Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Ethypharm, 194, Bureaux de la Colline – Bâtiment D, 92213 Saint-Cloud Cedex, France
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This product should not be given to patients with a known sensitivity to nitrates.
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.
Nyzamac SR Capsules 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.
Nyzamac SR Capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Nyzamac SR Capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency 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 Nyzamac SR Capsules (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.
Nyzamac SR Capsules should not be taken at the same time as alcohol. In vitro data suggests that in combination with Nyzamac SR Capsules, alcohol may increase the rate of in vivo release of the product from the prolonged release preparation. Alcohol may increase dose-dependent effects and lead to potential adverse pharmacodynamic interactions.
Alcohol use could therefore increase the rate and seriousness of isosorbide mononitrate adverse drug reactions such as vasodilatory related events.
There is no evidence of interaction with food.
The safety and efficacy of Nyzamac SR Capsules 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.
The safety and efficacy of Nyzamac SR Capsules 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.
The patient should be warned not to drive or operate machinery if hypotension or dizziness occurs. These effects may be increased by alcohol.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent.
The frequency of possible side effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1000), Not known (cannot be estimated from available data).
Very common:Headache1
Not Known: Restlessness, Somnolence, Pituitary haemorrhage
Rare: Tachycardia2, Paroxysmal bradycardia2
Vascular disorders
Common: Hypotension3, Light-headedness in the upright position (orthostatic hypotension) (may be associated with flushing, dizziness, drowsiness, tachycardia, feeling of weakness).
Uncommon: Collapse4
Not Known: Hypoxia
Uncommon: Nausea, Vomiting, Heartburn5
Not Known: Diarrhoea
Uncommon: Hyperhidrosis
Not Known: Pruritus, Exfoliative dermatitis, Allergic skin reaction (e.g. rash)
Not Known: Myalgia
Not Known: Asthenia
1 The incidence of headache usually disappears after 1-2 weeks of treatment. (see section 4.2)
2 These symptoms generally disappear during long-term treatment.
3 Severe hypotensive responses have been reported with organic nitrates with nausea, vomiting, restlessness, pallor, and excessive perspiration. Uncommonly, severe hypotension may lead to enhanced angina pectoris symptom (see section 4.4).
4 Sometimes accompanied by bradyarrhythmia, bradycardia and syncope.
5 Most likely due to a nitrate-induced sphincter relaxation.
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.
Not applicable.
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