Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Losartan potassium; Hydrochlorothiazide
Organon Pharma (UK) Ltd
C09DA01
Losartan potassium; Hydrochlorothiazide
100mg ; 25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5013945000511
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COZAAR® COMP 50MG/12.5MG FILM-COATED TABLETS COZAAR® COMP 100MG/12.5MG FILM-COATED TABLETS COZAAR® COMP 100MG/25MG FILM-COATED TABLETS LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 Cozaar Comp is and what it is used for 2. What you need to know before you take Cozaar Comp 3. How to take Cozaar Comp 4. Possible side effects 5. How to store Cozaar Comp 6. Contents of the pack and other information 1. WHAT COZAAR COMP IS AND WHAT IT IS USED FOR Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COZAAR COMP DO NOT TAKE COZAAR COMP • if you are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6), • if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial drugs such as c Lue koko asiakirja
OBJECT 1 COZAAR - COMP 50/12.5MG FILM-COATED TABLETS Summary of Product Characteristics Updated 17-Oct-2017 | Merck Sharp & Dohme Limited 1. Name of the medicinal product Cozaar Comp® 50 mg/12.5 mg film-coated tablets Cozaar Comp® 100 mg/12.5 mg film-coated tablets Cozaar Comp® 100 mg/25 mg film-coated tablets 2. Qualitative and quantitative composition Cozaar Comp 50 mg/12.5 mg Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ). Cozaar Comp 100 mg/12.5 mg Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ). Cozaar Comp 100 mg/25 mg Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide (HCTZ). Cozaar Comp 50 mg/12.5 mg: each tablet contains 63.13 mg lactose monohydrate. Cozaar Comp 100 mg/12.5 mg: each tablet contains 88.40 mg lactose monohydrate. Cozaar Comp 100 mg/25 mg: each tablet contains 126.26 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film coated tablet Cozaar Comp 50 mg/12.5 mg Yellow, oval film-coated tablets marked 717 on one side and plain or scored on the other. The score line is not intended for breaking the tablet. Cozaar Comp 100 mg/12.5 mg White, oval film-coated tablets marked 745 on one side and plain on the other. Cozaar Comp 100 mg/25 mg Light yellow, oval film-coated tablets marked 747 on one side and plain on the other. 4. Clinical particulars 4.1 Therapeutic indications Cozaar Comp is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone. 4.2 Posology and method of administration Posology Hypertension Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone. Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended. When clinically appropriate direct change from Lue koko asiakirja