When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
1. Trade Name of the Medicinal Product
AUGMENTIN Tablets 250 mg/125 mg
2. Qualitative and Quantitative Composition
Each tablet contains Amoxicillin trihydrate equivalent to 250 mg Amoxicillin with potassium clavulanate equivalent to 125 mg of clavulanic acid .
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Film-coated tablets (tablet)
White to off-white, oval shaped, film-coated tablets engraved ‘Augmentin’ on one side.
6.4 Special Precautions for Storage
Do not store above 25°C.
Bottles : Keep container tightly closed. The enclosed desiccants should not be removed. Store in the original package.
Blisters and foil strips: Store in the original package. Keep blister in the outer carton.
4.5...............
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of amoxicillin-clavulanate and allopurinol.
In common with other antibiotics, amoxicillin-clavulanate may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
4.8...................
Gastrointestinal disorders
Very common Diarrhoea
Common Nausea, vomiting
Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking AUGMENTIN at the start of a meal.
Uncommon Indigestion
Very Rare Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis).
Black hairy tongue
............................