ISOSORBIDE DINITRATE

Posology Adults • Angina: 30-120mg daily in divided doses according to individual requirements. Dosage should be gradually increased to minimise the possibility of nitrate headache and/or tolerance. • Congestive cardiac failure: In severe congestive cardiac failure doses of 40-160mg, daily in divided doses may be employed depending on individual requirements.

The optimum dosage is best determined by continuous haemodynamic monitoring. g. cardiac glycosides, diuretics). The maximum daily dose should not exceed 240mg in divided doses. Elderly • Dosage may be reduced in the elderly especially where there is impairment of renal or hepatic function.

Paediatric population • The safety and efficacy of isosorbide dinitrate has yet to be established in children. Method of Administration For oral administration

g. rash), flushing Very rare angioedema, Stevens-Johnson Syndrome Skin and subcutaneous tissue disorders Not known exfoliative dermatitis General disorders and administration site conditions Common asthenia Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration.

During treatment with these tablets, a temporary hypoxaemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Use with caution in patients with closed-angle glaucoma (increased intra-ocular pressure). These tablets should be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition, severe liver disease or renal disease.

Symptoms of circulatory collapse may arise after the first dose, particularly in patients with labile circulation. This product may give rise to symptoms of postural hypotension and syncope in some patients. g. in acute myocardial infarction, impaired left ventricular function (left ventricular failure).

• Reducing systolic blood-pressure below 90 mmHg must be avoided patients with aortic/mitral valve stenosis. Hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis, and diseases associated with raised intracranial pressure.

Treatment with these tablets must not be interrupted or stopped to take phosphodiestearase inhibitor products due to the increased risk of inducing an attack of angina pectoris. If these tablets are not taken as indicated, tolerance to the medication could develop.

Hypoxaemia Caution should be exercised in patients with hypoxaemia and ventilation/perfusion imbalance due to lung disease or ischaemic heart failure. As a potent vasodilator, ISDN could result in increased perfusion of poorly ventilated areas, worsening of the ventilation/perfusion imbalance, and a further decrease in the arterial partial pressure of oxygen.

5). Excipients This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. This product should not be given to patients with a known sensitivity to nitrates, very low blood pressure, acute myocardial infarction with low filling pressure, marked anaemia, head trauma, cerebral haemorrhage, acute circulatory failure, severe hypotension or hypovolaemia.

g. sildenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contraindicated. 5).