Comprimés d'azithromycine GMP 500 mg GMP

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Description du produit

Overview

Le tableau ci-dessous répertorie les effets indésirables identifiés par l'expérience des essais cliniques et la surveillance post-commercialisation par classe de système d'organe et fréquence.

Le groupe de fréquences est défini à l'aide de la convention suivante:

Très fréquent (≥1 / 10); Fréquent (≥ 1/100 à <1/10); Peu fréquent (≥ 1/1 000 à <1/100); Rare (≥ 1/10 000 à <1/1 000); Très rare (<1/10 000) et inconnu (ne peut être estimé à partir des données disponibles).

Dans chaque groupe de fréquence, les effets indésirables sont présentés par ordre décroissant de gravité.

Effets indésirables possiblement ou probablement liés à l'azithromycine sur la base de l'expérience des essais cliniques et de la surveillance post-commercialisation:

System Organ Class	Frequency	Adverse reaction
Infections and infestations	Uncommon	Candidiasis Vaginal infection Pneumonia Fungal infection Bacterial infection Pharyngitis Gastroenteritis Respiratory disorder Rhinitis Oral candidiasis
Infections and infestations	Not known	Pseudomembranous colitis (see section 4.4)
Blood and lymphatic system disorders	Uncommon	Leukopenia Neutropenia Eosinophilia
Blood and lymphatic system disorders	Not known	Thrombocytopenia Haemolytic anaemia
Immune system disorders	Uncommon	Angioedema Hypersensitivity
Immune system disorders	Not known	Anaphylactic reaction (see section 4.4)
Metabolism and nutrition disorders	Uncommon	Anorexia
Psychiatric disorders	Uncommon	Nervousness Insomnia
	Rare	Agitation Depersonalisation
	Not known	Aggression Anxiety Delirium Hallucination
Nervous system disorders	Common	Headache
	Uncommon	Dizziness Somnolence Dysgeusia Paraesthesia
	Not known	Syncope, convulsion Hypoaesthesia Psychomotor hyperactivity Anosmia Ageusia Parosmia Myasthenia gravis (see section 4.4).
Eye disorders	Uncommon	Visual impairment
Eye disorders	Not known	Blurred vision
Ear and labyrinth disorders	Uncommon	Ear disorder Vertigo
Ear and labyrinth disorders	Not known	Hearing impairment including deafness and/or tinnitus
Cardiac disorders	Uncommon	Palpitations
Cardiac disorders	Not known	Torsades de pointes (see section 4.4) Arrhythmia (see section 4.4) including ventricular tachycardia electrocardiogram QT prolonged (see section 4.4)
Vascular disorders	Uncommon	Hot flush
Vascular disorders	Not known	Hypotension
Respiratory, thoracic and mediastinal disorders	Uncommon	Dyspnoea Epistaxis
Gastrointestinal disorders	Very common	Diarrhoea
	Common	Vomiting Abdominal pain Nausea
	Uncommon	Constipation Flatulence Dyspepsia Gastritis Dysphagia Abdominal distension Dry mouth Eructation Mouth ulceration Salivary hypersecretion
	Not known	Pancreatitis Tongue discolouration
Hepatobiliary disorders	Uncommon	Hepatitis
	Rare	Hepatic function abnormal Jaundice cholestatic
	Not known	Hepatic failure (which has rarely resulted in death) (see section 4.4)* Hepatitis fulminant Hepatic necrosis
Skin and subcutaneous tissue disorders	Uncommon	Rash Pruritus Urticaria Dermatitis Dry skin Hyperhidrosis
	Rare	Photosensitivity reaction Acute generalised exanthematous pustulosis (AGEP)
	Not known	Steven-Johnson syndrome Toxic epidermal necrolysis Erythema multiforme
Musculoskeletal and connective tissue disorders	Uncommon	Osteoarthritis Myalgia Back pain Neck pain
Musculoskeletal and connective tissue disorders	Not known	Arthralgia
Renal and urinary disorders	Uncommon	Dysuria Renal pain
Renal and urinary disorders	Not known	Renal failure acute Nephritis interstitial
Reproductive system and breast disorders	Uncommon	Metrorrhagia Testicular disorder
General disorders and administration site conditions	Uncommon	Oedema Asthenia Malaise Fatigue Face oedema Chest pain Pyrexia Pain Peripheral oedema
Investigations	Common	Lymphocyte count decreased Eosinophil count increased Blood bicarbonate decreased Basophils increased Monocytes increased Neutrophils increased
Investigations	Uncommon	Aspartate aminotransferase increased Alanine aminotransferase increased Blood bilirubine increased Blood urea increased Blood creatinine increased Blood potassium abnormal Blood alkaline phosphatase increased Chloride increased Glucose increased Platelets increased Hematocrit decreased Bicarbonate increased Abnormal sodium
Injury and poisoning	Uncommon	Post procedural complication