Medicinal Products

AMLOR 5 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Amlodipine, Amlodipine
laboratory: BB Farma Srl

capsule
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.

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