Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gliclazide
DE Pharmaceuticals
A10BB09
Gliclazide
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Gliclazide Tablets 40mg x 28’s (UK) 296x210 (Reel Fed) 50965118 Leaflet for Blisters 4266 R.Wrey 18/02/19 * 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 UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. GLICLAZIDE 40MG 28 TABLES PIL - UK Black Profile BBBA4382 R.Wrey 01/04/19 05/04/19 R.Wrey 296 x 210 9pt Accord Barnstaple n/a n/a 02 page 4 page 1 50965118 GLICLAZIDE 40MG TABLETS _Continued top of next column_ _Continued over page_ BBBA4382 _Continued top of next column_ 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 GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLICLAZIDE TABLETS 3 HOW TO TAKE GLICLAZIDE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE GLICLAZIDE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR Gliclazide belongs to a group of medicines called sulfonylureas that are used to lower the blood sugar level. Gliclazide tablets are used in the treatment of di Baca dokumen lengkapnya
OBJECT 1 GLICLAZIDE 40MG TABLETS Summary of Product Characteristics Updated 17-May-2019 | Accord-UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Gliclazide 40mg Tablets 2. Qualitative and quantitative composition Each tablet contains 40mg gliclazide For the full list of excipients, see section 6.1 3. Pharmaceutical form Tablet White, circular, flat, bevelled-edge uncoated tablet plain on one face and the identifying letters “GU” on the reverse 4. Clinical particulars 4.1 Therapeutic indications Non insulin dependent diabetes mellitus (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 4.2 Posology and method of administration Posology _Adults _ The total daily dose may vary from 40-320mg. The dose should be adjusted according to the individual's response, commencing with 40-80mg (1 - 2 tablets) daily and increasing until adequate control is achieved. A single dose should not exceed 160m Baca dokumen lengkapnya