Wind-Eze
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Wind-Eze
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Grade |
% w/w |
Approx mg | |
|
Active Constituent | |||
|
Simeticone [Equivalent to |
Ph. Eur. |
11.57 |
125.00 |
|
Poly(Dimethylsiloxane)] |
3 PHARMACEUTICAL FORM
Chewable tablets for oral administration.
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
For oral 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.
Maximum daily dose:
Four tablets (500mg Simeticone) in any 24 hours.
Do not exceed the stated dose.
Children under 12 years of age:
Not recommended.
4.3 Contraindications
Simeticone is contraindicated in patients with a previous history of hypersensitivity to simeticone or excipients.
4.4 Special warnings and special precautions for use
If symptoms persist for more than 14 days, or if symptoms worsen, medical advice must be sought.
This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Keep out of the reach and sight of children.
Not to be taken by children under 12 years.
4.5 Interaction with other medicinal products and other forms of interaction
Although no studies have been presented, the concomitant use of this drug and mineral oil (paraffin) based laxatives is not recommended since mixing of these two will diminish the efficacy.
Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Wind-eze is taken concurrently to treatment for thyroid disorders.
4.6 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
Minor adverse effects: nausea and constipation. Rarely hypersensitivity reactions such as rash, pruritus, facial oedema, tongue oedema, respiratory difficulty.
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
Pharmacodynamic properties
5.1
Simeticone is an anti-flatulent with ATC code A03AX13. Physiologically simeticone is extremely inert, and therefore it will not be pharmacologically active. It acts by changing the surface tension of gas bubbles, causing them to coalesce.
5.2 Pharmacokinetic properties
Simeticone (activated dimeticone) is not absorbed following oral administration
5.3 Preclinical safety data
Simeticone is physiologically inert and considered to be non-toxic. Preclinical data reveal no hazard for humans.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dextrates (hydrated) USNF
Sorbitol Crystalline EP
Tribasic Calcium Phosphate (Powder) USNF
Citric Acid Anhydrous (Powder) EP
Natural and artificial peppermint flavour No. 517
(Spray dried) HSE
Talc (purified) EP
Non-pareil seeds (Starch/Sucrose) HSE
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years in PVC/PVDC A1 foil blister packs. 3 years in PYC/PE/Aclar A1. foil blister packs.
6.4 Special precautions for storage
Store below 25°C.
Store in a dry place.
6.5 Nature and contents of container
Blister packs of construction 190 pm PVC (product contact side)/51pm PE/38pm aclar and 25pm aluminium foil with vinyl sealing coat (product contact side).
or
Blister packs of construction 250 pm PVC (product contact side)/PVDC 60 g/m2 and 20 pm aluminium foil with vinyl heat sealing coat (product contact side).
Pack sizes: 4, 10, 20, 30, 50.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited,
Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00108/0336
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/07/1996 / 25/05/2001
10
DATE OF REVISION OF THE TEXT
20/08/2015