Medicinal Products

AXELER 40 mg / 10 mg

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

Coated tablet
Box of 90
All forms

Indication

Treatment of essential hypertension.

AXELER is indicated in adult patients whose blood pressure is not adequately controlled by olmesartan medoxomil or amlodipine monotherapy (see sections Posology and method of administration and Pharmacodynamic properties ).

Dosage AXELER 40 mg / 10 mg Film-coated tablet Box of 90

adults

The recommended dosage of AXELER is one tablet per day.

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

Gradual adjustment of the dose of each component is recommended before switching to the fixed dose combination. Direct switching from monotherapy to fixed-dose combination may be considered if clinically justified.

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

AXELER can be taken during or after meals.

Elderly (65 years old and over)

In most cases, no dose adjustment of the recommended dose is required in the elderly, but any increase in dosage should be done with caution (see Warnings and Precautions and Pharmacokinetic Properties sections). If an increase to the maximum dose of olmesartan medoxomil 40 mg daily is required, blood pressure should be closely monitored.

Renal failure

In patients with mild to moderate renal impairment (creatinine clearance 20-60 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. In patients with severe renal impairment (creatinine clearance <20 ml / min), the use of AXELER is not recommended (see sections Warnings and Precautions and Pharmacokinetic Properties ). In patients with moderate renal impairment, it is advisable to monitor potassium and creatinine levels.

Hepatic insufficiency

AXELER should be used with caution in patients with mild to moderate hepatic impairment (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 is 20 mg once daily.

Close monitoring of blood pressure and renal function is recommended in patients with hepatic insufficiency already treated with diuretics and / or other antihypertensives. There is no experience of using olmesartan medoxomil in patients with severe hepatic impairment.

As with any calcium antagonist, the half-life of amlodipine is prolonged in patients with impaired hepatic function and dosing recommendations have not been established. Therefore, AXELER should be administered with caution in these patients. The pharmacokinetic properties of amlodipine have not been studied in patients with severe hepatic impairment. Amlodipine should be started at the lowest dose and slowly increased in patients with severe hepatic impairment. The use of AXELER in patients with severe hepatic impairment is contraindicated (see section 4.3 ).

Pediatric population

The safety and effectiveness of AXELER in children and adolescents under 18 years of age have not been established. No data available.

Mode of administration :

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 the active substances, dihydropyridines or to any of the excipients (see section Composition ).

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

· Severe hepatic impairment and obstruction of the biliary tract (see section Pharmacokinetic properties ).

· Due to the presence of amlodipine, AXELER is also contraindicated in patients with:

o severe hypotension,

o shock (including cardiogenic shock),

o Obstruction of the left ventricular outflow tract (eg, high grade aortic stenosis),

o Hemodynamically unstable heart failure after acute myocardial infarction.

Axeler side effects

Axeler

The most commonly reported adverse reactions during treatment with AXELER are peripheral edema (11.3%), headache (5.3%) and dizziness (4.5%).

The adverse effects observed with AXELER 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 amlodipine, 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 (≥ 1/10 000 to <1/1000)

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data)

Classes of MedDRA Organ Systems

Side effects

Frequency

Olmesartan medoxomil / amlodipine combination

Olmesartan medoxomil

amlodipine

Blood and lymphatic system disorders

leucocytopenia

Very rare

thrombocytopenia

Rare

Very rare

Immune system disorders

Allergic reaction / Hypersensitivity to the product

Rare

Very rare

Anaphylactic reaction

Rare

Metabolism and nutrition disorders

hyperglycemia

Very rare

hyperkalemia

Rare

Rare

hypertriglyceridemia

Frequent

hyperuricemia

Frequent

Psychiatric disorders

Confusion

Rare

Depression

Rare

Insomnia

Rare

Irritability

Rare

Decreased libido

Rare

Mood changes (including anxiety)

Rare

Nervous system disorders

Dizzying sensations

Frequent

Frequent

Frequent

dysgeusia

Rare

headaches

Frequent

Frequent

Frequent (especially at the beginning of treatment)

hypertonia

Very rare

Hypoaesthesia

Rare

Rare

Lethargy

Rare

paresthesia

Rare

Rare

Peripheral neuropathy

Very rare

Postural dizziness

Rare

Sleeping troubles

Rare

Drowsiness

Frequent

Syncope

Rare

Rare

tremors

Rare

Eye disorders

Visual disorders (including diplopia)

Rare

Affections of the ear and labyrinth

tinnitus

Rare

Dizziness

Rare

Rare

Heart conditions

Angina pectoris

Rare

Uncommon (including aggravation of angina pectoris)

Arrhythmias (including bradycardia, ventricular tachycardias and atrial fibrillation)

Very rare

Myocardial infarction

Very rare

palpitations

Rare

Rare

tachycardia

Rare

Vascular disorders

hypotension

Rare

Rare

Rare

Orthostatic hypotension

Rare

Congestive flushes

Rare

Frequent

vasculitis

Very rare

Respiratory, thoracic and mediastinal disorders

Bronchitis

Frequent

Cough

Rare

Frequent

Very rare

Dyspnea

Rare

Rare

Pharyngitis

Frequent

rhinitis

Frequent

Rare

Gastrointestinal disorders

Abdominal pain

Frequent

Frequent

Altered intestinal transit (including diarrhea and constipation)

Rare

Constipation

Rare

Diarrhea

Rare

Frequent

Dryness of the mouth

Rare

Rare

Dyspepsia

Rare

Frequent

Rare

Gastritis

Very rare

Gastroenteritis

Frequent

Gingival hyperplasia

Very rare

nausea

Rare

Frequent

Frequent

pancreatitis

Very rare

Epigastric pain

Rare

vomiting

Rare

Rare

Rare

Hepatobiliary disorders

Increased liver enzymes

Frequent

Very rare (mostly associated with cholestasis)

Hepatitis

Very rare

Jaundice

Very rare

Skin and subcutaneous tissue disorders

Alopecia

Rare

Angioneurotic edema

Rare

Very rare

Allergic dermatitis

Rare

Erythema multiforme

Very rare

Exanthema

Rare

Rare

Exfoliative dermatitis

Very rare

Hyperhidrosis

Rare

Photosensitivity

Very rare

itching

Rare

Rare

purpura

Rare

Angioedema

Very rare

rash

Rare

Rare

Rare

Discoloration of the skin

Rare

Stevens Johnson Syndrome

Very rare

Urticaria

Rare

Rare

Very rare

Musculoskeletal and systemic disorders

Swelling of the ankles

Frequent

arthralgia

Rare

Arthritis

Frequent

Back pain

Rare

Frequent

Rare

Muscle spasms

Rare

Rare

Rare

myalgia

Rare

Rare

Pain in the extremities

Rare

Bone pain

Frequent

Renal and urinary disorders

Acute renal failure

Rare

hematuria

Frequent

Increased frequency of voiding

Rare

Troubles with urination

Rare

nocturia

Rare

Urinary frequency

Rare

Renal failure

Rare

Urinary tract infection

Frequent

Disorders of reproductive organs and breast

Erectile dysfunction / impotence

Rare

Rare

gynecomastia

Rare

General disorders and administration site conditions

Asthenia

Rare

Rare

Rare

Chest pains

Frequent

Rare

Edema of the face

Rare

Rare

Tired

Frequent

Frequent

Frequent

Flu syndrome

Frequent

Lethargy

Rare

Discomfort

Rare

Rare

Edema

Frequent

Frequent

pains

Frequent

Rare

Peripheral edema

Frequent

Frequent

Edema taking the bucket

Frequent

investigations

elevated serum creatinine concentrations

Rare

Rare

Increased blood creatine phosphokinase

Frequent

hypokalemia

Rare

Increased blood urea

Frequent

hyperuricemia

Rare

Increase in gamma-GT

Rare

Weightloss

Rare

Weight gain

Rare

Isolated cases of rhabdomyolysis have been reported with combinations of angiotensin II receptor antagonists. Isolated cases of extrapyramidal syndrome have been reported in patients treated with amlodipine.

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