Olmetec plus

Olmetec Plus®

Olmestran Medoxomil (20mg/12.5 mg), (40mg/12.5 mg), (40mg/25mg)

Tablets for oral use

Product leaflet summary

Therapeutic Indications

OLMETEC PLUS is indicated for the treatment of hypertension. It is also indicated for use in patients whose blood pressure is not adequately controlled by Olmesartan Medoxomil or hydrochlorothiazide alone.

 

Dosage and Administration

OLMETEC PLUS is administered once daily, with or without food.

 

Contraindications

Hypersensitivity to the active substances, to any of the excipients or to other sulfonamide-derived substances (since hydrochlorothiazide is a sulfonamide-derived medicinal product).

Olmesartan / Hydrochlorothiazide should not be co-administered with Aliskiren in patients with diabetes mellitus or renal impairment

Severe renal impairment (creatinine clearance < 30 ml/min).

Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia.

Severe hepatic impairment, cholestasis and biliary obstructive disorders.

2nd and 3rd trimester of pregnancy.

In general arteriosclerosis, in patients with ischaemic heart disease or ischaemic cerebrovascular disease, there is always a risk that the excessive blood pressure decrease could result in a myocardial infarction or stroke.

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

 

 

Pregnancy and Lactation

Pregnancy:

Angiotensin II antagonists should not be initiated during pregnancy. Unless continued angiotensin II antagonists therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.

Given the effects of the individual components in this combination product on pregnancy, the use of OLMETEC PLUS is not recommended during the first trimester of pregnancy. The use of OLMETEC PLUS is contra-indicated during the 2nd and 3rd trimester of pregnancy.

Lactation:

The use of OLMETEC PLUS during breastfeeding is not recommended. If OLMETEC PLUS is used during breastfeeding, doses should be kept as low as possible.

 

Ability to drive and use machinery

OLMETEC PLUS can have minor or moderate influence on the ability to drive and use machines. Dizziness or fatigue may occasionally occur in patients taking antihypertensive therapy, which may impair the ability to react.

 

Package Presentation:

1- A box of 28 tables each contains Olmesartan medoxomil 20mg \ HCTz 12.5 mg.

2- A box of 28 tables each contains Olmesartan medoxomil 40mg \ HCTz 12.5 mg.

3- A box of 28 tables each contains Olmesartan medoxomil 40mg \ HCTz 25 mg.