Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Irbesartan; Hydrochlorothiazide
Mylan
C09DA04
Irbesartan; Hydrochlorothiazide
300mg ; 12.5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5016695005263
OBJECT 1 IRBESARTAN/HYDROCHLOROTHIAZIDE MYLAN 300 MG/12.5 MG TABLETS Summary of Product Characteristics Updated 06-Sep-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Irbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg tablets 2. Qualitative and quantitative composition 300 mg/12.5 mg tablets Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect Each tablet contains 120 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. 300 mg/12.5 mg tablets A peach, 0.3400” x 0.7350” (8.64 mm x 18.67 mm) oval, biconvex tablet debossed with “M” on one side of the tablet and “I34” on the other side. 4. Clinical particulars 4.1 Therapeutic indications Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 Posology and method of administration Posology Irbesartan/Hydrochlorothiazide Mylan can be taken once daily. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: • Irbesartan/Hydrochlorothiazide Mylan 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone • Irbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan/Hydrochlorothiazide Mylan 150 mg/12.5 mg. • Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, Irbesartan/Hydrochlorothiazide Mylan may be administered with a Aqra d-dokument sħiħ