Generic drug of Amlor
Therapeutic class: Cardiology and angiology
active ingredients: Amlodipine
laboratory: Sanofi-Aventis France
Box of 90
Chronic stable angina
Vasospastic angina (Prinzmetal syndrome)
Dosage AMLODIPINE ZENTIVA 10 mg Capsule Box of 90
For hypertension and angina, the usual starting dose is 5 mg AMLODIPINE ZENTIVA once daily, which can be increased to a maximum dosage of 10 mg depending on the patient's individual response.
In hypertensive patients, AMLODIPINE ZENTIVA has been used in combination with a thiazide diuretic, an alpha blocker, a beta-blocker or an angiotensin converting enzyme inhibitor. In angina, AMLODIPINE ZENTIVA may be used alone or in combination with other antianginal agents in patients with nitrate-refractory angina and / or adequate doses of beta-blockers.
No dose adjustment of AMLODIPINE ZENTIVA is necessary when coadministered with thiazide diuretics, beta-blockers and angiotensin converting enzyme inhibitors.
AMLODIPINE ZENTIVA used at similar doses shows good equivalent tolerance in elderly patients and younger patients. Normal dosing regimens are recommended for elderly patients, but dosage increases should be made with caution (see Warnings and Precautions and Pharmacokinetic Properties sections).
Dose recommendations have not been established in patients with mild to moderate hepatic impairment therefore the dose should be selected with caution and should start at the lowest effective dose (see sections Warnings and Precautions for Use). and pharmacokinetic properties ). 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.
Changes in plasma concentrations of amlodipine are not correlated with the degree of renal impairment, so a usual dosage is recommended. Amlodipine is not dialysable.
Children and adolescents
Hypertensive children and adolescents from 6 to 17 years old.
The recommended oral antihypertensive dosage in children aged 6 to 17 years is 2.5 mg once daily as the initial dose, which can be increased to 5 mg once daily if the desired blood pressure is not reached after four weeks. Doses greater than 5 mg once daily have not been studied in pediatric patients (see sections Pharmacodynamic properties and Pharmacokinetic properties ).
A dosage of 2.5 mg amlodipine is not possible with this drug.
Children under 6 years old.
There is no data available.
Capsule for oral administration.
Amlodipine is contraindicated in patients with:
· Hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients.
· Severe hypotension.
· Shock (including cardiogenic shock)
· Obstruction of the left ventricular outflow tract (eg, high degree of aortic stenosis).
· Hemodynamically unstable heart failure after acute myocardial infarction.
Adverse effects Amlodipine Zentiva
Summary of the security profile
The most common side effects reported during treatment are drowsiness, dizziness, headache, palpitations, flushing, abdominal pain, nausea, swollen ants, edema, and fatigue.
List of undesirable effects
The following adverse reactions have been observed and reported during treatment with amlodipine at the following frequencies: very common (≥ 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to ≤ 1/100); rare (≥ 1/10 000 to ≤ 1/1 000); very rare (≤1 / 10, 000).
In each frequency group, the adverse effects are presented in order of decreasing severity.
Class of organ systems
Blood and lymphatic system disorders
Immune system disorders
Metabolism and nutrition disorders
Insomnia, change of mood (including anxiety), depression
Nervous system disorders
Drowsiness, dizziness, headache (especially at the beginning of treatment)
Tremor, dysgeusia, syncope, hypoaesthesia, paresthesia
Hypertonia, peripheral neuropathy
Visual disorder (including, diplopia)
Affections of the ear and labyrinth
Myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Respiratory, thoracic and mediastinal disorders
Abdominal pain, nausea
Vomiting, dyspepsia, transit disorders (including diarrhea and constipation), dry mouth
Pancreatitis, gastritis, gingival hyperplasia
Hepatitis, jaundice, elevated liver enzymes *
Skin and subcutaneous tissue disorders
Alopecia, purpura, change of skin color, hyperhidrosis, pruritus, rash, exanthema
Angioedema, erythema multiforme, urticaria, exfoliating dermatitis, Stevens-Johnson syndrome, angioedema, photosensitivity
Musculoskeletal, Connective Tissue and Bone Disorders
Edema of the ankles
Arthralgia, myalgia, muscle cramp, back pain
Renal and urinary disorders
Micturition disorder, nocturia, increased urinary frequency
Disorders of reproductive organs and breast
General disorders and administration site conditions
Chest pain, asthenia, pain, discomfort
Increased weight, decreased weight
* Generally suggestive of cholestasis
Exceptional cases of extrapyramidal syndrome have been reported.