Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Repaglinide
DE Pharmaceuticals
A10BX02
Repaglinide
1mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010203
AAAI6580 Repaglinide 0.5mg 1mg and 2mg tablet leaflet - UK item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: supplier: technically app. date: min pt size: TECHNICAL APPROVAL AAAI6580 1 12.01.16 jh Malta Zejtun 190 x 380 9 N/A N/A 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT REPAGLINIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE 3 HOW TO TAKE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT REPAGLINIDE TABLETS ARE AND WHAT THEY ARE USED FOR Repaglinide tablets are an oral antidiabetic medicine containing repaglinide_ _which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose). Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces. Repaglinide is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar. Repaglinide can also be given with metformin, another medicine for diabetes. Repaglinide has been shown to lower the blood sugar, which helps to prevent complications from your diabetes. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAK Les hele dokumentet
OBJECT 1 REPAGLINIDE 1MG TABLETS Summary of Product Characteristics Updated 11-Jul-2016 | 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 • 11. Dosimetry • 12 Instructions for preparation of radiopharmaceuticals 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 Repaglinde 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 Les hele dokumentet