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 precautions for use

If symptoms persist or worsen, medical advice should be sought.

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 scrase-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    Pregnancy and lactation

Since Simethicone is not absorbed by the gastro-intestinal tract, Trapped Wind Relief Chewable tablets may be taken during pregnancy and lactation.

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.

6.1    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

7    MARKETING AUTHORISATION HOLDER

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

29/06/2015