Cupal Antacid Sugar Free Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cupal Antacid Sugar Free Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aluminium hydroxide dried gel BP 200mg/tablet Magnesium hydroxide BP 200mg/tablet Simethicone USP 25mg/tablet
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Antacid - Deflatulent for the relief of indigestion, heartburn, wind and dyspepsia
4.2 Posology and method of administration
Oral
Adults, the elderly and children aged over 12 years: two tablets to be sucked or chewed twenty minutes to one hour after meals and at bedtime if required.
Children under 12 years: not to be given to children under 12 years except on the advice of a doctor.
4.3 Contraindications
These tablets should not be taken by patients who are severely debilitated or suffering from kidney failure or hypophosphataemia
4.4 Special warnings and precautions for use
If you are taking other medication consult your doctor or pharmacist before taking this product.
If symptoms persist consult your doctor. Keep out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
If taken simultaneously with cimetidine, it can reduce absorption of this drug. It can also reduce or delay the absorption of the following drugs: mexilitine, diflunisal, chlorpromazine, ketoconazole, pivampicillin and tetracycline.
4.6 Pregnancy and lactation
Asilone Sugar Free Tablets can be used in pregnancy. (General literature indicates no adverse effects for the active ingredients of Asilone Sugar Free Tablets on pregnancy or on the health of the foetus/newborn child).
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
None stated.
4.9 Overdose
Severe symptoms are unlikely to follow overdose.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Antacid, deflatulent.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Peppermint flav-o-lok 610115E, aerosil R972, magnesium stearate, sorbitol.
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months unopened.
6.4 Special precautions for storage
To be stored in a cool, dry place.
6.5 Nature and contents of container
Tablets are packed in blister packs of 2 x 5 - 10 strips.
The blisters are constructed of:
a) Plain 250p, clear rigid UPVC
b) 0.02mmp, hard temper aluminium foil.
The blisters are sealed in an outer carton containing 20, 30, 40, 50, 80 or 100 tablets.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd,
9 Arkwright Road, Astmoor Industrial Estate,
Runcorn, Cheshire, WA7 1NU
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0089
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
8/10/90 / 28/01/2008
10 DATE OF REVISION OF THE TEXT
28/01/2008