Smecta 3.0 N8 suspension package for oral administration

Dosage form

a homogeneous suspension of yellowish-gray color with a characteristic caramel smell.

Structure

COMPOSITION for 1 sachet:

Active ingredient: dioctahedral smectite - 3.00 g

Excipients: caramel-cocoa flavor1 - 0.10 g, xanthan gum - 0.03 g, citric acid monohydrate - 0.02 g, ascorbic acid -

0.01 g, potassium sorbate - 0.01 g, sucralose - 0.00375 g, purified water up to 10.00 g

1 Flavoring caramel-cocoa consists of natural flavors (2.7%), flavoring substances (1.0%), natural flavoring substances (0.3%), caffeine (0.04%), dye caramel" E150d (0.06 %) caramelized sugar syrup (49.8%), propylene glycol E1520 (22.4%), ethanol (8.6%), water (15.0%).

Special conditions

Smecta® should be used with special precautions in patients with a history of severe chronic constipation.

In children, the drug must be used in conjunction with rehydration therapy to prevent dehydration.

In adults, no rehydration measures are taken unless they are deemed necessary.

The amount of oral rehydration solution or the dosage of injectable rehydration solutions should be calculated and adapted according to the intensity of the diarrhea, the age of the patient and the characteristics of his condition.

The patient should be warned about the need:

Replenish fluid loss associated with diarrhea by consuming large amounts of salty or sugary fluids (the average daily fluid requirement for an adult patient is 2 liters)

Maintain a diet while diarrhea persists:

- excluding certain foods, especially raw vegetables and fruits, green vegetables, spicy foods, and frozen foods or drinks

- giving preference to grilled meat and rice.

This drug contains a small amount of ethanol (alcohol), less than 100 mg per day.

Drug interactions

The absorbing properties of Smecta® can affect the time and / or degree of absorption of other substances, therefore it is not recommended to take Smecta simultaneously with other drugs.

Pharmacodynamics

Smecta® is a double aluminosilicate of natural origin, has an adsorbing effect.

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

Has selective sorption properties, adsorbs bacteria, viruses and toxins located in the lumen of the gastrointestinal tract.

In therapeutic doses, it does not directly affect intestinal motility.

Dioctahedral smectite is radiolucent, does not stain the stool.

Indications

Symptomatic treatment of acute and chronic diarrhea.

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

Contraindications

Hypersensitivity to diosmectitis or to one of the excipients, intestinal obstruction.

CAREFULLY

A history of severe chronic constipation.

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING

Smecta is approved for use in pregnant and lactating women.

No dosage and regimen adjustments are required.

Overdose

Overdose can cause severe constipation or bezoar.

Side effects

During clinical trials of the drug in children and adults, the following undesirable effects were noted.

As a rule, these undesirable effects were mild, transient and usually related to the functioning of the digestive system.

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.

Disorders of the gastrointestinal tract:

Often: constipation.

The manifestation of constipation is usually resolved with a dose reduction, but, in rare cases, the manifestation of this effect may lead to discontinuation of treatment.

Uncommon: flatulence, vomiting.

During the post-registration period, there have been several reports of cases of hypersensitivity reactions (frequency unknown), including urticaria, rash, pruritus and Quincke's edema.

Cases of worsening constipation have also been reported.

Dosage

3g x 10.27g

Indications

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

diarrhea of ​​infectious origin (as part of complex therapy)

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

Contraindications

Intestinal obstruction

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

deficiency of sucrase-isomaltase

hypersensitivity to drug components.

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

INN / Active ingredient

Dioctahedral smectite

Specifications

Category

Flatulence

Scope of the drug

Gastrointestinal tract

Release form

Oral suspension

Manufacturer country

France

Package quantity, pcs

8

Vacation conditions

Without recipe

Brand name

Bofur Ipsen

The amount of the dosage form in the primary package

10.27 g

Primary packaging type

Sachet (sachet)

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antidiarrheal agent

Anatomical and therapeutic characteristics

A07BC05 Diosmectite

Dosage form

Suspension for oral administration

Expiration date in days

1095

Package weight, g

65

Information on technical characteristics, delivery set, country of manufacture "