QUALITATIVE AND QUANTITATIVE COMPOSITION

• AMOXIL Capsules 250 mg contain 250 mg amoxicillin per capsule.
• AMOXIL Capsules 500 mg contain 500 mg amoxicillin per capsule.
• AMOXIL Suspension 125 mg contains 125 mg amoxicillin per 5 ml dose.
• AMOXIL Suspension Forte 250 mg contains 250 mg amoxicillin per 5 ml dose.
• AMOXIL Paediatric Suspension contains 125 mg amoxicillin per 1.25 ml dose.

The amoxicillin is present as the trihydrate in AMOXIL oral presentations.

Indications

AMOXIL is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:

• Respiratory tract infections e.g. ear, nose and throat infections.
• Gastrointestinal tract infections e.g. enteric fever.
• Urinary tract infections.
• Skin and soft tissue infections.
• Biliary tract infections.
• Bone infections.
• Pelvic infections.
• Gonorrhoea (non-penicillinase producing strains).
• Syphilis.
• Septicaemia.
• Endocarditis.
• Meningitis.
• Peritonitis.
• Dental abscess (as an adjunct to surgical management).
• Prophylaxis of endocarditis- AMOXIL may be used for the prevention of bacteraemia associated with procedures such as dental extraction, in patients at risk of developing of endocarditis.

Dosage and Administration

Adult dosage (including elderly patients)

• Standard adult dosage: 250 mg 3 times daily, increasing to 500 mg 3 times daily for more severe infections.
• Dental Abscess: two 3 g doses with 8 hours between the doses.
• Gonorrhoea 3 g dose.

Children’s dosage: (up to 10 years of age)

Standard children’s dosage: 125 mg 3 times daily, increasing to 250 mg 3 times daily for more severe infections.

Side Effects

Blood and lymphatic system disorders

Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin time.

Immune system disorders

Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis , serum sickness and hypersensitivity vasculitis. If a hypersensitivity reaction is reported, the treatment must be discontinued.

Nervous system disorders

Very rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Infections and Infestations

Very rare: Mucocutaneous candidiasis.

Gastrointestinal disorders

• Common: Diarrhoea and nausea.
• Uncommon: Vomiting.
• Very rare: Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis), Black hairy tongue.
• Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing (for suspension only).

Hepatobiliary disorders

Very rare: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT. The significance of a rise in AST and/or ALT is unclear.

Skin and subcutaneous tissue disorders

• Common: Skin rash.
• Uncommon: Urticaria and pruritus.
• Very rare: Skin reactions such as erythema multiforme, Stevens – Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP).

Renal and urinary tract disorders

Very rare: Interstitial nephritis, crystalluria.

AMOXIL®- Information Leaflet