Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Olmesartan medoxomil, Hydrochlorothiazide
laboratory: Menarini Inter OP Luxemb
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 | ||
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 | ||
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 |
Isolated cases of rhabdomyolysis have been reported with combinations of angiotensin II receptor antagonists.