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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

OLMESARTAN Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Olmesartan 10mg Film-coated Tablets.

Qualitative and quantitative composition

Olmesartan medoxomil. Each 10 mg tablet contains 10 mg of olmesartan medoxomil. Excipients with known effect: Each 10 mg tablet contains 75.53mg of lactose monohydrate. For the full list of excipients, ...

Pharmaceutical form

Film-coated tablet. Olmesartan 10 mg film-coated tablets are white, round, biconvex and 6.5mm in diameter, with OL 10 debossed on one side.

Therapeutic indications

Adults Treatment of essential hypertension. Paediatric population Treatment of hypertension in children and adolescents from 6 to less than 18 years of age.

Posology and method of administration

Posology Adults The recommended starting dose of olmesartan medoxomil is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second and third trimesters of pregnancy (see sections 4.4 and 4.6). Biliary obstruction (see section 5.2). ...

Special warnings and precautions for use

Intravascular volume depletion Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Effects of other medicinal products on olmesartan medoxomil Other antihypertensive medications The blood pressure lowering effect of olmesartan medoxomil ...

Pregnancy and lactation

Pregnancy The use of angiotensin II antagonists is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II antagonists is contraindicated during the second ...

Effects on ability to drive and use machines

Olmesartan Tablets has minor or moderate influence on the ablility to drive and use machines. Dizziness or fatigue may occasionally occur in patients taking antihypertensive therapy, which may impair the ...

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions during treatment with olmesartan are headache (7.7%), influenza-like symptoms (4.0%) and dizziness (3.7%). In placebo-controlled ...

Overdose

Only limited information is available regarding overdosage in humans. The most likely effect of overdosage is hypotension. In the event of overdosage, the patient should be carefully monitored and treatment ...

Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin II antagonists ATC code: C09CA08 Mechanism of action/Pharmacodynamic effects Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor (type ...

Pharmacokinetic properties

Absorption and distribution Olmesartan medoxomil is a prodrug. It is rapidly converted to the pharmacologically active metabolite, olmesartan, by esterases in the gut mucosa and in portal blood during ...

Preclinical safety data

In chronic toxicity studies in rats and dogs, olmesartan medoxomil showed similar effects to other AT<sub>1</sub> receptor antagonists and ACE inhibitors: raised blood urea (BUN) and creatinine (through ...

List of excipients

Tablet core: Cellulose, microcrystalline Lactose monohydrate Hydroxypropylcellulose Low substituted hydroxypropylcellulose Magnesium stearate Film-coating: Opadry II White 33G28435 containing: Titanium ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Aluminium/aluminium blister pack. Packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Marketing authorization number(s)

PL 30306/0701

Date of first authorization / renewal of the authorization

18/08/2016 / 16/05/2018

Date of revision of the text

16/05/2018

Πηγαίο έγγραφο

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