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 The name of your medicine is Chemydur 60XL Tablets. The active ingredient is isosorbide-5mononitrate. Chemydur 60XL Tablets belong to a group of medicines called nitrates. Chemydur 60XL Tablets are used in adults to prevent angina (chest pain) and work by opening up blood vessels and reducing the pain.
E CHEMYDUR 60XL TABLETS Do not take Chemydur 60XL Tablets if you:
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 Chemydur 60XL Tablets during pregnancy or whilst breast-feeding has not been established. Driving and using machines You can drive while taking Chemydur 60XL Tablets but do not drive until you know how the tablets 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. Chemydur 60XL Tablets contain 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.
CHEMYDUR 60XL TABLETS Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The recommended dose for adults is 1 or 2 tablets a day, taken in the morning. A dose of half a tablet may be prescribed for the first 2-4 days. The tablets should be swallowed with half a glass of water. Do not crush or chew the tablets. If Chemydur 60XL Tablets are taken frequently and for long periods the effectiveness of the drug may decrease. If you notice that your tablets are no longer working as well at relieving the pain as they have done before, consult your doctor. If you take more Chemydur 60XL Tablets than you should If you take more Chemydur 60XL than you should, contact your doctor or nearest hospital emergency department immediately. Take this leaflet and any remaining tablets 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 unconciousness. If you forget to take Chemydur 60XL Tablets If you forget to take a dose, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Chemydur 60XL Tablets Ask your doctor before stopping treatment with Chemydur 60XL, as treatment should be reduced gradually over several days and you must be monitored carefully by your doctor. If you have further questions on the use of this medicine, as your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS Like all medicines, Chemydur 60XL Tablets can cause side effects, although not everyone gets them. Very common: (may affect more than 1 in 10 people)
not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine. If Chemydur 60XL Tablets are taken frequently and for long periods the effectiveness of the drug may decrease. If you notice that your tablets are no longer working as well at relieving the pain as they have done before, consult your doctor.
CHEMYDUR 60XL TABLETS Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Store your medicine in a dry place below 25°C. Keep it out of direct sunlight.
What Chemydur 60XL Tablets contains Each tablet contains 60 mg of the active substance isosorbide-5-mononitrate. The other ingredients are: Polyethylene glycol 4000, hydroxypropyl methylcellulose, stearic acid, talc, purified siliceous earth, lactose, carnauba wax, magnesium stearate and the colourings titanium dioxide (E171) and yellow iron oxide (E172). What Chemydur 60XL Tablets looks like and contents of the pack Chemydur 60XL Tablets are oval, cream-coloured tablets with a score line on both sides and a crown and `60` on one side. They are packaged in blister packs of 28, 30, 56, 60 and 100 tablets. Not all packs sizes may be marketed. Marketing Authorisation Holder: Amdipharm UK Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer: Aesica Queenborough Ltd, North Road, Queenborough, ME11 5EL, United Kingdom Chemydur is a registered trademark of Amdipharm mercury international Limited. This leaflet was last revised in January 2024.
Chemydur 60XL Tablets comes as tablet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Chemydur 60XL Tablets is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: Eumon 40 XL Modified Release Tablets (Isosorbide Mononitrate), Tardisc XL 60 Prolonged Release Tablets, Xismox 60 XL Prolonged Release Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Chemydur 60XL Tablets, 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.
Chemydur 60XL Tablets/Mitrate 60XL Tablets are indicated in adults for the prophylactic treatment of angina pectoris
Posology
Adults
One tablet (60 mg) once daily given in the morning. The dose may be increased to two tablets (120 mg), to be taken together.
The dose can be titrated to minimise the possibility of headache by initiating treatment with half a tablet (30 mg) for the first two to four days.
The tablets should not be chewed or crushed and should be swallowed with half a glass of fluid.
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 modified release preparations. In such patients intermittent therapy may be more appropriate.
As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing long-term treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored (see section 4.4).
Paediatric population
The safety and efficacy of Chemydur 60XL Tablets/Mitrate 60XL Tablets in children have not yet been established.
Method of administration
Oral.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
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.
Chemydur 60XL Tablets/Mitrate 60XL Tablets 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.
Chemydur 60XL Tablets/Mitrate 60XL Tablets contain lactose:
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 Chemydur 60XL Tablets//Mitrate 60XL Tablets (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.
Pregnancy
The safety and efficacy of Chemydur 60XL Tablets/Mitrate 60XL Tablets 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 Chemydur 60XL Tablets/Mitrate 60XL Tablets 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.
Fertility
Not available.
The patient should be warned not to drive or operate machinery if hypotension or dizziness occurs.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent.
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: the most frequent first, using the following convention:
Very common: (≥ 1/10),
Not known: cannot be estimated from the available data.
System organ class
Frequency
Adverse reactions
Immune system disorders
Not known
Allergic dermatitis, exfoliative dermatitis.
Nervous system disorders
Very common
Headache. The incidence of headache usually disappears after 1-2 weeks of treatment. (see section 4.2)
Not known
Restlessness, somnolence, pituitary haemorrhage.
Cardiac disorders
Not known
Tachycardia, bradycardia - these symptoms generally disappear during long-term treatment.
Vascular disorders
Not known
Flushing, dizziness, orthostatic hypotension - these symptoms generally disappear during long-term treatment. Pallor. Circulatory collapse (sometimes accompanied by bradyarrhythmia, bradycardia and syncope). Severe hypotension may lead to enhanced angina pectoris symptoms.
Respiratory, thoracic and mediastinal disorders
Not known
Hypoxia.
Gastrointestinal disorders
Not known
Nausea, vomiting, diarrhoea
Musculoskeletal and connective tissue disorders
Not known
Myalgia.
General disorders and administration site conditions
Not known
Asthenia.
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 (Website: www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
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.
Ask anything about Chemydur 60XL Tablets. 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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