AFLETIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AFLETIN (AFLETIN)

Composition:

Active substance: simethicone;

1 capsule contains simethicone 125 mg;

Excipients: gelatin, glycerin.

Pharmaceutical form. Soft capsules.

Main physico-chemical properties: soft gelatin capsules of spherical or round shape with a seam, light yellow in color, filled with a viscous, opalescent, grayish-white liquid.

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

ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics.

Simethicone, which is part of the medicinal product, is a non-toxic, inert surfactant based on silicon, an antifoaming agent. It alters the surface tension of gas bubbles formed in the intestine, causing their breakdown. The gases released in this process may either be absorbed by the intestinal walls or eliminated from the body through intestinal peristalsis. Administration of the drug prior to diagnostic examinations of abdominal organs prevents image artifacts caused by gas bubbles; it promotes thorough coating of the colonic mucosa with contrast medium, thus preventing disruption of the contrast film even in cases of intestinal distension.

Pharmacokinetics.

Simethicone acts exclusively on the surface of gas bubbles and is not absorbed by the mucosa of the gastrointestinal tract. After oral administration, simethicone is excreted unchanged. Simethicone has no central effects.

Clinical characteristics.

Indications.

˗ Symptomatic treatment of gastrointestinal disorders associated with gas formation, such as meteorism, including in the postoperative period.

˗ As an adjunctive agent during diagnostic examinations of abdominal organs (X-ray, ultrasound) and in preparation for gastro-duodenoscopy.

˗ As an anti-foaming agent in intoxications with surface-active substances (detergent powders or other cleaning agents).

Contraindications.

˗ Hypersensitivity to the components of the medicinal product.

˗ Intestinal obstruction.

˗ Obstructive gastrointestinal disorders.

Interaction with other medicinal products and other types of interactions.

Concomitant use of simethicone and laxatives containing mineral oil (paraffin) is not recommended, as mixing these substances leads to reduced effectiveness of simethicone.

Levothyroxine may bind to simethicone. Intestinal absorption of levothyroxine may be impaired when administered simultaneously with simethicone.

Usage Notes

If gastrointestinal symptoms (complaints) recur, persist for more than 14 days, or worsen, consult a physician.

Use during pregnancy or breastfeeding.

There are no clinical data on the use of the medicinal product Aflatine in pregnant women. Since the active ingredient is not absorbed through the gastrointestinal mucosa, no effect of the drug on the fetus or accumulation in breast milk is expected.

The use of the medicinal product Aflatine during pregnancy or breastfeeding is possible only when the expected benefit to the woman outweighs the potential risk to the fetus or child.

Ability to influence reaction speed when driving vehicles or operating machinery.

Since simethicone is an inert substance that is not absorbed, its effect on driving vehicles or operating machinery is practically excluded.

Dosage and Administration

The medicinal product should be administered orally to adults and children aged 12 years and older. The administration of the drug is not affected by food intake.

Symptomatic treatment of gastrointestinal disorders: 1 capsule three times daily.

As an adjunct in diagnostic examinations of abdominal organs: 1 capsule three times daily the day before the examination and an additional 1 capsule in the morning on the day of the examination.

As an antifoaming agent in intoxications with surfactants (detergents or other cleaning agents): dosage depends on the severity of intoxication. The minimum recommended dose is 3 capsules.

The duration of treatment is determined individually. If necessary, the medicinal product can be used for prolonged periods.

Children.

The medicinal product is used in children aged 12 years and older.

For children under 12 years of age, the drug should be administered in liquid dosage forms.

Overdose.

Cases of overdose have not been reported to date. Since simethicone is chemically and physiologically inert, intoxication is practically impossible. In case of administration of doses higher than recommended, medical advice should be sought.

Side effects.

Immune system disorders: allergic manifestations, hypersensitivity reactions such as itching, skin rashes, urticaria, facial swelling, tongue swelling, and difficulty breathing.

Gastrointestinal disorders: nausea, constipation.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 capsules in a blister; 2 blisters per carton.

20 capsules in a blister; 1 blister per carton.

Supply category. Over-the-counter (without prescription).

Manufacturer.

JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business operations.

38, Kopilivska St., Kyiv, 04073, Ukraine.

Website: www.vitamin.com.ua