Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinine sulfate
Bristol Laboratories Ltd
P01BC01
Quinine sulfate
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05040100; GTIN: 5060013940682 5060013940309
PACKAGE LEAFLET: INFORMATION FOR THE USER QUININE SULFATE 300MG 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 or pharmacist. 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 The name of your medicine is Quinine Sulfate tablets BP 300mg. The active ingredient is Quinine Sulfate. Quinine Sulfate belongs to a group of medicines called anti- protozoal agents and they are used to treat: • malaria • and prevent night cramps in adults and the elderly when sleep is regularly disrupted. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULFATE TABLETS DO NOT TAKE Quinine Sulfate tablets and tell your doctor if you have: • an allergy to quinine (including that in tonic waters or other beverages), quinoline or any of the other ingredients of this medicine (listed in section 6) • BLOOD IN YOUR URINE • RINGING IN YOUR EARS • suffer from muscle weakness (MYASTHENIA GRAVIS) • problems with your EYES or difficulty seeing • been told you have a disorder affecting the red blood cells (HAEMOLYSIS) WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST before taking Quinine Sulfate tablets if you: • have IRREGULAR HEART BEATS or other HEART DISEASE • have had MALARIA for a long time • Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinine Sulfate Tablets BP 300 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of Quinine Sulfate. Excipients of known effect: Also contains 34mg of lactose and 156mg of sucrose. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Tablet White, bi-convex, sugar coated tablets 4.1. THERAPEUTIC INDICATIONS 1) Treatment of falciparum (malignant tertian) malaria. 2) 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 (MALIGNANT TERTIAN) MALARIA _ _ _ _Adults (including the elderly) and children aged 12 years and over:_ Two tablets (600 mg) to be taken every 8 hours for a period of 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. 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. _Children aged 10-12 years_: Dosage is dependent on bodyweight as follows- 10 mg/kg to be taken every 8 hours for a period of 7 days. _Children under 10 years:_ Not recommended _FOR THE TREATMENT AND PREVENTION OF NOCTURNAL LEG CRAMPS: _ _Adults (including 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 Prečítajte si celý dokument