OMESAR Film-coated tablet Ref.[50287] Active ingredients: Olmesartan medoxomil

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, 1611 Luxembourg, Luxembourg

4.1. Therapeutic indications

Treatment of essential hypertension in adults.

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

4.2. 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 be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, olmesartan medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added.

The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient.

Elderly (65 years or over)

No adjustment of dosage is generally required in elderly people (see below for dose recommendations in patients with renal impairment). If up-titration to the maximum dose of 40mg daily is required, blood pressure should be closely monitored.

Renal impairment

The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min) is 20 mg olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of olmesartan medoxomil in patients with severe renal impairment (creatinine clearance <20 mL/min) is not recommended, since there is only limited experience in this patient group (see sections 4.4, 5.2).

Hepatic impairment

No adjustment of dosage recommendations is required for patients with mild hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10 mg olmesartan medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents. There is no experience of olmesartan medoxomil in patients with severe hepatic impairment, therefore use is not recommended in this patient group (see sections 4.4 and 5.2). Olmesartan medoxomil should not be used in patients with biliary obstruction (see section 4.3).

Paediatric population

Children and adolescents from 6 to less than 18 years of age: The recommended starting dose of olmesartan medoxomil in children from 6 to less than 18 years of age is 10 mg olmesartan medoxomil once daily. In children whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily. If additional blood pressure reduction is required, in children who weigh ≥35 kg, the olmesartan medoxomil dose may be increased to a maximum of 40 mg. In children who weigh <35 kg, the daily dose should not exceed 20 mg.

Other paediatric population

The safety and efficacy of olmesartan medoxomil in children aged 1 to 5 years old have not been established. Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.

Olmesartan medoxomil should not be used in children below 1 years of age because of safety concerns and lack of data in this age group.

Method of administration

In order to assist compliance, it is recommended that Omesar tablets be taken at about the same time each day, with or without food, for example at breakfast time. The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet should not be chewed.

4.9. 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 should be symptomatic and supportive.

No information is available regarding the dialysability of olmesartan.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Laminated polyamide / aluminium/polyvinyl chloride // aluminium blister pack.

Packs of 14, 28, 30, 56, 84, 90, 98 and 10 × 28 film-coated tablets.

Packs with perforated unit dose blisters of 10, 50 and 500 film-coated tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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