Smecta: The active substance is: Diosmectite 3 g.
Diosmectite: This is a natural double silicate of aluminum and magnesium which is distinguished from other silicates by its X-ray diffraction spectrum. Iron, magnesium and calcium partially replace aluminum in the octahedral layer of alumina.
Excipients/Inactive Ingredients: Per sachet of 3.760 g: Glucose monohydrate 0.679 g, saccharin sodium 0.021 g, orange flavor* 0.010 g, vanilla flavor* 0.050 g.
*Composition of orange flavour: maltodextrin, sucrose, acacia gum (E414), mono- and diacetyl tartaric acid ester of mono- and diglycerides of fatty acids (E472e), silicon dioxide (E551), flavouring ingredients.
*Composition of vanilla flavour: maltodextrin, sucrose, glyceryl triacetate (E1518), silicon dioxide (E551), ethyl alcohol, soya lecithins (E322) flavouring ingredients.
SmectaGo: Dioctahedral smectite 3 g for one sachet.
Excipient with known effect: Ethanol, propylene glycol.
Excipients/Inactive Ingredients: Xanthan gum, citric acid monohydrate, ascorbic acid, potassium sorbate, sucralose, caramel-cocoa flavour*, purified water.
*Composition of caramel-cocoa flavouring: mixture of natural and synthetic flavourings, caramel colour (E 150d), caramelized sugar syrup, propylene glycol, water, ethanol, caffeine.
Drug class: Other intestinal adsorbent agents. ATC code: A07BC05.
Pharmacology: Pharmacodynamics: It has been shown in clinical pharmacology studies that dioctahedral smectite: Adsorbs intestinal gas in adults; Restores the normal permeability of the mucous membrane, observed during a clinical study in children with gastroenteritis.
Due to its layered structure and high plastic viscosity, dioctahedral smectite covers the intestinal mucosa. The combined results of 2 double-blind randomized controlled trials comparing the efficacy of dioctahedral smectite against a placebo, in 602 patients aged 1 to 36 months who were suffering from acute diarrhea, show a significant reduction in stool output during the first 72 hours in the patient group treated with dioctahedral smectite combined with oral rehydration.
Pharmacokinetics: Given the layered structure of dioctahedral smectite, it stays on the luminal side of intestinal epithelium. It is neither absorbed nor metabolized.
Dioctahedral smectite is eliminated in the stool by the natural process of intestinal transit.
Toxicology: Preclinical safety data: The preclinical safety data, obtained from standard acute toxicity studies and at repeated doses, and from genotoxicity studies show no evidence of particular risk to humans.
Smecta: Symptomatic treatment of acute diarrhea in children and infants in addition to oral rehydration and in adults.
Symptomatic treatment of chronic diarrhea.
Symptomatic treatment of pain associated to oesophagus and gastroduodenal and colic disease.
SmectaGo: Treatment of acute diarrhoea in children over 2 years in addition to oral rehydration and in adults.
Symptomatic treatment of chronic functional diarrhoea in adults.
Symptomatic treatment of pain associated with functional bowel diseases in adults.
Smecta: Treatment of acute diarrhea: 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 a day.
In practice, the daily dosage can be doubled at the beginning of the treatment.
Other indications: In 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.
Administration: The content of the sachet must be mixed in suspension directly before use.
Preferably to be taken: After meals if oesophagitis; Between meals, for other indications.
Children and infants: The content of the sachet may be mixed in a bottle of 50ml of water to be given during the day, or well mixed with a semi-liquid food, such as broth, compote, puree, baby food.
Adults: The content of the sachet may be mixed with half a glass of water.
SmectaGo: Treatment of acute diarrhoea: In children 2 years and older: 4 sachets per day for 3 days, then 2 sachets per day for 4 days.
In adults: An average of 3 sachets per day for 7 days. In practice, the daily dose can be doubled at the start of treatment.
Other indications: In adults: An average of 3 sachets per day.
Method of administration: The suspension can be liquefied by kneading the sachet between the fingers before opening it. The contents of the sachet may be swallowed undiluted or mixed into some water before drinking. Preferably administer between meals.
In children, the contents of the sachet can be mixed with a little water in a feeding bottle or mixed with semi-liquid food, such as broth, compote, puree, baby food.
In adults: the contents of the sachet can be mixed into half a glass of water.
Overdose may lead to severe constipation or a bezoar.
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Smecta: Due to the presence of glucose and saccharose, this medication is contraindicated for patients who are fructose intolerant.
Dioctahedral smectite must be used with caution in patients with a history of severe chronic constipation.
In adults, treatment does not dispense with rehydration, if this is considered to be necessary.
The amount of rehydration by oral rehydration solution or intravenously must be adapted to the intensity of the diarrhoea, and the patient's age and characteristics.
The patient must be informed of the need to: Rehydrate with plenty of salty or sweet fluids, to make up for fluid loss due to diarrhoea (the average daily water requirement in adult is 2 liters).
Keep up food intake while the diarrhoea persists: excluding some foods, especially raw vegetables and fruit, green vegetables, spicy dishes as well as frozen foods or drinks; preferring grilled meat and rice.
Smecta: In children, acute diarrhea must be treated in association with the early administration of an oral rehydration solution (ORS) to avoid dehydration.
SmectaGo: In infants and children below 2 years, the use of SMECTAGO should be avoided. The reference treatment in acute diarrhoea is oral rehydration solution (ORS).
In children above 2 years, acute diarrhoea must be treated in conjunction with early administration of an oral rehydration solution (ORS), to avoid dehydration. The chronic use of SMECTAGO should be avoided.
This drug contains small amounts of ethanol (alcohol), below 100 mg per daily dose.
This drug contains 22.4 mg of propylene glycol in each sachet.
Effects on ability to drive and use machines: SMECTAGO has no effect or a negligible effect on the ability to drive vehicles and operate machines.
Smecta: There is no reliable data of teratogenesis in animals.
Clinically, no malformation or foetotoxic effect has currently come to light. However, there is not enough evidence of pregnancies exposed to SMECTA to exclude any risk.
Consequently, given that SMECTA is not absorbed, its use could be envisaged during pregnancy only if necessary.
SmectaGo: Pregnancy: There are no data or there is limited data (less than 300 pregnancies) on the use of SMECTAGO in pregnant women.
Studies in animals are insufficient to conclude on reproductive toxicity.
SMECTAGO is not recommended during pregnancy.
Breastfeeding: There is limited data on the use of SMECTAGO during breastfeeding.
SMECTAGO is not recommended during breastfeeding.
Fertility: The effect on fertility in humans has not been studied.
The following adverse effects have been reported during clinical trials carried out with children and adults. These adverse effects have usually been minor and temporary and were mainly related to the digestive system.
The frequencies of adverse events have been classified as follows: frequent (≥1/100, <1/10), infrequent (≥1/1,000, ≤1/100).
Frequents: constipation usually resulting with the reduction of the dose, but which, in rare cases, may result in the treatment being stopped.
Infrequent: flatulence, vomiting.
During post-marketing experience, cases of hypersensitive reactions (unknown frequency), comprising urticarial, rashes, pruritus and angio-edema have been reported.
Cases of aggravation of the constipation have also been reported.
The most commonly reported adverse reaction during treatment is constipation, occurring in approximately 7% of adults and approximately 1% of children. If constipation occurs, dioctahedral smectite should be discontinued, and if necessary re-started at a lower dose.
The table as follows lists adverse drug reactions reported from clinical trials and from post-marketing sources. Their frequencies are 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), Very rare (<1/10,000), Unknown (cannot be estimated from the available data). (See table.)
Click on icon to see table/diagram/image
Declaration of suspected adverse events:
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.
Smecta: This product's absorbent properties may interfere with the absorption periods and/or rates of another substance. It is recommended that this medication is not taken with any other medications together.
SmectaGo: The absorbent properties of this product could interfere with absorption times and/or rates of another substance, so it is recommended that any other drug is administered at distance of SMECTAGO (more than 2 hours if possible).
Incompatibilities: Not applicable.
Special precautions for disposal and other handling: No special requirements.
Smecta: To be stored in a dry place, below 25°C.
SmectaGo: Store below 30°C.
Shelf life: 3 years.
A07BC05 - diosmectite ; Belongs to the class of other intestinal adsorbents.
SmectaGo oral susp 3 g
(caramel-cocoa flavor) 12 × 1's
Smecta powd for oral susp 3 g
(orange-vanilla flavor) 10 × 1's; (orange-vanilla flavor) 30 × 1's; (strawberry flavor) 12 × 1's