SMECTA FRAISE

Treatment of acute diarrhoea in children over 2 years of age in addition to oral rehydration and adults.

• Symptomatic treatment of chronic functional diarrhoea in adults.

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

The use of diosmectitis 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 VIATRIS DIOSMECTITE should be avoided.

The reference treatment of acute diarrhoea is the administration of oral rehydration solute (ORS).

In children over 2 years of age, treatment of acute diarrhoea should be performed in combination with the early administration of oral rehydration solute (ORS) to avoid dehydration.

Chronic use of VIATRIS

DIOSMECTITE should be avoided.

In adults, treatment should not dispense with rehydration if it is necessary.

The importance of rehydration by oral rehydration solute or by intravenous route should be adapted to the intensity of diarrhoea, age and patient's particularities.

• rehydrate by abundant, salty or sweet drinks.

The amount of rehydration by laboratory or intravenous route.

ADSORBANTS, ATC code: A07BC05.

• absorb intestinal gases in adults.

• restores normal mucosal permeability in a clinical study in children with gastroenteritis.

Diosmectitis has a significant ability to cover the digestive mucosa through its leaf structure and high plastic viscosity.

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

The most frequently reported adverse reaction during treatment is constipation, which occurs in approximately 7% of adults and 1% of children.

If constipation occurs, treatment with diosmectitis should be discontinued and reintroduced if necessary at a lower dose.

Adverse reactions reported in clinical studies and post-marketing follow-up 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 00 0 to < 1/1 00 0) unknown (cannot be estimated from available sources).

Adverse reactions reported in clinical studies and post-marketing network: System Class Organ Frequency Adverse reactions Gastrointestal disorders Common Constipation Uncommon Vomiting Skin and subcutaneous tissue disorders Uncommon Eruption Rare Urticary Unknown Angioedema, pruritus Occupational site: adverse drug reaction/disabled disease after adverse drug history Unknown Hypersensitivity Recording of clinical events from the time of the reported adverse reaction Erroriously known Erroriously known Erroriously known Errormetic .