País: Holanda
Língua: holandês
Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
REPAGLINIDE 1 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
A10BX02
REPAGLINIDE 1 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188,
Oraal gebruik
Repaglinide
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); MAGNESIUMSTEARAAT (E 470b); POLOXAMEER 188;
2009-12-02
PACKAGE LEAFLET: INFORMATION FOR THE USER REPAGLINIDE STADA 0.5 MG TABLETTEN REPAGLINIDE STADA 1 MG TABLETTEN REPAGLINIDE STADA 2 MG TABLETTEN REPAGLINIDE STADA 4 MG TABLETTEN Repaglinide 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 STADA is and what it is used for 2. What you need to know before you take Repaglinide STADA 3. How to take Repaglinide STADA 4. Possible side effects 5. How to store Repaglinide STADA 6. Contents of the pack and other information 1. WHAT REPAGLINIDE STADA IS AND WHAT IT IS USED FOR Repaglinide STADA is an _ oral antidiabetic agent_ 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 (formerly known _as non-insulin-dependent diabetes mellitus or maturity onset diabetes_). Repaglinide STADA is used to control type 2 diabetes 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 STADA can also be given with metformin, another medicine for diabetes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REPAGLINIDE STADA DO NOT TAKE REPAGLINIDE STADA: • If you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6.) • If you have TYPE 1 DIABETES _(insul Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Repaglinide STADA 0,5 mg, tabletten Repaglinide STADA 1 mg, tabletten Repaglinide STADA 2 mg, tabletten Repaglinide STADA 4 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Repaglinide STADA 0.5 mg tablets Each tablet contains: 0.5 mg Repaglinide Repaglinide STADA 1 mg tablets Each tablet contains: 1 mg Repaglinide Repaglinide STADA 2 mg tablets Each tablet contains: 2 mg Repaglinide Repaglinide STADA 4 mg tablets Each tablet contains: 4 mg Repaglinide Excipient(s) with known effect Repaglinide STADA 0.5 mg tablets Each tablet contains 0.33 mg sodium. Repaglinide STADA 1 mg tablets Each tablet contains 0.33 mg sodium. Repaglinide STADA 2 mg tablets Each tablet contains 0.66 mg sodium. Repaglinide STADA 4 mg tablets Each tablet contains 0.66 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Repaglinide STADA 0.5 mg tablets are white, round, 3.4 mm thick and biconvex tablets. Repaglinide STADA 1 mg tablets are white, round, 3.4 mm thick and biconvex tablets with embossment “1”. Repaglinide STADA 2 mg tablets are white, round, 4.2 mm thick and biconvex tablets with embossment “2”. Repaglinide STADA 4 mg tablets are white, round, 4.0 mm thick tablets with breaking notch on both sides. Repaglinide STADA 4 mg tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repaglinide is indicated in patients with type 2 diabetes (Non Insulin-Dependent Diabetes Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients 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 glycae Leia o documento completo