Espumisan Baby for newborns: instructions for use, where to buy

Active components

The active substance is simecticone, a carminative defoaming agent. It passes through the baby’s gastrointestinal tract, collapses the gas bubbles resulting from fermentation and comes out unchanged.

1 milliliter of the drug contains 100 milligrams of simecticone. Macrogol stearate, glyceryl monostearate, sorbic acid, water, sodium chloride, sodium citrate, and natural hypoallergenic Banana flavor are used as additional components.

Espumisan Baby is sold in dark glass bottles. It is a viscous milky-white liquid with a banana aroma.

Espumisan L for children 30 ml drops for oral administration

Instructions for medical use of the drug Espumisan® L drops for children Trade name Espumisan® L drops for children International nonproprietary name Simethicone Dosage form Oral drops (emulsion) 30 ml Composition 1 ml (25 drops) contains the active substance simethicone 40 mg excipients : macrogol stearate, glycerol monostearate 40-55, carbomers, banana flavor, acesulfame potassium, liquid sorbitol (non-crystallizing), sodium chloride, sodium citrate, sodium hydroxide, sorbic acid, purified water. Description Milky white emulsion with low viscosity, with a fruity banana aroma. Pharmacotherapeutic group Drugs for the treatment of functional gastrointestinal disorders. Other drugs for the treatment of functional bowel disorders. Silicones. ATC code A03AX13 Pharmacological properties Pharmacokinetics Simethicone is not absorbed after oral administration, and after passing through the gastrointestinal tract it is again excreted unchanged. Pharmacodynamics The drug Espumisan® L drops for children contains simethicone, a stable surfactant polydimethylsiloxane, as an active ingredient. It changes the surface tension of gas bubbles found in the chyme and mucus of the digestive tract, causing them to break apart. The released gases can then be absorbed by the intestinal wall and also excreted by intestinal peristalsis. The action of simethicone is purely physical; it does not participate in chemical reactions and is not pharmacologically or physiologically active. Indications for use - symptomatic treatment of gastrointestinal disorders caused by increased gas formation, for example, flatulence, colic in infants - as an aid in diagnostic studies of the abdominal organs, for example, during X-ray examination, ultrasound of the abdominal organs and gastroscopy - as an antifoaming agent for intoxication with surfactants. Method of administration and dosage: Shake before use; To dispense drops, the bottle is held upside down. A cap with milliliter graduations is attached to the screw cap of the bottle with a dropper. If necessary, it can be used to measure the dose instead of a dropper. Do not allow the measuring cap to fall into the hands of children (risk of swallowing). If gastrointestinal disorders reoccur and/or if they are prolonged, a clinical examination should be performed. 25 drops correspond to 40 mg (1 ml). For the symptomatic treatment of gastrointestinal disorders caused by increased gas production, for example, with flatulence, colic in infants Age Dosage in drops Dosage in ml Frequency of administration Children 0 - 1 year 25 drops (40 mg) 1 ml added to a bottle of baby food or give before or after each breastfeeding Children aged 1 - 6 years 25 drops (40 mg) 1 ml 3 - 5 times a day Children aged 6 - 14 years 25 - 50 drops (40 - 80 mg) 1 - 2 ml 3 – 5 times a day Adolescents over 14 years of age and adults 50 drops (80 mg) 2 ml 3 – 5 times a day Espumisan® L drops for children can also be used after operations. Espumisan® L drops for children are used during or after meals, and, if necessary, also before going to bed. The duration of therapeutic use depends on the dynamics of the disorders. If necessary, Espumisan® L drops for children can be taken for a long time. As an aid in diagnostic studies of the abdominal organs · X-ray examination, ultrasound The day before the examination In the morning on the day of the examination, 2 ml 3 times a day (50 drops 3 times a day) 2 ml (50 drops) · as additives to suspensions of contrast agents 4 – 8 ml (100 – 200 drops) per 1 liter of suspension of contrast agent for obtaining images with double contrast for preparation for gastroscopy Before endoscopy 4 – 8 ml (100 – 200 drops) During endoscopy you can - in if necessary, inject a few milliliters of emulsion through the endoscope channel to eliminate gas bubbles that interfere with the study. As an antifoam in case of intoxication with surfactants Depending on the severity of poisoning Age Dosage Children 2.5 – 10 ml Adults 10 – 20 ml Side effects To date, no side effects have been observed as a result of using “Espumisan® L drops for children”. Contraindications - hypersensitivity to the active substance simethicone or to any other components of the drug Drug interactions Unknown Special instructions This drug contains sorbitol. The drug should not be used in cases of a rare hereditary pathology - fructose intolerance. Pregnancy and lactation There are no restrictions for taking Espumisan® L drops for children during pregnancy and lactation. Peculiarities of the drug's influence on the ability to drive a vehicle or potentially dangerous machinery "Espumisan® L drops for children" does not affect the ability to drive vehicles or maintain machinery. Overdose No cases of overdose have been reported. Since simethicone is completely inert in chemical and physiological terms, intoxication is practically excluded. In large quantities, Espumisan® L drops for children are also tolerated asymptomatically. Release form and packaging 30 ml in brown glass bottles with tamper-evident protection, consisting of a polypropylene screw cap with a tear-off ring and a drip nozzle. A cap with milliliter graduations is attached to the screw cap of the bottle with a dropper. If necessary, it can be used to measure the dose instead of a dropper. The bottle, together with instructions for medical use in the state and Russian languages, is placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 30 °C. Keep out of the reach of children! Shelf life: 3 years After opening the bottle, the drug is used for 6 months. After the expiration date, this medicine should not be used. Conditions for dispensing from pharmacies Without a prescription Manufacturer Berlin-Chemie AG (Menarini Group) Glinker Veg 125 D-12489 Berlin, Germany Registration certificate holder Berlin-Chemie AG (Menarini Group), Germany Organization - packer Berlin-Chemie AG (Menarini Group), Germany Address of the organization receiving complaints from consumers regarding the quality of products (products) in the Republic of Kazakhstan: Representative office of JSC Berlin-Chemie AG in the Republic of Kazakhstan Tel.: +7 727 2446183, 2446184, 2446185 Fax: +7 727 2446180 Email address

Indications for use

Drops are prescribed in the following cases:

• when the first symptoms of infant colic occur;
• when the first symptoms of flatulence occur in children (including during the period after surgery);
• with bloating as a result of dyspeptic disorders;
• during preparation for diagnostic studies of the abdominal and pelvic organs;
• in case of acute poisoning with detergents that contain foam-forming tensides. In this situation, Espumisan Baby acts as an antifoaming drug.

Dosage regimen

Espumisan Baby is used internally. Immediately before use, the suspension must be thoroughly shaken in the bottle. The required amount of the drug is measured in drops:

• For babies under 12 months of age, to relieve and prevent the development of infant colic, give 5-10 drops of the suspension at each feeding in a bottle (if the child is bottle-fed) or from a spoon with mother's milk immediately before feeding (if the child is breastfed) , children aged 1-6 years are prescribed 10-15 drops of Espumisan 4-5 times a day. For older children, the dose of the drug is increased to 20 drops at a time;
• during the period of preparation for diagnostic procedures, it is necessary to take Espumisan Baby after each meal, 25 drops (1 ml);
• in case of poisoning with foaming detergents, a single emergency dose for a child is 4 ml (100 drops) and 6 ml (150 drops) for an adult.

The drug can be used for a long time. No cases of overdose have been recorded. The use of the drug after surgery is possible only under the supervision of the attending physician.

Espumisan® baby

Compound:

1 ml (25 drops) of the drug contains:

Active substance

: simethicone* - 100.00 mg.

Excipients

: macrogol stearate 40, glyceryl monostearate 40-55, carbomer, banana flavor, acesulfame potassium, liquid sorbitol (non-crystallizing), sodium chloride, sodium citrate, sodium hydroxide, sorbic acid, purified water.

*Simethicone consists of dimethicone (polydimethylsiloxane (PDMS)) and silica in a ratio of 96:4

Description: slightly viscous milky-white liquid with a banana odor.

Pharmacotherapeutic group: carminative

ATX code: A03AX13

Pharmacological properties

Pharmacodynamics

The active ingredient simethicone reduces the amount of gases in the gastrointestinal tract (GIT): it has surface-active properties and the ability to reduce surface tension at the liquid/gas interface, which promotes the fusion of gas bubbles and the destruction of foam in the intestines, as a result of which the released gas is absorbed or is excreted naturally under the influence of intestinal peristalsis. The use of simethicone in preparation for diagnostic examinations of the abdominal organs is aimed at preventing the occurrence of image defects caused by gas bubbles.

Pharmacokinetics

Simethicone is chemically inert, after oral administration it is not absorbed from the gastrointestinal tract and acts only in its lumen. Does not interact with microorganisms and enzymes and does not affect digestion processes. It is excreted unchanged by the intestines.

Indications for use

• symptoms of intestinal colic in infants;
• symptoms of excessive formation and accumulation of gases in the gastrointestinal tract (including flatulence, increased gas formation in the postoperative period);
• symptoms of excessive gas formation caused by functional dyspepsia;
• preparation for diagnostic studies of the abdominal and pelvic organs (ultrasound, radiography, esophagogastroduodenoscopy, etc.), including as an additive to suspensions of contrast agents to obtain images using the double contrast method;
• acute poisoning with detergents containing foaming agents (tensides) as defoamers.

Contraindications

Hypersensitivity to the components of the drug, intestinal obstruction, hereditary fructose intolerance.

Use during pregnancy and breastfeeding

Since simethicone is not absorbed from the gastrointestinal tract, no negative effects are expected when using the drug during pregnancy and breastfeeding.

However, as with the use of any other medicines, the drug should be prescribed with caution during pregnancy and breastfeeding.

Directions for use and doses

Inside. The bottle of emulsion must be shaken before use. The drug is dosed in drops, holding the bottle vertically with the opening down. For convenience, you can also dose in milliliters using the measuring cap.

25 drops are equivalent to 1 ml (or 100 mg of simethicone).

The drug is taken before/during or after each meal and, if necessary, before bedtime.

The frequency of administration and duration of use depend on the severity of symptoms.

If necessary, Espumisan® baby can be taken for a long time.

After surgery, Espumisan® baby should be taken under medical supervision.

For complaints related to infant colic and excessive gas formation

Children under 1 year: 5-10 drops of Espumisan® baby (added to a bottle of baby food or given with a small spoon before/during or after feeding).

Children from 1 year to 6 years: 10 drops of Espumisan® baby 3-5 times a day.

Children from 6 to 14 years old: 10-20 drops of Espumisan® baby 3-5 times a day.

Children over 14 and adults: 20 drops of Espumisan® baby 3-5 times a day.

In preparation for diagnostic studies (radiography, ultrasound, etc.)

Take 1 ml of Espumisan® baby 3 times a day after meals the day before the study and 1 ml of Espumisan® baby in the morning on the day of the study.

To obtain a double contrast image

Add 2 - 4 ml of Espumisan® baby per 1 liter of contrast suspension.

In preparation for esophagogastroduodenoscopy

Take 2 - 3 ml of Espumisan® baby orally before the study.

During endoscopy, if necessary, a few milliliters of emulsion can be injected through the endoscope channel to eliminate gas bubbles that interfere with the examination.

In case of acute poisoning with detergents containing tensides

Children: 1 - 4 ml of Espumisan® baby; adults - 4-8 ml of Espumisan® baby is prescribed by a doctor depending on the severity of the poisoning.

Side effect

No side effects were observed when using Espumisan® baby.

It is possible to develop allergic reactions to the components of the drug.

If you experience the side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

There are no known cases of overdose.

Interaction with other drugs

Clinically significant interactions of simethicone with other drugs have not been established.

special instructions

If gastrointestinal symptoms persist for a long time (more than 14 days of therapy) or new symptoms occur, a medical examination is necessary.

The drug Espumisan® baby contains sorbitol (sorbitol), therefore its use in patients with hereditary fructose intolerance is contraindicated.

Information for patents with diabetes

: 1 ml of emulsion (25 drops) contains 199.17 mg of sorbitol, which corresponds to 0.017 bread unit (XE).

Impact on the ability to drive vehicles and machinery

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, working as a dispatcher, operator).

Release form

Drops for oral administration, 100 mg/ml.

30 ml or 50 ml in a dark glass bottle, equipped with a dropper dispenser, a screw cap with a first-opening control system and a measuring cap.

1 bottle with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C. Do not freeze!

Keep out of the reach of children!

Best before date

3 years.

Do not use after the expiration date.

After opening the bottle for the first time, use the drug within 6 months.

Vacation conditions

Available without a prescription.

Registration Certificate Holder

Berlin-Chemie AG, Germany

Manufacturer

Berlin-Chemie AG Glinker Weg 125 12489 Berlin Germany

Organization receiving complaints from consumers:

LLC "Berlin-Chemie/A. Menarini", Russia 123112, Moscow, Presnenskaya embankment, building 10, BC "Tower on the Naberezhnaya", Block B, tel., fax.

Additional Information

When using a medicinal substance, several points should be taken into account:

• the drug does not contain sugar, so the drug is approved for children diagnosed with diabetes mellitus;
• simecticone is not absorbed into the blood, has no effect on the central nervous system, does not affect the ability to drive, does not affect concentration, attention and memory;
• when taking sorbents (in case of food poisoning), you must wait 2 hours between taking these two drugs;
• the drug is safe for pregnant women, nursing mothers and babies from the first day of life;
• If signs of a food allergy appear, you should stop taking the drug and consult your pediatrician.