QUININE SULFATE

Posology For the treatment of falciparum malaria Adults 600mg (two tablets) every eight hours for seven days. Paediatric population Children:10mg/kg bodyweight every eight hours for seven days. For the treatment and prevention of nocturnal leg cramps Adults (including elderly) The recommended dose is 200mg at bedtime.

The maximum dose is 300mg.

Paediatric population Children under ten years:

Not recommended 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. Method of administration For oral use.

MedDRA system organ class Adverse Reaction Blood and lymphatic system disorders Thrombocytopenia, intravascular coagulation, hypoprothrombinaemia, haemoglobinuria, oliguria, haemolytic-uremic syndrome, pancytopenia, haemolysis, agranulocytosis, thrombocytopenic purpura Immune system disorders Generalised hypersensitivity reactions including angioneurotic oedema and fever Metabolism and nutrition disorders Hypoglycaemia Psychiatric disorders Agitation, confusion Nervous system disorders Headache, vertigo Eye disorders Blurred vision, defective colour perception, visual field constriction Ear and labyrinth disorders Tinnitus, impaired hearing Cardiac disorders Atrioventricular conduction disturbances, hypotension, prolongation of the QT interval, widening of the QRS complex and T wave flattening Respiratory, thoracic and mediastinal disorders Bronchospasm Gastrointestinal disorders Nausea, vomiting, diarrhoea, abdominal pain Skin and subcutaneous tissue disorders Flushing, rash, urticaria, eczematous dermatitis, oedema, erythema, lichen planus, pruritis, photosensitivity Musculoskeletal and connective tissue disorders Muscle weakness, aggravation of myasthenia gravis Renal and urinary disorders Renal insufficiency, acute renal failure 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.

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.

6). Quinine may cause unpredictable serious and life-threatening thrombocytopenia, which is thought to be an idiosyncratic hypersensitivity reaction. Quinine should not be prescribed or administered to patients who have previously experienced any adverse reaction to quinine, including that in tonic water or other beverages.

Patients should be instructed to stop treatment and consult a physician if signs of thrombocytopenia such as unexplained bruising or bleeding occur. 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.

Quinine should be used with caution in patients with atrial fibrillation, heart block, other cardiac conduction defects, or other serious heart disease. Quinine may cause hypoprothrombinaemia and enhance the effects of anticoagulants.

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 deficiency may be at increased risk of haemolysis during quinine therapy and may develop acute haemolytic anaemia.

Patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption should not take this medicine. Administration of quinine may give rise to cinchonism, which is generally more severe in overdose, but may also occur in normal therapeutic doses.

1, in tinnitus or optic neuritis, in myasthenia gravis and in the presence of haemolysis or haemoglobinuria. As quinine has been implicated in precipitating blackwater fever, it is generally contraindicated in patients who have already suffered an attack.