Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Olmesartan medoxomil; Amlodipine besilate
Daiichi Sankyo UK Ltd
C09DB02
Olmesartan medoxomil; Amlodipine besilate
40mg ; 10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050502; GTIN: 5015494400101
0 1.3.1.3 TEXT PROPOSED FOR THE PACKAGE LEAFLET SEVIKAR 20 MG/5 MG SEVIKAR 40 MG/5 MG SEVIKAR 40 MG/10 MG FILM-COATED TABLETS VARIATION APPLICATION NL/H/1113/001-003/IB/031 ATTACHED PLEASE FIND: - APPROVED UK PACKAGE LEAFLET - END OF PROCEDURE – CLEAN VERSION 1 PACKAGE LEAFLET: INFORMATION FOR THE USER SEVIKAR 20 MG/5 MG SEVIKAR 40 MG/5 MG SEVIKAR 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 Sevikar is and what it is used for 2. What you need to know before you take Sevikar 3. How to take Sevikar 4. Possible side effects 5. How to store Sevikar 6. Contents of the pack and other information 1. WHAT SEVIKAR IS AND WHAT IT IS USED FOR Sevikar 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. Sevikar is used for the treatment of high blood pressure in patients whose blood pressur Read the complete document
OBJECT 1 SEVIKAR 20 MG/5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 16-Oct-2017 | Daiichi Sankyo UK Limited 1. Name of the medicinal product Sevikar 20 mg/5 mg film-coated tablets Sevikar 40 mg/5 mg film-coated tablets Sevikar 40 mg/10 mg film-coated tablets 2. Qualitative and quantitative composition Sevikar 20 mg/5 mg film-coated tablets: Each film-coated tablet of Sevikar contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate). Sevikar 40 mg/5 mg film-coated tablets: Each film-coated tablet of Sevikar contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate). Sevikar 40 mg/10 mg film-coated tablets: Each film-coated tablet of Sevikar contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate). Excipients with known effect For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Sevikar 20 mg/5 mg film-coated tablets: White, round, film-coated tablet of 6 mm with C73 debossed on one side. Sevikar 40 mg/5 mg film-coated tablets: Cream, round, film-coated tablet of 8 mm with C75 debossed on one side. Sevikar 40 mg/10 mg film-coated tablets: Brownish-red, round, film-coated tablet of 8 mm with C77 debossed on one side 4. Clinical particulars 4.1 Therapeutic indications Treatment of essential hypertension. Sevikar 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 Sevikar is 1 tablet per day. Sevikar 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. Sevikar 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by Sevikar 20 mg/5 mg. Sevikar 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled by Sevik Read the complete document