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Homepage > Smecta® Orange-Vanilla Diosmectite 3g

Smecta® OTC Anti-Diarrhoeal

Smecta® active ingredient is diosmectite, a purified natural clay1

Smecta® meets the criteria of : 1

✓ Naturality

 

✓ Efficacy

Thereby aligning with current patients and healthcare professionals’ expectations.

A unique, dual mode of action that treats and relieves diarrhoea1

1

Smecta® has a high binding capacity and acts on the gastrointestinal mucous barrier, thereby protecting the gastrointestinal mucosa1.

TO RELIEVE DIARRHOEA

2

Smecta® does not modify the physiological intestinal transit time1.

TO TREAT DIARRHOEA

Powered for quick recovery from acute diarrhoea in both adults and children (>2 years old)

As of day 1

Decreased stool frequency2-3

Nearly half of patients recovered within 48 hours3

Percentage of therapeutic success (patients having achieved the primary efficacy endpoint**):
43.7% with Smecta® vs 29.5% with placebo (p=0.009)

Study Guarino.2 Methodology: National, prospective, randomized, case-controlled study. Population: 804 children aged 3 months to 5 years***, with mild to moderate acute gastroenteritis. Intervention: oral rehydration solution alone (n=398) or Smecta® + oral rehydration solution (n=406). Outcomes: Total duration of diarrhoea judged by the number of stools per day and their features; incidence of vomiting; incidence of fever; number of children with an unusually protracted (> 7 days) course of diarrhoea; rate of hospitalization. Primary endpoint: Mean duration of diarrhoea: 96 ± 21 hours with Smecta® vs 119 ± 23 hours with oral rehydration solution (p<0.001).

Study Khediri.4 Methodology: Multicentre randomized double-blind, placebo-controlled trial. Population: 346 patients with acute diarrhoea episode. Interventions: Smecta® (n=173) or placebo (n=173). Primary outcome: time to recovery (hours from first drug intake to diarrhoea recovery).

** Primary endpoint: Median time to recovery: 53.8 hours with Smecta® vs 69.0 hours with placebo (p=0.0294).

*** Smecta® should only be used in children > 2 years old.

Smart and flexible to match patients’ needs

Powder sachet 3g Diosmectite for oral suspension

  • 10 sachets / 30 sachets
  • Orange-vanilla flavour

The contents of the sachet are used to prepare the suspension immediately before use, for example, by dissolving it with 1/2 cup of water.

Administration1

  • Directly before use, contents of the sachet can be mixed with water in a glass, feeding bottle, and Semi-liquid food (compote, puree, etc.).
  • To help dilute Smecta®, it is advised to put the powder, then the water into the glass and wait a moment before mixing.
  • In children and fragile poulation, oral rehydration solution should be administered1-2.

Recommended dosing for acute diarrhoea1

*In addition to Oral Rehydration solutions (ORS)

≥ 2 years old
2 years: Up to
2x per day
> 2 years: Up to
3x per day
adults
Up to 6x per day
at the beginning of treatment
3x per day
for 7 days

Smecta® Patient Information Leaflet (PDF, 597 КB)

References:
1. Smecta (Patient Information Leaflet). Singapore: IPSEN; Date of revision of text: May 2019
2. Guarino A, et al. Smectite in the Treatment of Acute Diarrhea: A Nationwide Randomized Controlled Study of the Italian Society of Pediatric Gastroenterology and Hepatology (SIGEP) in Collaboration With Primary Care
Pediatricians. J Ped Gastroenterol Nutr 2001;32:71 75.
3. Khediri F, et al. Efficacy of Diosmectite smecta ®) in the treatment of acute watery diarrhea in adults: a multicentre , randomized, double blind, placebo controlled, parallel group study. Gastroenterol Res Pract 2011;2011:783196.