Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Amlodipine, Amlodipine
laboratory: BB Farma Srl
box of 90
All forms
Indication
Hypertension.
Chronic stable angina.
Vasospastic angina (Prinzmetal syndrome).
Dosage AMLOR 5 mg capsule box of 90
Hypertension.
Chronic stable angina.
Vasospastic angina (Prinzmetal syndrome).
Against indications
Amlodipine is contraindicated in patients with:
· Hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients listed under Composition .
· 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 Amlor
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 side effects have been observed and reported during treatment with amlopidine 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 | Frequency | Side effects |
Blood and lymphatic system disorders | Very rare | Leukocytopenia, thrombocytopenia |
Immune system disorders | Very rare | Allergic reaction |
Metabolism and nutrition disorders | Very rare | hyperglycemia |
Psychiatric disorders | Rare | Depression, change of mood (including anxiety), insomnia |
Rare | Confusion | |
Nervous system disorders | Frequent | Drowsiness, dizziness, headache (especially at the beginning of treatment) |
Rare | Tremor, dysgeusia, syncope, hypoaesthesia, paresthesia | |
Very rare | Hypertonia, peripheral neuropathy | |
Eye disorders | Frequent | Visual disorder (including, diplopia) |
Affections of the ear and labyrinth | Rare | tinnitus |
Heart conditions | Frequent | palpitations |
Rare | Arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation) | |
Very rare | Myocardial infarction | |
Vascular disorders | Frequent | Flushing |
Rare | hypotension | |
Very rare | vasculitis | |
Respiratory, thoracic and mediastinal disorders | Frequent | Dyspnea |
Rare | Cough rhinitis | |
Gastrointestinal disorders | Frequent | Abdominal pain, nausea, dyspepsia, transit disorders (including diarrhea and constipation) |
Rare | Vomiting, dry mouth | |
Very rare | Pancreatitis, gastritis, gingival hyperplasia | |
Hepatobiliary disorders | Very rare | Hepatitis, jaundice, hepatic enzyme elevation * |
Skin and subcutaneous tissue disorders | Rare | Alopecia, purpura, change of skin color, hyperhidrosis, pruritus, rash, exanthema, urticaria |
Very rare | Angioedema, erythema multiforme, exfoliating dermatitis, Stevens-Johnson syndrome, angioedema, photosensitivity | |
Musculoskeletal, Connective Tissue and Bone Disorders | Frequent | Edema of the ankles, muscle cramps |
Rare | Arthralgia, myalgia, back pain | |
Renal and urinary disorders | Rare | Micturition disorder, nocturia, increased urinary frequency |
Disorders of reproductive organs and breast | Rare | Impotence, gynecomastia |
General disorders and administration site conditions | Very common | Edema |
Frequent | Fatigue, asthenia | |
Rare | Chest pain, pain, discomfort | |
investigations | Rare | Increased weight, decreased weight |
* Evoking generally cholestasis.
Exceptional cases of extrapyramidal syndrome have been reported.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.
