Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinine sulfate
Accord-UK Ltd
P01BC01
Quinine sulfate
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05040100; GTIN: 5012617009982
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Quinine sulfate, Tablets, 200mg, 28s - UK 148x210 (Reel Fed) 51016395 Leaflet for Blisters 1459 RH 31-10-22 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com QUININE SULFATE 200MG 28 TABLETS PIL - UK Black Profile BBBB5908 S.Anson 01.11.2022 03.11.2022 S.Anson 148 x 210 7pt Accord Barnstaple n/a n/a 2 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) QUININE SULFATE 200MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 belongs to a group of medicines called anti- protozoa Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT QUININE SULFATE TABLETS BP 200mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg Quinine Sulfate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, circular, biconvex film-coated tablets with the identifying letters “QC” embossed on one face. 4 CLINICAL PARTICULARS 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 elderly) and children aged 12 years and over: _600mg 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: _10mg/kg 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 assess the need for continuation of treatment with quinine. Method of Administration For oral administration. 4 Przeczytaj cały dokument