Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrochlorothiazide; Irbesartan
Actavis UK Ltd
C09DA04
Hydrochlorothiazide; Irbesartan
12.5mg ; 150mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5012617022721
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. IRBESRTAN HCT 150MG/12.5MG, 300MG/12.5MG & 300MG/25MG TABLETS PIL - UK Black BBBA1375 S.Anson 20.10.17 21.11.17 S.Anson 190 x 380 8pt Actavis Bulgaria Dupnitsa 20.10.17 20.10.17 3 IRBESARTAN HYDROCHLOROTHIAZIDE 150MG/12.5MG, 300MG/12.5MG AND 300MG/25MG FILM-COATED TABLETS _continued over page_ _continued top of next column_ BBBA1375 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. • The full name of this product is Irbesartan Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg and 300mg/25mg Film- coated Tablets but within the leaflet it will be referred to as Irbesartan Hydrochlorothiazide tablets. WHAT IS IN THIS LEAFLET: 1 WHAT IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS 3 HOW TO TAKE IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR Irbesartan Hydrochlorothiazide table Aqra d-dokument sħiħ
OBJECT 1 IRBESARTAN HYDROCHLOROTHIAZIDE ACTAVIS 150MG/12.5MG FILM-COATED TABLETS Summary of Product Characteristics Updated 18-Dec-2017 | Accord-UK Ltd 1. Name of the medicinal product Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg Film-coated Tablets. 2. Qualitative and quantitative composition Each film-coated tablet contains 150mg of irbesartan and 12.5mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg film-coated tablets. Pink, biconvex, oval-shaped, 6.5 x 12.7 mm film-coated tablet with an H engraved on one side and I 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 Actavis 150mg/12.5mg Film-coated Tablets can be taken once daily, with or without food. 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 Actavis 150mg/12.5mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150mg alone; ▪ Irbesartan Hydrochlorothiazide Actavis 300mg/12.5mg may be administered in patients insufficiently controlled by irbesartan 300mg or by Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg; ▪ Irbesartan Hydrochlorothiazide Actavis 300mg/25mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Actavis 300mg/12.5mg. Doses higher than 300mg irbesartan/25mg hydrochlorothiazide once daily are not recommended. When necessary, Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg Film-coated Tablets m Aqra d-dokument sħiħ