Consumer medicine information

1. Why am I taking AMOXICILLIN-WGR?

AMOXICILLIN-WGR contains a penicillin called amoxicillin (as trihydrate) as the active ingredient.
AMOXICILLIN-WGR belongs to the penicillin group of antibiotics.
AMOXICILLIN-WGR 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 tissue.
For more information, see Section 1. Why am I taking AMOXICILLIN-WGR? in the full CMI.

2. What should I know before I take AMOXICILLIN-WGR?

Do not take if you are allergic to penicillin or similar types of antibiotics (such as cephalosporins), or any of the ingredients listed at the end of the CMI. If you have ever had an allergic reaction (such as a rash) when taking an antibiotic, you should tell your doctor before you take AMOXICILLIN-WGR.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take AMOXICILLIN-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AMOXICILLIN-WGR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take AMOXICILLIN-WGR?

• Follow the directions given to you by your doctor and pharmacist. Their directions may differ from the information contained in this leaflet.

5. What should I know while taking AMOXICILLIN-WGR?

6. Are there any side effects?

Less serious side effects are diarrhoea, indigestion, feeling sick (nausea), vomiting. White furry, sore tongue and mouth (oral thrush). Soreness or itching of the vagina or vaginal discharge (vaginal thrush). Headache, dizziness, tiredness. Teeth discolouration. Unusually active (hyperactivity).
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 (as amoxicillin trihydrate).

2 Qualitative and Quantitative Composition

Each capsule contains 250 mg or 500 mg amoxicillin (as trihydrate).
Excipient with known effect. Contains phenylalanine and sulfites.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Amoxicillin-WGR 250 mg capsules. Yellow/yellow, hard gelatin capsules (size no. 2), imprinted with "RX 654" in black.
Amoxicillin-WGR 500 mg capsules. Maroon/yellow, hard gelatin capsules (size no. 0), imprinted with "RX 655" in black.

4 Clinical Particulars

4.9 Overdose

Symptoms. Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident.
Treatment. 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 minimise 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 131126 (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 white or almost white, crystalline powder, slightly soluble in water and in alcohol.
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.
Chemical structre.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXTR.gif Chemical name: (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
Molecular formula: C₁₆H₁₉N₃O₅S.3H₂O.
Molecular weight: 419.4.
CAS number. 61336-70-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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