Infacol oral suspension 40 mg/ml bottle 50 ml

Instructions Infacol oral suspension 40 mg/ml bottle 50 ml

Composition

active ingredient: simethicone;

1 ml of suspension contains 40 mg of simethicone;

Excipients: sodium saccharin, hydroxypropyl methylcellulose, orange flavoring, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water.

Dosage form

Oral suspension.

Main physicochemical properties: homogeneous translucent suspension without visible inclusions with an orange odor.

Pharmacotherapeutic group

Drugs used in functional gastrointestinal disorders. Silicones. ATX code A03A X13.

Pharmacological properties

Pharmacodynamics

Simethicone is a stable surface-active polymethyloxane. It changes the surface tension of gas bubbles formed in the stomach contents and intestinal mucus, causing them to collapse. The released gases are absorbed by the intestinal wall or removed during intestinal peristalsis.

Simethicone removes gas bubbles only physically, does not enter into chemical reactions and is chemically inert.

Pharmacokinetics

Simethicone is not absorbed when taken orally and is excreted unchanged in the intestines.

Indication

Symptomatic treatment of gastrointestinal complaints associated with gas formation, e.g. abdominal pain, colic, bloating, flatulence.

Contraindication

Infacol suspension should not be used in cases of known hypersensitivity to simethicone or any other component of the drug.

Intestinal obstruction, obstructive diseases of the gastrointestinal tract.

Interaction with other medicinal products and other types of interactions

Levothyroxine may bind to simethicone. The absorption of levothyroxine in the intestine may be impaired when taken simultaneously with simethicone.

Application features

Infacol should not be used without consulting a doctor if the child is undergoing treatment for thyroid disease.

The parahydrobenzoates used in Infacol may cause a delayed-type hypersensitivity reaction.

If symptoms persist, you should consult a doctor.

Use during pregnancy or breastfeeding

Do not apply.

Ability to influence reaction speed when driving vehicles or other mechanisms

Do not apply.

Method of administration and doses

For children under 1 year of age, administer 20 mg (0.5 ml) before feeding, if necessary, the dose can be increased to 40 mg (1 ml). Treatment with Infacol provides a gradual improvement in symptoms over several days. The duration of treatment depends on the presence of complaints and is decided by the doctor individually.

Children

The drug should be used in children under 1 year of age.

Overdose

There are currently no known toxic effects from the use of simethicone. If doses higher than recommended are used, a doctor should be consulted.

Adverse reactions

The possibility of skin rash, itching, hyperemia cannot be ruled out. May cause allergic reactions (possibly delayed).

Expiration date

. 2 years.

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Store at a temperature not exceeding 25 °C out of the reach of children.

Packaging

Bottle of 50 ml or 75 ml or 100 ml of suspension with a dropper.

1 bottle in a cardboard box.

Vacation category

Without a prescription.

Producer

Purna Pharmaceuticals NV.

Location of the manufacturer and its business address

Rijksweg 17, Puurs, B-2870, Belgium.

Applicant

Forest Laboratories UK Limited.

Applicant's location

Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom.