GlaxoSmithKline (Ireland) Ltd

Amoxil Paediatric 125mg/1.25ml Powder for Oral Suspension

125mg amoxicillin per 1.25ml as amoxicillin trihydrate

For excipients see section 6.1.

Powder for oral suspension

White free flowing powder

In the treatment of infections due to organisms sensitive to amoxicillin and in the oral prophylaxis of endocarditis related to dental procedures, acute uncomplicated gonorrhoea and dental abscess (as an adjunct to surgical management).

Route of administration: oral

The absorption of 'Amoxil' is virtually unimpaired by the presence of food.

Standard adult dosage: The usual daily dosage is 750mg in divided doses (i.e. 250mg three times daily by the oral route).

In cases of severe infection the dosage may be doubled, or 'Amoxil' given by injection.

High dosage therapy: (maximum recommended oral dosage of 6g daily in divided doses): A dosage of 3g 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 3g doses with 10-12 hours between the doses.

Gonorrhoea: 3g as a single dose.

Dental Abscess: two 3g doses with 8 hours between the doses.

Children up to 10 years of age:

The usual total daily dosage is 375mg in divided doses (i.e. 125mg three times daily by the oral route).

Dosage may be increased in the case of severe infection.

In severe or recurrent acute otitis media, especially where compliance may be a problem, 750mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

Prophylaxis of Endocarditis

For dental procedures where an oral dose is appropriate:

Renal impairment: In renal impairment the excretion of the antibiotic will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dosage.

Adults:

Children under 40kg

Amoxicillin Paediatric Suspension is recommended for children under 6 months of age.

Amoxicillin may be removed from the circulation by haemodialysis.

Use in patients with a history of hypersensitivity to beta-lactam antibiotics including penicillins or cephalosporins.

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins. Cross-sensitivity between penicillins and cephalosporins is well documented.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) has been reported in patients receiving beta-lactam antibiotics. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate alternative therapy instituted.

Amoxicillin should be avoided if infectious mononucleosis (glandular fever) is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Prolonged use of an anti-infective may occasionally result in overgrowth of non-susceptible organisms.

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 concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

'Amoxil' Paediatric Suspension contains sodium benzoate.

Dosage should be adjusted in patients with renal impairment (see Section 4.2).

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 crytalluria.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

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.

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. Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Use in lactation:

Amoxicillin may be administered during the period of 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 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 (more than 1/10), common (more than 1/100, less than 1/10), uncommon (more than 1/1000, less than 1/100), rare (more than 1/10,000, less than 1/1000), very rare (less than 1/10,000).

The majority of the side-effects listed below are not unique to amoxicillin and may occur when using other penicillins.

Unless otherwise stated, the frequency of adverse events (AEs) has been derived from more than 30 years of post-marketing reports.

Gross overdose will produce very high urinary concentrations, more so after parenteral administration. Symptoms of water/electrolyte imbalance should be treated symptomatically. Problems are unlikely to occur if adequate fluid intake and urinary output are maintained; however amoxicillin crystalluria in some cases leading to renal failure, has been observed (see Section 4.4, Special Warnings and Special Precautions for Use). More specific measures may be necessary in patients with impaired renal function: the antibiotic is removed by haemodialysis.

'Amoxil' is a broad-spectrum antibiotic which possesses the safety profile of the penicillins and is rapidly bactericidal against a wide range of Gram-negative and Gram-positive organisms.

'Amoxil' is well absorbed by the oral and parenteral routes, peak levels are achieved one to two hours after administration. Oral administration produces high serum levels independent of the time at which the food is taken. 'Amoxil' gives good penetration into the bronchial secretions and the high urinary concentrations of unchanged antibiotic. The average serum half life is 60 minutes. Elimination is mainly via the urine.

There are no pre-clinical data of relevance to the subscriber which are additional to that already included in other sections of the SPC.

Sodium benzoate (E211)

carmellose sodium (E466)

peach dry flavour

strawberry dry flavour

lemon dry flavour

sucrose.

Not applicable.

Unopened: 3 years.

reconstituted 14 days.

As packaged for resale

Do not Store above 25°C. Keep bottle tightly closed in order to protect from moisture

Reconstituted Suspension:

Do not store above 25°C

A clear 45ml glass bottle moulded from type III Ph. Eur. glass. The bottles are fitted with an aluminium roll-on pilfer-proof (ROPP), internally lacquered, externally enamelled closure containing a flowed-in PVC liner.

At time of dispensing, the dry powder should be reconstituted to form an oral suspension, as detailed below:

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

PA 1077/33/5

8 August 1983/8 August 2008

October 2010