Generic drug of Amlor
Therapeutic class: Cardiology and angiology
active ingredients: Amlodipine, Amlodipine
laboratory: Biogaran
bottle of 30
All forms
Indication
Hypertension
Chronic stable angina
Vasospastic angina (Prinzmetal syndrome)
Dosage AMLODIPINE BIOGARAN 10 mg gel bottle of 30
Hypertension
Chronic stable angina
Vasospastic angina (Prinzmetal syndrome)
Against indications
Amlodipine is contraindicated in patients with:
To hypersensitivity to dihydropyridine, amlodipine or any of the excipients.
A severe hypotension.á
A shock (including cardiogenic shock).
An obstruction of the left ventricular ejection pathway (for example, aortic stenosis of degree high).
A hemodynamically unstable heart failure after an acute myocardial infarction.
Adverse effects Amlodipine Biogaran
Summary of the safety profile
The most commonly reported undesirable effects during treatment are drowsiness, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle rash, swelling, and fatigue.
List of undesirable effects
The following undesirable effects have been observed and reported during treatment with amlodipine at the following frequencies: very common (≥ 1/10); frequent (≥ 1/100 to "<1/10); not very frequent (≥ 1/1000 Ã "≤ 1/100); rare (≥ 1/10 000 Ã "≤ 1/1 000); very rare (≤1 / 10, 000).
In each frequency group, the undesirable effects are presented in decreasing order of desirability.
Class of organ systems | FrÚquence | Undesirable effects |
Hematological and lymphatic system disorders | Very rare | Leukocytopenia, thrombocytopenia, |
Immune system disorders | Very rare | Allergic reaction |
Metabolism and nutrition disorders | Very rare | HyperglycÚmie |
Psychiatric disorders | Not very frequent | Insomnia, change of mood (including anxiety), depression |
Rare | Confusion | |
Nervous System Affections | FrÚquent | Drowsiness, dizziness, cephalosis (especially at the beginning of treatment) |
Not very frequent | Tremor, dysgeusia, syncope, hypoesthesia, paresthesia | |
Very rare | Hypertonia, Peripheral neuropathy | |
Eye disorders | Not very frequent | Visual disorder (including, diplopia) |
Affections of the ear and labyrinth | Not very frequent | AcouphÞne |
Heart conditions | FrÚquent | palpitations |
Very rare | Myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation) | |
Vascular disorders | FrÚquent | Vasomotor flush |
Not very frequent | hypotension | |
Very rare | vasculitis | |
Respiratory, thoracic and mediastinal disorders | Not very frequent | Dyspneas, rhinitis |
Very rare | Cough | |
Gastrointestinal disorders | FrÚquent | Abdominal pain, nausea |
Not very frequent | Vomiting, dyspepsia, transit disorders (including diarrhea and constipation), dry mouth | |
Very rare | Pancreatitis, gastritis, gingival hyperplasia | |
Hospital diseases | Very rare | Hepatitis, jaundice, elevation of hepatic enzymes * |
Skin and subcutaneous tissue disorders | Not very frequent | Alopecia, purpura, cutaneous discoloration, hyperhidrosis, pruritus, rash, exanthritis |
Very rare | Angioedema, polymorphous erythema, urticaria, exfoliating dermatitis, Stevens-Johnson syndrome, Quincke's oedîme, photosensibilites | |
Musculoskeletal, Connective Tissue and Bone Disorders | FrÚquent | Ankles of the ankles |
Not very frequent | Arthralgia, myalgia, muscle cramp, back pain | |
Renal and urinary disorders | Not very frequent | Micturition disorder, nocturia, increased urinary frequency |
Disorders of reproductive organs and breast | Not very frequent | Impotence, gynÚcomastieá |
General disorders and administration site abnormalities | FrÚquent | ÃŽdÃÂme, tiredness |
Not very frequent | Chest pain, asthenia, pain, discomfort | |
investigations | Not very frequent | Increased weight, decreased weight |
*? usually referring to cholestasis
Exceptional cases of extrapyramidal syndrome have been reported.
Declaration of suspected undesirable effects
The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national reporting system: National Agency of Safety of Medicines and Health Products (Ansm) and Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.
