Olmesartan Medoxomil / Amlodipine Besilate
(20 mg/5 mg) – (20 mg/10 mg) – (40 mg/5 mg) – (40 mg/10 mg)
Tablets for oral use
Product leaflet summary
SEVIKAR is indicated for the treatment of hypertension, alone or with other antihypertensive agents
SEVIKAR is indicated in adult patients whose blood pressure is not adequately controlled on Olmesartan Medoxomil or Amlodipine monotherapy.
SEVIKAR may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.
In Patients over 65 years of age, the doctor will regularly check blood pressure at any dose increase, to make sure that blood pressure does not become too low.
Dosage and Administration
The recommended dosage of SEVIKAR is 1 tablet per day.
Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients.
Second and third trimesters of pregnancy.
Severe hepatic insufficiency and biliary obstruction.
Due to the component Amlodipine SEVIKAR is also contraindicated in patients with:
– Severe hypotension.
– Shock (including cardiogenic shock).
– Obstruction of the outflow tract of the left ventricle (e.g. high-grade aortic stenosis).
– Hemodynamically unstable heart failure after acute myocardial infarction.
SEVIKAR should not be co-administered with Aliskiren in patients with diabetes mellitus or renal impairment.
Pregnancy and Lactation
It is not advised to prescribe SEVIKAR.
SEVIKAR is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you.
Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated with calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Ability to Drive and Use Machinery
SEVIKAR can have a minor or moderate influence on the ability to drive and use machines.
The most commonly reported adverse reactions during treatment with SEVIKAR are peripheral edema, headache, and dizziness.
1- A box of 28 tablets each contains (20 mg/5 mg).
2- A box of 28 tablets each contains (20 mg/10 mg).
3- A box of 28 tablets each contains (40 mg/5 mg).
4- A box of 28 tablets each contains (40 mg/10 mg).