Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Losartan potassium
Sigma Pharmaceuticals Plc
C09CA01
Losartan potassium
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COZAAR ® COMP 100MG/25MG 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. The name of your medicine is Cozaar Comp 100mg/25mg tablets but will be referred to as Cozaar Comp throughout this leaflet. Please note that the leaflet also contains information about other strengths Cozaar Comp 50mg/12.5mg and 100mg/12.5mg tablets. 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 medi Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT COZAAR 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each COZAAR 100 mg tablet contains 100 mg of losartan potassium. Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets COZAAR 100 mg tablet White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of essential hypertension in adults and in children and adolescents 6 - 18 years of age. • Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment (see sections 4.3, 4.4, 4.5, and 5.1). • Treatment of chronic heart failure in adult patients when treatment with Angiotensin-converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure. • Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide) (see sections 4.3, 4.4, 4.5, and 5.1). Hypertensive type II diabetic patients with proteinuria ≥ 0.5 Prečítajte si celý dokument