Instructions Enterosmectite 3.6G No. 30
Composition
active ingredient: diosmectite;
1 sachet (3.76 g of powder) contains 3 g of diosmectite (dioctahedral smectite);
excipients: glucose monohydrate, sodium saccharin, orange flavoring (orange oil, tangerine oil, C10 aldehyde, α-terpineol, maltodextrin, starch sodium octynyl succinate, glucose, ascorbyl palmitate, butyl hydroxyanisole).
Dosage form
Powder for oral suspension.
Main physicochemical properties: powder from grayish-white to beige color, in which white inclusions are allowed, with an orange odor when preparing the suspension.
Pharmacotherapeutic group
Antidiarrheal drugs used in infectious and inflammatory diseases of the intestines. Enterosorbents. ATX code A07B C05.
Pharmacological properties
Pharmacodynamics.
Enterosmectite is a double silicate of aluminum and magnesium.
Due to its stereometric structure and high plastic viscosity, the drug has a high enveloping ability on the mucous membrane of the digestive tract.
By interacting with glycoproteins of the mucous membrane, it increases the resistance of mucus to irritants. By affecting the barrier function of the mucous membrane of the digestive system and due to its high ability to bind to the mucous membrane, it protects the mucous membrane of the digestive tract. Enterosmectite is radiolucent, in normal doses does not stain feces and does not affect the physiological time of passage through the intestine.
Pharmacokinetics.
Due to the structure of diosmectite, the drug is retained on the inner side of the epithelium, is not adsorbed and is not metabolized. Diosmectite is excreted in the feces through normal intestinal transit.
Clinical characteristics.
Indication
Symptomatic treatment of acute diarrhea in children aged 2 years and older (in addition to oral rehydration) and in adults.
Symptomatic treatment of chronic diarrhea in adults.
Symptomatic treatment of pain associated with functional bowel diseases in adults.
Contraindication
· Hypersensitivity to diosmectite or to any of the excipients of the drug.
Intestinal obstruction.
Interaction with other medicinal products and other types of interactions
The adsorbing properties of this medicinal product may affect the extent and/or rate of absorption of other substances, therefore it is recommended not to use other medicinal products simultaneously with Enterosmectite (if possible, an interval of more than 2 hours should be ensured).
Application features
Diosmectite should be used with caution in patients with a history of severe chronic constipation.
The use of the drug Enterosmectite should be avoided in infants and children under 2 years of age.
The standard of care for acute diarrhea is oral rehydration solution (ORS).
In children aged 2 years and older, acute diarrhea should be treated in conjunction with early administration of oral rehydration solution (ORS) to prevent dehydration. Prolonged use of Enterosmectite should be avoided.
In adults, treatment does not exclude rehydration if necessary.
The volume of rehydration using oral rehydration solution or intravenous rehydration depends on the intensity of diarrhea, the patient's age, and the characteristics of the course of the disease.
The patient should be informed about the need to:
· rehydration using a significant volume of salty or sweet liquids to compensate for fluid loss due to diarrhea (the average daily water requirement of an adult is 2 liters);
· maintaining food intake while diarrhea continues:
- excluding certain foods, especially raw vegetables and fruits, green vegetables, spicy dishes, as well as frozen foods or drinks;
- with preference for baked meat and rice.
This medicinal product contains glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains 0.05 mmol (or 1.23 mg) sodium/dose. Caution should be exercised when administering this medicinal product to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Pregnancy
There are no or limited data (less than 300 pregnancy outcomes) on the use of diosmectite in pregnant women.
Animal studies are insufficient to draw conclusions regarding reproductive toxicity.
It is not recommended to use the drug Enterosmectite during pregnancy.
Breast-feeding
Data on the use of diosmectite during breastfeeding are limited.
It is not recommended to use the drug Enterosmectite during breastfeeding.
Fertility
The effect of this medicinal product on human fertility has not been studied.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted on the ability to drive and use machines under the influence of this medicinal product. However, its effects are expected to be negligible or absent.
Method of administration and doses
Doses
Treatment of acute diarrhea
Children aged 2 years and over: 4 sachets per day for 3 days, then 2 sachets per day for 4 days.
Adults: 3 sachets per day for 7 days. If necessary, the dose of the drug can be doubled at the beginning of treatment.
Other indications
Adults: an average of 9 g (3 sachets) per day.
Method of application
For oral use.
The contents of the sachet must be mixed to form a suspension immediately before use.
For children, the contents of the sachet can be mixed in a bottle with 50 ml of water for use at intervals throughout the day or mixed well with semi-liquid food such as broth, compote, puree, baby food, etc.
For adults, the contents of the sachet can be mixed with half a glass of water.
Children.
Use for the treatment of children aged 2 years and over.
Overdose
Overdose may lead to severe constipation or the formation of a bezoar.
Adverse reactions
The most frequently reported adverse reaction during treatment is constipation, which occurs in approximately 7% of adults and approximately 1% of children. If constipation occurs, treatment with diosmectite should be discontinued and, if necessary, resumed at a lower dose. The table below lists the adverse reactions to the active substance that occurred during clinical trials and in the post-marketing period.
The frequency of adverse reactions is classified as follows: very common ((≥1/10); common (≥1/100,
<1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data).
Adverse reactions to diosmectite identified during clinical trials and in the post-marketing period.
| Organ system class | Frequency | Adverse reaction |
| Gastrointestinal tract | Often* | Constipation |
| Infrequently* | Vomiting | |
| Skin and subcutaneous tissue disorders | Infrequently* | Rash |
| Rarely* | Urticaria | |
| Unknown | Angioedema, pruritus | |
| On the part of the immune system | Unknown | Hypersensitivity |
| * Frequency determined from clinical trial data. | | |
Reporting of suspected adverse reactions
It is important to report suspected adverse reactions after a medicine has been authorised. This allows for continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to the reporting system website.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
3.76 g of powder in a sachet; 10 or 30 sachets in a cardboard pack.
Vacation category
Without a prescription.
Manufacturer/Applicant
"Ternofarm" LLC.
Location of the manufacturer and address of its place of business/location of the applicant.
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Phone/fax: (0352) 521-444, www.ternopharm.com.ua
