ALTEISDUO 40 mg / 12.5 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Olmesartan medoxomil, Hydrochlorothiazide
laboratory: Menarini Inter OP Luxemb

Indication

Treatment of essential hypertension.

ALTEISDUO is a fixed combination indicated in adult patients whose blood pressure is not adequately controlled by 40 mg olmesartan medoxomil alone.

Dosage ALTEISDUO 40 mg / 12.5 mg Film-coated tablet Box of 90

adults

The recommended dosage of ALTEISDUO is one tablet per day.

ALTEISDUO 40 mg / 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by 40 mg olmesartan medoxomil alone.

ALTEISDUO 40 mg / 25 mg may be administered in patients whose blood pressure is not sufficiently controlled by the fixed combination ALTEISDUO 40 mg / 12.5 mg.

For convenience, patients taking olmesartan medoxomil and hydrochlorothiazide separately in tablet form may instead take the dosage of ALTEISDUO corresponding to the same doses of these two components.

ALTEISDUO can be taken during or after meals.

Elderly (65 years old and over)

No dosage adjustment is necessary in the elderly. Blood pressure should be closely monitored.

Renal failure

ALTEISDUO is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml / min). In patients with mild to moderate renal impairment (creatinine clearance between 30 and 60 ml / min), the maximum dose of olmesartan medoxomil is 20 mg once daily, given the limited experience of higher dosages in this group of patients, and periodic monitoring is recommended. Therefore, ALTEISDUO is contraindicated in all stages of renal failure (see sections Contraindications, Warnings and Precautions, and Pharmacokinetic Properties ).

Hepatic insufficiency

In patients with mild hepatic impairment, ALTEISDUO 40 mg / 12.5 mg and 40 mg / 25 mg should be used with caution (see Warnings and Precautions and Pharmacokinetic Properties sections). Close monitoring of blood pressure and renal function is recommended in patients with hepatic impairment treated with diuretics and / or other antihypertensive agents. In patients with moderate hepatic impairment, the recommended starting dose of olmesartan medoxomil is 10 mg once daily and the maximum dosage should not exceed 20 mg once daily. There is no experience of using olmesartan medoxomil in patients with severe hepatic impairment.

Therefore, ALTEISDUO 40 mg / 12.5 mg and 40 mg / 25 mg should not be used in patients with moderate to severe hepatic impairment (see sections Contraindications and Pharmacokinetic Properties ), as well as in patients with moderate to severe hepatic impairment. cholestasis or biliary obstruction (see section 4.3 ).

Pediatric population

The safety and efficacy of ALTEISDUO 40 mg / 12.5 mg and 40 mg / 25 mg in children and adolescents under 18 years of age have not been established. No data available.

Administration mode :

The tablet should be swallowed with a sufficient amount of liquid (eg a glass of water). The tablet should not be chewed and should be taken at the same time each day.

Against indications

· Hypersensitivity to any of the active substances, to any of the excipients (see section Composition ) or to other substances derived from sulfonamides (hydrochlorothiazide being a substance derived from sulphonamides);

· Renal impairment (see sections Warnings and Precautions and Pharmacokinetic Properties );

· Refractory hypokalemia, hypercalcemia, hyponatremia and symptomatic hyperuricemia;

· Moderate to severe hepatic impairment, cholestasis and biliary obstruction (see section 5.2 ).

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

Alteisduo side effects

The most common side effects reported with ALTEISDUO 40 mg / 12.5 mg and 40 mg / 25 mg are headache (2.9%), dizziness (1.9%) and fatigue. (1.0%).

Hydrochlorothiazide may induce or exacerbate hypovolemia causing electrolyte disturbances (see Warnings and Precautions ).

The safety of ALTEISDUO 40 mg / 12.5 mg and 40 mg / 25 mg was evaluated in clinical trials in 3709 patients receiving olmesartan medoxomil in combination with hydrochlorothiazide.

Other adverse reactions reported with the fixed combination of olmesartan medoxomil and hydrochlorothiazide at lower dosages of 20 mg / 12.5 mg and 20 mg / 25 mg may be potential adverse effects with ALTEISDUO 40 mg / 12.5 mg and 40 mg / 25 mg.

Adverse effects observed under ALTEISDUO in clinical trials, tolerance studies after marketing authorization and spontaneous reports are summarized in the table below, as well as adverse effects reported with one of the components, olmesartan medoxomil and hydrochlorothiazide, taking into account the known safety profiles of these substances.

The following definitions have been used to classify adverse effects in order of frequency:

Very common (≥ 1/10)

Frequent (≥1 / 100 to <1/10);

Uncommon (≥1 / 1000 to <1/100)

Rare (≥1 / 10000 to <1/1000);

Very rare (<1/10000)

Isolated cases of rhabdomyolysis have been reported with combinations of angiotensin II receptor antagonists.