Medine.co.uk

Wind-Eze

Document: spc-doc_PL 00108-0335 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Wind-eze Gel Caps

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each soft capsule contains: 125mg Simeticone (activated dimeticone)

For excipients see 6.1

3 PHARMACEUTICAL FORM

Capsule, soft.

The capsules are oval gelatin capsules with a white to off white opaque gelatin shell.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with gastrointestinal gas.

4.2 Posology and method of administration

For oral administration:

Adults, children (12 years and above) and elderly:

One gel capsule to be taken three or four times daily or as required for relief, after meals and upon retiring. Maximum daily dose: Four gel capsules (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 precautions for use

If symptoms persist for more than 14 days, or if symptoms worsen, medical advice must be sought.

Keep out of the reach and sight of children.

This medicinal product contains glycerol. Harmful in high doses. Can cause headache and can cause stomach upset and diarrhoea.

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 Gel Caps are 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, pruritis, 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 Yellowcard 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

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 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

Capsule shell

Gelatin

Glycerol

Titanium Dioxide (E171) Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Blister packs of construction PVDC /PVC and aluminium foil with heat sealing coat.

Pack sizes: 10, 20, 30, 50 and 60.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Forest Laboratories UK Limited,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

8    MARKETING AUTHORISATION NUMBER(S)

PL 00108/0335

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16 June 1997

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DATE OF REVISION OF THE TEXT

11/08/2015