Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
OLMESARTAN MEDOXOMIL
Glenmark Pharmaceuticals Europe Limited
C09C
OLMESARTAN MEDOXOMIL
40 Milligram
Film Coated Tablet
Oral use
Packs of 28, 30, 56, 90 and 98 film-coated tablets
Product subject to prescription which may be renewed (B)
Glenmark Pharmaceuticals Europe Limited
Angiotensin II antagonists
ANGIOTENSIN II ANTAGONISTS, PLAIN
Treatment of essential hypertension in adults and treatment of hypertension in children and adolescents from 6 to less than 18 years of age.
Authorised
2015-07-10
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. WHAT IS IN THIS LEAFLET 1. What Olmesartan medoxomil is and what it is used for 2. What you need to know before you take Olmesartan medoxomil 3. How to take Olmesartan medoxomil 4. Possible side effects 5. How to store Olmesartan medoxomil 6. Contents of the pack and other information 1. WHAT OLMESARTAN MEDOXOMIL IS AND WHAT IT IS USED FOR Olmesartan medoxomil belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels. The tablets are used for the treatment of high blood pressure (also known as “hypertension”) in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain and eyes. In some cases this may lead to a heart attack, heart or kidney failure, stroke or blindness. Usually high blood pressure has no symptoms. It is important to have your blood pressure checked to prevent damage occurring. High blood pressure can be controlled with medicines such as Olmesartan medoxomil . Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also have urged you to take regular exercise, such as walking or swimming. It is important to follow this advice from your doctor. 2. WHAT YOU NEED TO KNOW B Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan Medoxomil 40 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Olmesartan medoxomil Each film-coated tablet contains 40 mg olmesartan medoxomil Excipient with known effect: Olmesartan medoxomil 40 mg film-coated tablets: each film-coated tablet contains 301.65mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Olmesartan medoxomil 40 mg are white to off white, oval-shaped film-coated tablets debossed with 438 on one side and plain on the other side with a characteristic odour, approx.15.3 mm in length and 7.2 mm in breadth. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Treatment of hypertension in children and adolescents from 6 to less than 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The recommended starting dose of olmesartan medoxomil is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, olmesartan medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added. The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient. _Older people (65 years or older)_ No adjustment of dosage is generally required in older people (see below for dose recommendations in patients with renal impairment). If up-titration to the maximum dose of 40mg daily is required, blood pressure should be closely monitored. _Renal impairment_ The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20 – 60 mL/min) is 20 mg olmesartan medoxomil once Прочитајте комплетан документ