Smecta

Active substance is: Diosmectite 3 g in each sachet.
Smecta: SMECTA is packed in soft, flat sachet. The product is presented as greyish-white to ochre powder, with slightly reminiscent odour of orange when preparing the oral suspension for use or strawberry (before and after reconstituted).
SmectaGo: SMECTAGO is a beige to light beige homogeneous suspension with a characteristic odour of caramel.
Excipients/Inactive Ingredients: Smecta orange-vanilla: Glucose monohydrate, saccharine sodium, orange-vanilla flavour (containing sucrose).
Contains ethanol 0.00798% w/w.
Smecta strawberry: Glucose monohydrate, saccharine sodium, strawberry flavour*.
*Composition of the strawberry flavour: maltodextrin, propylene glycol, gum Arabic, mixture of natural and synthetic flavours.
SmectaGo: Xanthan gum, hydrochloric acid, potassium sorbate, sodium benzoate, 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 (E 1520), water, ethanol, caffeine.

Pharmacotherapeutic class: Smecta orange-vanilla: Antidiarrheal, Gastro-intestinal protectant. Smecta strawberry/SmectaGo: OTHER INTESTINAL ADSORBENTS. ATC code: A07BC05. (A: Alimentary/digestive tract and metabolism).
Pharmacology: Pharmacodynamics: Due to its leaflet structure and its high plastic viscosity, SMECTA/SMECTAGO possesses a powerful coating property on the gastrointestinal mucosa. By interacting with glycoprotein of mucus, SMECTA/SMECTAGO 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/SMECTAGO protects the gastrointestinal mucosa. SMECTA/SMECTAGO is radiolucent, does not colour the stools and, at usual doses, does not modify the physiological intestinal transit time.
Pharmacokinetics: According to structure of diosmectite (active ingredient), SMECTA/SMECTAGO is neither absorbed nor metabolised.

Treatment of acute diarrhoea in adults and children above 2 years, in addition to oral rehydration.
Symptomatic treatment of chronic functional diarrhoea in adults.
Symptomatic treatment of pain associated with functional bowel diseases in adults.

Recommended Dosage: Treatment of Acute Diarrhoea: In children of 2 years of age and above: 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 can be doubled at the start of treatment.
Other Indications: In adults: An average of 3 sachets a day.
Method of Administration: Oral route.
Smecta: The contents of the sachet must be mixed into a liquid to form a suspension, just before use.
In children of 2 years of age and above: The contents of the sachet can be added and thoroughly stirred in the feeding bottle with 50 ml of water, to be given at intervals during the day, or thoroughly mixed with a semi-liquid food: broth, stewed fruit, mashed vegetables, or baby food.
In adults: Contents of one sachet should be thoroughly stirred in half a glass or 50 ml of water before taking.
When should this medicine be taken: Patient should take this medicine preferably in between meals in other indications.
How long should the patient take this medication for: If the symptoms do not improve within 7 days, patient should consult a doctor.
SmectaGo: SMECTAGO is taken orally and is a ready to drink preparation. The content of the sachet can be swallowed directly. Massage the sachet before opening it. Each sachet should only be used once after opening.

Overdose may lead to severe constipation, vomiting or bezoar.
Smecta strawberry/SmectaGo: Bezoar is a solid mass of indigestible material that accumulates in your digestive tract, sometimes even causing a blockage.
Smecta orange-vanilla: If the patient takes too much of this medicine: Taking too much SMECTA may cause constipation.
The constipation usually disappears when treatment is stopped or when the dose is reduced. Ask a doctor or pharmacist.
SmectaGo: Symptoms are usually mild in intensity, and there is good recovery when Diosmectite dose is decreased or discontinued.
In case of overdose, treatment should be decreased or discontinued, particularly in case of vomiting.
Management should be symptomatic and supportive. If symptoms persist or worsen the patient should be advised to consult a doctor.

Hypersensitivity to diosmectite or to one of the excipients.

In infants and children below 2 years, the use of SMECTA/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 SMECTA/SMECTAGO should be avoided.
Smecta strawberry/SmectaGo: Diosmectite must be used with care in patients with a history of severe chronic constipation.
In adults, the 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 told 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 an 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 orange-vanilla: In infants and children below 2 years: SMECTA should not be used.
In children above 2 years: SMECTA should be used only in the treatment of acute diarrhoea (7 days maximum), in association with early administration of an oral rehydration solution (ORS). Any chronic use of SMECTA should be avoided.
In adults: Prolonged or repeated use of SMECTA is not recommended without medical advice.
Consult a doctor or pharmacist: If patient has an intolerance to particular sugar(s).This medicine contains glucose, sucrose and saccharin. Its use is not recommended in patients with fructose intolerance, glucose or galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disease); In case of history of severe constipation; In case of acute diarrhoea, if patient's symptoms do not improve or worsen within 3 days of treatment; If patient's digestive pain is associated with fever and vomiting.
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per daily dose.
Smecta strawberry: This medicinal product contains glucose. Its use is not recommended in patients presenting with glucose or galactose malabsorption syndrome.
This medicinal product contains 0.128 mg of propylene glycol in each sachet.
SmectaGo: SMECTAGO contains 13 mg of ethanol (alcohol) in each sachet. The amount per sachet is equivalent to less than 0.325 ml of beer or 0.13 ml of wine.
This drug contains 22.4 mg of propylene glycol (E 1520) in each sachet. This drug contains 15 mg of sodium benzoate in each sachet.
If patient has been told by a doctor that patient has an intolerance to some sugars, contact a doctor before taking this medicinal product.
Effects on Ability to Drive Vehicles and Operate Machines: Smecta strawberry: There have been no studies on the ability to drive vehicles and operate machines with this drug. However, it is expected that there is a negligible or zero effect.
SmectaGo: Not applicable.

SMECTA/SMECTAGO is not recommended during pregnancy and breastfeeding.
Smecta orange-vanilla: If the patient is pregnant, thinks might be pregnant or is planning to become pregnant or is breast feeding, patient should seek the advice from a doctor or pharmacist before taking this medicine.

Smecta strawberry/SmectaGo: The most commonly reported adverse reaction during treatment is constipation, occurring in approximately 7% of adults and approximately 1% of children. If constipation occurs, diosmectite should be discontinued, and if necessary, re-started at a lower dose.
Smecta: Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects that can occur with SMECTA are listed as follows according to their frequency.
Common (may affect up to 1 in 10 people): Constipation.
Uncommon (may affect up to 1 in 100 people): Rash, Vomiting.
Rare (may affect up to 1 in 1000 people): Hives (itchy rash).
Not known (frequency cannot be estimated from available data): Symptoms of an allergic reaction such as skin redness, itching, swelling of face or throat, breathing difficulties, faintness, collapse.
If patient feels any of these effects, patient should see a doctor immediately.
SmectaGo: 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

The absorbent properties of this product could interfere with absorption times and/or rates of another substance, so it is recommended that other drugs are not administered at the same time as SMECTA/SMECTAGO (more than 2 hours, if possible). In case of doubts, it is advisable to seek advice from a doctor or pharmacist. In order to avoid possible interactions among several medicines, patient must always tell a doctor or pharmacist what prescription and non-prescription medications patient is taking.

SMECTA/SMECTAGO should be kept in a dry place, below 30°C.
Smecta: SMECTA should be consumed immediately after mixing.

Antidiarrheals

A07BC05 - diosmectite ; Belongs to the class of other intestinal adsorbents.

NP