Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Repaglinide
A A H Pharmaceuticals Ltd
A10BX02
Repaglinide
1mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010203
Repaglinide, UK/H/6936/001-003, 03.09.18 14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1. NAME OF THE MEDICINAL PRODUCT /.../ 0.5 mg tablets /.../ 1 mg tablets /.../ 2 mg tablets Repaglinide 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg, 1 mg or 2 mg of repaglinide 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS Tablet 30, 60, 90, 100, 120, 180 tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION _ _ Read the package leaflet before use Oral use 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP 9. SPECIAL STORAGE CONDITIONS 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Repaglinide, UK/H/6936/001-003, 03.09.18 15 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER <[To be completed nationally]> {Name and Address} <{tel}> <{fax}> <{e-mail}> 12. MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]> 13. BATCH NUMBER Lot: 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE /…/ 0.5 mg /.../ 1 mg /.../ 2 mg 17. UNIQUE IDENTIFIER – 2D BARCODE_ _ 2D barcode carrying the unique identifier included. 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA_ _ PC: SN: NN: Repaglinide, UK/H/6936/001-003, 03.09.18 16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL 1. NAME OF THE MEDICINAL PRODUCT /.../ 0.5 mg tablets /.../ 1 mg tablets /.../ 2 mg tablets Repaglinide 2. NAME OF THE MARKETING AUTHORISATION HOLDER <[To be completed nationally]> 3. EXPIRY DATE EXP: 4. BATCH NUMBER Lot: 5. OTHER Repaglinide, UK/H/6936/001-003, 03.09.18 17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TABLET CONTAINER 1. NAME OF THE MEDICINAL PRODUCT /.../ 0.5 mg tablets /.../ 1 mg tablets /.../ 2 mg tablets Repaglinide 2. STATEMENT OF ACTIVE SUBSTANCE(S) Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Repaglinide 1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of repaglinide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Repaglinide 1mg Tablets are mottled yellow, round, biconvex and engraved with RE1 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient. Glycosylated haemoglobin levels are also of value in monitoring the patient’s response to therapy. Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose lowering response after an initial period of effectiveness (i.e. secondary failure). Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic patients usually controlled well on diet. _ _ _Initial dose _ The dosage should be determined by the physician, according to the patient’s requirements. The recommended starting dose is 0.5 mg. One to two weeks should elapse between titration steps (as determined by blood glucose response). If patients are transferred from another oral hy Lire le document complet