McNeil Healthcare (Ireland) Ltd

IMOGAS 240 mg, soft capsule

Each capsule contains:

Simeticone 240.00 mg

For a full list of excipients, see section 6.1.

Soft capsule.

Egg-shaped transparent soft capsule.

Symptomatic treatment of abdominal distension (flatulence) in adults (from the age of 15 years).

Oral use.

Reserved for use in adults (from the age of 15 years).

Take one capsule at the end of each main meal with a glass of water.

The duration of treatment is restricted to 10 days.

Hypersensitivity to simeticone or to any of the excipients.

If the symptoms persist or worsen, or in the event of prolonged constipation, the patient should seek medical advice.

Simeticone is not recommended for the treatment of infant colic because of limited information on its safety in infants and children.

Interaction studies have not been performed.

For simeticone no clinical data on exposed pregnancies are available. Animal studies are insufficient with respect to toxicity to reproduction (see section 5.3).

There is insufficient information on the excretion of simeticone in human or animal breast milk.

Since simeticone is not absorbed from the gastrointestinal tract, Imogas can be used in pregnant and lactating women.

No studies on the effects on the ability to drive and use machines have been performed.

*cannot be estimated from the available data

No case of overdose has been reported.

Pharmacotherapeutic group: Other medicinal products for functional bowel disorders, ATC Code: AO3AX13 (silicones)

Simeticone is a physiologically inert substance, which is therefore pharmacologically inactive. It acts by modifying the surface tension of gas bubbles, thus causing their coalescence.

Following oral administration, simeticone is not absorbed and passes through the digestive tract before being excreted in an unchanged form.

Bioavailability:

Simeticone is not absorbed.

There are no preclinical data considered relevant to clinical safety other than data included in other sections of the SPC. Simeticone is chemically inert and is not absorbed systemically. Systemic toxic effects are therefore unlikely.

Gelatine, glycerol (E422).

Not applicable.

3 years

This medicinal product does not require any special storage conditions.

10, 20 or 30 soft capsules in heat-formed blister strips (PVC/PVDC/Aluminium).

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.

McNeil Healthcare (Ireland) Ltd

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/65/1

Date of first authorisation: 1 June 2007

Date of last renewal: 26^th December 2010

July 2011