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 MONOSORB XL 60mg Prolonged release Tablets (referred to as MONOSORB XL 60mg throughout this leaflet) contains the active substance called isosorbide mononitrate. This belongs to a group of medicines called 'nitrates'.
E MONOSORB XL 60mg DO NOT use these tablets to treat sudden chest pain (acute angina). Instead seek immediate medical attention. These tablets work too slowly to treat this and are only used to prevent symptoms of angina from happening. Do not take MONOSORB XL 60mg:
patients with acute myocardial infarction with low filling pressure, head trauma, cerebral haemorrhage and severe hypotension or hypovolaemia. Do not take Monosorb XL 60mg if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Monosorb XL 60mg. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Monosorb XL 60mg:
MONOSORB XL 60mg contains lactose and sucrose If you have been told by your doctor that you have intolerance to one of more sugars, contact your doctor before taking this medicinal product.
Hypotension with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment.
MONOSORB XL 60 mg 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.
Common (may affect up to 1 in 10 people)
Taking this medicine
Like all medicines, this medicine can cause side effects, although not everybody gets them. Headache may occur when treatment is initiated but usually disappears after 1-2 weeks of treatment.
Other possible side effects:
Uncommon (may affect up to 1 in 100 people)
MONOSORB XL 60 mg
What MONOSORB XL 60 mg contains
Monosorb XL 60mg Prolonged-Release Tablets comes as tablet containing 60mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Monosorb XL 60mg Prolonged-Release Tablets is isosorbide mononitrate.
Medicines with the same active substance, strength and form include: Carmil XL 60 mg Tablets, Imdur Tablets 60mg, Isotard 60 mg XL Tablets. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Monosorb XL 60mg Prolonged-Release 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.
Prophylactic treatment of angina pectoris.
Posology
Adults
Monosorb 60mg Tablets (one tablet) once daily given in the morning. The dose may be increased to 120mg (two tablets) daily, both to be taken once daily in the morning. This will produce effective nitrate blood levels during the day with low blood levels at night to prevent the development of tolerance. The dose can be titrated to minimize the possibility of headache, by initiating treatment with 30mg (half a tablet) for the first 2-4 days.
Paediatric population
The safety and efficacy of Monosorb XL 60mg Tablets in children has not yet been established.
Elderly
No evidence of a 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.
There is a risk of tolerance developing when nitrate therapy is given. For this reason it is important that Monosorb XL 60mg tablets are taken once a day to achieve an interval with low nitrate concentration, thereby reducing the risk of tolerance development.
When necessary the product may be used in combination with beta-adrenoreceptor blockers and calcium antagonists. Dose adjustments of either class of agent may be necessary.
Method of administration
Monosorb XL 60mg Tablets must not be chewed or crushed. They should be swallowed with half a glass of water.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Acute myocardial infarction with low filling pressure, head trauma, cerebral haemorrhage, severe hypotension or hypovolaemia
Constrictive cardiomyophaty and pericarditis, aortic stenosis, cardiac temponade, mitral stenosis and severe anaemia.
Patients treated with Monosorb XL 60mg Tablets must not be given Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil).
Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of Monosorb XL 60mg Tablets.
Monosorb XL 60mg Tablets is not indicated for relief of accute angina attacks; in the event of accute attack, sublingual or buccal glyceril trinitrate tablets should be used.
Nitrates may give rise to symptoms of collapse after the first dose in patients with labile circulation. These symptoms can largely be avoided if the treatment is started with a 30 mg dose.
Other special warnings and precautions with Isosorbide mononitrate:
Hypoxaemia, Hypothyroidism, Hypothermia, Malnutrition, severe liver or renal disease.
Patients with rare hereditary problems of fructose intolerance or galactose intolerance, total lactase deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medicine.
Isosorbide mononitrate may act as a physiological antagonist to noradrenaline, acetylcholine, histamine and many other agents. The effect of anti-hypertensive drugs may be enhanced. Alcohol may enhance the hypotensive effects of isosorbide mononitrate.
Concomitant administration of Monosorb XL 60mg Tablets and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of Monosorb XL 60mg Tablets with the potential result of serious side effects such as syncope or myocardial infacrction. Therefore, Monosorb XL 60mg Tablets and Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil) must not be given concomitantly.
The safety and efficacy of Isosorbide Mononitrate Tablets during pregnancy or lactation has not been established. Monosorb XL 60mg should not be used during pregnancy and lactation.
Patients may develop headache or dizziness when first using Monosorb XL 60mg Tablets. Patients should be advised to determine how they react to Monosorb XL 60mg Tablets before they drive or use machinery.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent.
Headache may occur when treatment is initiated but usually disappears after 1-2 weeks of treatment. The dose can be titrated to minimize the possibility of headache, by initiating treatment with 30mg. Hypotension with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment.
The following definitions of frequencies are used: 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) and very rare (<1/10,000).
Adverse drug reactions by frequency and system organ class (SOC)
System Organ Class
Frequency
Reaction
Nervous system disorders
Common
Headache, dizziness
Rare
Fainting
Cardiac and vascular disorders
Common
Hypotension, tachycardia
Gastrointestinal disorders
Common
Nausea
Uncommon
Vomiting, diarrhoea
Skin and subcutaneous tissue disorders
Rare
Rash, pruritus
Musculoskeletal and connective tissue disorders
Very rare
Myalgia
Reporting side effects
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 Yellow Card SchemeWebsite: 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. Very large doses may give rise to methaemoglobinaemia (Very rare).
Treatment: In cases of cyanosis as a result of methaemoglobinaemia, methyl thionine (methylene blue) 1-2mg/Kg, slow intravenous delivery.
Management
Induction of emesis, activated charcoal. In case of pronounced hypothension the patient should first be placed in the supine position with legs raised. If necessary fluids should be administrated intravenously.
Ask anything about Monosorb XL 60mg Prolonged-Release 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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