Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Olmesartan medoxomil
laboratory: Menarini Inter OP Luxemb
Box of 90
Treatment of essential hypertension.
Dosage ALTEIS 20 mg Film-coated tablet Box of 90
The initial dosage of olmesartan is 10 mg once daily. In patients inadequately controlled at this dose, the dosage of olmesartan may be increased to the optimal dose of 20 mg once daily.
If a greater decrease in blood pressure is required, the dosage of olmesartan may be increased to 40 mg once daily or the combination with hydrochlorothiazide (diuretic) may be considered.
The antihypertensive action appears within 2 weeks after initiation of treatment and reaches its maximum in about 8 weeks. Take this into account when adjusting each patient's dosage.
To promote adherence to treatment, it is recommended to take ALTEIS every day at the same time, during or after meals.
In most cases, no dosage adjustment is required in the elderly (see below for dose adjustments in renal impairment). If the maximum dosage of 40 mg per day is required, blood pressure should be closely monitored.
In patients with mild to moderate renal impairment (creatinine clearance 20-60 ml / min), the maximum dose of olmesartan is 20 mg once daily. In patients with severe renal impairment (creatinine clearance <20 ml / min), the use of olmesartan is not recommended (see sections 4.4 and 5.2 ).
No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment, the recommended starting dose of olmesartan is 10 mg once daily and the maximum dosage is 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 antihypertensives. There is no experience of using olmesartan in patients with severe hepatic impairment, so the use of olmesartan is not recommended in this population (see sections 4.4 Special warnings and precautions for use of olmesartan in patients with severe hepatic impairment ). use and pharmacokinetic properties ). Olmesartan should not be used in patients with biliary obstruction (see section 4.3 ).
Children and adolescents
The use of ALTEIS is not recommended for children under the age of 18, given the lack of data concerning their safety and effectiveness in this population.
Hypersensitivity to the active substance or to any of the excipients of ALTEIS (see section List of excipients );
· 2nd and 3rd trimesters of pregnancy (see sections Special warnings and precautions for use and Pregnancy and lactation );
· Breastfeeding (see section on Pregnancy and lactation )
· Biliary obstruction (see section Pharmacokinetic properties ).
Alteis side effects
The following side effects have been reported during the post-marketing experience. They are classified by organ type and order of frequency: very common (≥1 / 10), frequent (≥1 / 100, <1/10), uncommon (≥1 / 1000, <1/100), rare (≥1 / 10000, <1/1000) and very rare (<1/10000) including isolated cases.
Blood and lymphatic system disorders
Metabolism and nutrition disorders
Nervous system disorders
Respiratory, thoracic and mediastinal disorders
Abdominal pain, nausea, vomiting
Skin and subcutaneous disorders
Pruritus, rash, skin rash
Allergic manifestations such as angioneurotic edema, allergic dermatitis, edema of the face and urticaria
Musculoskeletal and Connective Tissue Disorders
Muscle cramps, myalgia
Renal and urinary disorders
Acute renal failure and renal insufficiency (see also Explorations)
Asthenic states such as asthenia, fatigue, lethargy, malaise
Abnormal renal function results such as increased creatinine and uremia
Increased liver enzymes
Isolated cases of rhabdomyolysis have been reported with combinations of angiotensin II receptor antagonists. A causal relationship has not been established.
Clinical trials in monotherapy, double-blind, versus placebo, showed that the total incidence of adverse events was 42.4% under olmesartan and 40.9% under placebo. In these trials, the only unambiguous adverse event attributable to treatment was dizziness (2.5% olmesartan and 0.9% placebo).
The percentage of treatment discontinuations for adverse events during long-term treatment (2 years) was 3.7% in patients treated with 10 to 20 mg / day of olmesartan taken once.
The following adverse events have been observed in clinical trials with olmesartan versus reference or placebo, regardless of the causality or incidence of these effects compared to placebo. They are listed below, classified by type of organ and in order of frequency, according to the same criteria as before:
Central nervous system disorders
Cardiovascular system disorders
Uncommon: angina pectoris
Respiratory system disorders
Frequent: bronchitis, cough, pharyngitis, rhinitis
Common: abdominal pain, diarrhea, dyspepsia, gastroenteritis, nausea
Frequent: arthritis, back pain, bone pain
Urinary tract disorders
Frequent: hematuria, urinary tract infection
Frequent: chest pain, fatigue, flu syndrome, peripheral edema, pain
In placebo-controlled clinical trials, the incidence of hypertriglyceridemia (2.0% versus 1.1%) and creatine phosphokinase increase (1.3% versus 0.7%) was slightly higher on olmesartan than on placebo.
Undesirable effects on the biological endpoints observed in clinical trials with olmesartan (including trials without placebo), regardless of the causality or incidence of these effects compared to placebo, included:
Metabolic and nutritional disorders
Frequent: elevation of creatine phosphokinase, hypertriglyceridemia, hyperuricemia
Hepatic and biliary disorders
Frequent: elevation of liver enzymes
Other information on particular populations
In the elderly, the frequency of hypotension is slightly increased from "rare" to "infrequent".