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Isosorbide Dinitrate Tablets contain isosorbide dinitrate which is a nitrate vasodilator. Nitrate vasodilators cause the blood vessels to widen which helps the heart to pump blood through the blood vessels. They may also improve blood supply to the heart itself. They are used to:
e Isosorbide Dinitrate Tablets
Do not take Isosorbide Dinitrate Tablets:
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Warnings and precautions Talk to your doctor before taking Isosorbide Dinitrate Tablets:
Isosorbide Dinitrate Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets whole with water. The recommended dose is 1 or 2 tablets three or four times daily. Take at the times directed by your doctor or pharmacist, to allow a "nitrate free" period (usually when you are sleeping) when no tablets are taken. This is to prevent your tablets from becoming less effective. 2
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Use in children This medicine is not suitable for children. If you take more Isosorbide Dinitrate Tablets than you should Do not take more Isosorbide Dinitrate Tablets than you should, If you accidentally take more tablets than you should, you may feel very drowsy or faint. If this happens it could mean your blood pressure is low; lie down and raise your legs. 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take your tablets pack and any remaining tablets with you so that people can see what you have taken. 3. Do this even if you feel well. If you forget to take Isosorbide Dinitrate Tablets If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a missed dose. If you stop taking Isosorbide Dinitrate Tablets Do not stop taking these tablets, or lower the dose, without first checking with your doctor. Keep taking your tablets until the doctor tells you to stop. Do not let yourself run out of medicine especially over the weekend or on holidays. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.
Like all medicines, this product can cause side effects, although not everybody gets them. STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions:
severe itching of the skin, with a red rash or raised lumps blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin.
Seek immediate medical attention if you have any of the following symptoms:
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flushing nausea or vomiting
Other side effects (unknown frequency)
Isosorbide Dinitrate Tablets
Keep this medicine out of sight and reach of children. Do not take after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. 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. 6.
What Isosorbide Dinitrate Tablets contains
Isosorbide Dinitrate Tablets 10 mg are white round tablets marked 'IDN 10' on one side. Isosorbide Dinitrate Tablets 20 mg are white round tablets marked 'IDN 20" on one side.
They are available in white or grey plastic containers of 30, 56, 60, 90, 100, 120, 180 and 240 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd, trading as Essential Generics, 8a Crabtree Road, Egham, Surrey TW20 8RN. Manufacturer Lelypharma B.V., Zuiveringweg 42, 8243 PZ Lelystad, the Netherlands. This leaflet was last revised in July 2024
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Isosorbide Dinitrate Tablets 20 mg comes as tablet containing 20mg. 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 Dinitrate Tablets 20 mg is isosorbide dinitrate.
Medicines with the same active substance, strength and form include: Isoket Retard 20mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Isosorbide Dinitrate Tablets 20 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.
Prophylaxis of angina pectoris; congestive cardiac failure.
Posology
Adults and elderly patients
One or two tablets taken three or four times daily.
Paediatric population
The safety and efficacy of Isosorbide Dinitrate Tablets 20 mg has not yet been established in children. .
Method of administration
For oral administration.
Hypersensitivity to the active substance, other nitrates or to any of the excipients.
Acute myocardial infarction with low filling pressures, acute circulatory failure (shock, vascular collapse), severe hypotension, hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and disease associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage, marked anaemia, hypovolaemia.
Phosphodiesterase inhibitors (e.g.sildenafil, tadalafil and vardenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contraindicated.
These tablets should be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition, angle closure glaucoma, severe hepatic or renal impairment.
Symptoms of circulatory collapse may arise after the first dose, particularly in patients with labile circulation.
This product may give rise to symptoms of postural hypotension and syncope in some patients.
Tolerance and cross-tolerance to other nitrates and nitrites may occur.
This medicine contains lactose and sucrose. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, galactosaemia, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The hypotensive effects of nitrates are potentiated by concurrent administration of phosphodiestearase inhibitors (e.g. sildenafil, tadalafil and vardenafil). This might lead to life threatening cardiovascular complications. Concurrent use is contraindicated (see Section 4.3).
Concurrent intake of drugs with blood pressure lowering properties e.g. betablockers, calcium antagonists, vasodilators, alprostadil, aldesleukin, angiotensin II receptor antagonists etc. and/or alcohol may potentiate the hypotensive effect of the tablets. This may also occur with neuroleptics and tricyclic antidepressants.
Symptoms of circulatory collapse can arise in patients already taking ACE inhibitors. Nitrate preparations can act as physiological antagonists to noradrenaline, acetylcholine, histamine and other agents.
Pregnancy and breast-feeding
Safety in pregnancy has not been established for isosorbide dinitrate. There is data that nitrates are excreted in breast milk and may cause methemoglobinemia in infants. Therefore, Isosorbide Dinitrate Tablets 20 mg should only be used in pregnancy and during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.
Breast-feeding
The extent of excretion of isosorbide dinitrate in human breast milk has not been determined. Therefore, caution should be exercised when administered to nursing women.
Fertililty
No data on effects of fertility are available.
Isosorbide Dinitrate Tablets 20 mg has minor influence on the ability to drive and use machines. Headache, tiredness and dizziness may occur. Patients are advised not to drive or operate machinery if so affected.
Headache, dizziness, fatigue, palpitations, orthostatic hypotension, and flushing may occur at the beginning of treatment. These reactions are usually controlled by lowering the dose; and tend to decline with time.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/100,000), not known (cannot be estimated from the available data).
Immune system disorders
Uncommon: allergic skin reaction (e.g. rash) which may sometimes be severe.
Nervous system disorders
Very common: headache. The incidence of headache diminishes gradually with time and continued use.
Cardiac disorders
Not known: hypoxaemia. During treatment with these tablets, a temporary hypoxaemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia.
Vascular disorders
Common: hypotension. At start of therapy or when the dosage is increased, hypotension and/or light-headedness on standing may occur. These symptoms may be associated with dizziness, drowsiness, reflex tachycardia, and a feeling of weakness.
Uncommon: flushing.
Collapse may occur (sometimes accompanied by bradyarrhythmia and syncope).
Severe hypotension may lead to enhanced angina symptoms.
Not known: severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration.
Gastrointestinal disorders and administration site conditions
Uncommon: nausea, vomiting
Not known: a few reports of heartburn, most likely due to a nitrate induced sphincter relaxation have been recorded.
Skin and subcutaneous tissue disorders
Very rare: Stevens-Johnson syndrome, angioedema
Not known: exfoliative dermatitis.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose should be treated symptomatically. Symptoms of hypotension may be treated by elevation of the legs.
If large numbers of tablets have recently been swallowed, gastric lavage may be employed.
Ask anything about Isosorbide Dinitrate Tablets 20 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.
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