Sevikar

Sevikar®

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

Therapeutic Indications

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.

 

Elderly patients

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.

 

Contraindications

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

Pregnancy:

It is not advised to prescribe SEVIKAR.

Lactation:

SEVIKAR is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you.

Fertility:

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 minor or moderate influence on the ability to drive and use machines.

Undesirable effects:

The most commonly reported adverse reactions during treatment with Sevikar are peripheral edema, headache and dizziness.

Package Presentation:

1- A box of 28 tabletes each contains (20 mg/5 mg).
2- A box of 28 tabletes each contains (20 mg/10 mg).
3- A box of 28 tabletes each contains (40 mg/5 mg).
4- A box of 28 tabletes each contains (40 mg/10 mg).