ISOSORBIDE DINITRATE

Posology Adults and elderly patients One or two tablets taken three or four times daily. Paediatric population The safety and efficacy of Isosorbide Dinitrate Tablets 20 mg has not yet been established in children. Method of administration For oral administration.

Headache, dizziness, fatigue, palpitations, orthostatic hypotension, and flushing may occur at the beginning of treatment. These reactions are usually controlled by lowering the dose; and tend to decline with time. Adverse reactions are listed below by system organ class and frequency.

Frequencies are defined as follows: 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), very rare (< 1/100,000), not known (cannot be estimated from the available data).

g. rash) which may sometimes be severe. Nervous system disorders Very common: headache. The incidence of headache diminishes gradually with time and continued use. Cardiac disorders Not known: hypoxaemia. 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. Vascular disorders Common: hypotension. At start of therapy or when the dosage is increased, hypotension and/or light-headedness on standing may occur.

These symptoms may be associated with dizziness, drowsiness, reflex tachycardia, and a feeling of weakness. Uncommon: flushing. Collapse may occur (sometimes accompanied by bradyarrhythmia and syncope). Severe hypotension may lead to enhanced angina symptoms.

Not known: severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration. Gastrointestinal disorders and administration site conditions Uncommon: nausea, vomiting Not known: a few reports of heartburn, most likely due to a nitrate induced sphincter relaxation have been recorded.

Skin and subcutaneous tissue disorders Very rare:

These tablets should be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition, angle closure glaucoma, severe hepatic or renal impairment. 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. Tolerance and cross-tolerance to other nitrates and nitrites may occur. This medicine contains lactose and sucrose. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, galactosaemia, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Hypersensitivity to the active substance, other nitrates or to any of the excipients. g. following a head trauma and including cerebral haemorrhage, marked anaemia, hypovolaemia. 5).