Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Amlodipine
Accord Healthcare Ireland Ltd.
C09DB; C09DB02
Olmesartan medoxomil; Amlodipine
40/10 mg/mg
Film-coated tablet
Angiotensin II antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine
Marketed
2018-01-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLMESARTAN MEDOXOMIL/AMLODIPINE 20 MG/5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE 40 MG/5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE 40 MG/10 MG FILM-COATED TABLETS Olmesartan medoxomil/Amlodipine 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/Amlodipine is and what it is used for 2. What you need to know before you take Olmesartan medoxomil/Amlodipine 3. How to take Olmesartan medoxomil/Amlodipine 4. Possible side effects 5. How to store Olmesartan medoxomil/Amlodipine 6. Contents of the pack and other information 1. WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE IS AND WHAT IT IS USED FOR Olmesartan medoxomil/Amlodipine contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both of these substances help to control high blood pressure. • Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists” which lower blood pressure by relaxing the blood vessels. • Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening thereby also reducing blood pressure. The actions of both these substances contribute to stopping the tightening of blood vessels, so that blood vessels relax and blood pressure decreases. Olmesartan medoxomil/Amlodipine is used for the treatment of high blood pressure in patients whose blo Прочитајте комплетан документ
Health Products Regulatory Authority 02 March 2023 CRN00DF5Q Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan medoxomil/Amlodipine 40 mg/10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg olmesartan medoxomil and 10 mg amlodipine (as amlodipine besilate). Excipients- with known effect: Each 40 mg/10 mg film-coated tablet contains 10 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Brownish-red, round, film-coated tablets debossed with “OA4” on one side and plain on other side. Dimension: Diameter 8.10 mm ± 0.20 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmesartan medoxomil/Amlodipine is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy (see section 4.2 and section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The recommended dosage of Olmesartan medoxomil/Amlodipine is 1 tablet per day. Olmesartan medoxomil/Amlodipine 20 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil or 5 mg amlodipine alone. Olmesartan medoxomil/Amlodipine 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by Olmesartan medoxomil/Amlodipine 20 mg/5 mg. Olmesartan medoxomil/Amlodipine 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled by Olmesartan medoxomil/Amlodipine 40 mg/5 mg. A step-wise titration of the dosage of the individual components is recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. For convenience, patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to Olmesartan medoxomil/Amlodipine tablets containing the same compon Прочитајте комплетан документ