CUPAL ANTACID SUGAR FREE TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cupal Antacid Sugar Free Tablets

2

Aluminium hydroxide dried gel BP 200mg/tablet

Magnesium hydroxide BP 200mg/tablet

Simethicone USP 25mg/tablet

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

4.1 Therapeutic indications

Antacid/antifla­tulent for the relief of indigestion, heartburn, wind and dyspepsia.

4.2 Posology and method of administration

Posology

Paediatric population

Children under 12 years: not to be given to children under 12 years except on the advice of a doctor.

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.

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: mexiletine, diflunisal, chlorpromazine, ketoconazole, pivampicillin and tetracycline.

4.6 Fertility, pregnancy and lactation

Pregnancy

Cupal Antacid Sugar Free Tablets can be used in pregnancy. (General literature indicates no adverse effects for the active ingredients of Cupal Antacid 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

5.1   Pharmacodynamic properties

None stated.

Preclinical safety data None stated.

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 × 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