Medicinal Products

AMLODIPINE BIOGARAN 10 mg

Generic drug of Amlor
Therapeutic class: Cardiology and angiology
active ingredients: Amlodipine, Amlodipine
laboratory: Biogaran

GÚlule
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.

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