Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; LINAGLIPTIN
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
METFORMIN HYDROCHLORIDE; LINAGLIPTIN
60 tablets BOTTLE
Boehringer Ingelheim Promeco S.A. de C.V.
TRAJENTA DUO ® Linagliptin / Metformin hydrochloride (2.5mg/500mg, 2.5mg/850mg, 2.5mg/1000mg) 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What TRAJENTA DUO is used for 2. How TRAJENTA DUO works 3. Before you use TRAJENTA DUO 4. How to use TRAJENTA DUO 5. While you are using it 6. Side effects 7. Storage and Disposal of TRAJENTA DUO 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial number 1. What TRAJENTA DUO is used for The name of your tablet is Trajenta Duo. It contains two different active substances linagliptin and metformin. • Linagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). • Metformin belongs to a class of medicines called biguanides. 2. How TRAJENTA DUO works The two active substances work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’. Type 2 diabetes mellitus is also called non-insulin-dependent diabetes mellitus, or NIDDM. 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 disease, blindness, and amputation. This medicine helps to improve the levels of insulin 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. Trajenta Duo can be used alone or with certain other medicines for diabetes like sulphonylureas or insulin. 3. Before you use TRAJENTA DUO - When you must not use it • if you are allergic to linagliptin or metformin or any of the other ingredients of this medicine (listed in section ingredients). • if you have severely reduced kidneys function. • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (h Izlasiet visu dokumentu
1 TRAJENTA DUO ® Abcd 1. NAME OF THE MEDICINAL PRODUCT Trajenta Duo 2.5 mg/500 mg film-coated tablets Trajenta Duo 2.5 mg/850 mg film-coated tablets Trajenta Duo 2.5 mg/1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of linagliptin and 500 mg, 850 mg or 1000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Oval, biconvex, light yellow, film-coated tablet of 16.3 mm x 8.6 mm debossed with "D2/500" on one side and the company logo on the other. Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with "D2/850" on one side and the company logo on the other. Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm debossed with "D2/1000" on one side and the company logo on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trajenta Duo is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate (see _Posology _ _and Method of Administration _ and _Clinical Studies_ ) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (GFR≥ 90 ml/min)_ The dose of antihyperglycaemic therapy with Trajenta Duo should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability, while not exceeding the maximum recommended daily dose of 5 mg linagliptin plus 2000 mg of metformin hydrochloride. _For patients currently not treated with metformin _ In patient currently not treated with metformin, initiate treatment with 2.5mg linagliptin/ 500mg metformin hydrochloride twice daily. 2 _For patients inadequately controlled on maximal tolerated dose of metformin monotherapy _ For patients not adequately controlled on metformin alone, the usual starting dose of Trajenta Duo should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) plus the dose of met Izlasiet visu dokumentu