Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
alogliptin, pioglitazone
Takeda Pharma A/S
A10BD09
alogliptin, pioglitazone
Drugs used in diabetes, Combinations of oral blood glucose lowering drugs
Diabetes Mellitus, Type 2
Incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. , In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination. After initiation of therapy with Incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).,
Revision: 13
Authorised
2013-09-19
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT INCRESYNC 12.5 MG/30 MG FILM-COATED TABLETS INCRESYNC 25 MG/30 MG FILM-COATED TABLETS INCRESYNC 25 MG/45 MG FILM-COATED TABLETS alogliptin/pioglitazone 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 Incresync is and what it is used for 2. What you need to know before you take Incresync 3. How to take Incresync 4. Possible side effects 5. How to store Incresync 6. Contents of the pack and other information 1. WHAT INCRESYNC IS AND WHAT IT IS USED FOR WHAT INCRESYNC IS Incresync contains two different medicines called alogliptin and pioglitazone in one tablet: - alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body. - pioglitazone belongs to a group of medicines called thiazolidinediones. It helps your body make better use of the insulin it produces. Both of these groups of medicines are “oral anti-diabetics”. WHAT INCRESYNC IS USED FOR Incresync is used to lower blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus or NIDDM. Incresync is taken when your blood sugar cannot be adequately controlled by diet, exercise and other oral anti-diabetic medicines such as pioglitazone; or pioglitazone and metformin taken together. Your doctor will check whether Incresync is working 3 to 6 months afte Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Incresync 12.5 mg/30 mg film-coated tablets Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone. _Excipient(s) with known effect_ Each tablet contains 121 mg of lactose (as monohydrate). Incresync 25 mg/30 mg film-coated tablets Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone. _Excipient(s) with known effect_ Each tablet contains 121 mg of lactose (as monohydrate). Incresync 25 mg/45 mg film-coated tablets Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone. _Excipient(s) with known effect_ Each tablet contains 105 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Incresync 12.5 mg/30 mg film-coated tablets Pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/30” printed in red ink on one side. Incresync 25 mg/30 mg film-coated tablets Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/30” printed in grey ink on one side. Incresync 25 mg/45 mg film-coated tablets Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pio Aqra d-dokument sħiħ