Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as: Upper respiratory tract infections Otitis media Acute and chronic bronchitis Chronic bronchial sepsis Lobar and bronchopneumonia Cystitis, urethritis, pyelonephritis Bacteriuria in pregnancy Gynaecological infections including puerperal sepsis and septic abortion Gonorrhoea Peritonitis Intra-abdominal sepsis Septicaemia Bacterial endocarditis Typhoid and paratyphoid fever Skin and soft tissue infections Osteomyelitis Dental abscess (as an adjunct to surgical management) In children with urinary tract infection the need for investigation should be considered. 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 bacterial endocarditis. Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents.”Susceptibility of the causative organism to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.

Treatment of Infection: Adult dosage (including elderly patients): Oral: Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections. High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract. Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12

hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose. Children weighing 30ml/min No adjustment necessary. Glomerular filtration rate 10-30ml/min: Amoxicillin. max. 500mg b.d Glomerular filtration rate <10ml/min: Amoxicillin. max. 500mg/day Renal impairment in children under 40 kg:

Amoxil Powder for oral suspensionis recommended for children under six months of age. Prophylaxis of endocarditis:

Prophylaxis of endocarditis: see table on previous page. Administration: Oral. Treatment should be continued for 2 to 3 days following the disappearance of symptoms. It is recommended that at least 10 days treatment be given for any infection caused by beta-haemolytic streptococci in order to achieve eradictaion of the organism.

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3). Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms. In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9 Overdose). In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly (see section 4.2). Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see sections 4.5 and 4.8). Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored. Amoxil Powder for oral suspensioncontains 4 mg of aspartame (E951) per 1.25 ml dose, a source of phenylalanine. This medicine should be used with caution in patients with phenylketonuria.

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxil may result in increased and prolonged blood levels of amoxicillin

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co- administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin (see sections 4.4 and 4.8). It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

Use in pregnancy: Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment. Use in lactation: Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.

Adverse effects on the ability to drive or operate machinery have not been observed.

The following convention has been utilised for the classification of undesirable effects:-

Very common ( >1/10), common ( >1/100, 1/1000,1/10,000, <1/1000), very rare (<1/10,000) The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins. Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

Infections and infestations

Very Rare: Mucocutaneous candidiasis

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 (see section 4.4 – Special Warnings and Precautions for Use .

Immune system disorders

Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis. If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).

Nervous system disorders

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

Gastrointestinal disorders

Clinical Trial Data

*Common: Diarrhoea and nausea.

*Uncommon: Vomiting.

Post-marketing Data

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.

Hepato-biliary 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

Clinical Trial Data

*Common: Skin rash

*Uncommon: Urticaria and pruritus

Post-marketing Data

Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP) (See also Immune system disorders).

Renal and urinary tract disorders

Very rare: Interstitial nephritis. Very rare: Crystalluria (see Section 4.9 Overdose).

*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use). Amoxicillin may be removed from the circulation by haemodialysis.

.1 Pharmacodynamic properties Amoxil is a broad spectrum antibiotic. It is rapidly bactericidal and possesses the safety profile of a penicillin. The wide range of organisms sensitive to the bactericidal action of Amoxil include:

Aerobes:

Gram-positive

Streptococcus faecalis 

Streptococcus pneumoniae 

Streptococcus pyogenes

Streptococcus viridans

Staphylococcus aureus 

(penicillin-sensitive strains only)

Corynebacterium species

Bacillus anthracis

Listeria monocytogenes

Gram-negative

Haemophilus influenzae

Escherichia coli 

Proteus mirabilis 

Salmonella species

Shigella species

Bordetella pertussi

Brucella species

Neisseria gonorrhoeae

Neisseria meningitidis

Vibrio cholerae

Pasteurella septica

Anaerobes: Clostridium species

Amoxil is well absorbed by the oral and parenteral routes. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic. In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 – 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally.

Not applicable.

Amoxil Paediatric Suspension Sodium Benzoate, Sodium Citrate Anhydrous, Disodium Edetate, Quinoline Yellow, Citric Acid Anhydrous, Peach Dry Flavour, Strawberry Dry Flavour, Lemon Dry Flavour, Sucrose (Milled), Kletrol (Xanthan Gum), Bubble Gum Flavour Powder, Sicovit Azofubine 85 E122 and Silicon Dioxide NF 18 (Silica Gel)

None known.

Prior to use, Amoxil Powder for oral suspension should be stored in a dry place. Once dispensed, Amoxil Powder for oral suspension should be stored at 25°C or below and used within 14 days.

100ml/pack (125mg/250mg) Clear bottle with tamper evident ring cap

• Check cap seal is intact before use. • Invert and shake bottle to loosen powder. • Fill the bottle with water to just below the mark on the bottle label. • Invert and shake well, then top up with water to the mark. Invert and shake again. • Shake well before taking each dose.