Country: Malta
Language: English
Source: Medicines Authority
SITAGLIPTIN
Rafarm S.A. 12, Korinthou Str., 15451 Neo Psihiko, Athens, Greece
A10BH01
SITAGLIPTIN 25 mg
FILM-COATED TABLET
SITAGLIPTIN 25 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-04-03
PAGE 1 OF 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN RAFARM 25 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, 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 Sitagliptin RAFARM is and what it is used for 2. What you need to know before you take Sitagliptin RAFARM 3. How to take Sitagliptin RAFARM 4. Possible side effects 5. How to store Sitagliptin RAFARM 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN RAFARM IS AND WHAT IT IS USED FOR Sitagliptin RAFARM 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. This can lead to serious Read the complete document
1 1. NAME OF THE MEDICINAL PRODUCT Sitagliptin RAFARM 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg sitagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Round, pink film-coated tablets of approximately 6.3 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus, Sitagliptin RAFARM 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 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 ) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR 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 adequately glycaemic control. • A PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. PAGE 2 OF 18 Sitagliptin RAFARM is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose is 100 mg sitagliptin once daily. When used in combination with metformin and/or a P Read the complete document