Olmetec®
Olmetec®
Olmesartan Medoxomil 20mg, 40mg
Tablets for oral use
Product leaflet summary
Therapeutic Indications:
Treatment of essential hypertension
Dosage and Administration
The recommended starting dose of OLMETEC is 10 mg once daily, in patients whose blood pressure is not adequately controlled at this dose, the dose of OLMETEC may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, OLMETEC dose may be increased to a maximum of 40 mg daily.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Second and third trimesters of pregnancy.
Biliary obstruction.
OLMETEC should not be co-administered with Aliskiren in patients with diabetes mellitus or renal impairment.
As with any antihypertensive agent, excessive blood pressure decrease in patients with ischemic heart disease or ischemic cerebrovascular disease could result in a myocardial infarction or stroke.
This medicinal product contains lactose. Patients with rare hereditary problems of lactose 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. The use of OLMETEC is not recommended during the first trimester of pregnancy. The use of OLMETEC is contra-indicated during the 2nd and 3rd trimester of pregnancy.
- Lactation: Olmesartan is excreted in the milk of lactating rats, but it is not known whether Olmesartan is excreted in human milk. Because no information is available regarding the use of OLMETEC during breastfeeding, OLMETEC is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Ability to Drive and Use Machinery
No studies on the effect on the ability to drive and use machines have been performed. With respect to driving vehicles or operating machines, it should be taken into account that occasionally dizziness or fatigue may occur in patients taking antihypertensive therapy.
