Smecta

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

SMECTA(Smecta orange-vanille)

3 g, powder for oral suspension

Diosmectite
SMECTA and Smecta orange-vanille are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 2 to 3 days, they should contact their 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 for the mucous membrane of the gastrointestinal tract, strengthening the barrier that protects it 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 there is no improvement or the patient feels worse after 2 to 3 days, they should contact their doctor.
It is not recommended to use Smecta for a long time or frequently 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 your 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 the treatment of diarrhea, it is necessary to replenish fluids and electrolytes. The volume of solutions administered and their route of administration should be adjusted according to the patient's age, health status, and severity of diarrhea.

Additional dietary rules:

• It is necessary to ensure hydration with a large amount of salty or sweet drinks to compensate for fluid loss due to diarrhea (the average daily water requirement for an adult is 2 liters).
• It is necessary to continue eating until the diarrhea stops, 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 your doctor:
• if symptoms do not improve 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 therapy to avoid dehydration. Chronic use of Smecta is not recommended.

Smecta and other medicines

You should 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, you should 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 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 your doctor or pharmacist. If you are unsure, you should consult your 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 per day are used.
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 chronic functional diarrhea:

In adults:

Usually, 3 sachets per day are used.

Duration of treatment

If there is no improvement or the patient feels worse after 2 to 3 days, they should contact their doctor. It is not recommended to use Smecta for a long time or frequently 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 dishes 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

Using 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 use more than the recommended dose of Smecta, you should consult your doctor.

Missing a dose of Smecta

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult your 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 your doctor immediately:

• allergic reaction (hypersensitivity) - symptoms may include: skin redness, itching, swelling,
• severe allergic reaction causing swelling of the face and throat, difficulty breathing, fainting, or collapse (angioedema). The frequency of these 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 (itching rash)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.

5. How to store Smecta

The medicine should be stored 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 stated.
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. 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, gum arabic (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, glycerol triacetate (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 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 Ethe Virton
28100 Dreux
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in France, the country of export:34009 319 230 77
319 230 – 7
319 231 – 3
34009 319 231 38
319 233 – 6
34009 319 233 67

Parallel import authorization number: 279/22 Date of leaflet approval: 11.07.2022

[Information about the trademark]