ISOKET RETARD

Posology Adults:

One tablet to be taken twice daily without chewing and with a sufficient amount of fluid. The second dose should be given 6 to 8 hours after the first dose. For patients with higher nitrate requirements the dose may be increased to one tablet three times daily, but ensuring a 12 hours treatment free interval every 24 hours.

Elderly population:

Clinical experience has not necessitated alternative advice for use in elderly patients.

Paediatric population:

The safety and efficacy of Isoket Retard has yet to be established. Method of administration For oral administration

Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100,<1/10), uncommon (≥1/1,000,<1/100), rare ≥1/10,000,<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). g. rash), flushing Very rare: angioedema, Stevens-Johnson- Syndrome 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.

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.

2) 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). 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).