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Author: Admin | 2025-04-28
During pregnancy if clinically needed and the benefit of treatment is expected to outweigh any small increased risks which may exist. Breastfeeding Azithromycin has been reported to be secreted into human breast milk, The limited information available from published literature indicates azithromycin is present in human milk at an estimated highest median daily dose of 0.1 to 0.7 mg / kg / day. No serious side effects have been observed by azithromycin in breast-fed infants. A decision should be taken whether breastfeeding is discontinued or that treatment with azithromycin is discontinued/initiated or not, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the woman. Fertility In fertility studies conducted in rat, reduced pregnancy rates were noted following administration of azithromycin. The relevance of this finding to humans is unknown. 4.7 Effects on ability to drive and use machines No data are available regarding the influence of azithromycin on a patient's ability to drive or operate machinery. However, the possibility of undesirable effects like dizziness and convulsions should be taken into account when performing these activities. Visual impairment and vision blurred may have an effect on a patient's ability to drive or operate machinery (section 4.8). 4.8 Undesirable effects Azithromycin is well tolerated with a low incidence of side effects. The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥ 1/100 to Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post-marketing surveillance: Very common ≥ 1/10 Common ≥ 1/100 to Uncommon ≥ 1/1,000 to Rare ≥ 1/10,000 to Very rare Not known frequency cannot be estimated from available data Infections and infestations Candidiasis, Oral candidiasis Vaginal infection Pneumonia Fungal infection Bacterial infection Pharyngitis Gastroenteritis Respiratory disorder, Rhinitis. Pseudo-membranous colitis (see section 4.4) Blood and lymphatic system disorders Leukopenia Neutropenia Eosinophilia Thrombocytopenia, Haemolytic anaemia Immune system disorders Angioedema Hypersensitivity Anaphylactic reaction (see section 4.4.)
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