| Updates to sections 4.2, 4.3, 4.4, 4.5 and 4.8 in line with current medical knowledge below in bold. Also change date in section 10.
4.2
There is a risk of tolerance developing to sustained release preparations. In such patients intermittent therapy may be more appropriate.
4.3
Hypersensitivity to Isosorbide Mononitrate or to any of the excipients.
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.
Phosphodiesterase type-5 inhibitors (e.g. sildenafil) have been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.
Severe cerebrovascular insufficiency or hypotension are contra-indications to use.
4.4
The lowest effective dose should be used.
There is a risk of tolerance developing to sustained 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).
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.
Isosorbide mononitrate modified release 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 ERPF (Effective Renal Plasma Flow) 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.
Chemydur 60XL 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.
4.5
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 (e.g. alcohol, vasodilators, 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.
4.8
Most of the adverse reactions are pharmacodynamically mediated and dose dependent.
Headache is very common (>10%). The incidence of headache usually disappears after 1-2 weeks of treatment. (See section 4.2)
Flushing, dizziness, postural hypotension, tachycardia and paradoxical bradycardia have been reported. These symptoms generally disappear during long-term treatment.
Severe hypotensive responses have been reported for organic nitrates and include nausea, 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.
Allergic skin reaction, pruritus, myalgia and, drowsiness, diarrhoea or vomiting may occur.
Cases of exfoliative dermatitis have been reported.
10.
August 2010
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