Smecta

1. What is Smecta and what is it used for

Due to its structure and high viscosity, Smecta has strong coating properties, strengthening the barrier that protects the gastrointestinal tract from irritating factors and pathogens.
Smecta is used:

• to treat acute diarrhea in children over 2 years of age in combination with oral rehydration fluid and acute diarrhea in adults
• to treat symptomatic functional chronic diarrhea in adults

If there is no improvement after 2 to 3 days or the patient feels worse, they should contact their doctor.
Long-term or frequent use of Smecta is not recommended without consulting a doctor.

2. Important information before taking Smecta

When not to take Smecta

• If the patient is allergic to diosmectite or any of the other ingredients of this medicine (listed in section 6).
• Smecta should not be used in infants and children under 2 years of age.

Warnings and precautions

Before starting to take Smecta, you should consult a doctor or pharmacist:

• if the patient has been informed by their doctor that they have an intolerance to some sugars (see also the section "Smecta contains glucose and sucrose"),
• if the patient has had severe constipation in the past.

During diarrhea treatment, it is necessary to replenish fluids and electrolytes. The volume of administered solutions and their route of administration should be adjusted according to the patient's age, health status, and severity of diarrhea.

Additional dietary rules:

• Hydration with a large amount of salty or sweet drinks should be ensured to compensate for fluid loss due to diarrhea (the average daily water requirement for an adult is 2 liters).
• Food intake should be maintained until diarrhea subsides, but excluding some foods, especially raw vegetables and fruits, green vegetables, spicy dishes, and frozen foods or drinks.
• Grilled meat and rice are preferred.

You should consult a doctor:

• if symptoms do not subside within 3 days.

Children and adolescents

Smecta should not be used in infants and children under 2 years of age. In children over 2 years of age, acute diarrhea must be treated in combination with early administration of oral rehydration fluid to avoid dehydration. Long-term use of Smecta is not recommended.

Smecta and other medicines

You should tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
The adsorptive properties of this medicine may affect the rate and/or extent of absorption of other substances. Therefore, no other medicine should be administered at the same time as diosmectite.
A 2-hour interval is recommended between taking Smecta and other medicines.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of Smecta in pregnant or breastfeeding women.
Smecta is not recommended during pregnancy.
Smecta should not be used during breastfeeding. The effect of Smecta on human fertility has not been evaluated.

Driving and using machines

No studies have been conducted on the effect of Smecta on the ability to drive and use machines, but it is expected that there will be no such effect.

Smecta contains glucose and sucrose

If the patient has previously been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Smecta.
Smecta contains 0.679 g of glucose and 0.27 g of sucrose in one sachet. This should be taken into account in patients with diabetes.

3. How to take Smecta

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.

Treatment of acute diarrhea:

In children over 2 years of age

• 2 sachets per day. At the beginning of an episode of acute diarrhea, the dose can be doubled (i.e., up to 4 sachets per day)

In adults:

Usually, 3 sachets are taken per day.
At the beginning of an episode of acute diarrhea, the dose can be doubled (i.e., up to 6 sachets per day)

Treatment of symptomatic functional chronic diarrhea:

In adults:

Usually, 3 sachets are taken per day

Duration of treatment

If there is no improvement after 2 to 3 days or the patient feels worse, they should contact their doctor. Long-term or frequent use of Smecta is not recommended without consulting a doctor.

Method and route of administration

Oral administration.
Immediately before administration, the contents of the sachet should be dissolved in a liquid until a suspension is obtained.
In children over 2 years of age: The contents of the sachet can be dissolved in a 50 ml bottle of water and administered in small portions throughout the day; it can also be mixed with semi-liquid foods: broth, cooked fruits, purees, cooked meals for children.
In adults: The contents of the sachet can be dissolved in half a glass of water.

Using more than the recommended dose of Smecta

Taking more than the recommended dose of Smecta may cause severe constipation or the formation of a bezoar, which is an accumulation of undigested substances in the gastrointestinal tract.
If more than the recommended dose of Smecta is taken, you should consult a doctor.

Missing a dose of Smecta

A double dose should not be taken to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Smecta can cause side effects, although not everybody gets them.

If you notice any of the following symptoms, you should stop taking Smecta and consult a doctor immediately:

• allergic reaction (hypersensitivity) - symptoms may include: skin redness, itching, swelling,
• severe allergic reaction causing facial and throat swelling, difficulty breathing, fainting, or collapse (angioedema). The frequency of the above side effects is unknown (cannot be determined from available data). Other side effects include:

Frequent (may occur in up to 1 in 10 patients):

• Constipation

Uncommon (may occur in up to 1 in 100 patients):

• Rash

Rare (may occur in up to 1 in 1,000 patients)

• Urticaria (itching rash)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should consult a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder or parallel importer.

5. How to store Smecta

The medicine should be stored out of sight and reach of children.
Store in a dry place.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Smecta contains

• The active substance is: diosmectite (silicate). One sachet contains 3 g of diosmectite in the form of silicate.
• The other excipients are: glucose monohydrate, sodium saccharin, orange flavor*, vanilla flavor** *Orange flavor :maltodextrin, sucrose, arabic gum (E 414), mono- and diglycerides of fatty acid esters with mono- and diacetylated tartaric acid (E 472e), silicon dioxide (E 551), orange flavor. ** Vanilla flavor: maltodextrin, sucrose, glycerin trioctanoate (E 1518), silicon dioxide (E 551), ethanol, soy lecithin (E 322), vanilla flavor.

What Smecta looks like and what the pack contains

Smecta is a powder for oral suspension preparation in sachets.
Smecta is available in packs containing 10 or 30 sachets in a cardboard box.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

IPSEN Consumer HealthCare
65, quai Georges Gorse
92100 Boulogne Billancourt
France

Manufacturer:

Beaufour Ipsen Industrie
rue Ethé Virton
28100 Dreux
France

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń

Marketing authorization number in France, the country of export:

34009 319 230 7 7
34009 319 231 3 8
34009 319 233 6 7
34009 279 158 9 5
Parallel import authorization number:122/23

Date of leaflet approval: 13.02.2025

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