Simeotic® 100 mg/ml
Simeotic for bloating and excess gas "collapses" the gas bubbles, and the released gas is either easily absorbed or eliminated naturally. The pain diminishes, and simultaneously, the intestinal mucosa is "cleared," allowing other medications to be absorbed as intended.
Description
Dosage form and composition
Oral drops, 40 mg/ml and 100 mg/ml.
30 ml in a dark glass bottle with a dosing device (dropper plug) and a plastic cap or a cap with a first-opening control.
A self-adhesive label is affixed to the bottle.
1 bottle, together with a polypropylene measuring cup and the package insert, is placed in a cardboard carton.
|
Active ingredient:
Simethicone* |
40.0 mg/ml
40.00 mg |
100.0 mg/ml
100.00 mg |
Indications for use
-
Excessive formation and accumulation of gas in the GI tract (flatulence, postoperative gas buildup);
-
Acute poisoning by detergents containing foaming agents (tensides), as an antifoaming agent.
-
Preparation for diagnostic examinations of the abdominal and pelvic organs (ultrasound, radiography, esophagogastroduodenoscopy, etc.), including as an additive to contrast agent suspensions for double-contrast imaging;
-
Symptoms of intestinal colic in newborns and infants;
-
Symptoms of excess gas caused by functional dyspepsia;
- All indications for use (instructions)
Dosage and administration
Orally. The bottle with the emulsion must be shaken before use. The drug can be dosed in drops or in milliliters using the measuring cup. For drop dosing, the bottle must be held vertically with the opening facing downwards.
The drug is taken during or after meals and, if necessary, at bedtime. The frequency of administration and duration of use depend on the severity of symptoms. If necessary, Simeotic® can be used for a long time.
Administration method for Simeotic® in dosage 40 mg/ml:
For complaints related to excess gas and intestinal colic
Children from birth to 1 year: 1 ml (20 drops) of Simeotic® with each feeding (added to the bottle with infant formula or given with a small spoon during or after feeding).
Children from 1 to 6 years: 1 ml (20 drops) of Simeotic® 3-5 times daily.
Children from 6 to 14 years: 1-2 ml (20-40 drops) of Simeotic® 3-5 times daily.
Children from 14 years and adults: 2 ml (40 drops) of Simeotic® 3-5 times daily.
For preparation for radiography and ultrasound examination
2 ml (40 drops) of Simeotic® 3 times daily the day before the examination and 2 ml (40 drops) of Simeotic® on the morning of the examination.
For obtaining a double-contrast image
Add 4-8 ml of Simeotic® per liter of contrast suspension.
For preparation for esophagogastroduodenoscopy
Orally, 4-8 ml of Simeotic® before the examination. During endoscopy, if necessary, a few milliliters of the emulsion can be introduced through the endoscope channel to eliminate gas bubbles that interfere with the examination.
For acute poisoning by detergents containing tensides
Children: 2.5-10 ml of Simeotic®; Adults: 10-20 ml of Simeotic® depending on the severity of poisoning.
Administration method for Simeotic® in dosage 100 mg/ml:
For complaints related to excess gas and intestinal colic
Children from birth to 1 year: 8 drops of Simeotic® with each feeding (added to the bottle with infant formula or given with a small spoon during or after feeding).
Children from 1 to 6 years: 8 drops of Simeotic® 3-5 times daily.
Children from 6 to 14 years: 8-16 drops of Simeotic® 3-5 times daily.
Children from 14 years and adults: 16 drops of Simeotic® 3-5 times daily.
For preparation for radiography and ultrasound examination
1 ml (20 drops) of Simeotic® 3 times daily after meals the day before the examination and 1 ml (20 drops) of Simeotic® on the morning of the examination.
For obtaining a double-contrast image
Add 2-4 ml of Simeotic® per liter of contrast suspension.
For preparation for esophagogastroduodenoscopy
Orally, 2-3 ml of Simeotic® before the examination. During endoscopy, if necessary, a few milliliters of the emulsion can be introduced through the endoscope channel to eliminate gas bubbles that interfere with the examination.
For acute poisoning by detergents containing tensides
Children: 1-4 ml of Simeotic®; Adults: 4-8 ml of Simeotic® depending on the severity of poisoning.
Regulatory status
Over-the-counter
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Our certificates:
Package Insert for Simeotic® oral drops 40 mg/ml
Marketing Authorization Number: LP-006132
International Nonproprietary Name: Simethicone
Brand Name: Simeotic®
Dosage Form: Oral drops
Composition per 1 ml:
|
Active substance: |
40 mg/ml |
100 mg/ml |
|
Simethicone* |
40.00 mg |
100.00 mg |
|
Inactive ingredients: |
|
|
|
Macrogol Stearyl Ether 20 |
14.00 mg |
14.00 mg |
|
Macrogol Stearyl Ether 2 |
11.00 mg |
11.00 mg |
|
Carbomer |
3.00 mg |
3.00 mg |
|
Banana flavor |
2.00 mg |
2.00 mg |
|
Potassium Sorbate |
1.42 mg |
1.42 mg |
|
Sucralose |
0.10 mg |
0.10 mg |
|
Purified Water |
up to 1.00 ml |
up to 1.00 ml |
* – Simethicone is a mixture of polydimethylsiloxane (dimethicone) and silicon dioxide in a ratio of 95:5
Description
A white or almost white emulsion, homogeneous after shaking, with a characteristic odor.
ATC Code: A03AX13
Pharmacological properties
Pharmacodynamics
The active substance, simethicone, reduces the amount of gas in the gastrointestinal tract (GIT). It has surface-active properties and the ability to reduce surface tension at the gas/liquid interface, which hinders the formation of gas bubbles and also promotes their coalescence and the breakdown of foam in the intestine. Consequently, the released gas is absorbed or eliminated naturally under the influence of intestinal peristalsis. The use of simethicone in preparation for diagnostic examinations of the abdominal organs prevents the occurrence of image defects caused by gas bubbles.
Pharmacokinetics
Simethicone is chemically inert. After oral administration, it is not absorbed from the GIT and acts only within its lumen. It does not interact with microorganisms or enzymes and does not affect digestive processes. It is excreted by the intestines unchanged.
Indications for use
-
Excessive formation and accumulation of gas in the GIT (flatulence, postoperative gas buildup);
-
Acute poisoning by detergents containing foaming agents (tensides), as an antifoaming agent.
-
Preparation for diagnostic examinations of the abdominal and pelvic organs (ultrasound, radiography, esophagogastroduodenoscopy, etc.), including as an additive to contrast agent suspensions for double-contrast imaging;
-
Symptoms of intestinal colic in newborns and infants;
-
Symptoms of excess gas caused by functional dyspepsia;
Contraindications
Hypersensitivity to the components of the drug, intestinal obstruction, galactosemia, glucose-galactose malabsorption, hereditary fructose intolerance.
Use in Pregnancy and Lactation
Simeotic® can be used during pregnancy and breastfeeding.
Dosage and Administration
Orally. The bottle with the emulsion must be shaken before use. The drug can be dosed in drops or in milliliters using the measuring cup. For drop dosing, the bottle must be held vertically with the opening facing downwards.
The drug is taken during or after meals and, if necessary, at bedtime. The frequency of administration and duration of use depend on the severity of symptoms. If necessary, Simeotic® can be used for a long time.
Administration method for Simeotic® in dosage 40 mg/ml:
For complaints related to excess gas and intestinal colic
Children from birth to 1 year: 1 ml (20 drops) of Simeotic® with each feeding (added to the bottle with infant formula or given with a small spoon during or after feeding).
Children from 1 to 6 years: 1 ml (20 drops) of Simeotic® 3-5 times a day.
Children from 6 to 14 years: 1-2 ml (20-40 drops) of Simeotic® 3-5 times a day.
Children from 14 years and adults: 2 ml (40 drops) of Simeotic® 3-5 times a day.
For preparation for radiography and ultrasound examination
2 ml (40 drops) of Simeotic® 3 times a day the day before the examination and 2 ml (40 drops) of Simeotic® on the morning of the examination.
For obtaining a double-contrast image
Add 4-8 ml of Simeotic® per liter of contrast suspension.
For preparation for esophagogastroduodenoscopy
Orally, 4-8 ml of Simeotic® before the examination. During endoscopy, if necessary, a few milliliters of the emulsion can be introduced through the endoscope channel to eliminate gas bubbles that interfere with the examination.
For acute poisoning by detergents containing tensides
Children: 2.5-10 ml of Simeotic®; Adults: 10-20 ml of Simeotic® depending on the severity of poisoning.
Administration method for Simeotic® in dosage 100 mg/ml:
For complaints related to excess gas and intestinal colic
Children from birth to 1 year: 8 drops of Simeotic® with each feeding (added to the bottle with infant formula or given with a small spoon during or after feeding).
Children from 1 to 6 years: 8 drops of Simeotic® 3-5 times a day.
Children from 6 to 14 years: 8-16 drops of Simeotic® 3-5 times a day.
Children from 14 years and adults: 16 drops of Simeotic® 3-5 times a day.
For preparation for radiography and ultrasound examination
1 ml (20 drops) of Simeotic® 3 times a day after meals the day before the examination and 1 ml (20 drops) of Simeotic® on the morning of the examination.
For obtaining a double-contrast image
Add 2-4 ml of Simeotic® per liter of contrast suspension.
For preparation for esophagogastroduodenoscopy
Orally, 2-3 ml of Simeotic® before the examination. During endoscopy, if necessary, a few milliliters of the emulsion can be introduced through the endoscope channel to eliminate gas bubbles that interfere with the examination.
For acute poisoning by detergents containing tensides
Children: 1-4 ml of Simeotic®; Adults: 4-8 ml of Simeotic® depending on the severity of poisoning.
Adverse Reactions
No side effects have been observed with the use of Simeotic®. Allergic reactions to the inactive components of the drug are possible.
Overdose
Cases of overdose are unknown.
Drug Interactions
No clinically significant interaction of Simeotic® with other medicinal products has been established.
Special Instructions
If symptoms of excess gas and/or intestinal colic persist for a long time, it is necessary to consult a doctor for a medical examination.
Simeotic® contains sucralose; therefore, its use is contraindicated in galactosemia, glucose-galactose malabsorption, and hereditary fructose intolerance.
Effect on ability to drive and operate machinery
The drug does not affect the ability to drive vehicles, operate other machinery, or perform work requiring increased concentration.
Pharmaceutical form
Oral drops, 40 mg/ml and 100 mg/ml.
30 ml in a dark glass bottle with a dosing device (dropper plug) and a plastic cap or a cap with a first-opening control.
A self-adhesive label is affixed to the bottle.
1 bottle, together with a polypropylene measuring cup and the package insert, is placed in a cardboard carton.
Storage conditions
In the original packaging (carton) at a temperature not above 25 °C.
Do not freeze.
Keep out of reach of children.
Shelf life
2 years.
Opened bottle should be stored for no more than 6 months.
Do not use after the expiration date printed on the packaging.
Regulatory status
Over-the-counter
Marketing Authorization Holder/Organization Accepting Consumer Complaints:
JSC "AVVA RUS", Russia 121614, Moscow, Krylatskie Kholmy St., 30, building 9.
Tel./Fax: +7 (495) 956-75-54. avva.com.ru
Manufacturer:
JSC "AVVA RUS", Russia, Kirov Region, Kirov, Luganskaya St., 53A.
Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.
