DEFLAT®

Deflat®

Simethicone

Properties:

Deflat (Simethicone), is an antiflatulent drug that reduces the surface tension of gas bubbles which may be formed excessively in the gastrointestinal tract. Then, small gas bubbles will coalesce forming larger bubbles that can be easily expelled through belching or passing flatus.

Indications:

• Deflat® is indicated for the relief of painful symptoms as: sensation of pressure, fullness in the epigastrium and intestinal spasm due to excessive accumulation of gases that may be formed in the digestive tract in the following cases:

- Air swallowing (aerophagia).

- Functional dyspepsia.

- Irritable bowel syndrome.

- Peptic ulcer.

- Postoperative gaseous distension.

- Infant colic.

- Gastro-cardiac symptom complex.

• Deflat is used as a diagnostic aid to remove gases from the gastrointestinal tract before gastroscopy, x-ray examination and sonography of the spine and abdominal organs.

Dosage and administration:

Deflat should be given as prescribed by the physician after meals and at bedtime, the following dosages are recommended:

• Deflat drops:

- Infants (less than 2 years): half a dropperful (1/2 mL or 10 drops approximately) equivalent to 20 mg Simethicone, four times daily after meals and at bedtime.

- Children (2-12 years): one dropperful (1 mL or 20 drops approximately) equivalent to 40 mg Simethicone, four times daily after meals and at bedtime.

- Adults: take 25-50 drops, possibly with a little fluid, after every meal and before retiring to bed.

- For diagnostic purposes (endoscopic, radiological, and sonographic investigations) 50 drops 3-4 times a day on the two preceding days to investigation, and 50 drops each when fasting on the morning of the day of investigation and immediately before the investigation.

- For infants and children, it is not recommended to exceed 240 mg/day of Simethicone, except under the advice and supervision of a physician.

• Deflat tablets:

- It is recommended to take one tablet four times daily after meals and at bedtime. Tablets are to be chewed well before being swallowed alone or with some water.

- For diagnostic purposes (endoscopic, radiological, and sonographic investigations) Deflat® tablets can be given in the recommended dosage for 2-3 days before the day of examination, additional tablet on the day of examination is recommended.

• Deflat® soft:

- It is recommended to take one capsule four times daily after meals and at bedtime.

Contraindications:

• lleus.

• Obstructive gastrointestinal disorders.

Drug interactions:

No interactions with other agents have been reported.

Precautions:

No special precautionary measures are necessary.

• Pregnancy: since the active ingredient is not absorbed it is not expected to have any risk for the foetus.

• Lactation: it is not expected to enter breast milk.

Adverse reactions:

Simethicone is physiologically inert, and is not absorbed from the stomach and intestine, so it has a high safe profile even when used for long periods of time.

Overdosage:

Toxic effects from overdosage have not been reported.

Information for the patient:

- Deflat drops:

• Shake well before use.

• Fill the dropper to the recommended dosage level and dispense liquid slowly into mouth, toward inner cheek.

• To ease administration, the dose can be mixed with 30 mL of cool water, infant formula or other suitable liquid.

• Deflat® drops contains artificial sweeteners and is suitable for diabetics.

- Deflat chewable tablets:

Tablets are to be chewed well before being swallowed alone or with some water.

Presentations:

Deflat drops: each mL of the emulsion contains 40 mg Simethicone in bottles of 30, 50 and 60 mL.

Deflat chewable tablets: each chewable tablet contains 120 mg Simethicone in packs of 24,40 and 504 tablets.

Deflat® soft gelatin capsules: each soft gelatin capsule contains 125 mg Simethicone in packs of 30 capsules.

* Some presentations may not be available in certain countries.