Wind-Eze Gel Caps: Indications, Dosage, Precautions, Adverse Effects
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Wind-Eze Gel Caps - Product Information

Manufacture: Forest Laboratories, Inc.
Country: Great Britain
Condition: Functional Gastric Disorder, Gas
Class: Miscellaneous GI agents
Form: Capsules
Ingredients: simeticone, gelatin, glycerol, titanium dioxide (e171), purified water

Name of the Medicinal Product

Wind-eze Gel Caps

Qualitative and Quantitative Composition

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

For excipients see List of Excipients

Pharmaceutical Form

Capsule, soft.

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

Clinical Particulars

Therapeutic indications

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

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.

Contraindications

Simeticone is contraindicated in patients with a previous history of hypersensitivity to simeticone or excipients.

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.

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.

Pregnancy and lactation

Medical advice should be sought prior to taking this product if pregnant.

Effects on ability to drive and use machines

None known.

Undesirable effects

Minor adverse effects: nausea and constipation. Rarely hypersensitivity reactions such as rash, pruritis, facial oedema, tongue oedema, respiratory difficulty.

Overdose

In the unlikely event of deliberate or accidental overdosage, treat symptoms on appearance. There are no special procedures recommended.

Pharmacological Properties

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.

Pharmacokinetic properties

Simeticone is not absorbed following oral administration.

Preclinical safety data

Simeticone is physiologically inert and considered to be non-toxic. Preclinical data reveal no hazard for humans.

Pharmaceutical Particulars

List of excipients

Capsule shell:

Gelatin

Glycerol

Titanium Dioxide (E171)

Purified Water

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C.

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

Special precautions for disposal and other handling

No special requirements.

Administrative data

Marketing Authorisation Holder

Forest Laboratories UK Limited,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

Marketing Authorisation Number(s)

PL 00108/0335

Date of First Authorisation/Renewal of the Authorisation

16 June 1997

Date of Revision of the Text

11/08/2015

Company Contact Details

Forest Laboratories UK Limited (a subsidiary of Actavis PLC)

http://www.actavis.co.uk

Address

Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346106

Medical Information e-mail

medinfo@actavis.co.uk

Telephone

+44 (0)1271 311 200

Medical Information Direct Line

+44(0)1271 385 257