QUININE SULPHATE

For oral administration. Swallow the tablets with a drink of water. For the treatment of malaria Adults, the elderly and children over 12 years of age: Two tablets to be taken every 8 hours for a period of 7 days.

Children under 12 years of age:

Dosage is dependent on bodyweight as follows – 10 mg/kg to be taken every 8 hours for a period of 7 days. For the treatment and prevention of nocturnal leg cramps Adults (including the elderly): The recommended dose is 200mg at bedtime.

The maximum dose is 300mg. A reduction in frequency of leg cramps may take up to 4 weeks to become apparent. Patients should be monitored closely during the early stages of treatment for adverse effects. After an initial trial of 4 weeks, treatment should be stopped if there is no benefit.

Treatment should be interrupted at approximately three monthly intervals to reassess the benefit of treatment.

Adverse drug reactions are ranked by frequency, the most frequent first, 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 < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

MedDRA system organ class Frequency Adverse reaction Blood and lymphatic system disorders Not Known Thrombocytopenia, intravascular coagulation, hypoprothrombinaemia, haemoglobinuria, haemolytic- uremic syndrome, pancytopenia, haemolysis, agranulocytosis, thrombocytopenic purpura Immune system disorders Not Known Eczematous dermatitis, oedema, erythema, lichen planus, generalised hypersensitivity reactions( angioneurotic oedema, asthma and fever, photosensitivity, hot and flushed skin, fever, pruritis, thrombocytopenic purpura and urticaria).

Metabolism and nutrition disorders Not Known Hypoglycaemia Psychiatric disorders Not Known Agitation, confusion Nervous system disorders Not Known Headache, vertigo, excitement, loss of consciousness, coma, death Eye disorders Not Known Blurred vision, defective colour perception, visual field constriction Ear and labyrinth Not Known Tinnitus, impaired hearing disorders Cardiac disorders Not Known Atrioventricular conduction disturbances, a fall in blood pressure coupled with a feeble pulse, prolongation of the QT interval, widening of the QRS complex and T wave flattening.

Respiratory, thoracic and mediastinal disorders Not Known Bronchospasm, dyspnoea Gastrointestinal disorders Not Known Nausea, vomiting, diarrhoea, abdominal pain* Skin and subcutaneous tissue disorders Not Known Flushing, rash, urticaria, eczematous dermatitis, oedema, erythema, lichen planus, pruritis, photosensitivity, Stevens- Johnson syndrome Musculoskeletal and connective tissue disorders Not Known Muscle weakness, aggravation of myasthenia gravis Renal and urinary disorders Not Known Renal insufficiency, acute renal failure (May be due to an immune mechanism or to circulatory failure), oliguria Pregnancy, puerperium and perinatal conditions Not Known Abortion** General disorders and administration site conditions Not Known Cinchonism*** * May occur after long term administration of quinine.

Cinochonism Administration of quinine may give rise to cinchonism, which is generally more severe in overdose, but may also occur in normal therapeutic doses. Patients should be warned not to exceed the prescribed dose, because of the possibility of serious, irreversible side effects in overdose.

Treatment for night cramps should be stopped if symptoms of cinchonism emerge. 9). Hypersensitivity Hypersensitivity to quinine may also occur with symptoms of cinchonism together with urticaria, flushing, pruritis, rash, fever, angioedema, dyspnoea and asthma.

Serious hypersensitivity reactions including Stevens-Johnson syndrome have been reported with quinine. Cardiac disorders Quinine has dose-dependent QT-prolonging effects. Caution is recommended in patients with conditions which predispose to QT-prolongation and in patients with atrioventricular block.

Caution is required if administered to patients with atrial fibrillation, heart block, other cardiac conduction defects or other serious heart disease. It may cause hypoprothrombinaemia and enhance the effects of anticoagulants. Quinine may cause severe respiratory distress and dysphagia in patients with myasthenia gravis and should not be used in such patients.

Glucose-6-Phosphate Dehydrogenase (G-6-PD) Deficiency Quinine has been implicated in precipitating blackwater fever when given for prolonged periods, although in some cases, glucose-6-phosphate dehydrogenase deficiency may have been involved.

Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at increased risk of haemolysis during quinine therapy and may develop acute haemolytic anaemia. 6). Treatment with quinine should be monitored in all patients in case signs of resistance develop.

8), should be carefully considered relative to the potential benefits. These risks are likely to be of particular concern in the elderly. Quinine should only be considered when cramps are very painful or frequent, when other treatable causes of cramp have been ruled out, and when non-pharmacological measures have not worked.

1. Contraindicated in those with myasthenia gravis, optic neuritis, tinnitus, haemolysis or haemoglobinuria. Quinine may cause severe respiratory distress and dysphagia in these patients. As quinine has been implicated in precipitating blackwater fever, it is generally contraindicated in patients who have already suffered an attack.