GlaxoSmithKline (Ireland) Ltd

Amoxil 3g Powder for Oral Suspension Sachets

Each sachet contains Amoxicillin Trihydrate equivalent to 3.0g amoxicillin.

Each sachet also contains sorbitol (E420)

For a full list of excipients see section 6.1

Powder for oral suspension.

A white to off-white, free flowing powder with characteristic odour which on reconstitution with water forms a white to off-white coloured suspension.

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

Lobar and bronchopneumonia

Cystitis, urethritis, pylelonephritis

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

Dental abscess (as adjunct to surgical management)

In children with urinary tract infection, the need for investigation should be considered.

Parental therapy is indicated if the oral route is considered impracticable or unsuitable and particularly for the urgent treatment of severe episodes of the above conditions.

Oral prophylaxis of endocarditis: `Amoxil` may be used for the prevention of bacteraemia associated with the procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

Route of Administration: oral

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

Adults and Children over 10

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: 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 cases 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:

Adults: Patients not having a general anaesthetic - 3g dose 1 hour before procedure followed by (6 hours later) a further 3g dose if considered necessary.

Patients having general anaesthetic - initially 3 g `Amoxil` orally 4 hours prior to anaesthesia, followed by 3g orally (or 1g IM if oral dose not tolerated) 6 hours after the initial dose

Children: Under 10: half the adult dose.

Under 5: quarter the adult dose.

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.

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 infections 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.

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 f;uid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria.

Patients with rare hereditary problems of fructose intolerance should not take this medication.

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 (AE's) 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 inpatients 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 blood levels are achieved 1-2 hours after administration. Oral administration produces high serum levels independent of the time at which the food is taken. `Amoxil` gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic. The average serum half life is 60 minutes. Elimination is mainly via the urine.

Not relevant.

Saccharin sodium (dried),

Xanthan gum (E415),

Peach dry flavour,

Strawberry dry flavour

Lemon dry flavour,

Sorbitol (E420).

Not applicable.

Powder: 3 years

Use immediately following reconstitution.

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Paper/aluminium foil/Copolymer film laminate

The copolymer consists of ethylene and acrylic acid.

Pack size: 2 sachets

1. Cut sachet along dotted line;

2. Empty contents into a glass;

3. Half fill sachet with water;

4. Pour into glass, stir well and drink immediately.

A white to off-white coloured suspension is formed on reconstitution with water.

GlaxoSmithKline (Ireland) Limited.,

Stonemasons Way,

Rathfarnham.

Dublin 16.

PA 1077/33/6

17^th December 1979/17^th December 2009

July 2010