Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Olmesartan medoxomil
Daiichi Sankyo UK Ltd
C09CA08
Olmesartan medoxomil
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5015494280406
OLMETEC ® 10 MG TABLETS OLMESARTAN MEDOXOMIL 10MG TABLETS OLMETEC ® 40 MG TABLETS OLMESARTAN MEDOXOMIL 40MG TABLETS (olmesartan medoxomil) PATIENT INFORMATION LEAFLET 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. Your medicine is known by the above names but will be referred to as Olmetec throughout this leaflet. WHAT IS IN THIS LEAFLET 1. What Olmetec is and what it is used for 2. What you need to know before you take Olmetec 3. How to take Olmetec 4. Possible side effects 5. How to store Olmetec 6. Contents of the pack and other information 1. WHAT OLMETEC IS AND WHAT IT IS USED FOR Olmetec belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels. Olmetec is 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 Olmetec tablets. 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) Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmetec Plus 40 mg/12.5 mg film-coated tablets ▼ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide. Excipient(s) with known effect: Each film-coated tablet contains 233.9 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Reddish-yellow, oval, film-coated tablets of 15 x 7 mm with C23 debossed on one side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmetec Plus 40 mg/12.5 mg and 40 mg/25 mg fixed dose combinations are indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil 40 mg alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended dose of Olmetec Plus 40 mg/12.5 mg or 40 mg/25 mg is 1 tablet per day. Olmetec Plus 40 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil 40 mg alone. Olmetec Plus 40 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled on Olmetec Plus 40 mg/12.5 mg fixed dose combination. For convenience, patients receiving olmesartan medoxomil and hydrochlorothiazide from separate tablets may be switched to Olmetec Plus 40 mg/12.5 mg and 40 mg/25 mg tablets containing the same component doses. Olmetec Plus 40 mg/12.5 mg and 40 mg/25 mg can be taken with or without food. _Elderly (age 65 years or over) _ In elderly people the same dosage of the combination is recommended as for adults. Blood pressure should be closely monitored. _Renal impairment _ Olmetec Plus is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min). The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 30 – 60 mL/min) is 20 mg olmesartan medoxomil once daily, owing to limited experience of hig Прочитать полный документ