SMECTALIA 3 g Oral Powder Suspension in Sachet 18 Sachets

Powder for oral suspension.
Sachet containing 3,76 g of powder. Box of 18.

For one sachet:

Diosmectite: 3,000 g

Excipients with known effect: glucose, sucrose, ethanol.

Short-term treatment of acute diarrhoea in adults and children over 15 years. This treatment is a complement to dietary measures.

Dosage

1 sachet (3 g) then 1 sachet after each new unformed stool, without exceeding 6 sachets per day.

The maximum duration of treatment is 3 days.

Method of administration

Oral use.

The contents of the sachet must be suspended just before use, for example in half a glass of water.

Hypersensitivity to diosmectite or to any of the excipients listed in the section Composition.

Diosmectite should be used with caution in patients with a history of severe chronic constipation.

The use of SMECTALIA is not recommended in infants and children under 15 years of age.

In adults and children over 15 years, chronic use of SMECTALIA should be avoided.

In the treatment of acute diarrhoea, treatment does not replace rehydration if it proves necessary. The extent of rehydration by oral rehydration solution or by intravenous route must be adapted according to the intensity of the diarrhoea, the age and the particularities of the patient.

The patient should be informed of the need to:

• rehydrate by drinking plenty of fluids, salty or sweet, in order to compensate for fluid losses due to diarrhoea (the average daily water ration for an adult is 2 litres).
• maintain food intake for the duration of the diarrhoea:
  • excluding certain foods and particularly raw vegetables, fruit, green vegetables, spicy dishes, as well as iced foods or drinks;
  • by favouring grilled meats and rice.

This medicine contains glucose and sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

This medicine contains small amounts of ethanol (alcohol) less than 100 mg per daily dose.

As the adsorbent properties of this product may interfere with the timing and/or the rate of absorption of another substance, it is recommended to administer any other medicine at a distance from SMECTALIA (more than 2 hours if possible).

Pregnancy

There are no data or there are limited data (fewer than 300 pregnancies) on the use of SMECTALIA in pregnant women.

Studies performed in animals are insufficient to allow a conclusion regarding reproductive toxicity.

SMECTALIA is not recommended during pregnancy.

Breast-feeding

There are limited data on the use of SMECTALIA during breastfeeding.

SMECTALIA is not recommended during breastfeeding.

Fertility

The effect on human fertility has not been studied.

No studies on the ability to drive vehicles and use machines have been performed. However, the expected effect is nil or negligible.

The most frequently reported adverse effect during treatment is constipation, which occurs in approximately 7 % of adults and 1 % of children. If constipation occurs, treatment with diosmectite must be stopped, and reintroduced if necessary at a lower dose.

The adverse effects reported during clinical studies and post-marketing surveillance are listed below. Their frequency is defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); not known (cannot be estimated from the available data).

Undesirable effects reported during clinical studies and post-marketing surveillance:

* Frequency estimated from the incidence rates observed during clinical studies

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

An overdose may cause severe constipation or a bezoar.

Pharmacotherapeutic class: other intestinal adsorbents, ATC code: A07BC05.

It has been demonstrated in clinical pharmacology that diosmectite:

• Adsorbs intestinal gases in adults
• Restores normal mucosal permeability, in a clinical study conducted in children with gastroenteritis.

Due to its layered structure and high plastic viscosity, diosmectite has a significant covering capacity on the digestive mucosa.

Given the structure of diosmectite, SMECTALIA remains on the luminal side of the digestive epithelium. It is neither absorbed nor metabolised.

Diosmectite is eliminated in the stools through the natural process of intestinal transit.

Preclinical safety data, obtained from conventional acute and repeated-dose toxicity studies and genotoxicity studies, did not reveal any particular risk for humans.

3 years.

This medicine does not require any particular storage precautions.

No special requirements.