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

Manufacture: Forest Laboratories, Inc.
Country: Great Britain
Condition: Functional Gastric Disorder, Gas
Class: Miscellaneous GI agents
Form: Tablets
Ingredients: simeticone, starch, sorbitol (E 420), tribasic calcium phosphate, citric acid, talc, peppermint flavour, nonpareil seeds (sugar and starch)

Name of the Medicinal Product

Wind-Eze

Qualitative and Quantitative Composition

Simeticone [Equivalent to Poly(Dimethylsiloxane)], 11.57% w/w, approx. 125.00mg

Pharmaceutical Form

Chewable tablets for oral administration.

Clinical Particulars

Therapeutic Indications

Antiflatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other similar symptoms associated with gastrointestinal gas.

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.

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.

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.

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.

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, 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.

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 (activated dimeticone) 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

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

Incompatibilities

None known.

Shelf Life

3 years in PVC/PVDC Al foil blister packs. 3 years in PVC/PE/Aclar Al. foil blister packs.

Special Precautions for Storage

Store below 25°C.

Store in a dry place.

Nature and Contents of Container

Blister packs of construction 190 μm PVC (product contact side)/51μm PE/38μm aclar and 25μm aluminium foil with vinyl sealing coat (product contact side).

or

Blister packs of construction 250μm PVC (product contact side)/PVDC 60 g/m2 and 20 μm aluminium foil with vinyl heat sealing coat (product contact side).

Pack sizes: 4, 10, 20, 30, 50.

Special Precautions for Disposal and Other Handling

Not applicable.

Marketing Authorisation Holder

Forest Laboratories UK Limited,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

Marketing Authorisation Number(s)

PL 00108/0336

Date of First Authorisation/Renewal of the Authorisation

25th May 2001

Date of Revision of the Text

08.02.2016

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