CLAMELLE

Posology A single 1g (2 x 500mg tablets) dose. Special populations Renal impairment No dose adjustment is required in patients with GFR ≥10 ml/min. 2). 2). No data are available in patients with severe hepatic impairment (Child-Pugh Class C).

4). 2). 4). Method of administration For oral use. Tablets should be swallowed whole as a single dose and may be taken with or without a meal. Administration immediately before a meal may enhance the gastrointestinal tolerability. Other pharmaceutical forms are available that may be more appropriate to treat patients unable to swallow tablets as well as paediatric patients weighing less than 45 kg.

Summary of the safety profile The most commonly reported adverse reactions during treatment include diarrhoea, headache, vomiting, abdominal pain, nausea and abnormal laboratory test values. 4). 4). Tabulated list of adverse reactions Adverse reactions identified through clinical trial experience and post marketing surveillance are listed below, by system organ class and frequency.

Frequencies of adverse reaction occurrence are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 3:

Tabulated list of adverse reactions Very Common Common Uncommon Rare Unknown System Organ Class > 1/10 ≥ 1/100 to < 1/10 ≥ 1/1,000 to < 1/100 ≥ 1/10,000 to < 1/1,000 Infections and infestations Candidia infection Oral candidiasis Vaginal infection Pneumonia, Fungal infection Bacterial infection Pharyngitis Gastroenteritis Rhinitis.

4) Hepatitis fulminant Hepatic necrosis, Skin and subcutaneous tissue disorders Rash Pruritus Urticaria Dermatitis Dry skin Hyperhidrosis Acute generalised exanthemat ous pustulosis (AGEP) Drug reaction with eosinophilia and systemic symptoms (DRESS) Photosensiti vity reaction Toxic epidermal necrolysis Stevens- Johnson syndrome Erythema multiforme Musculoskele tal and connective tissue disorders Osteoarthritis Myalgia Back pain Neck pain Arthralgia Renal and urinary disorders Dysuria Renal pain Blood urea Acute kidney injury Very Common Common Uncommon Rare Unknown System Organ Class > 1/10 ≥ 1/100 to < 1/10 ≥ 1/1,000 to < 1/100 ≥ 1/10,000 to < 1/1,000 increased Blood creatinine increased Tubulointersti tial nephritis Reproductive system and breast disorders Intermenstrual bleeding Testicular disorder General disorders and administratio n site conditions Oedema Face oedema Chest pain Pyrexia Pain Peripheral oedema Malaise Fatigue Asthenia Investigations Blood bicarbonate decreased Blood potassium abnormal Blood chloride increased Blood glucose increased Blood bicarbonate increased Blood sodium abnormal Injury, poisoning and procedural complications Post procedural complications Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

2). Treatment with azithromycin should only be initiated after a careful assessment of the benefit and the risks, considering the local prevalence of resistance, and when preferred treatment regimens are not indicated. 8). At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.

Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment. If an allergic reaction occurs, azithromycin should be discontinued and appropriate therapy should be instituted.

Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. 8). 5) • With electrolyte disturbance, particularly in cases of hypokalaemia and hypomagnesaemia • With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency • Elderly patients: Elderly patients may be more susceptible to drug-associated effects on the QT interval Hepatotoxicity Since liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease.

Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin. 8). Some patients may have had pre- existing hepatic disease or may have been taking other hepatotoxic medicinal products.

Patients should be advised to stop azithromycin administration and to contact their physician if signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy develop.

In such cases liver function tests/investigations should be performed immediately. 8). CDAD and pseudomembranous colitis must be considered in patients who present with diarrhoea during or subsequent to the administration of azithromycin.

1. - Relative for Azithromycin sold as a Pharmacy Medicine. - Symptomatic infection. g. any unusual genital or anal swellings or lesions. - Children aged under 16 years. - Individuals receiving terfenadine and disopyramide. - Individuals receiving azithromycin for treatment of other infections.