Smecta pore. prigot. suspension d / int. reception (strawberry) pack. 3g # 10

Dosage form

Grayish-white to light grayish-yellow powder with faint strawberry odor

Structure

Composition of the preparation for 1 sachet.

Active ingredient: dioctahedral smectite 3 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

Pharmacodynamics

The drug is an aluminosilicate of natural origin, has an adsorbing effect.

It 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.

The pooled results of two double-blind, randomized trials comparing the efficacy of diosmectite versus placebo, and enrolling 602 patients aged 1 to 36 months with acute diarrhea, indicate a significant reduction in fecal excretion during the first 72 hours in the patient group. treated with diosmectitis in addition to oral rehydration.

Side effects

During clinical studies in children and adults, the following side effects have been reported.

These side effects were usually mild and transient, and mainly associated with digestive disorders.

The frequency of occurrence of adverse reactions is classified as follows: very often> 1/10, often from> 1/100 to < 1/10, infrequently from> 1/1000 to 1/100, rarely from> 1/10000 to 1/1000, very rarely from < 1/10000, including isolated reports.

Often: constipation, usually resolves with dose reduction, but in rare cases may lead to discontinuation of treatment.

Uncommon: flatulence, vomiting.

During the post-marketing experience of use, some cases of hypersensitivity reactions (frequency unknown) were reported, including urticaria, rash, pruritus and angio-edema.

Cases of exacerbation of constipation have also been reported.

Indications

In children (including infants) and adults:

Acute and chronic diarrhea (allergic, drug genesis violation of the diet and the quality 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 during pregnancy and during breastfeeding

Pregnancy

Smecta is approved for use in pregnant and lactating women.

No dosage and regimen adjustments are required.

Contraindications

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

Carefully

It is recommended to observe an interval of 1-2 hours between taking the drug 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 complex of measures for rehydration is prescribed depending on the course of the disease, the age and characteristics of the patient.

Drug interactions

The drug can reduce the rate and extent of absorption of drugs taken simultaneously.

It is not recommended to take the drug Smecta simultaneously with other drugs.

Influence on the ability to drive vehicles and work with mechanisms

No information available.

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, the drug Smecta should be taken orally after meals, for other indications - between meals.

A suspension should be prepared before use.

For adults, the contents of the sachet are dissolved in 1/2 glass of water, gradually adding the powder and stirring it evenly.

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

Overdose

Overdose can cause severe constipation or bezoar.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 В° C.

Shelf life

3 years

Name ENG

SMECTA

Clinical and pharmacological group

Antidiarrheal drug with adsorbing effect

ATX code

Diosmectite

Dosage

3g x 3.76g

Structure

Composition of the preparation for 1 sachet.

Active ingredient: dioctahedral smectite 3 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

Indications

In children (including infants) and adults: Acute and chronic diarrhea (allergic, drug genesis violation of the diet and the quality 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.

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

Contraindications

intestinal obstruction fructose intolerance, syndrome of impaired absorption of glucose-galactose deficiency of sucrase-isomaltase hypersensitivity to the components of the drug.

INN / Active ingredient

Dioctahedral smectite

Specifications

Category

Preparations for the gastrointestinal tract

,

Enterosorbents and antidotes

Scope of the drug

Gastrointestinal tract

Release form

Oral suspension

Manufacturer country

France

Package quantity, pcs

ten

Scope of application

Gastroenterology

Minimum age from

From birth

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Ipsen

The amount of the dosage form in the primary package

3.76 g

Primary packaging type

Sachet (sachet)

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antidiarrheal agent

Anatomical and therapeutic characteristics

A07BC05 Diosmectite

The target audience

Children

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

1 sachet: dioctahedral smectite 3 g

Package weight, g

45

Mode of application

:

Dosage form

:

Powder for oral suspension, [strawberry]

Information on technical characteristics, delivery set, country of manufacture