Summary of Product Characteristics (SmPC) - Mucogel suspension
1 NAME OF THE MEDICINAL PRODUCT
Mucogel Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 44 mg dried aluminium hydroxide and 39 mg magnesium hydroxide.
Excipients with known effect
Each ml suspension contains 8.75 mg sorbitol (E 420), 1 mg methyl parahydroxybenzoate (E 218) and 0.5 mg propyl parahydroxybenzoate (E 216).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
A white uniform suspension with odour and taste of peppermint.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Mucogel is indicated in adults and children aged 12 years and older.
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
Posology
Adults, elderly and children aged 12 years and older
10 20 ml three times daily 20 minutes to one hour after meals, and at bedtime, or as required.
Children less than 12 years of age
Mucogel should not be used in children less than 12 years of age.
Method of administration
Oral use.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Should not be used in patients who are severely debilitated or suffering from kidney failure
4.4 Special warnings and precautions for use
Paediatric population
In young children the use of magnesium hydroxide can produce a hypermagnesemia, especially if they present with renal impairment or dehydration.
Excipients
This medicine contains 8.75 mg sorbitol (E 420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) which may cause allergic reactions (possible delayed).
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.
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.
Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.
4.6 Fertility, Pregnancy and lactation
For Mucogel 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
Mucogel has no or negligible influence on the ability to drive and use machines
4.8 Undesirable effects
Gastrointestinal side-effects are uncommon. This formulation minimises the problems of diarrhoea and constipation.
Metabolism and nutrition disorders
Very rare (<1(10,000)
Hypermagnesemia. Observed after prolonged administration of magnesium hydroxide to patients with renal impairment.
Gastrointestinal disorders
Not known (cannot be estimated from the available data) Abdominal pain.
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
Serious symptoms are unlikely to follow overdosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for acid related disorders, combinations and complexes of aluminium, calcium and magnesium compounds, ATC code: A02AD01.
The product contains two established antacids, magnesium and aluminium hydroxides with an acid neutralising capacity in excess of 25 ml 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 SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol, liquid (non-crystallising) (E 420)
Mannitol (E 421)
Hydrochloric acid
Methyl parahydroxybenzoate (E 218)
Propyl parahydroxybenzoate (E 216)
Citric acid monohydrate
Simethicone emulsion 30%
Saccharin sodium
Hydrogen peroxide solution 35%
Peppermint oil
Sodium hypochlorite solution, strong
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Unopened: 2 years.
After opening: 28 days
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
6.5 Nature and contents of container
High density polyethylene (HDPE) bottle with a HDPE closure fitted with a tamper evident ring.
Pack sizes: 100 ml, 120 ml, 125 ml, 200 ml, 240 ml, 250 ml, 300 ml and 500 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Rosemont Pharmaceuticals Ltd
Rosemont House
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00427/0287
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 06/12/1997
Date of latest renewal: 15/01/1999
10 DATE OF REVISION OF THE TEXT
25/01/2022