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 medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please contact a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 to 3 days, or if the patient feels worse, consult a doctor.

Table of contents:

1. What Smecta is and what it is used for
2. What you need to know 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 Smecta is and what it is used for

Due to its structure and high viscosity, Smecta has strong coating properties that protect the gastrointestinal mucosa by reinforcing the protective barrier against irritants and pathogens.
Smecta is indicated:

• for the treatment of acute diarrhoea in children over 2 years of age, in combination with oral rehydration solutions, and in adults with acute diarrhoea;
• for the symptomatic treatment of chronic functional diarrhoea in adults.

If there is no improvement after 2 to 3 days, or if the patient feels worse, consult a doctor.
Prolonged or frequent use of Smecta without medical advice is not recommended.

2. Important information before using Smecta

When not to use Smecta

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

Warnings and precautions
Before starting treatment with Smecta, consult a doctor or pharmacist:

• if the patient has been informed by a doctor of having an intolerance to certain sugars (see also section "Smecta contains glucose and sucrose"),
• if the patient has previously experienced severe constipation.

During treatment of diarrhoea, it is essential to replenish fluids and electrolytes. The volume and route of administration of rehydration solutions should be adjusted according to the patient's age, health status, and severity of diarrhoea.
Additional dietary guidelines:

• Ensure hydration with large amounts of salty or sweet drinks to compensate for fluid loss due to diarrhoea (average daily water requirement in adults is 2 litres).
• Continue feeding until diarrhoea resolves, but exclude certain foods, especially raw vegetables and fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.
• Grilled meat and rice are preferred.

Consult a doctor:

• if symptoms do not improve within 3 days.

Children and adolescents
Smecta must not be used in infants and children under 2 years of age. In children over 2 years of age, acute diarrhoea must be treated in combination with early administration of oral rehydration solution to prevent dehydration. Prolonged use of Smecta is not recommended.
Smecta and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Due to its adsorptive properties, 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 available on the use of Smecta in pregnant or breastfeeding women.
The use of Smecta during pregnancy is not recommended.
Smecta should not be used during breastfeeding.
The effect of Smecta on fertility in humans has not been evaluated.
Driving and operating machinery
Studies on the effect of Smecta on the ability to drive and operate machinery have not been conducted; however, an effect is not expected.
Smecta contains glucose and sucrose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Smecta contains 0.679 g of glucose and sucrose per sachet. This should be taken into account in patients with diabetes.

3. How to use Smecta

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Treatment of acute diarrhoea:

In children over 2 years of age:

• 2 sachets per day. At the onset of an acute diarrhoea episode, the dose may be doubled (i.e. up to 4 sachets per day).

In adults:

• Usually 3 sachets per day. At the onset of an acute diarrhoea episode, the dose may be doubled (i.e. up to 6 sachets per day).

Symptomatic treatment of chronic functional diarrhoea:

In adults:

• Usually 3 sachets per day.

Duration of treatment:

If there is no improvement after 2 to 3 days, or if the patient feels worse, consult a doctor. Prolonged or frequent use of Smecta without medical advice is not recommended.

Method and route of administration:

For oral use. Before administration, dissolve the contents of the sachet in liquid to form a suspension.

• In children over 2 years of age: The contents of one sachet may be dissolved in a bottle containing 50 ml of water and administered in small portions throughout the day. It may also be mixed with semi-liquid foods such as broth, cooked fruit, purees, or ready-made baby food.
• In adults: The contents of one sachet may be dissolved in half a glass of water.

Use of more than the recommended dose of Smecta:

Taking more than the recommended dose of Smecta may cause severe constipation or formation of a bezoar, i.e. accumulation of undigested material in the gastrointestinal tract.

If more than the recommended dose has been 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If you notice any of the following symptoms, stop taking Smecta and contact a doctor immediately:

• allergic reaction (hypersensitivity) – symptoms may include skin redness, itching, swelling,
• severe allergic reaction causing facial and throat swelling, breathing difficulties, fainting or collapse (angioedema). The frequency of the above-mentioned adverse reactions is unknown (cannot be estimated from the available data).

Other adverse reactions include:
Common (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 1000 patients):

• Urticaria (itchy rash)

Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, please contact your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Smecta

Keep this medicine 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 stated month.
Medicines must 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 (aluminosilicate). One sachet contains 3 g of diosmectite.
• Other excipients are: glucose monohydrate, sodium saccharin, orange flavour*, vanilla flavour **
  * Orange flavour: maltodextrin, sucrose, acacia gum (E 414), mono- and diglycerides of fatty acids esterified with acetylated tartaric acid (E 472e), silicon dioxide (E 551), orange aroma.
  ** Vanilla flavour: maltodextrin, sucrose, glyceryl triacetate (E 1518), silicon dioxide (E 551), ethyl alcohol, soy lecithin (E 322), vanilla aroma.

What Smecta looks like and contents of the pack
Smecta is a powder for oral suspension contained in sachets.
The medicine is available in packs containing 10 or 30 sachets, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation 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
Poland

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

Marketing Authorisation numbers in France, the country of export:
319 230-7
34009 319 230 7 7
319 231-3
34009 319 231 3 8

Parallel Import Licence Number: 28/07