Smecta

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging 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 drug.

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

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Package contents 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, reinforcing 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 fluid 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.
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 treatment with Smecta, the patient should consult their 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.

Dietary recommendations:

• Adequate hydration with large amounts 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 resolves, but some foods should be excluded, especially raw vegetables and fruits, green vegetables, spicy dishes, and frozen foods or drinks.
• Grilled meat and rice are preferred.

The patient should consult their doctor:

• if symptoms do not resolve 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 should be treated in combination with early administration of oral rehydration fluid to avoid dehydration. Chronic use of Smecta is not recommended.

Smecta and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 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 intolerance to some sugars, they should consult their doctor before taking Smecta.
Smecta contains 0.679 g of glucose in one sachet and sucrose. 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 according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their 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 used. 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 used.

Duration of treatment

If there is no improvement or the patient feels worse after 2 to 3 days, 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. The contents of the sachet should be dissolved in a liquid just before administration to obtain a suspension. 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.

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.
In case of overdose, the patient should consult their doctor.

Missed dose of Smecta

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient notices any of the following symptoms, they should stop taking Smecta and immediately consult their doctor:

• 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should consult their 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 (smectite). One sachet contains 3 g of diosmectite.
• The other excipients are: glucose monohydrate, sodium saccharin, orange flavor*, vanilla flavor** * Orange flavor: maltodextrin, sucrose, arabic gum (E 414), mono- and diacetylated mono- and diglycerides (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 package contains

Smecta is a powder for oral suspension in sachets.
Smecta is available in packages containing 10 or 30 sachets in a cardboard box.
For more detailed information, the patient should contact 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
French marketing authorization number: 319 230-7
34009 319 230 7 7
319 231-3
34009 319 231 3 8

Parallel import authorization number: 28/07 Date of approval of the leaflet: 26.04.2022

[Information about the trademark]