Trapped Wind Relief 125mg Chewable Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trapped Wind Relief 125mg Chewable Tablets.
Tesco Trapped Wind Relief 125mg Chewable Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains simeticone equivalent to dimeticone 125mg For excipients, see 6.1
3 PHARMACEUTICAL FORM
Chewable tablet.
Cream/white round tablet with odour of peppermint with “Sim 125” embossed on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Antiflatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other similar symptoms associated with gastrointestinal gas.
4.2 Posology and method of administration
Adults, elderly and children over 12 years:
One tablet to be taken three or four times daily or as required for relief, after meals and upon retiring. The tablets are to be chewed before swallowing.
4.3 Contraindications
The product should not be used in patients with known hypersensitivity to any of the ingredients.
4.4 Special warnings and special precautions for use
If symptoms persist or worsen, medical advice should be sought.
Keep out of the reach and sight of children.
Not to be taken by children under 12 years.
This product contains lactose.
Patients with rare heredity problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This product contains sorbitol.
Patients with rare heredity problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltose insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Levothyroxine may bind to the silica in simeticone which can impair the absorption of levothyroxine.
4.6 Use during pregnancy and lactation
Medical advice should be sought prior to taking this product if pregnant.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Post-marketing experience
Within each system organ class, the adverse drug reactions are ranked under the headings of reporting frequency, using the following convention:
Very common (>1/10); Common (>1/100 to < 1/10); Uncommon (>1/1000 to < 1/100); Rare >1/10,000 to <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).
Immune system disorders
Not known: hypersensitivity reactions such as rash, pruritus, facial oedema, tongue oedema, respiratory difficulty.
Gastrointestinal disorders
Not known: stomach upset, diarrhoea
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
In the unlikely event of deliberate or accidental overdosage, treat symptoms on appearance. There are no special procedures recommended.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiflatulent ATC code: AO2DA
5.2 Pharmacokinetic properties
Simethicone (activated dimethicone) is not absorbed following oral administration. It acts by changing the surface tension of gas bubbles, causing them to coalesce.
5.3
Preclinical safety data
Simethicone is physiologically inert and considered to be non-toxic. It is not absorbed following oral administration, nor is it pharmacologically active. Preclinical data reveal no hazard for humans.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anhydrous Lactose Tribasic Calcium Phosphate Magnesium Stearate Sorbitol
Peppermint Flavour
6.2 Incompatibilities
Not applicable
6.3 Shelf life
30 months.
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
Clear colourless PVC/LDPE/PVDC/aluminium or PVC/PVDC/aluminium blister strips in an outer carton. Each blister strip contains 10 tablets. Each carton contains 10 or 30 tablets.
6.6 Special precautions for disposal
No special requirements
MARKETING AUTHORISATION HOLDER
7
Wrafton Laboratories Limited
Wrafton
Braunton
North Devon
EX33 2DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 12063/0037
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/10/2005
10 DATE OF REVISION OF THE TEXT
02/09/2016