Sevikar 20 mg/5mg, 40mg/5mg, 40mg/10mg Film-Coated Tablets
Daiichi Sankyo UK Limited
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Active ingredient
olmesartan medoxomil
amlodipine besilate
Legal Category
POM: Prescription only medicine
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 Sevikar 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 Sevikar tablets containing the same component doses.
Sevikar can be taken with or without food.
Elderly (age 65 years or over)
No adjustment of the recommended dose is generally required for elderly people but increase of the dosage should take place with care (see sections 4.4 and 5.2).
If up-titration to the maximum dose of 40 mg olmesartan medoxomil daily is required, blood pressure should be closely monitored.
Renal impairment
The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 20 – 60 mL/min) is 20 mg olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of Sevikar in patients with severe renal impairment (creatinine clearance < 20 mL/min) is not recommended (see 4.4, 5.2).
Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment.
Hepatic impairment
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