Mucogel Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MUCOGEL SUSPENSION
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose contains:
Aluminium Hydroxide Gel 220mg
BP
Magnesium Hydroxide BP 195mg
3 PHARMACEUTICAL FORM
Antacid 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. Relief of symptoms of heartburn and dyspepsia associated with gastric reflux in hiatus hernia, reflux oesophagitis and similar conditions.
4.2 Posology and method of administration
Adults, elderly and children over 12 years of age:
10-20ml three times daily 20 minutes to one hour after meals, and at bedtime, or as required.
Children under 12 years of age:
Not recommended.
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 Mucogel Suspension no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/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
None stated.
Undesirable effects
4.8
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 Y ellow 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.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Sorbitol Solution 70%
Mannitol
Hydrochloric Acid Methyl P-Hydoxybenzoate Propyl P-Hydroxybenzoate Citric Acid
Simethicone Emulsion 30% Saccharin Sodium Hydrogen Peroxide 35% Solution Peppermint Oil
Strong Sodium Hypochlorite Soln. Purified Water
6.2 Incompatibilities
None stated.
6.3 Shelf life
Unopened - 2 years
Opened - 28 days
6.4 Special precautions for storage
Do not freeze. Store below 25°C.
6.5 Nature and contents of container
High density polyethylene bottle with a high density polyethylene closure fitted with a tamper evident ring.
Pack sizes: 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 17736/0113
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
6th December 1997 / 15th January 1999
10 DATE OF REVISION OF THE TEXT
26/09/2016