INFACOL

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Infacolâ

Composition:

Active substance: simethicone;

1 ml of suspension contains 40 mg of simethicone;

Excipients: sodium saccharin, hydroxypropylmethylcellulose, orange flavour, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: homogeneous white or almost white opaque suspension without visible inclusions, with an orange odour.

Pharmacotherapeutic group. Agents used in functional gastrointestinal disorders. Silicones.

ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics.

Simethicone is a stable surface-active polymethylsiloxane, an antifoaming agent. It alters the surface tension of gas bubbles formed in the contents of the stomach and intestinal mucosa, causing them to break down or coalesce, thus facilitating their elimination. The released gases are absorbed by the intestinal wall or expelled by intestinal peristalsis. Simethicone eliminates gas bubbles solely by physical means, does not enter into chemical reactions, and is chemically inert.

Pharmacokinetics.

Simethicone is not absorbed following oral administration and is excreted unchanged in the feces.

Clinical characteristics.

Indications.

Symptomatic treatment of gastrointestinal complaints associated with gas formation, such as abdominal pain, colic, bloating, and flatulence.

Contraindications.

Hypersensitivity to simethicone or to any of the excipients.

Intestinal obstruction, obstructive gastrointestinal disorders.

Interaction with other medicinal products and other forms of interaction.

Levothyroxine may bind to simethicone. The intestinal absorption of levothyroxine may be impaired when administered concomitantly with simethicone.

Special precautions for use

Do not use the medicinal product Infacol without consulting a doctor if the child is undergoing treatment for thyroid gland disorders.

Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) contained in the medicinal product Infacol may cause allergic reactions (possibly delayed).

If symptoms persist, consult a doctor.

Use during pregnancy or breastfeeding

Do not use.

Ability to affect reaction speed when driving or operating machinery

Do not use.

Dosage and Administration.

For children under 1 year of age, administer 20 mg (0.5 ml) before each feeding. If necessary, the dose may be increased to 40 mg (1 ml). Treatment with Infacol provides gradual symptom improvement over several days. The duration of treatment depends on the presence of symptoms and is determined individually by a physician.

Children.

This medicinal product is intended for use in children under 1 year of age.

Overdose.

To date, no toxic effects have been reported following administration of simethicone. In case of doses exceeding those recommended, consult a physician. In the event of intentional or accidental overdose, symptomatic treatment should be administered.

Adverse reactions.

Skin rash, itching, hyperemia may occur. May cause allergic reactions (possibly delayed).

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

Shelf life. 3 years. After first opening – 28 days.

Storage conditions.

Store at temperatures not exceeding 25 °C in a place inaccessible to children.

Packaging.

Bottle containing 50 ml, 75 ml or 100 ml of suspension with dropper dispenser. One bottle per cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

Purna Pharmaceuticals NV.

Manufacturer's address and location of operations.

Rijksweg 17, Puurs-Sint-Amands, 2870, Belgium.