Smecta powder d / suspension d / vnut prim vanilla 3g N10

Release form, composition and packaging

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Powder for preparation of suspension for oral administration (vanilla) from grayish-white to light grayish-yellow color, from weak nonspecific to weak vanilla odor.

1 pack.

dioctahedral smectite 3 g

vanillin - 4 mg, dextrose monohydrate - 749 mg, sodium saccharinate - 7 mg.

3.76 g - laminated paper sachets (10) - cardboard packs.

3.76 g - laminated paper sachets (30) - cardboard packs.

pharmachologic effect

Antidiarrheal drug, is a natural aluminosilicate.

It has an adsorbing effect.

It stabilizes the mucous barrier of the gastrointestinal tract, forms polyvalent bonds with mucus glycoproteins, increases the amount of mucus and improves its cytoprotective properties (against 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.

SmectaВ® in therapeutic doses does not affect intestinal motility.

Diosmectite is radiolucent and does not stain the stool.

Aluminum in the composition of diosmectite is not absorbed from the gastrointestinal tract, incl.

in diseases of the gastrointestinal tract, accompanied by symptoms of colitis and colonopathy.

Pharmacokinetics

SmectaВ® is not absorbed.

It is excreted from the body unchanged.

Indications for use

- acute and chronic diarrhea (allergic, medicinal origin in violation of the diet and the quality of food)

- diarrhea of ��infectious genesis (as part of complex therapy)

- symptomatic treatment of heartburn, bloating and discomfort in the abdomen and other symptoms of dyspepsia accompanying diseases of the gastrointestinal tract.

Contraindications for use

- intestinal obstruction

- fructose intolerance, syndrome of impaired absorption of glucose-galactose

- deficiency of sucrase-isomaltase

- hypersensitivity to drug components.

Dosage regimen

Acute diarrhea Adults are recommended to use 6 sachets per day. Children under the age of 1 year - 2 sachets / day for 3 days, then 1 sachet / day children over 1 year old - 4 sachets / day for 3 days, then - 2 sachets / day. Other indications Adults are prescribed 3 sachets / day. Children under 1 year old - 1 sachet / day, at the age of 1-2 years - 1-2 sachets / day over 2 years old - 2-3 sachets / day. The recommended course of treatment is 3-7 days. In case of esophagitis, SmectaВ® should be taken orally after meals, for other indications - between meals. Rules for taking the drug For adults, the contents of the sachets are dissolved in 1/2 glass of water, gradually pouring out the powder and stirring it evenly. The prescribed dose is divided into 3 doses during the day.For children, the contents of the sachets are dissolved in a baby bottle (50 ml) and distributed in several doses throughout the day or mixed with any semi-liquid product (porridge, puree, compote, baby food).

Overdose

Severe constipation or bezoar is possible.

Side effect

On the part of the digestive system: in clinical studies, rarely - constipation (mild, passed after adjusting the dose of the drug).

Allergic reactions: in routine practice, very rarely - urticaria, rash, itching, Quincke's edema.

Drug interactions

With the simultaneous use of SmectaВ®, it can reduce the rate and degree of absorption of other drugs.

It is not recommended to take the drug at the same time as other drugs.

Application during pregnancy and lactation

The drug SmectaВ® is approved for use during pregnancy and lactation according to indications.

No dosage adjustment is required.

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

Adults therapy with SmectaВ® in com

Name ENG

SMECTA

Clinical and pharmacological group

Antidiarrheal drug with adsorbing effect

ATX code

Diosmectite

Dosage

3g x 3.76g

Structure

1 sachet of powder for preparation of suspension for oral administration contains: Active substance: dioctahedral smectite 3 g

Excipients: flavoring, dextrose monohydrate, sodium saccharinate.

Indications

For adults and children (including babies):

- 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

INN / Active ingredient

diosmectite (dioctahedral smectite)

Contraindications

hypersensitivity

intestinal obstruction

intolerance to fructose

glucose-galactose malabsorption

sucrase-isomaltase deficiency.

With care: history of severe chronic constipation.

Specifications

Category

Preparations for the gastrointestinal tract

,

Enterosorbents and antidotes

Scope of the drug

Gastrointestinal tract

Release form

Powder

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 Pharma Biotech

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

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

3 g

The target audience

Children

Package weight, g

55

Mode of application

:

Inside. Acute diarrhea Children, including infants: under 1 year old - 2 sachets per day for 3 days, then - 1 sachet per day over 1 year old - 4 sachets per day for 3 days, then - 2 sachets per day. Adults: the recommended dosage regimen is 6 sachets per day. Other indications Children, including infants: up to 1 year old - 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. For esophagitis, Smecta® should be taken after meals, for other indications - between meals. For children, the contents of the sachets are dissolved in a baby bottle (50 ml) and distributed in 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 1/2 cup of water, gradually adding the powder and stirring it evenly. The prescribed dose is divided into 3 doses during the day.

Dosage form

:

Powder for oral suspension, [vanilla]

Information on technical characteristics, delivery set, country of manufacture