País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinine sulfate
A A H Pharmaceuticals Ltd
P01BC01
Quinine sulfate
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05040100; GTIN: 5012252102918
Dimension: 180 x 270 mm Front Side PACKAGE LEAFLET: INFORMATION FOR THE USER QUININE SULFATE 200 MG TABLETS [Quinine Sulfate] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, 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 leaflet. See section 4. 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 Quinine Sulfate is one of a group of medicines called antiprotozoal agents. Quinine Sulfate Tablets are used to: • Treat malaria • Treat and prevent nocturnal (night-time) leg cramps in adults and the elderly when sleep is regularly disturbed. 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) • Suffer from tinnitus (ringing or buzzing in the ears) • Have problems with your eyes or difficulty seeing • Suffer from inflammation of the optic nerve causing problems with your eye sight • Have blood in the urine (haemoglobinuria) • Suffer from a particular type of muscle weakness (myasthenia gravis). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Quinine Sulfate Tablets if you: • Are sensitive to Quinine. See section 4 for possible symptoms • Have had malaria for a long time Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinine Sulfate 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains quinine sulfate 200mg Excipient(s) with known effect Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. A white, biconvex film-coated tablet, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chloroquine resistant falciparum malaria in adults and children aged 5 years or older (and ≥ 20kg) 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 Treatment of chloroquine resistant falciparum malaria _Adults (including the elderly) and children aged 12 years and over:_ 600mg of quinine sulfate given every 8 hours for 7 days. The dose may depend upon the size of the patient, severity of infection, and evidence of renal or liver disease (when the intervals should be increased), due to a prolonged half-life of the drug. _Note _ If quinine resistance is known or suspected on completion of the course, additional treatment may be given. This may be one of the following: 1. doxycycline 200mg daily (as a single dose or in 2 divided doses) for at least 7 days. 2. clindamycin 300mg four times daily for 5 days. 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 the elderly): _ The recommended dose is 200mg at bedtime. 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 reass Leia o documento completo