Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
QUININE SULFATE
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
P01BC01
QUININE SULFATE 300 mg
COATED TABLET
QUININE SULFATE 300 mg
POM
ANTIPROTOZOALS
Withdrawn
2006-11-15
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text WHAT IS IN THIS LEAFLET 1. What Quinine Sulfate Tablets are and what they are used for 2. What you need to know before you take Quinine Sulfate Tablets 3. How to take Quinine Sulfate Tablets 4. Possible side effects 5. How to store Quinine Sulfate Tablets 6. Contents of the pack and other information 1. WHAT QUININE SULFATE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Quinine Sulfate 300mg Coated Tablets. Quinine Sulfate Tablets contain the anti-malarial drug quinine sulfate and are used to treat a type of malaria known as falciparum malaria (malignant malaria). Malaria is a disease caused by infection with a malaria parasite. This is carried by mosquitoes, which flourish in tropical and subtropical countries. Human beings become infected as a result of being bitten by malaria carrying mosquitoes. Quinine sulfate has a relaxant action on skeletal muscle. Your doctor may have prescribed this medicine for the treatment of night leg cramps. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULFATE TABLETS DO NOT TAKE QUININE SULFATE TABLETS: • if you are allergic to quinine or any of the other ingredients of this medicine (listed in section 6) • if you have problems with your eye sight • if you suffer from tinnitus (ringing noises in the ear) • if you have blood in the urine (or have had during a previous attack of malaria) • if you have been told you have haemolysis (a disorder affecting the red blood cells) • if you suffer from myasthenia gravis (a disease characterised by weakness of certain groups of muscles) • if you are pregnant or breast-feeding, unless the benefits outweigh the risks WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Quinine Sulfate Tablets, if you suffer from, or have ever had: • an enzyme deficiency, called glucose-6-phosphate dehydrogenase deficiency • your doctor has told you that you have Læs hele dokumentet
_ _ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinine Sulfate 300mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Quinine Sulfate 300mg Excipients with known effect Lactose and methyl hydroxyl benzoate (E218) For the full list of excipients see 6.1 3 PHARMACEUTICAL FORM Coated tablet for oral use. White, biconvex, sugar-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of falciparum malaria. Treatment and prevention of nocturnal leg cramps in adults and the elderly, when cramps cause regular disruption of sleep (see section 4.2 and Section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 _ _ Page 2 of 8 _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. 4.3 CONTRAINDICATIONS Quinine is contraindicated in patients with a history of hypersensitivity to the active substance or any of the excipients listed in section 6.1, 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Before use for nocturnal Læs hele dokumentet