Disflatyl (Drops) Instructions for Use

Marketing Authorization Holder

Valeant Pharmaceuticals Switzerland GmbH (Switzerland)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Form

Disflatyl

Oral drops 40 mg/1 ml: 30 ml bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a homogeneous milky-white emulsion with a pineapple odor.

Preservatives benzoic acid (E 210), sodium benzoate (E 211).

Excipients: polyoxyethylene (2) stearate, polyoxyethylene (20) stearate, sodium saccharin, flavoring (pineapple), purified water.

30 ml – dark glass bottles (1) with a dispenser – cardboard boxes.

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Carminative agent

Pharmacological Action

The active component of the drug Disflatyl – Simeticone – is a silicon-containing compound with surface activity and antifoaming properties.

Due to its physicochemical properties, Simeticone is a chemically and physiologically inert substance, non-toxic and not absorbed by the cell membranes of the gastrointestinal mucosa. Simeticone destroys gas bubbles physically by changing their surface tension and thereby causing them to collapse. Due to this property, Simeticone is used for the symptomatic treatment of excessive gas formation in the gastrointestinal tract. The released gas is then eliminated naturally.

Indications

• Symptomatic treatment of all types of excessive gas formation and gas accumulation in the gastrointestinal tract: abdominal bloating, flatulence (including postoperative flatulence), aerophagia. The use of Disflatyl reduces the feeling of fullness and tension in the abdomen;
• Preparation for endoscopic, radiological, ultrasound, sonographic examinations of the stomach and/or intestines to remove gases and air from the gastrointestinal tract.

ICD codes

Dosage Regimen

Symptomatic treatment

Adults 25-50 drops, if possible, accompanied by a small amount of liquid, after each meal and before bedtime.

Children aged 6 to 15 years 25-50 drops, if possible, accompanied by a small amount of liquid, after each meal and before bedtime.

Newborns and children under 6 years 10-15 drops 2-3 times a day during meals (in the feeding bottle for infants) or after meals.

Prophylactic use for preparation for examination of the stomach and/or intestines.

50 drops 3-4 times a day for the 2 days preceding the examination, 50 drops in the morning, on an empty stomach, on the day of the examination and 50 drops immediately before the examination.

The bottle with the drops must be shaken well before use.

Adverse Reactions

Since Simeticone is not absorbed from the gastrointestinal tract and is excreted from the body unchanged, the drug is considered safe and does not cause side effects.

In some cases, allergic reactions to the components of the drug are possible.

Contraindications

• Intestinal obstruction accompanied by severe colic and vomiting (in these cases, a doctor should be consulted immediately);
• Increased sensitivity to the components of the drug.

Use in Pregnancy and Lactation

Pregnant women and nursing mothers should, as a precaution, avoid taking medications altogether or consult their attending physician.

Special studies have not been conducted in humans or animals. Since Simeticone is not absorbed from the gastrointestinal tract and is excreted unchanged, the use of Disflatyl during pregnancy does not affect fetal development. During breastfeeding, the drug does not pass into breast milk.

Special Precautions

In case of prolonged and recurring digestive disorders, it is necessary to determine the cause of these phenomena. This may be due to improper nutrition or lack of physical activity. If organic disorders or disorders of the nervous system are also present, in all these cases it is necessary to consult a doctor.

Use of Disflatyl in patients with diabetes.

Disflatyl drops do not contain sugar. The drug contains a synthetic sweetener – sodium saccharinate. Therefore, the drug can be used by patients with diabetes.

Use of Disflatyl when operating machinery and driving vehicles.

The drug does not have a systemic effect on the body and can be used when driving vehicles and operating machinery.

Overdose

To date, no cases of excessive drug dosage are known.

Drug Interactions

No special precautions are required when using Disflatyl drops simultaneously with other medicines and food products, including tea, coffee, and alcoholic beverages.

In the presence of other diseases, a tendency to allergic reactions, or when taking other medications, it is necessary to consult a doctor beforehand.

Storage Conditions

Store at a temperature between 15°C and 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 5 years. Do not use the drug after the expiration date printed on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.