SUMMARY CMI

AMOXIL Paediatric Drops

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I giving AMOXIL to my child?

AMOXIL contains the active ingredient amoxicillin (as amoxicillin trihydrate). AMOXIL is used to treat a range of infections caused by bacteria.

For more information, see Section 1. Why am I giving AMOXIL to my child? in the full CMI.

2. What should I know before giving AMOXIL?

Do not use if your child has ever had an allergic reaction to AMOXIL or any of the ingredients listed at the end of the CMI.

Talk to your child's doctor if they have any other medical conditions or take any other medicines.

For more information, see Section 2. What should I know before giving AMOXIL? in the full CMI.

3. What if my child is taking other medicines?

Some medicines may interfere with AMOXIL and affect how it works.

A list of these medicines is in Section 3. What if my child is taking other medicines? in the full CMI.

4. How do I give AMOXIL to my child?

• The usual dose of AMOXIL is one dose given three times a day.
• AMOXIL doses should be spaced evenly throughout the day e.g. every eight hours if giving it three times a day.
• The dispensing pharmacist will typically reconstitute the dry powder with 18 mL water to form a suspension. Shake the resulting suspension before use. The dose of AMOXIL Paediatric Drops is drawn up and given using the dosing syringe provided with the medicine. Ensure the whole dose is swallowed each time.
• Keep giving AMOXIL until the course is finished or for as long as your child's doctor tells you.

More instructions can be found in Section 4. How do I give AMOXIL to my child? in the full CMI.

5. What should I know while giving AMOXIL to my child?

For more information, see Section 5. What should I know while giving AMOXIL to my child? in the full CMI.

6. Are there any side effects?

Mild side effects of giving AMOXIL include diarrhoea, soreness of the mouth or tongue, or overgrowth of yeast infections (thrush).

Serious side effects include itching; rash; unusual bleeding or bruising; yellowing of the skin or eyes; dark urine or pale stools; difficulty or pain on passing urine; severe diarrhoea, tooth discolouration; excessive abnormal muscle movements; dizziness or convulsions; or a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, or neck. Other serious side effects include an allergic reaction. Signs of this include wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives), or fainting.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

AMOXIL Paediatric Drops

Active ingredient: amoxicillin (as amoxicillin trihydrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using AMOXIL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about giving AMOXIL.

Where to find information in this leaflet:

1. Why am I giving AMOXIL to my child?
2. What should I know before giving AMOXIL?
3. What if my child is taking other medicines?
4. How do I give AMOXIL to my child?
5. What should I know while giving AMOXIL to my child?
6. Are there any side effects?
7. Product details

1. Why am I giving AMOXIL to my child?

AMOXIL contains the active ingredient amoxicillin (as amoxicillin trihydrate). AMOXIL belongs to a group of antibiotic medicines called penicillins.

AMOXIL is used to treat a range of infections caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues.

AMOXIL works by killing the bacteria that cause these infections.

AMOXIL can also be used to prevent infection.

Ask your doctor if you have any questions about why AMOXIL has been prescribed for your child.

Your child's doctor may have prescribed it for another reason.

2. What should I know before giving AMOXIL?

Warnings

Do not give AMOXIL if:

• your child is allergic to penicillin or similar types of antibiotics such as cephalosporins. If your child has ever had an allergic reaction (such as rash) when taking an antibiotic, you should tell your doctor before any AMOXIL is given.
• your child is allergic to amoxicillin, or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue, or any other parts of the body; rash, itching or hives on the skin.
• The expiry date (EXP) printed on the pack has passed.
• The packaging is torn or shows signs of tampering.

Check with your child's doctor if:

• your child has any other medical conditions, especially the following:
  - glandular fever (mononucleosis)
  - blood disorders
  - kidney or liver problems (the dose may need to be changed or your child may need to be given an alternate medicine)
• your child is taking any medicines for any other condition.
• your child has ever had an allergic reaction (such as a rash) to any antibiotics in the past.
• your child has had any allergy to any other medicines, or any other substances, such as foods, preservatives, or dyes.

During treatment, your child may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

3. What if my child is taking other medicines?

Tell your doctor or pharmacist if your child is taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with AMOXIL and affect how it works. These include:

• medicines used to treat gout e.g. probenecid or allopurinol.
• other antibiotics
• anticoagulants (used to prevent blood clots) such as warfarin
• methotrexate, a medicine used to treat arthritis and some types of cancers.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements your child is taking and if these affect AMOXIL.

AMOXIL may influence the results of some laboratory tests.

4. How do I give AMOXIL to my child?

How much to give

Give AMOXIL as directed by your child's doctor or pharmacist.

The dosage varies widely and depends on the patient, the child's weight, the condition being treated and the response to the treatment.

The usual dose is one dose taken three times a day. The doses should be spaced evenly throughout the day e.g. every eight hours if taking it three times a day.

How to give AMOXIL

Shake the bottle to loosen the powder, before reconstituting with 18 mL of water. Shake well to suspend the powder and before use. Note: This part is typically prepared by the pharmacist prior to dispensing.

The suspension is drawn up and given using the dosing syringe provided with the medicine. Ensure the whole dose is swallowed each time.

For oral use only.

AMOXIL can be given with or without food.

How long to give AMOXIL for

Keep giving AMOXIL to your child until the course is finished or for as long as the doctor tells you.

Do not stop giving AMOXIL just because your child feels better as the infection can return.

Do not stop giving AMOXIL to your child or change the dose without first checking with your child's doctor.

If you forget to give AMOXIL

If you forget to give a dose of AMOXIL, give it as soon as you remember. Then go back to giving it as directed by the doctor.

If it is almost time for your child's next dose, skip the dose you missed and give their next dose when you are meant to.

Do not give a double dose to make up for the dose that was missed.

Do not give two doses within an hour or so of each other.

Giving more than the prescribed dose can increase the chance of unwanted side effects.

If you give too much AMOXIL

If you think that you have given too much AMOXIL, your child may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if your child shows no signs of discomfort or poisoning.

5. What should I know while giving AMOXIL to my child?

Things you should do

Tell your child's doctor if, for any reason, you have not given the medicine exactly as directed.

Otherwise, your child's 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 AMOXIL before giving any other prescribed medicine.

Some medicines may affect the way other medicines work.

Call your doctor straight away if:

• your child develops itching, swelling or a skin rash while taking AMOXIL. Do not give any more AMOXIL.
• your child develops severe diarrhoea while taking AMOXIL. Do not give any medication to stop the diarrhoea (e.g. Lomotil or Imodium).

Remind any doctor, dentist or pharmacist your child visits that they are using AMOXIL.

Things you should not do

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

Do not use AMOXIL to treat any other complaints unless the doctor says to.

Looking after your medicine

Store the dry powder and the reconstituted suspension in a cool dry place, away from moisture or heat, where the temperature stays below 25°C.

For example, do not store it:

• in the bathroom or near a sink, or
• in the car on a hot day

Heat and dampness can destroy some medicines.

Follow the instructions on the pack on how to take care of your child's medicine properly.

Keep it where young children cannot reach it.

When to discard this medicine

Discard reconstituted suspension after 14 days.

Ask your pharmacist what to do with any doses that are left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not give this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If your child experiences any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making your child feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects your child experiences, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop giving this medicine to your child.

7. Product details

This medicine is only available with a doctor's prescription.

What AMOXIL PAEDIATRIC DROPS contain

AMOXIL Paediatric Drops is sugar free.

Do not give this medicine if your child is allergic to any of these ingredients.

What AMOXIL look like

AMOXIL Paediatric Drops are a white free flowing powder, which when reconstituted with 18 mL water forms an off-white oral suspension. Available in a pack containing a:

• single, sealed glass bottle containing powder for preparing 20 mL amoxicillin oral suspension;
• dosing syringe.

Australian Registration number:

AMOXIL Paediatric Drops: AUST R 201566

Who distributes AMOXIL

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

This leaflet was prepared in January 2025.

Published by MIMS March 2025

1 Name of Medicine

Amoxicillin trihydrate.

2 Qualitative and Quantitative Composition

Each Amoxil 250 and 500 mg capsule contains amoxicillin trihydrate equivalent to either 250 mg or 500 mg of amoxicillin.
Each bottle of Amoxil powder for oral liquid contains amoxicillin trihydrate equivalent to 125 mg, 250 mg per 5 mL or 100 mg per 1 mL of amoxicillin when reconstituted.

Excipients with known effect.

Amoxil Sugar Free Syrup and Amoxil Forte Sugar Free Syrup.

Amoxil Paediatric Drops.

3 Pharmaceutical Form

Amoxil 250 and 500 mg capsules.

250 mg.

500 mg.

Amoxil Sugar Free Syrup.

Amoxicillin 125 mg/5 mL (as trihydrate) powder for oral liquid bottle.

Amoxil Forte Sugar Free Syrup.

Amoxicillin 250 mg/5 mL (as trihydrate) powder for oral liquid bottle.

Amoxil Paediatric Drops.

Amoxicillin 100 mg/mL (as trihydrate) powder for oral liquid bottle.

4 Clinical Particulars

4.1 Therapeutic Indications

It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms.

Note.

Skin and skin structure.

Respiratory (acute and chronic).

Genitourinary tract (complicated and uncomplicated, acute and chronic).

Gonorrhoea.

Prophylaxis of endocarditis.

4.2 Dose and Method of Administration

Normal renal function.

Adults.

Children (under 20 kg).

Adults.

Children (under 20 kg).

Adults.

Adults.

Note.

Renal impairment.

Prophylaxis of endocarditis.

Directions for reconstitution of Amoxil Paediatric Drops.

4.3 Contraindications

Amoxicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins).

4.4 Special Warnings and Precautions for Use

Serious, and occasionally fatal, hypersensitivity reactions (including anaphylaxis, anaphylactoid, and severe cutaneous reactions) have been reported in patients receiving beta-lactam antibiotics. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. Before commencing therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and amoxicillin therapy discontinued.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see Section 4.8 Adverse Effects (Undesirable Effects)). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after administration of amoxicillin) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. Clostridium difficile associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhoea to fatal colitis. 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). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. 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 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.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.
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.
Amoxicillin 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 amoxicillin.
Prolonged use my occasionally result in overgrowth of non-susceptible organisms.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. 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.
Amoxicillin, an aminopenicillin, 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 amoxicillin is used.
Amoxicillin should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to ampicillin-induced skin rashes.
Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A positive culture may be evidence of a complicated or upper urinary tract infection and call for longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.
Dosage should be adjusted in patients with renal impairment (see Section 4.2 Dose and Method of Administration).

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
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. Similar reactions can be expected with amoxicillin.
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.
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Methotrexate.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins.
The following adverse reactions have been reported as associated with the use of amoxicillin.

Cardiac disorders.

Infections and infestations.

Gastrointestinal.

Skin and subcutaneous tissue disorders.

Hypersensitivity reactions.

Note.

Liver.

Haemic and lymphatic systems.

Renal and urinary tract disorders.

CNS effects.

Miscellaneous.

Reporting suspected adverse effects.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water/ electrolyte imbalance should be treated symptomatically. During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimize the possibility of amoxicillin crystalluria. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin can be removed from the circulation by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Note.

Note.

Cross-resistance.

Resistance mechanisms.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Amoxil capsules.

Amoxil and Amoxil Forte Sugar Free Syrup.

Amoxil Paediatric Drops.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Amoxil capsules.

Amoxil and Amoxil Forte Sugar Free Syrup and Amoxil Paediatric Drops.

6.5 Nature and Contents of Container

Amoxil capsules.

Amoxil Sugar Free Syrup and Amoxil Forte Sugar Free Syrup.

Amoxil Paediatric Drops.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Amoxicillin trihydrate is a semisynthetic antibiotic and is a member of the penicillinase-stable group of penicillins derived from the penicillin nucleus, 6-aminopenicillanic acid, isolated at Beecham Research Laboratories.
Amoxicillin trihydrate is a white or almost white, crystalline powder, slightly soluble in water and in alcohol.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes