Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinine sulfate
Strides Pharma UK Ltd
P01BC01
Quinine sulfate
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05040100; GTIN: 5031676004554
180 X 230 MM FRONT SIDE PACKAGE LEAFLET: INFORMATION FOR THE USER QUININE SULFATE TABLETS 300 MG [Quinine Sulfate] READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. You may need to read it again. • If you have any further questions, ask your doctor, or pharmacist or nurse • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leafl et. See section 4. WHAT IS IN THIS LEAFL ET: 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 Quinine Sulfate is one of a group of medicines called anti- protozoal agents. Quinine Sulfate Tablets are used to: • Treat malaria. • Treat and prevent nocturnal (night-time) leg cramps in adults and the elderly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULFATE TABLETS DO NOT TAKE QUININE SULFATE IF YOU: • Are allergic to quinine or any other ingredients of this medicine (Listed in section 6). • Have problems with your eyes or diffi culty seeing. • Suffer from tinnitus (ringing or buzzing in the ears). • Have blood in the urine (haemoglobinuria). • Suffer from muscle weakness (myasthenia gravis). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Quinine Sulfate Tablets if you: • Are sensitive to Quinine. See section 4 for possible symptoms. • Have had malaria for a long time. • Have irregular heartbeats or other heart disease. • Have conduction defects of the heart (this is where the heart cannot conduct electrical sign Lire le document complet
1. NAME OF THE MEDICINAL PRODUCT Quinine Sulfate Tablets BP 300mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains quinine sulfate 300mg Lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex, film coated tablets marked “3” on one side and plain on the other side. 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 For falciparum malaria Adults: the adult dosage regimen by mouth is 600mg of quinine sulfate given every 8 hours for 7 days. The elderly: as for adults Children: the dosage regimen for children by mouth is 10mg of quinine sulfate per kg body weight given every 8 hours for 7 days. Note If quinine resistance is known or suspected in the patient, then supplementary treatment with another recommended antimalarial drug is necessary. If part or all of the dose is vomited within 1 hour of administration, then the same amount must be administered immediately. For the treatment and prevention of nocturnal leg cramps: Adults (including elderly): The recommended dose is 300mg at bedtime. 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. 4.3 CONTRAINDICATIONS -Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. -Optic neuritis -Tinnitus -Myasthenia gravis, quinine may cause severe respiratory distress and dysphagia in these patients -Haemoglobinuria 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Cinchonism Administration of quinine may g Lire le document complet