Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Losartan potassium; Hydrochlorothiazide
PCO Manufacturing Ltd.
C09CA; C09CA01
Losartan potassium; Hydrochlorothiazide
100/25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; losartan
Authorised
2008-02-08
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 losartan potassium and hydrochlorothiazide 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, 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, som Lees het volledige document
Health Products Regulatory Authority 04 July 2023 CRN00DNW6 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg of losartan potassium and 25mg of hydrochlorothiazide (HCTZ) as the active ingredients. Excipient(s) with known effect: Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet _Product imported from Italy, Hungary and France:_ 'Cozaar' Comp is supplied as oval, yellow, film-coated tablets with '747' on one side and plain on the other. 4 CLINICAL PARTICULARS As per PA23198/001/003 5 PHARMACOLOGICAL PROPERTIES As per PA23198/001/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Hydroxypropyl cellulose (E463) Hypromellose (E464) Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Pregelatinised starch Titanium dioxide (E171) Quinoline yellow aluminium lake (E104) Carnauba wax (E903) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. Store in the original package in order to protect from light and moisture. Health Products Regulatory Authority 04 July 2023 CRN00DNW6 Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER White, opaque PVC/PE/PVDC blisters containing 28 tablets with aluminium foil lidding. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/109/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of First Authorisation: 8th February 2008 10 DATE OF R Lees het volledige document