Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinine sulfate
Kent Pharma (UK) Ltd
P01BC01
Quinine sulfate
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05040100
PATIENT INFORMATION LEAFLET QUININE SULFATE 300MG TABLETS 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 or pharmacist. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section-4. IN THIS LEAFLET: 1. What Quinine Sulfate is and what it is used for 2. What you need to know before you take Quinine Sulfate 3. How to take Quinine Sulfate 4. Possible side effects 5. How to store Quinine Sulfate 6. Contents of the pack and other information 1. WHAT QUININE SULFATE IS AND WHAT IT IS USED FOR Quinine Sulfate belongs to a group of medicines called anti-protozoal agents and they are used to treat: x malaria x 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 DO NOT TAKE QUININE SULFATE IF YOU: x are ALLERGIC (hypersensitive) to QUININE or any of the other ingredients of this medicine (listed in section 6) x have HAEMOLYTIC ANAEMIA (tiredness caused by the destruction of red blood cells) x have TINNITUS (ringing sound in the ears) x have OPTIC NEURITIS (loss of vision or difficulty seeing) x have HAEMOGLOBINURIA (high concentration of haemoglobin in urine) x have MYASTHENIA GRAVIS (suffer from muscle weakness) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking these tablets if you: x have irregular HEARTBEATS or other heart problems x have conduction defects of the heart (this is where the heart cannot conduct electrical signals properly) x have blood in your URINE x suffer from KIDNEY OR LIVER problems x have had MALARIA for a long time x suffer from glucose-6-phosphate dehydrogenase Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinine Sulfate Tablets 300mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains 300mg Quinine Sulfate. Also contains lactose and sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Sugar coated tablets White, round, biconvex sugar coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS a) Treatment of uncomplicated attacks of falciparum malaria due to chloroquine or multi-drug resistant strains. b) 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 TREATMENT OF UNCOMPLICATED (FALCIPARUM) MALARIA: ADULT (INCLUDING ELDERLY) AND CHILDREN AGED 12 YEARS AND OVER: 600mg of Quinine Sulfate every eight 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. 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 11 YEARS AND UNDER: Equivalent of 10mg/kg Quinine Sulfate every eight hours for 7 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. 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 administrati Đọc toàn bộ tài liệu