ALTEISDUO 20 mg / 12.5 mg

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

Coated tablet
Box of 90
All forms

Indication

Treatment of essential hypertension.

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

Dosage ALTEISDUO 20 mg / 12.5 mg Film-coated tablet Box of 90

adults

ALTEISDUO should not be used as first-line therapy but should be used in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil alone. ALTEISDUO will be given once daily, during or after meals.

Switching from 20 mg olmesartan medoxomil to this fixed combination can be considered depending on the clinical situation, taking into account that the antihypertensive action of olmesartan medoxomil peaks after 8 weeks of treatment. approximately (see section Pharmacodynamic properties ). The gradual adaptation of the doses of each individual component is recommended:

ALTEISDUO 20 mg / 12.5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil monotherapy at the optimal dose of 20 mg.

ALTEISDUO 20 mg / 25 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil 20 mg / hydrochlorothiazide 12.5 mg.

Elderly (65 years old and over)

No dosage adjustment is necessary in the elderly.

Renal failure

In patients with mild to moderate renal impairment (creatinine clearance between 30 and 60 ml / min) periodic monitoring of renal function is recommended (see Warnings and Precautions ). ALTEISDUO is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml / min) (see section 4.3 ).

Hepatic insufficiency

In patients with mild to moderate hepatic impairment, ALTEISDUO should be used with caution (see Warnings and Precautions and Pharmacokinetic Properties sections). 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. Close monitoring of blood pressure and renal function is recommended in patients with hepatic impairment treated with diuretics and / or other antihypertensive agents. There is no experience of using olmesartan medoxomil in patients with severe hepatic impairment.

ALTEISDUO should not be used in patients with severe hepatic impairment (see sections Contraindications and Pharmacokinetic Properties ), cholestasis or biliary obstruction (see section 4.3 ).

Pediatric population

The safety and efficacy of ALTEISDUO 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);

· Severe renal insufficiency (creatinine clearance <30 ml / min);

· Refractory hypokalemia, hypercalcemia, hyponatremia and symptomatic hyperuricemia;

· Severe hepatic insufficiency, cholestasis and obstruction of the bile ducts;

· ^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 are headache (2.9%), dizziness (1.9%) and fatigue (1.0%).

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

In clinical trials involving 1155 patients treated with olmesartan medoxomil / hydrochlorothizide at 20 mg / 12.5 mg or 20 mg / 25 mg and 466 placebo-treated patients for up to 21 months, The total frequency of adverse reactions found for this combination was comparable to placebo. Olmesartan medoxomil / hydrochlorothiazide 20 mg / 12.5 mg and 20 mg / 25 mg (2%) treatment discontinuations for adverse reactions were comparable to those treated with placebo (3%). Compared with placebo, the frequency of treatment-related adverse events with age (<65 years vs. ≥ 65 years), sex, or race did not occur, although the frequency of dizziness was somewhat slightly increased in patients aged 75 years or older.

In addition, the safety of ALTEISDUO as a high-dose combination was evaluated in clinical trials in 3709 patients receiving olmesartan medoxomil in combination with hydrochlorothiazide at 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 were used to rank the adverse events in order of frequency: very common (≥ 1/10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to < 1/100), rare (≥1 / 10000 to <1/1000), very rare (<1/10000).

Classes of MedDRA Organ Systems	Side effects	Frequency
Classes of MedDRA Organ Systems	Side effects	Olmesartan Medoxomil / Hydrochlorothiazide Association	Olmesartan medoxomil	hydrochlorothiazide
Infections and infestations	sialadenitis			Rare
Blood and lymphatic system disorders	Aplastic anemia			Rare
	Myelosuppression			Rare
	Hemolytic anemia			Rare
	leukopenia			Rare
	Neutropenia / agranulocytosis			Rare
	thrombocytopenia		Rare	Rare
Immune system disorder	Anaphylactic reactions		Rare	Rare
Metabolism and nutrition disorders	Anorexia			Rare
	glycosuria			Frequent
	hypercalcemia			Frequent
	hypercholesterolaemia	Rare		Very common
	hyperglycemia			Frequent
	hyperkalemia		Rare
	hypertriglyceridemia	Rare	Frequent	Very common
	hyperuricemia	Rare	Frequent	Very common
	hypochloraemia			Frequent
	Hypochloremic alkalosis			Very rare
	hypokalemia			Frequent
	hypomagnesemia			Frequent
	hyponatremia			Frequent
	hyperamylasemia			Frequent
Psychiatric disorders	Apathy			Rare
	Depression			Rare
	agitation			Rare
	Sleeping troubles			Rare
Nervous system disorders	Confusional state			Frequent
	convulsions			Rare
	Disorders of consciousness (such as loss of consciousness)	Rare
	Dizziness / lightheadedness	Frequent	Frequent	Frequent
	Headache	Frequent	Frequent	Rare
	Loss of appetite			Rare
	paresthesia			Rare
	Postural dizziness	Rare
	Drowsiness	Rare
	Syncope	Rare
Eye disorders	Decrease of lacrimal secretions			Rare
	Transient impairment of vision			Rare
	Aggravation of pre-existing myopia			Rare
	xanthopsia			Rare
Affections of the ear and labyrinth	Dizziness	Rare	Rare	Rare
Heart conditions	Angina pectoris		Rare
	Heart arrhythmias			Rare
	palpitations	Rare
Vascular disorders	embolisms			Rare
	hypotension	Rare	Rare
	Necrotizing vasculitis (vasculitis, cutaneous vasculitis)			Rare
	Orthostatic hypotension	Rare		Rare
	Thrombosis			Rare
Respiratory, thoracic and mediastinal disorders	Bronchitis		Frequent
	Cough	Rare	Frequent
	Dyspnea			Rare
	Interstitial pneumonia			Rare
	Pharyngitis		Frequent
	Pulmonary edema			Rare
	Respiratory distress			Rare
	rhinitis		Frequent
Gastrointestinal disorders	Abdominal pain	Rare	Frequent	Frequent
	Constipation			Frequent
	diarrhea	Rare	Frequent	Frequent
	Dyspepsia	Rare	Frequent
	Gastric irritation			Frequent
	Gastroenteritis		Frequent
	meteorism			Frequent
	nausea	Rare	Frequent	Frequent
	pancreatitis			Rare
	Paralytic ileus			Very rare
	vomiting	Rare	Rare	Frequent
Hepatobiliary disorders	Acute cholecystitis			Rare
Hepatobiliary disorders	Jaundice (intrahepatic cholestatic jaundice)			Rare
Skin and subcutaneous tissue disorders	Allergic dermatitis		Rare
	Cutaneous anaphylactic reactions			Rare
	Angioneurotic edema	Rare	Rare
	Lupus erythematous reactions			Rare
	Eczema	Rare
	Erythema			Rare
	Exanthema		Rare
	Photosensitivity reactions			Rare
	itching		Rare	Rare
	purpura			Rare
	rash	Rare	Rare	Rare
	Reactivation of cutaneous lupus erythematosus			Rare
	Toxic epidermal necrosis			Rare
	Urticaria	Rare	Rare	Rare
Musculoskeletal and systemic disorders	arthralgia	Rare
	Arthritis		Frequent
	Back pain	Rare	Frequent
	Muscle spasms	Rare	Rare
	Muscular weakness			Rare
	myalgia	Rare	Rare
	Pain at the extremities	Rare
	paresis			Rare
	Bone pain		Frequent
Renal and urinary disorders	Acute renal failure	Rare	Rare
	hematuria	Rare	Frequent
	Interstitial nephritis			Rare
	Renal failure		Rare
	Abnormalities of renal function			Rare
	Urinary tract infection		Frequent
Disorders of reproductive organs and breast	Erectile dysfunction	Rare		Rare
General disorders and administration site conditions	Asthenia	Frequent	Rare
	Chest pains	Frequent	Frequent
	Edema of the face		Rare
	Tired	Frequent	Frequent
	Fever			Rare
	Flu syndrome		Frequent
	Lethargy		Rare
	Discomfort	Rare	Rare
	pains		Frequent
	Peripheral edema	Frequent	Frequent
	Weakness	Rare
investigations	Increase in ALT	Rare
	Increase in ASAT	Rare
	hypercalcemia	Rare
	elevated serum creatinine concentrations	Rare	Rare	Frequent
	Increased blood creatine phosphokinase		Frequent
	hyperglycemia	Rare
	Decreased hematocrit	Rare
	Decreased hemoglobin level	Rare
	hyperlipidemia	Rare
	hypokalemia	Rare
	hyperkalemia	Rare
	Increased blood urea level	Rare	Frequent	Frequent
	Increase in blood nitrogen	Rare
	Increased blood uric acid level	Rare
	Increase in gamma-GT	Rare
	Increased liver enzymes		Frequent