Consumer medicine information

1. Why am I using Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125?

Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets contains the active ingredients amoxicillin and potassium clavulanate. Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets are used for the short term treatment of a wide range of infections caused by bacteria. For more information, see Section 1. Why am I using Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125? in the full CMI.

2. What should I know before I use Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets?

Do not use if you have ever had an allergic reaction to amoxicillin trihydrate, potassium clavulanate, penicillin or similar types of antibiotics (such as cephalosporins), or any of the ingredients listed at the end of the CMI. 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 use Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets 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 use Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets?

Follow the directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. More instructions can be found in Section 4. How do I use Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets? in the full CMI.

5. What should I know while using Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets?

6. Are there any side effects?

The most common side effects of Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 tablets are diarrrhoea, nausea and vomiting. 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 and potassium clavulanate.

2 Qualitative and Quantitative Composition

Blooms the Chemist Amoxicillin/Clavulanic Acid 875/125 tablets contain amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium clavulanate) 125 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Blooms the Chemist Amoxicillin/Clavulanic Acid 875/125 tablets: White to pale yellow, oblong, biconvex, film-coated and scored on both sides.

4 Clinical Particulars

4.9 Overdose

Serious and severe clinical symptoms are unlikely to occur after overdosage with amoxicillin/clavulanic acid. 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.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin may 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

Amoxicillin/Clavulanic Acid 500/125 tablets are unavailable in this brand, however this strength is available in other brands. Information on pharmacological properties obtained using Amoxicillin/Clavulanic Acid 500/125 tablets are also included in the following subsections for prescriber information.

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of amoxicillin/clavulanic acid was investigated in assays for chromosomal damage (mouse micronucleus test and a dominant lethal test) and gene conversion. All were negative.
Carcinogenicity. Long-term studies in animals have not been performed to evaluate carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Amoxicillin trihydrate. Amoxicillin trihydrate is white to almost white, crystalline powder, slightly soluble in water and in alcohol, practically insoluble in ether and in fatty oils. It dissolves in dilute acids and dilute solutions of alkali hydroxides.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXTR.gif Chemical name: (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 trihydrate.
Molecular formula: C₁₆H₁₉N₃O₅S.3H₂O.
Molecular weight: 419.4.
Potassium clavulanate. Potassium clavulanate is white to almost white, crystalline powder, hygroscopic, freely soluble in water, slightly soluble in alcohol, and very slightly soluble in acetone.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCLAVUL.gif Chemical name: Potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate.
Molecular formula: C₈H₈KNO₅.
Molecular weight: 237.3.
CAS number. Amoxicillin trihydrate. 61336-70-7.
Potassium clavulanate. 61177-45-5.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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