Excipients/Inactive Ingredients: Glucose monohydrate, saccharine sodium, orange-vanilla flavor (containing sucrose).
Pharmacotherapeutic Group: Antidiarrheal, Other intestinal adsorbents (A: Alimentary tract and metabolism).
Pharmacology: Pharmacodynamics: SMECTA possesses a coating property in the gastrointestinal mucosa. By interacting with glycoprotein of mucus, SMECTA increases the resistance of the mucosal gel in response to aggressive agents.
By its action on the gastrointestinal mucous barrier and its high binding capacity, SMECTA protects the gastrointestinal mucosa.
SMECTA is radiolucent, does not colour the stools and, at usual doses, does not modify the physiological intestinal transit time.
Pharmacokinetics: According to structure of dioctahedral smectite (active ingredient). SMECTA is neither absorbed nor metabolized.
Symptomatic treatment of acute diarrhoea in children in addition to oral rehydration and in adults; symptomatic treatment of chronic diarrhoea; symptomatic treatment of pain associated with oesogastroduodenal and colic disease.
Fluid and electrolyte depletion may occur in patients who have diarrhoea.
The use of SMECTA does not preclude the administration of appropriate fluid and electrolyte therapy, should this prove to be necessary.
The extent of rehydration and route of administration (orally or intravenously) must be adapted the severity of diarrhoea, the age and clinical context of the patient.
Treatment of Acute Diarrhoea: Children and Infants: Up to one year: 2 sachets a day for 3 days, then 1 sachet a day.
One Year and Older: 4 sachets a day for 3 days, then 2 sachets a day.
Adults: An average of 3 sachets per day.
In practice, the daily dosage can be doubled at the beginning of the treatment.
Other Indications: Children and Infants: Up to One Year: 1 sachet a day.
Between 1 and 2 Years: 1 to 2 sachets a day.
After 2 Years: 2 to 3 sachets a day.
In adults: An average of 3 sachets a day.
Method of Administration: Children: The contents of the sachet can be added and thoroughly stirred in the feeding bottle with 50 mL of water, to be given during the day, or thoroughly mixed with a semi-liquid food: broth, stewed fruit, mashed vegetables or baby food.
Adults: Contents of one sachet can be added and thoroughly stirred in half a glass of water before taking.
SMECTA should be taken preferably in between meals.
If the symptoms do not improve within 7 days, they should consult their doctor.
To date, very limited incidence of overdose has been reported. Symptoms of overdose reported include constipation, vomiting and bezoar.
Owing to the presence of glucose and saccharine, this medicinal product is contraindicated in patients with a fructose intolerance, glucose and galactose malabsorption syndrome or sucrose/somaltase deficiency (rare hereditary diseases).
Fluid and electrolyte depletion may occur in patients who have diarrhoea.
The use of SMECTA does not preclude the administration of appropriate fluid and electrolyte therapy, should this prove to be necessary.
The extent of rehydration and route of administration (orally or intravenously) must be adapted to the severity of diarrhoea, the age and clinical context of the patient.
In general, if the patient is pregnant or is planning to become pregnant or is breastfeeding, she should seek the advise from the physician or pharmacist before taking any medication.
Very rare cases of development or aggravation of constipation have been reported; treatment was able to be continued after decreasing the dosage. Report any side effect not described in this section to physician or pharmacist.
As the adsorbent properties of SMECTA may interfere with the rates and/or levels of absorption of other substances, it is recommended not to administer any other drugs at the same time as SMECTA. In case of doubts, it is advisable to seek advice from the physician or pharmacist.
Children and infants: The contents of the sachet can be added and thoroughly stirred in the feeding bottle with 50 ml of water, to be given during the day, or thoroughly mixed with a semiliquid food: broth, stewed fruit, mashed vegetables or baby food.
Adults: 3 sachets per day. To dilute with half a glass water.
SMECTA should be kept in a dry place, below 30°C.
A07BC05 - diosmectite ; Belongs to the class of other intestinal adsorbents.
Smecta powd for oral susp 3 g
10 × 1's;30 × 1's
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