SMECTALIA 3 g Oral Suspension in Sachet 12 Sachets/10 g

Oral suspension.
Sachet containing 10 g of suspension. Box of 12.

For one sachet:

Diosmectite: 3,000 g

Excipients with known effect:

Each sachet contains 13 mg of ethanol, 22,5 mg of propylene glycol (E1520), 15 mg of sodium benzoate, and sugar in the flavoring.

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.

To make the suspension more fluid, it is recommended to knead the sachet between the fingers before opening it.

The contents of the sachet may be swallowed neat or diluted in a little water before use.

Preferably administer away from meals.

Hypersensitivity to the active substance or to any of the excipients listed in 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. The treatment does not replace rehydration if this 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, salted or sweetened, 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 13 mg of alcohol (ethanol) in each sachet. The quantity contained in one sachet of this medicine is equivalent to less than 0.325 ml of beer or 0.13 ml of wine.

This medicine contains 22,5 mg of propylene glycol (E 1520) in each sachet.

This medicine contains 15 mg of sodium benzoate per sachet.

Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disorders) must not take this medicine.

As the adsorbent properties of this product may interfere with the timing and/or 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.

SMECTALIA has no or negligible effect on the ability to drive vehicles and use machines.

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); frequency not known (cannot be estimated from the available data).

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.