Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
SITAGLIPTIN
ALFRED E. TIEFEMBACHER (GmbH &Co. KG) Van-der-Smissen-Straße 1, 22767 Hamburg, Germany
A10BH01
SITAGLIPTIN 100 mg
FILM-COATED TABLET
SITAGLIPTIN 100 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2020-05-14
V01 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN TIEFENBACHER 100 MG FILM-COATED TABLETS sitagliptin 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 Sitagliptin Tiefenbacher is and what it is used for 2. What you need to know before you take Sitagliptin Tiefenbacher 3. How to take Sitagliptin Tiefenbacher 4. Possible side effects 5. How to store Sitagliptin Tiefenbacher 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN TIEFENBACHER IS AND WHAT IT IS USED FOR Sitagliptin Tiefenbacher contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body. Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan. What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. Th Læs hele dokumentet
1 1. NAME OF THE MEDICINAL PRODUCT Sitagliptin Tiefenbacher 25 mg film-coated tablets Sitagliptin Tiefenbacher 50 mg film-coated tablets Sitagliptin Tiefenbacher 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg sitagliptin. Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg sitagliptin. Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg sitagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Round, biconvex, pink film-coated tablet, approximate dimension 6.0 mm. Round, biconvex, light beige film-coated tablet, approximate dimension 8.0 mm. Round, biconvex, beige film-coated tablet with, approximate dimension 10.0 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus, sitagliptin is indicated to improve glycaemic control: as monotherapy • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. • a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. • a peroxisome proliferator-activated receptor gamma (PPAR γ ) agonist (i.e. a thiazolidinedione) when use of a PPAR γ agonist is appropriate and when diet and exercise plus the PPAR γ agonist alone do not provide adequate glycaemic control. • as triple oral therapy in combination with • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. • a PPAR γ agonist and metformin when use of a PPAR γ agonist is appropriate and when diet Læs hele dokumentet