Dialak forte

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIALAC FORTE

Composition:

Active substance: simethicone;

1 soft capsule contains simethicone 240 mg;

Excipients: gelatin, glycerin, purified water.

Dosage form. Soft capsules.

Main physicochemical properties: round, transparent, soft gelatin capsules filled with a viscous, slightly opalescent, grayish-white liquid.

Pharmacotherapeutic group. Agents used in functional intestinal disorders. Silicones. ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics. Simethicone is a physiologically inert surfactant based on silicon, an antifoaming agent. It has no pharmacological activity and acts by altering the surface tension of gas bubbles, promoting their coalescence and facilitating their elimination. The released gases may either be absorbed by the intestinal walls or expelled from the body through intestinal peristalsis.

Pharmacokinetics. Simethicone acts exclusively on the surface of gas bubbles and is not absorbed through the gastrointestinal mucosa.
It is completely excreted unchanged in feces.
Bioavailability: simethicone is not absorbed.

Non-clinical safety data
Simethicone is chemically inert and is not absorbed from the intestinal lumen. Systemic toxic effects are not expected. Non-clinical data based on conventional repeated-dose toxicity studies indicate no special hazard for humans regarding carcinogenicity or toxic effects on reproductive function.

Clinical characteristics.

Indications.

Dialac Forte is used in adult patients as symptomatic treatment of gastrointestinal disorders associated with gas formation, such as meteorism, including in the postoperative period.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients, intestinal obstruction, obstructive gastrointestinal disorders.

Interaction with other medicinal products and other forms of interaction.

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.

Special precautions for use.

If symptoms worsen or persist, or in case of prolonged constipation, the patient should consult a physician.

Simeticone is not recommended for the treatment of infant colic, as information on safety in children is limited.

Use during pregnancy or breastfeeding.

Pregnancy. Data on the use of simeticone in pregnant women are lacking or limited.
Animal studies are insufficient to evaluate reproductive toxicity.
No harm to pregnant women is expected, since simeticone is not absorbed through the gastrointestinal tract of the patient.

Breastfeeding. It is unknown whether simeticone or its metabolites are excreted in breast milk. Since simeticone is not absorbed through the mucous membrane of the gastrointestinal tract, no effect of the medicinal product on the fetus or accumulation in breast milk is expected.

The use of the drug during pregnancy or breastfeeding is possible only when the expected benefit to the woman outweighs the potential risk to the fetus or infant.

Fertility. Preclinical data indicate no particular hazard to humans with regard to toxic effects on fertility.

Ability to influence reaction speed when driving vehicles or operating machinery.
Studies on the influence on the ability to drive vehicles or operate machinery have not been conducted.
Since simeticone is an inert substance that is not absorbed, its effect on driving ability or operating machinery is practically excluded.

Dosage and Administration

Dosing

Take 1 capsule after each main meal (lunch and dinner) with a glass of water. Do not exceed the maximum daily dose of 480 mg (2 capsules).

Administration

Take orally with water.

The duration of treatment should not exceed 10 days.

Children

Not recommended for use in children due to lack of appropriate information.

Overdose

No cases of overdose have been reported.

Even if a larger amount of the drug is taken than recommended, the likelihood of adverse effects is very low, as the medicinal product is not absorbed following oral administration.

In case of accidental or intentional overdose, seek medical advice. There is no specific recommended procedure for managing overdose.

Side effects.

During the period of simethicone use, the following adverse reactions have been reported, with unknown frequency.

Gastrointestinal disorders: constipation, nausea, vomiting, abdominal pain.

When treating with the medicinal product Dialac Forte, belching may occur, which is a normal mechanism of gas elimination.

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

Skin and subcutaneous tissue disorders: rash, pruritus, angioneurotic edema.

If undesirable reactions occur, treatment should be discontinued and medical advice should be sought.

Reporting suspected adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store at temperatures not exceeding 30 °C.

Keep out of reach of children.

Packaging.

20 soft capsules in a blister; 1 blister per cardboard pack.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

Laboratorios Alcala Farma S.L. / Laboratorios Alcala Farma S.L.

Manufacturer's address and location of operations.

Avenida de Madrid, 82, Alcala de Henares, 28802, Spain / Avenida de Madrid, 82, Alcala de Henares, 28802, Spain.