Smecta

Package Leaflet: Information for the User

SMECTA, 3 g, Powder for Oral Suspension

Diosmectite

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 to 3 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet:

• 1. What is Smecta and what is it used for
• 2. Important information before taking Smecta
• 3. How to take Smecta
• 4. Possible side effects
• 5. How to store Smecta
• 6. Contents of the pack and other information

1. What is Smecta and what is it used for

Due to its structure and high viscosity, Smecta has strong coating properties, strengthening the protective barrier of the gastrointestinal mucosa against irritating factors and pathogens.
Smecta is used:

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

If after 2 to 3 days there is no improvement or you feel worse, contact a 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 you are allergic to diosmectite or any of the other ingredients of this medicine (listed in section 6).
• Do not take Smecta if you are under 2 years of age.

Warnings and precautions

Before taking Smecta, consult a doctor or pharmacist:

• if you have been informed by your doctor that you have an intolerance to some sugars (see also section "Smecta contains glucose and sucrose"),
• if you have 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.

Dietary supplements:

• Ensure hydration with a large amount of salty or sweet drinks to compensate for fluid loss due to diarrhea (average daily water intake for an adult is 2 liters).
• Maintain food intake until diarrhea resolves, but exclude some foods, especially raw vegetables and fruits, green vegetables, spicy dishes, and frozen foods or drinks.
• Grilled meat and rice are preferred.

Consult a doctor:

• if symptoms do not resolve within 3 days.

Children and adolescents

Do not take Smecta if you are 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 therapy to avoid dehydration. Long-term use of Smecta is not recommended.

Smecta and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The adsorptive properties of this medicine may affect the rate and/or extent of absorption of other substances. Therefore, do not take any other medicine 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 should not be used during pregnancy.
Smecta should not be used during breastfeeding.
The effect of Smecta on fertility in humans 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 to have no such effect.

Smecta contains glucose and sucrose

If you have previously been diagnosed with intolerance to some sugars, consult a 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

Take this medicine exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, 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 acute diarrhea episode, the dose can be doubled (i.e., up to 4 sachets per day)

In adults:

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

Treatment of symptomatic chronic functional diarrhea:

In adults:

Usually, 3 sachets per day are taken

Duration of treatment

If after 2 to 3 days there is no improvement or you feel worse, contact a doctor. Long-term or frequent use of Smecta is not recommended without consulting a doctor.

Method and route of administration

Oral administration.
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, ready-to-eat meals for children.
In adults: The contents of the sachet can be dissolved in half a glass of water.

Overdose 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 you take more than the recommended dose of Smecta, consult a doctor.

Missed dose of Smecta

Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, 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, 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 estimated from the available data).

Other side effects include:
Common (may affect up to 1 in 10 people):

• Constipation

Uncommon (may affect up to 1 in 100 people):

• Rash

Rare (may affect up to 1 in 1,000 people)

• Urticaria (itchy rash)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, consult a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder or its representative.

5. How to store Smecta

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

6. Contents of the pack and other information

What Smecta contains

• The active substance is: diosmectite (smectite). One sachet contains 3 g of diosmectite in the form of smectite.
• 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 acids esterified with mono- and diacetyltartaric acid [E 472e], silicon dioxide [E 551], orange flavor. **Vanilla flavor: maltodextrin, sucrose, glyceryl triacetate [E 1518], silicon dioxide [E 551], ethanol, soy lecithin [E 322], vanilla flavor.

What Smecta looks like and contents of the pack

Smecta is a powder for oral suspension in sachets.
The medicine is available in packs containing 10 or 30 sachets in a cardboard box.

Marketing authorization holder

MAYOLY PHARMA FRANCE
3 Place Renault
92500 Rueil-Malmaison
France

Manufacturer

MAYOLY Industrie
rue Ethé Virton
28100 Dreux
France
To obtain more detailed information, contact the local representative of the marketing authorization holder:
MAYOLY POLSKA Sp. z o.o.
ul. Domaniewska 39B
02-672 Warsaw
tel. 22 166 26 26
Date of last revision of the leaflet:April 2025