देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Amlodipine besilate
KRKA, d.d., Novo mesto
C09DB; C09DB02
Olmesartan medoxomil; Amlodipine besilate
40 mg/5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine
Marketed
2017-08-18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLMESARTAN/AMLODIPINE KRKA 20 MG/5 MG FILM-COATED TABLETS OLMESARTAN/AMLODIPINE KRKA 40 MG/5 MG FILM-COATED TABLETS OLMESARTAN/AMLODIPINE KRKA 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/Amlodipine Krka is and what it is used for 2. What you need to know before you take Olmesartan/Amlodipine Krka 3. How to take Olmesartan/Amlodipine Krka 4. Possible side effects 5. How to store Olmesartan/Amlodipine Krka 6. Contents of the pack and other information 1. WHAT OLMESARTAN/AMLODIPINE KRKA IS AND WHAT IT IS USED FOR Olmesartan/Amlodipine Krka 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/Amlodipine Krka is used for the treatment of high blood pressure in patients whose blood pressure is not controlled enough with either olme पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 19 August 2022 CRN00D0Q7 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan/Amlodipine Krka 40 mg/5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg olmesartan medoxomil and 5 mg amlodipine (as amlodipine besilate). Excipient(s) with known effect: Each film-coated tablet contains 8.40 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (Tablet) Pale brownish-yellow, round, biconvex, film-coated tablets with bevelled edges, engraved with mark 5 on one side of the tablet. Tablet dimension: diameter: 9 mm, thickness: 3.6 – 5.3 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmesartan/Amlodipine Krka is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy (see section 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The recommended dosage of Olmesartan/Amlodipine Krka is 1 tablet per day. Olmesartan/Amlodipine Krka 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/Amlodipine Krka 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by Olmesartan/Amlodipine Krka 20 mg/5 mg. Olmesartan/Amlodipine Krka 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled by Olmesartan/Amlodipine Krka 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/Amlodipine Krka tablets containing the same component dose पूरा दस्तावेज़ पढ़ें