Consumer medicine information

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 87 mL water to form a suspension. Shake the resulting suspension before use. 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.

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

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.

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. Benzoates and saccharin.
Amoxil Paediatric Drops. Benzoates.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Amoxil 250 and 500 mg capsules. 250 mg. A size '2' hard gelatin capsule with yellow body and maroon cap printed with 'AM250' on cap and body in white ink linearly and containing white/off white powder.
500 mg. A size 'OEL' hard gelatin capsule with yellow body and maroon cap printed with 'AM500' on cap and body in white ink linearly and containing white/off white powder.
Amoxil Sugar Free Syrup. Amoxicillin 125 mg/5 mL (as trihydrate) powder for oral liquid bottle. White free flowing powder. Each 5 mL of the off-white reconstituted oral suspension contains amoxicillin trihydrate equivalent to amoxicillin 125 mg.
Amoxil Forte Sugar Free Syrup. Amoxicillin 250 mg/5 mL (as trihydrate) powder for oral liquid bottle. White free flowing powder. Each 5 mL of the off-white reconstituted oral suspension contains amoxicillin trihydrate equivalent to amoxicillin 250 mg.
Amoxil Paediatric Drops. Amoxicillin 100 mg/mL (as trihydrate) powder for oral liquid bottle. White free flowing powder. Each 1 mL of off-white reconstituted oral suspension contains amoxicillin trihydrate equivalent to Amoxicillin 100 mg.

4 Clinical Particulars

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

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

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. Amoxicillin trihydrate may be represented structurally as:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXTR.gif It is identified chemically as (2S,5R,6R)-6-[(R)-2-amino-2-(4-hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
The molecular weight of amoxicillin trihydrate is 419.4.
Molecular formula: C₁₆H₁₉N₃O₅S, 3H₂O.
CAS number. 61336-70-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/AMOXILST.gif