Superdrug Indigestion Relief Liquid
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SUPERDRUG INDIGESTION RELIEF LIQUID
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose contains:
Aluminium Hydroxide Gel BP: 220mg
Magnesium Hydroxide BP: 195mg
3 PHARMACEUTICAL FORM
Suspension for oral administration
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Antacid therapy in gastric and duodenal ulcer, gastritis, heartburn, gastric hyperacidity. Treatment of indigestion.
4.2 Posology and method of administration
Adults and the Elderly:
10-20ml three times daily, 20 minutes to one hour after meals, and at bedtime, or as required.
4.3 Contraindications
Should not be used in patients who are severely debilitated or suffering from kidney failure.
4.4 Special warnings and precautions for use
None stated.
4.5 Interaction with other medicinal products and other forms of interaction
Antacids inhibit the absorption of tetracyclines and vitamins and should not be taken concomitantly.
4.6 Pregnancy and lactation
For Superdrug Indigestion Relief Liquid no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embroynal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Gastrointestinal side-effects are uncommon. This formulation minimises the problems of diarrhoea and constipation.
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.
4.9 Overdose
Serious symptoms are unlikely to follow overdosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The product contains two established antacids, magnesium and aluminium hydroxides with an acid neutralising capacity in excess of 25ml of 0.1N HC1 consumed, per gram of suspension.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol Solution 70%
Mannitol
Hydrochloric Acid Methyl P-Hydroxybenzoate Propyl P-Hydroxybenzoate Citric Acid
Simethicone Emulsion 30%
Saccharin Sodium
Hydrogen Peroxide 35% Solution
Peppermint Oil
Strong Sodium Hypochlorite Solution Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
Unopened shelf life: 2 years
Opened shelf life: 28 days
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
Use within 28 days of opening.
6.5 Nature and contents of container
High-density polyethylene bottle with a polypropylene closure fitted with a tamper evident ring.
The pack sizes are 100ml, 300ml and 500ml.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
CHEMIDEX PHARMA LIMITED
CHEMIDEX HOUSE, EGHAM BUSINESS VILLAGE
CRABTREE ROAD
EGHAM
SURREY
TW20 8RB
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 17736/0114
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25 November 1987 / 25 November 1997
10 DATE OF REVISION OF THE TEXT
13/05/2016