Consumer medicine information

What is in this leaflet?

Please read this leaflet carefully before you give AUGMENTIN SYRUP.

This leaflet answers some common questions about AUGMENTIN SYRUP. It does not contain all of the available information.

It does not take the place of talking to your child’s doctor or pharmacist.

All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years.

Your child’s doctor has weighed the expected benefits of your child taking AUGMENTIN SYRUP against the risks this medicine could have for your child.

AUGMENTIN must be given to your child as instructed. If you have any concerns about giving this medicine to your child, ask your child’s doctor or pharmacist. Keep this leaflet until your child has finished the course of AUGMENTIN SYRUP.

You may need to read it again.

What is AUGMENTIN SYRUP used for?

AUGMENTIN SYRUP contains two active ingredients. One of these is a penicillin called amoxycillin and the other is clavulanate. AUGMENTIN SYRUP belongs to the penicillin group of antibiotics.

AUGMENTIN SYRUP is used to treat a wide range of infections caused by bacteria. These infections may affect the chest (e.g. bronchitis or pneumonia), bladder (e.g. cystitis), sinuses (e.g. sinusitis), the ears (e.g. otitis media) or the skin.

AUGMENTIN SYRUP works by killing the bacteria that cause these infections.

AUGMENTIN SYRUP is used for the treatment of the infections listed. However the doctor may prescribe this medicine for another use. If you want more information ask the doctor.

Your doctor may have prescribed AUGMENTIN SYRUP for another reason.

There is no evidence that AUGMENTIN SYRUP is addictive.

Before you give AUGMENTIN SYRUP

AUGMENTIN SYRUP must not be given if:

• your child is allergic to penicillin or similar types of antibiotics (such as cephalosporins) or any of the ingredients contained in AUGMENTIN SYRUP. If your child has ever had an allergic reaction (such as a rash) when taking an antibiotic you should tell the doctor before any AUGMENTIN SYRUP is given.
• your child has previously experienced liver problems after taking AUGMENTIN SYRUP or any other medicines.
• the expiry date (EXP) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.
• This medicine is for the person named by the doctor. Do not give this medicine to anyone else.

Before your child starts taking AUGMENTIN SYRUP tell the doctor if:

• your child has ever had an allergic reaction (such as a rash) to any antibiotics in the past.
• your child is allergic to foods, dyes, preservatives or any other medicines.
• your child has glandular fever (mononucleosis) or a blood disorder.
• your child has liver or kidney problems. The dosage of AUGMENTIN SYRUP may need to be changed or your child may need to be given an alternative medicine.
• your child’s urine has to be tested for sugar. AUGMENTIN SYRUP may affect the results of these tests.
• your child is taking any other medicines, including medicines you buy without a prescription. In particular, tell the doctor if your child is taking any of the following:
  - probenecid or allopurinol.
  - warfarin or other medicines used to prevent blood clots
  - mycophenolate
  - other antibiotics. These may interfere with the actions of AUGMENTIN SYRUP.

Some medicines may affect the way other medicines work. Your child’s doctor or pharmacist will be able to tell you which medicines are safe to take with AUGMENTIN SYRUP.

If you have not told the doctor about any of these things, tell them before you give your child any AUGMENTIN SYRUP.

How to give AUGMENTIN SYRUP to your child

Follow the doctor’s instructions about how and when to give AUGMENTIN SYRUP. The doctor will advise how many doses are needed each day, and for how long your child will need to take AUGMENTIN SYRUP.

Please read the direction label carefully. If you have any concerns about how to give AUGMENTIN SYRUP, talk to the doctor or pharmacist.

How much to give:

Give AUGMENTIN SYRUP as directed by the doctor or pharmacist.

The usual dose of AUGMENTIN SYRUP is one dose taken three times a day. The dose may vary depending on your child’s weight.

How to give it:

Shake the suspension well before measuring out the dose in a suitable measure. Make sure the whole dose is swallowed each time.

AUGMENTIN SYRUP should be taken immediately before or with the first mouthful of food. AUGMENTIN SYRUP works best when taken this way. It may also help to prevent stomach upsets. However, AUGMENTIN SYRUP will still work if taken without food.

Space the doses as evenly as possible throughout the day. If your child is taking AUGMENTIN SYRUP three times a day, give a dose about every eight hours.

How long to give it for:

Keep giving AUGMENTIN SYRUP until the course is finished or for as long as the doctor advised. Do not stop giving AUGMENTIN SYRUP just because your child feels better as the infection can return.

Do not stop giving AUGMENTIN SYRUP or change the dose without first checking with the doctor.

If you forget to give it:

Give the missed dose as soon as you remember. Then give the next dose at the time it is normally due. Do not give two doses within four hours of each other.

Do not try to make up for missed doses by giving more than one dose at a time. Giving more than the prescribed dose can increase the chance of unwanted side-effects.

What do I do if I give too much? (Overdose)

Immediately telephone the doctor or Poisons Information Centre (telephone 131126) for advice if you think your child or anyone else may have taken too much AUGMENTIN SYRUP, even if there are no signs of discomfort or poisoning.

If you are not sure what to do, contact your child’s doctor, pharmacist or nearest hospital.

While you are giving AUGMENTIN SYRUP

Things you must do:

Tell the doctor if, for any reason, you have not given your medicine exactly as directed. Otherwise, the doctor may think that it was not working as it should and change your child’s treatment unnecessarily.

Tell the doctor or pharmacist your child is taking AUGMENTIN SYRUP, before giving any other prescribed medicine. Some medicines may affect the way other medicines work.

If your child develops itching, swelling or a skin rash while taking AUGMENTIN SYRUP, do not give any more AUGMENTIN SYRUP and tell the doctor immediately.

If your child develops severe diarrhoea either while taking AUGMENTIN SYRUP or within several weeks after treatment, tell the doctor as soon as possible. Do not give any medication to stop the diarrhoea (eg Lomotil® or Imodium®).

Things you must not do:

Do not give this medicine to anyone else, even if their symptoms seem similar to your child’s.

Do not use AUGMENTIN SYRUP to treat any other complaints unless your child’s doctor says to.

What are the side-effects?

Check with your child’s doctor as soon as possible if you think your child is experiencing any side effects or allergic reactions due to taking AUGMENTIN SYRUP, even if the problem is not listed below.

Like other medicines, AUGMENTIN SYRUP can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention. Tell the doctor about any effect which is troublesome or ongoing.

• Tell the doctor if you notice any of the following are troublesome or ongoing:
  - diarrhoea (several loose bowel movements per day), indigestion, pain in the stomach, feeling sick or being sick.
  - soreness of the mouth or tongue, abnormal taste, white or furry tongue (oral thrush).
  - headache, dizziness, tiredness, hot flushes.
  - soreness or itching of the vagina and/or discharge (vaginal thrush).
  - unusually active (hyperactivity)
• Tell your child’s doctor immediately if you notice any of the following:
  - itching, rash
  - yellowing of the skin or eyes
  - dark urine or pale stools
  - severe diarrhoea
  - unusual bleeding or bruising
• Stop giving AUGMENTIN SYRUP and contact the doctor or take your child to the emergency department of the nearest hospital if any of the following happens:
  - Wheezing, fainting, swelling of the lips/mouth, difficulty in breathing or swallowing, hayfever, lumpy rash (hives) joint discomfort or swelling, swollen lymph glands, nausea and vomiting or fever. These could be symptoms of an allergic reaction or other reaction.
• Rare events that have been reported with AUGMENTIN SYRUP include:
  - inflammation of the bowel (colitis)
  - inflammation of the liver or kidney
  - blood disorders
  - crystals in the urine (crystalluria)

Remember you should tell the doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems which are not mentioned here, occur during or after treatment with AUGMENTIN SYRUP.

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Do not be alarmed by this list of possible side-effects. Your child may not experience any of them.

How do I store AUGMENTIN SYRUP?

Keep this medicine where children cannot reach it, such as in a locked cupboard.

Keep the bottle in the refrigerator where the temperature stays between 2 and 8°C. Heat can destroy AUGMENTIN SYRUP.

Do not leave in a car, on a window sill or in the bathroom.

Do not use any suspension left in the bottle 7 days after collecting from the pharmacy. Ask your pharmacist what to do with any doses that are left over.

Product description

What AUGMENTIN SYRUP looks like:

AUGMENTIN SYRUP is available as:

• an off-white sugar free syrup containing 125 mg of amoxycillin and 31.25mg of clavulanate in each 5mL, in bottles of 75mL.

Other Ingredients

AUGMENTIN syrup contains the following inactive ingredients: xanthan gum, aspartame, colloidal anhydrous silica, silicon dioxide, succinic acid, hypromellose and mixed fruit flavour.

AUGMENTIN syrup does not contain sucrose, lactose, gluten, tartrazine or any other azo dyes.

Supplier:

Your AUGMENTIN SYRUP is supplied by:

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your child’s doctor or pharmacist is the best person to give you advice on the treatment of your condition.

The information provided applies only to AUGMENTIN SYRUP

AUGMENTIN® is a registered trademark of Aspen Global Incorporated.

AUGMENTIN SYRUP: AUST R 144172.

This leaflet is subject to copyright.

Revised in April 2015

Published by MIMS July 2017

Name of the medicine

Amoxycillin trihydrate and potassium clavulanate.

Excipients.

Description

Augmentin is a combination product containing the semisynthetic antibiotic amoxycillin and the β-lactamase inhibitor, potassium clavulanate (the potassium salt of clavulanic acid). Chemically, amoxycillin is D-(-)-α-amino-p-hydroxybenzyl-penicillin trihydrate. It is susceptible to hydrolysis by β-lactamases.
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is an irreversible inhibitor of many β-lactamase enzymes except type 1 (Richmond). It is a β-lactam compound with only weak antibacterial activity. Chemically potassium clavulanate is potassium Z-(2R,5R)-3-(B- hydroxyethylidene) clavam-2-carboxylate.
Augmentin syrup also contains the inactive ingredients xanthum gum, aspartame, silicon dioxide, colloidal anhydrous silica, succinic acid, hypromellose and mixed fruit flavour.

Pharmacology

Augmentin is stable in the presence of gastric acid. Its two components are rapidly absorbed if administered before or with a meal, but if given after meals, the serum levels of clavulanic acid are significantly reduced. In fasting subjects mean peak serum levels after 1 Augmentin tablet were 2.98 mg/L (range 1.2 to 5.1) for clavulanic acid and 3.89 mg/L (range 2.4 to 6.0) for amoxycillin. These levels occurred at 30 to 120 minutes and 60 to 240 minutes respectively after dosing. Following 1 Augmentin Forte tablet, peak serum levels in fasting subjects were 3.28 to 4.72 mg/L for clavulanic acid and 10.28 to 12.06 mg/L for amoxycillin, and were achieved 60 to 120 minutes after dosing.
Following oral administration of Augmentin syrup at a dose of 8.3 mg/kg (amoxycillin 6.6 mg/kg + clavulanic acid 1.7 mg/kg) to children with otitis media, the means of peak concentrations were 2.76 mg/L for amoxycillin and 0.78 mg/L for clavulanic acid. In children given Augmentin Forte syrup 16.6 mg/kg (amoxycillin 13.3 mg/kg + clavulanic acid 3.3 mg/kg), the means of peak values were 4.94 mg/L for amoxycillin and 1.53 mg/L for clavulanic acid. Peak concentrations were reached at approximately 60 minutes (range 40 to 120 minutes).
The half-life of the amoxycillin part of Augmentin is approximately 1.2 hours and that of clavulanic acid approximately 1.0 hour. Following administration of Augmentin, both amoxycillin and clavulanic acid have been shown to diffuse in significant concentrations into pus, pleural and peritoneal fluids. Both penetrate poorly into the CSF when the meninges are normal.
Amoxycillin penetrates into the CSF better through inflamed meninges but the maximum concentrations are still much lower than the peak serum levels. There are no data at present on the CSF penetration of clavulanic acid in patients with meningeal inflammation.
Approximately seventy percent of the dose of amoxycillin is excreted as amoxycillin and approximately thirty to forty percent of a dose of clavulanic acid is excreted in the urine, as clavulanic acid, during the first six hours after administration. Following the administration of 125 mg of radiolabelled potassium clavulanate orally to normal volunteers, 68% of the administered radioactivity was recovered in the 24 hour urine. Of this, 34% (i.e. 23% of the administered dose) represented unchanged clavulanic acid. 2,5-dihydro-4-(2- hydroxyethyl)-5- oxo-1H-pyrrole-3- carboxylic acid (the major metabolite) and 1-amino-4-hydroxy-butan-2-one accounted for a further 23 and 12% (i.e. 16 and 8% respectively of the administered dose). Small amounts of other yet unidentified metabolites were also present. These metabolites were also present in the urine of rat and dog. The extent of urinary excretion of clavulanic acid and its metabolites is lower in rat urine than in dog and human urine.
Concurrent administration of probenecid delays amoxycillin excretion but does not delay renal excretion of clavulanic acid.
Clavulanic acid has been variously reported to be bound to human serum in the range of 9-30% and amoxycillin approximately 20% bound.

Microbiology.

Susceptibility testing.

Indications

Augmentin is indicated in the treatment of the following infections when caused by Augmentin sensitive, β-lactamase producing organisms:
Skin and skin structure infections, including cases caused by β-lactamase producing S. aureus, E. coli and Klebsiella sp. (only some strains may be sensitive).
Urinary tract infections, including cases caused by β-lactamase producing E. coli, P. mirabilis and Klebsiella sp.
Upper respiratory tract infections, such as sinusitis, including cases caused by β-lactamase producing H. influenzae and M. catarrhalis, and otitis media, especially cases caused by β-lactamase producing H. influenzae, M. catarrhalis and S. aureus.
Lower respiratory tract infections, especially cases caused by β-lactamase producing H. influenzae and M. catarrhalis.
Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to Augmentin. However, when there is reason to believe an infection may involve any of the β-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate.
The treatment of mixed infections caused by amoxycillin susceptible organisms and β-lactamase producing organisms susceptible to Augmentin should not require the addition of another antibiotic due to the amoxycillin content of Augmentin.

Contraindications

A history of allergic reaction to β-lactams, e.g. penicillins or cephalosporins is a contraindication.
Augmentin is contraindicated in patients with a previous history of Augmentin associated jaundice/ hepatic dysfunction.

Precautions

Before initiating therapy with amoxycillin clavulanate, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, Augmentin should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxycillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However in moderate to severe cases appropriate therapy with a suitable oral antibiotic agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement therapy should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
As with any potent drug, periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, is advisable during prolonged therapy.
Since Augmentin contains amoxycillin, an aminopenicillin, it is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxycillin is used.
Augmentin should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxycillin induced skin rashes.
Amoxycillin clavulanate should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxycillin.
Prolonged use may also occasionally result in overgrowth of nonsusceptible organisms.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxycillin clavulanate 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.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Cholestatic hepatitis, which may be severe but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent until several weeks after treatment has ceased. In most cases resolution has occurred with time. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Hepatic events subsequent to Augmentin have occurred predominantly in adults and elderly patients. These events have been very rarely reported in children.
Augmentin should be used with care in patients with evidence of hepatic dysfunction.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxycillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxycillin crystalluria (see Overdosage).
In patients with moderate or severe renal impairment, Augmentin dosage should be adjusted (see Dosage and Administration).

Carcinogenicity.

Genotoxicity.

Effects on fertility.

Use in pregnancy.

Use in labour and delivery.

Use in lactation.

Effects on ability to drive and use machines.

Effect on laboratory tests.

Interactions

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxycillin but does not affect clavulanic acid excretion. Concurrent use with Augmentin may result in increased and prolonged blood levels of amoxycillin but not of clavulanic acid.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Augmentin and allopurinol administered concurrently.
No information is available about the concurrent use of Augmentin and alcohol. However, the ingestion of alcohol whilst being treated with some other beta-lactam antibiotics has precipitated a disulfiram (Antabuse)-like reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with Augmentin.
In common with other antibiotics, Augmentin 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 amoxycillin. If coadministration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxycillin.

Adverse Effects

Augmentin is generally well tolerated. In clinical trials, the overall incidence of adverse effects, of suspected or unknown relationship to the drug, varied between 16% and 23.3%, depending on the dose. The majority of side effects observed were of a mild and transient nature, but therapy was discontinued because of drug related side effects in 4.2% of cases at the low dose (one Augmentin tablet T.D.S.) and 7% of cases at the high dose (one Augmentin Forte tablet T.D.S.). The most frequently reported adverse effects were diarrhoea (6%), nausea (2%), vomiting (1%), abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes. The incidence and severity of adverse effects, particularly nausea and diarrhoea, increased with the higher recommended dose.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Augmentin.
Very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1000 and < 1/100; rare ≥ 1/10,000 and < 1/1000; very rare: < 1/10,000.

Infections and infestations.

Gastrointestinal disorders.

Hypersensitivity and skin.

Hepatobiliary.

Haematopoietic and lymphatic systems.

Nervous system disorders.

Renal and urinary disorders.

Miscellaneous.

Dosage and Administration

Augmentin preparations should be taken immediately before or with the first mouthful of food.

Children.

With impaired renal function.

Direction for mixing syrup.

Overdosage

Serious and severe clinical symptoms are unlikely to occur after overdosage with Augmentin. If encountered, gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically, with attention to the water/ electrolyte balance.
Amoxycillin crystalluria, in some cases leading to renal failure, has been observed (see Precautions).
Amoxycillin may be removed from circulation by hemodialysis.
Contact the Poisons Information Centre (telephone 131 126) for advice on overdose management.

Presentation

Augmentin syrup: Each 5 mL of reconstituted suspension contains 125 mg amoxycillin and 31.25 mg clavulanic acid as the potassium salt. Bottles of 75 mL.
Each 125 mg of potassium clavulanate is equivalent to 0.63 mmol of potassium.

Storage

Augmentin syrup (dry powder) should be stored below 25°C and protected from moisture. Under these conditions the shelf life for the syrup is 18 months.

Poison Schedule

S4.