DIOSMECTITE VIATRIS 3 g Pdr susp buv 30Sach/3g

Powder for oral suspension.

Diosmectite..........................................................................................................................................................3 g

Per sachet.

Excipients with known effect: aspartame (E 951) (16 mg), glucose (679 mg).

Excipients:

• Treatment of acute diarrhoea in children over 2 years old as a supplement to oral rehydration, and in adults.

• Symptomatic treatment of chronic functional diarrhoea in adults.

• Symptomatic treatment of pain associated with functional intestinal disorders in adults.

Dosage

Treatment of acute diarrhoea:

In children from 2 years of age: 4 sachets per day for 3 days, then 2 sachets per day for 4 days.

In adults:

On average 3 sachets per day for 7 days.

In practice, the daily dose may be doubled at the start of treatment.

Other indications:

In adults:

On average 9 grams (3 sachets) per day.

Method of administration

Oral use.

The contents of the sachet must be suspended just before use.

In children, the contents of the sachet may be dissolved in a 50 ml feeding bottle of water to be taken throughout the day, or mixed with a semi-liquid food: porridge, compote, purée, "baby food jar"…

In adults, the contents of the sachet may be dissolved in half a glass of water.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

• Due to the presence of aspartame, this medicine is contraindicated in cases of phenylketonuria.

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

In infants and children under 2 years of age, the use of DIOSMECTITE VIATRIS should be avoided. The reference treatment for acute diarrhoea is the administration of oral rehydration solution (ORS).

In children over 2 years, treatment of acute diarrhoea must be carried out in association with early administration of an oral rehydration solution (ORS) in order to prevent dehydration.

Chronic use of DIOSMECTITE VIATRIS should be avoided.

In adults, 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 with plenty of drinks, 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:

• by 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 16 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine. May be harmful for people with phenylketonuria (PKU), a rare genetic disease characterised by the accumulation of phenylalanine that cannot be properly eliminated.

This medicine contains glucose. Patients with glucose-galactose malabsorption syndrome (a rare hereditary disease) must not take this medicine.

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

Pregnancy

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

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

DIOSMECTITE VIATRIS is not recommended during pregnancy.

Breast-feeding

There are limited data on the use of DIOSMECTITE VIATRIS during breastfeeding.

DIOSMECTITE VIATRIS 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.

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).

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

System Organ Class	Frequency	Adverse reaction
Gastrointestinal disorders	Common*	Constipation
	Uncommon*	Vomiting
Skin and subcutaneous tissue disorders	Uncommon*	Eruption
	Rare*	Urticaria
	Unknown	Angioedema, pruritus
Immune system disorders	Unknown	Hypersensitivity

*Frequency estimated from 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - 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 permeability of the mucosa, in a clinical study carried out in children with gastroenteritis.

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

The combined results of 2 randomised, double-blind studies comparing the efficacy of DIOSMECTITE VIATRIS versus placebo and including 602 patients aged 1 to 36 months suffering from acute diarrhoea show a significant reduction in the flow rate of stools passed during the first 72 hours in the group of patients treated with DIOSMECTITE VIATRIS, in addition to oral rehydration.

Given the structure of diosmectite, DIOSMECTITE VIATRIS 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.

No special precautions for storage.

No special requirements.

Marketing authorisation (AMM)

CIP 3400939482255 (30 sachets/3 g). CIP 3400939482316 (60Sach/3g). CIP 3400927547140 (18Sach/3g).

Price:

2,47 euros (30Sach/3g). 4,26 euros (60Sach/3g).

Social Security reimbursement at 30% based on the TFR: 2.47 euros (30Sach/3g), 4.26 euros (60Sach/3g) in the indications:

• Functional colopathy in adults, symptomatic treatment of painful manifestations (of the) (30Sach/3g, 60Sach/3g)
• Acute diarrhea, symptomatic treatment (of the) (30Sach/3g, 60Sach/3g)

Not reimbursed by Social Security (18Sach/3g).
Collect (30Sach/3g, 60Sach/3g).