Smecta

Package Leaflet: Information for the User

Warning! Keep the Leaflet! 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.

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 2-3 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What Smecta is and what it is 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 Smecta is and what it is used for

Due to its structure and high viscosity, Smecta has strong coating properties, reinforcing the barrier that protects the gastrointestinal mucosa 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 chronic functional diarrhea in adults

If there is no improvement or the patient feels worse after 2-3 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 medication (listed in section 6).
• Smecta should not be used in infants and children under 2 years of age.

Warnings and precautions

Before starting Smecta, 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.

Dietary advice:

• Adequate 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 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.

Consult a 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 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 medications

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

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 in one sachet. This should be taken into account in patients with diabetes.

3. How to take Smecta

This medication should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, 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 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 2-3 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.
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, or baby food.
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 more than the recommended dose of Smecta is taken, 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 medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, 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 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 side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to 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.
Reporting side effects will help gather more information on the safety of this medication.

5. How to store Smecta

Keep the medication out of sight and reach of children.
Store in a dry place.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medications. 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 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 diacetyl 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 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, 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
Usine des Fontaines
20, rue Ethe Virton
28100 Dreux
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in France, the country of export:34009 319 230 7 7
34009 319 231 3 8
319 230-7
319 231-3
Parallel import authorization number:34/08
Date of leaflet approval: 17.03.2023
[Information about the trademark]