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 Eumon 40 XL belongs to a group of medicines called anti-anginals (organic nitrates) and is used to prevent chest pain (angina pectoris). It works by opening up blood vessels and reducing the pain.
e Do not take Eumon 40 XL if:
• • • •
You have a low water content of the blood, which may cause an increase in pulse rate, low blood pressure, pale skin, feeling dizzy or faint and feeling very thirsty (hypovolaemia) You have a rapid increase in pressure in the eye, which can cause pain, red eye, blurred vision and headache (closed−angle glaucoma) You are taking viagra (sildenafil) for erectile dysfunction or other phosphodiesterase-5inhibitors e.g. tadalafil or vardenafil. (See "Other medicines and Eumon 40 XL" section) You are taking riociguat e.g. Adempas for pulmonary hypertension. (See "Other medicines and Eumon 40 XL" section)
Warnings and precautions Talk to your doctor before taking Eumon 40 XL:
Pregnancy This medicine should only be used during pregnancy if your doctor thinks the benefits outweigh the possible risks. Breast-feeding This medicine should only be used whilst breast-feeding if your doctor thinks the benefits outweigh the possible risks. Driving and using machines This medicine may make you feel dizzy, light−headed or cause blurred vision. If affected, do not drive or operate machinery. Eumon 40 XL 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.
Eumon 40 XL Always take Eumon 40 XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. • •
These tablets should be swallowed whole with half a glass of water These tablets should not be crushed or chewed
Adults
• •
It is important to keep taking Eumon 40 XL for as long as your doctor has told you to. Treatment with Eumon 40 XL should not be stopped suddenly. When stopping, your doctor will help you to reduce the dose and frequency gradually. This should be done over several days and you should be monitored by your doctor.
Like all medicines, Eumon 40 XL can cause side effects, although not everyone gets them. Seek medical advice immediately if you develop the following:
Eumon 40 XL
What Eumon 40 XL contains: Each modified release tablet contains 40mg of isosorbide mononitrate.
The other ingredients are: hypromellose, stearic acid, talc, silica colloidal anhydrous, lactose, carnauba wax, magnesium stearate, macrogol 4000, titanium dioxide (E171) and iron oxide (E172). What Eumon 40 XL look like and the contents of the pack: Eumon 40 XL are round, biconvex, cream coloured, modified release tablets with an approximate diameter of 8mm x 4.5mm, marked "IM40" on one side. Eumon 40 XL is available in: Eumon 40 XL modified release tablets are available in packs of 28, 30, 56, 60 or 100 tablets. Not all pack sizes may be marketed. Product Licence Number: PL 11311/0455 Marketing Authorisation Holder and Manufacturer: Tillomed Laboratories Limited 220 Butterfield, Great Marlings, Luton, LU2 8DL. United Kingdom This leaflet was last revised in September 2023 Till−Ver.12.2
Eumon 40 XL Modified Release Tablets (Isosorbide Mononitrate) 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 Eumon 40 XL Modified Release Tablets (Isosorbide Mononitrate) is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: Chemydur 60XL Tablets, 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 Eumon 40 XL Modified Release Tablets (Isosorbide Mononitrate), 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.
Prophylactic treatment of angina pectoris.
Posology
Adults
One tablet (40 mg) once daily given in the morning. The dose may be increased to two tablets (80 mg), the whole dose to be given together (dose range 30mg to 120mg.) The dose can be titrated to minimise the possibility of headache by initiating treatment with lesser dose for the first two to four days.
Paediatric population
The safety and efficacy of Eumon 40 XL modified release tablets has not been established.
Older people
No need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.
The lowest effective dose should be used.
Attenuation of effect (tolerance) has occurred in some patients being treated with sustained release preparations. In such patients intermittent therapy may be more appropriate (see section 4.4).
As with other drugs for the treatment of angina pectoris, therapy should not be discontinued suddenly, as may lead to exacerbation of symptoms. Both dosage and frequency should be tapered gradually over several days, and the patient carefully monitored (see section 4.4).
The core of the tablet is insoluble in the digestive juices but disintegrates into small particles when all the active substance has been released. Very occasionally the matrix may pass through the gastrointestinal tract without disintegrating and be found inside the stool, but all active substance has been released
Method of administration
The tablets should not be chewed or crushed and should be swallowed with half a glass of fluid.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe cerebrovascular insufficiency.
Phosphodiesterase type-5 inhibitors e.g sildenafil, tadalafil and vardenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated (see section 4.5).
Acute myocardial infarction with low filling pressures, acute circulatory failure (shock, vascular collapse) or very low blood pressure.
Hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, aortic/mitral valve stenosis, hypovolaemia closed-angle glaucoma, severe anaemia, conditions causing raised intracranial pressure e.g following head trauma, cerebral haemorrhage.
Eumon 40 XL should not be given to patients with a known sensitivity to nitrates.
Concomitant use with the soluble guanylate cyclase stimulator, riociguat, can cause hypotension and is contraindicated (see section 4.5).
Eumon 40 XL modified release tablets are not indicated for relief of acute anginal attacks. In the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
Caution should be exercised in patients suffering from hypothyroidism, malnutrition, severe renal or hepatic impairment, hypothermia and recent history of myocardial infarction.
The lowest effective dose should be used.
Attenuation of effect (tolerance) has occurred in some patients being treated with sustained release preparations (prolonged release). In such patients intermittent therapy may be more appropriate (see section 4.2).
Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see section 4.2).
The administration of Isosorbide mononitrate causes a decrease of ERPF (Effective
Renal Plasma Flow) in cirrhotic patients and should be used with caution.
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 concomitant consumption of alcohol.
Eumon 40XL tablets contain lactose, and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The hypotensive effects of nitrates are potentiated by concurrent administration of phosphodiesterase type-5 inhibitors (e.g. sildenafil) (see section 4.3). This might lead to life threatening cardiovascular complications.
Any medication which may cause hypotension may have its hypotensive effects potentiated by concurrent administration of Eumon 40 XL (e.g. beta-blockers, ACE-inhibitors, alcohol, vasodilators (hydralazine), alprostadil, aldesleukin, angiotensin II receptor antagonists, calcium channel blockers, antihypertensives and diuretics).
Reports suggest that concomitant administration of Isosorbide Mononitrate may increase the blood level of dihydroergotamine and its hypertensive effect.
Concomitant use with the soluble guanylate cyclase stimulator, riociguat, can cause hypotension and is contraindicated (see section 4.3).
Pregnancy
No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide mononitrate in pregnancy.The safety and efficacy of Eumon 40 XL modified release tablets during pregnancy 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 possible hazards
Breastfeeding
The safety and efficacy of Eumon 40 XL modified release tablets during lactation 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 possible hazards.
The patient should be warned not to drive or operate machinery if hypotension, blurred vision or dizziness occurs.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent.
Headache is very common (>10%). Throbbing headache may occur when treatment is initiated, but usually disappears after 1-2 weeks of treatment. Hypotension including postural hypotension, with symptoms such as dizziness, fatigue and nausea has occasionally been reported. Infrequently, flushing and allergic reactions (including rashes) can occur. These symptoms generally disappear during long-term treatment.
Severe hypotensive responses have been reported for organic nitrates and include vomiting, restlessness, pallor and excessive perspiration. Uncommonly, collapse may occur (sometimes accompanied by bradyarrhythmia, bradycardia and syncope).
Uncommonly severe hypotension may lead to enhanced angina symptoms.
Dizziness, nausea, tachycardia and paroxysmal bradycardia have been reported. There have been isolated reports of myalgia.
Drowsiness, diarrhoea or vomiting may occur. Cases of exfoliative dermatitis have been reported.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Treatment should be symptomatic. The main symptom is likely to be hypotension.
Symptoms: Headache, excitation, cold perspiration, vertigo, nausea, vomiting, restlessness, warm flushed skin, blurred vision, fainting, tachycardia, hypotension and palpitations. 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, raised intracranial pressure).
Management:
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 (intravenous fluids should be administrated and ionotropes considered.). Other measures as indicated by the patient's clinical condition.
If methaemoglobinaemia occurs, 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.
If severe hypotension persists despite the above measures consider use of inotropes such as dopamine or dobutamine.
Ask anything about Eumon 40 XL Modified Release Tablets (Isosorbide Mononitrate). 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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