Country: Malta
Language: English
Source: Medicines Authority
Farmak International Sp. z o.o. Aleja Jana Pawla II 22 00-133 Warsaw , Poland
A10BD07
SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg
FILM-COATED TABLET
SITAGLIPTIN 50 mg METFORMIN HYDROCHLORIDE 850 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2022-06-17
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SYTENA PLUS 50 MG/850 MG FILM-COATED TABLETS sitagliptin/metformin hydrochloride 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 Sytena Plus is and what it is used for 2. What you need to know before you take Sytena Plus 3. How to take Sytena Plus 4. Possible side effects 5. How to store Sytena Plus 6. Contents of the pack and other information 1. WHAT SYTENA PLUS IS AND WHAT IT IS USED FOR Sytena Plus contains two different medicines called sitagliptin and metformin. • sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) • metformin belongs to a class of medicines called biguanides. They work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’. This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body. Along with diet and exercise, this medicine helps lower your blood sugar. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones). 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 medical problems like heart disease, kidney dise Read the complete document
Page 1 of 20 1. NAME OF THE MEDICINAL PRODUCT Sytena Plus 50 mg/850 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink, oblong oval-shaped film-coated tablets with a scoreline on one side and ‘SA’ on the other side. Tablet diameter: 19.5 ± 0.5mm The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Sytena Plus is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sytena Plus is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sytena Plus is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Sytena Plus is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose of antihyperglycaemic therapy with Sytena Plus should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin. Read the complete document