Actonorm 220mg/200mg/25mg In 5ml Oral Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonorm 220mg / 200mg / 25mg in 5ml Oral Suspension
2. QUALITATAIVE AND QUANTITATIVE COMPOSTION
Each 5ml contains:
Aluminium Hydroxide 220.0 mg
Magnesium Hydroxide 200.0 mg
Simeticone 25.0 mg
3. PHARMACEUTICAL FORM
Oral suspension.
White suspension with the odour of peppermint.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of dyspepsia and flatulence
4.2 Posology and method of administration
Adults, Elderly and children over 12 years One to Four 5ml spoonfuls Children 1 to 12 years One to Two 5ml spoonfuls
To be taken after meals and at night as required
4.3 Contraindications
Not known
4.4 Special warnings and precautions for use
Caution should be exercised when taking magnesium salts in renal failure. Patients should be advised that if symptoms persist for more than 7 days they should consult their doctor.
4.5 Interaction with other medicinal products and other forms of interaction
Reduced absorption may occur if taken simultaneously with pivampicillin, tetracyclines, ketoconazole, chlorpromazine, penicillamine and cimetidine.
4.6 Pregnancy and lactation
There have been no specific studies using Actonorm during pregnancy. To date, no other relevant epidemiological data are available. Caution should be advised when prescribing to pregnant women, who should check with their physicians before using antacids.
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
Occasional and mild disturbance of bowel function 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, Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Not applicable
5.1 Pharmacodynamic properties
Aluminium Hydroxide Antacid
Magnesium Hydroxide Antacid
Simeticone Anti-flatulent
5.2 Pharmacokinetic properties
Aqueous suspension, bioavailable
5.3 Preclinical safety data
None
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol Solution Sodium Saccharin Methyl hydroxybenzoate Ethyl hydroxybenzoate Propyl hydroxybenzoate
Butyl hydroxybenzoate, Propylene Glycol Buttermint Toffee Flavour Oil of Peppermint Purified Water
6.2 Incompatibilities
Not known
6.3 Shelf life
24 months in original container
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
6.5 Nature and contents of container
Amber Glass bottle of 200ml
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
Wallace Manufacturing Chemists Ltd.
Wallace House 51-53 Stert Street Abingdon Oxfordshire OX14 3JF United Kingdom
8 MARKETING AUTHORISATION NUMBER
PL 00400/0008R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/06/1982 / 28/01/2005
10 DATE OF REVISION OF THE TEXT
06/01/2016