Smecta powder for preparation of suspension for oral administration 3g, No. 10 pack. orange

In children (including infants) and adults:

• Acute and chronic diarrhea (allergic, drug genesis; violation of diet and quality composition of food), infectious diarrhea - as part of complex therapy

• Symptomatic treatment of heartburn, bloating, abdominal discomfort and other symptoms of dyspepsia accompanying diseases of the gastrointestinal tract

• Application for acute diarrhea.

Children, including infants:

- Up to 1 year: 2 sachets per day for 3 days, then - 1 sachet per day;

- Older than 1 year: 4 sachets per day for 3 days, then 2 sachets per day.

Adults:

- The recommended dosage regimen is 6 sachets per day.

• Application for other indications.

Children, including infants:

- up to 1 year: 1 sachet per day;

- 1-2 years: 1-2 sachets per day;

- over 2 years old: 2-3 sachets per day.

Adults:

3 sachets per day.

The recommended course of treatment is 3-7 days.

With esophagitis, Smecta should be taken orally after meals, for other indications - between meals.

For children, the contents of the sachets are dissolved in a baby bottle (50 ml) and distributed over several doses throughout the day or mixed with any semi-liquid product (porridge, puree, compote, baby food).

For adults, the contents of the sachets are dissolved in? glasses of water, gradually pouring in the powder and stirring it evenly. The prescribed dose is divided into 3 doses during the day.

Composition of the preparation for 1 sachet.

Active substances: dioctahedral smectite 3 g

Excipients:

powder for suspension for oral administration [orange]: orange flavor 0.010 g; vanilla flavor 0.050 g; dextrose monohydrate 0.679 g; sodium saccharinate 0.021 g;

powder for preparation of suspension for oral administration [vanilla]: vanillin 0.004 g; dextrose monohydrate 0.749 g; sodium saccharinate 0.007 g

Hypersensitivity, intestinal obstruction, fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency.

Tradename:

Smecta Ѓ

International non-proprietary or group name:

dioctahedral smectite

Dosage form:

powder for suspension for oral administration [orange, vanilla].

Composition

Composition of the preparation for 1 sachet.

Active substances: dioctahedral smectite 3 g

Excipients:

powder for suspension for oral administration [orange]: orange flavor 0.010 g; vanilla flavor 0.050 g; dextrose monohydrate 0.679 g; sodium saccharinate 0.021 g;

powder for preparation of suspension for oral administration [vanilla]: vanillin 0.004 g; dextrose monohydrate 0.749 g; sodium saccharinate 0.007 g

Excipients: powder for preparation of suspension for oral administration [strawberry]: strawberry flavor 0.032 g; dextrose monohydrate 0.721 g; sodium saccharinate 0.007 g

Description

Powder from grayish-white to light grayish-yellow in color with a weak nonspecific to weak vanilla odor.

Pharmacotherapeutic group

antidiarrheal agent

ATX code:

A07BC05

pharmachologic effect

The drug is an aluminosilicate of natural origin,
has an adsorbing effect. Stabilizes the mucous barrier
of the gastrointestinal tract, forms polyvalent bonds with mucus glycoproteins, increases its amount, improves cytoprotective properties (in relation to the negative effect of hydrogen ions of hydrochloric acid, bile salts, microorganisms and their toxins). Possesses selective sorption properties, which are explained by its discoid-crystalline structure; adsorbs bacteria and viruses located in the lumen of the gastrointestinal tract. In therapeutic doses, it does not affect intestinal motility. Diosmectite is radiolucent and does not stain the stool. Aluminum in smectite is not absorbed from the gastrointestinal tract, including in diseases of the gastrointestinal tract, accompanied by symptoms of colitis and colonopathy.

Indications for use

In children (including infants) and adults:

• Acute and chronic diarrhea (allergic, drug genesis; violation of diet and quality composition of food), infectious diarrhea - as part of complex therapy

• Symptomatic treatment of heartburn, bloating, abdominal discomfort and other symptoms of dyspepsia accompanying diseases of the gastrointestinal tract

Contraindications

Hypersensitivity, intestinal obstruction, fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency.

Method of administration and dosage

• Application for acute diarrhea.

Children, including infants:

- Up to 1 year: 2 sachets per day for 3 days, then - 1 sachet per day;

- Older than 1 year: 4 sachets per day for 3 days, then 2 sachets per day.

Adults:

- The recommended dosage regimen is 6 sachets per day.

• Application for other indications.

Children, including infants:

- up to 1 year: 1 sachet per day;

- 1-2 years: 1-2 sachets per day;

- over 2 years old: 2-3 sachets per day.

Adults:

3 sachets per day.

The recommended course of treatment is 3-7 days.

With esophagitis, Smecta should be taken orally after meals, for other indications - between meals.

For children, the contents of the sachets are dissolved in a baby bottle (50 ml) and distributed over several doses throughout the day or mixed with any semi-liquid product (porridge, puree, compote, baby food).

For adults, the contents of the sachets are dissolved in? glasses of water, gradually pouring in the powder and stirring it evenly. The prescribed dose is divided into 3 doses during the day.

Warnings and Precautions

It is recommended to observe an interval of 1-2 hours between taking Smecta and other medicines.

Use with caution in patients with a history of severe chronic constipation.

In children with acute diarrhea, the drug should be used in conjunction with rehydration measures. If necessary, adults can also be prescribed drug therapy in combination with rehydration measures.

A set of rehydration measures is prescribed depending on the course of the disease, the age and characteristics of the patient.

Overdose

Overdose can cause severe constipation or bezoar.

Side effect

In clinical studies, rare cases of constipation have been reported. In all cases, this phenomenon was poorly expressed and passed after an individual change in the dosage regimen.

In routine practice, in very rare cases, hypersensitivity reactions have been reported, incl. hives, rash, itching, or Quincke's edema.

Interaction with other medicinal products

The drug can reduce the rate and extent of absorption of concomitant medications. It is not recommended to take Smecta simultaneously with other medicines.

Application during pregnancy and during breastfeeding

Smecta is approved for use in pregnant and lactating women. No dosage and regimen adjustments are required.

Impact on vehicle driving and machine control

No information available.

Release form

Powder for oral suspension [orange, vanilla], 3 g.

3.76 g of the preparation are placed in paper bags, laminated with aluminum foil and polyethylene. 10 or 30 sachets together with the instructions are placed in a cardboard box.

Shelf life

3 years.

Do not use after the expiration date printed on the package.

Storage conditions

Store at a temperature not exceeding 25? C, out of the reach of children.

Conditions of dispensing from pharmacies

Without recipe