AZOREN FILM-COATED TABLET 40MG/10MG [SIN13966P]

Product Info

AZOREN FILM-COATED TABLET 40MG/10MG

[SIN13966P]

4.1 Therapeutic indications

Treatment of essential hypertension.

Azoren is indicated in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy (see sections 4.2 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Adults
The recommended dosage of Azoren is 1 tablet per day.

Azoren 20 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil or 5 mg amlodipine alone.

Azoren 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by Azoren 20 mg/5 mg.

Azoren 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled by Azoren 40 mg/5 mg.

A step-wise titration of the dosage of the individual components is recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.

For convenience, patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to Azoren tablets containing the same component doses.

Azoren can be taken with or without food.

Elderly (age 65 years or over)
No adjustment of the recommended dose is generally required for elderly patients but increase of the dosage should take place with care (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If up-titration to the maximum dose of 40 mg olmesartan medoxomil daily is required, blood pressure should be closely monitored.

Renal impairment
The maximum dose of olmesartan medoxomil 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 Azoren in patients with severe renal impairment (creatinine clearance <20 mL/min) is not recommended (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment.

Hepatic impairment
Azoren should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

As with all calcium antagonists, amlodipine’s half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Azoren should therefore, be administered with caution in these patients. The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with impaired liver function. Use of Azoren in patients with severe hepatic impairment is contraindicated (see section 4.3).

Paediatric population
The safety and efficacy of Azoren in children and adolescents below 18 years has not been established. No data are available.

Method of administration
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet should not be chewed and should be taken at the same time each day.

4.3 Contraindications

Hypersensitivity to the active substances, to dihydropyridine derivatives or to any of the excipients (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Second and third trimester of pregnancy (see sections 4.4 and 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Severe hepatic insufficiency and biliary obstruction (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Due to the component amlodipine, Azoren 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)

• haemodynamically unstable heart failure after acute myocardial infarction

Do not co-administer aliskiren with Azoren in patients with diabetes (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The concomitant use of Azoren with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).