PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this 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 of the same medicine.
Please read all of this leaflet carefully before taking this medicine because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 to 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

What Smecta is and what it is used for
Important information before taking Smecta
How to take Smecta
Possible side effects
How to store Smecta
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 on the gastrointestinal mucosa, 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 you feel worse, consult your 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, replacement of fluids and electrolytes is necessary. 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 recommendations:

Ensure adequate 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 food intake until diarrhoea resolves, but exclude certain foods, especially raw vegetables and fruits, green vegetables, spicy dishes, as well as frozen foods or beverages.
Grilled meat and rice are preferred.

Consult a doctor:

if symptoms do not resolve 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 conjunction with early administration of oral rehydration solution to prevent dehydration. Prolonged use of Smecta is not recommended.
Smecta and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use. 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 between administration of Smecta and other medicines is recommended.
Pregnancy, breastfeeding and fertility
There are no data or limited data available on the use of Smecta in pregnant or breastfeeding women.
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 influence of Smecta on the ability to drive vehicles and operate machinery have not been conducted; however, no such effect is expected.
Smecta contains glucose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Smecta contains 0.679 g of glucose and 0.27 g of sucrose per sachet. This should be taken into account in patients with diabetes.

3. How to use the medicine Smecta

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician 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:
The usual dose is 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:
The usual dose is 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 physician.
Prolonged or frequent use of Smecta without consulting a physician is not recommended.
Method and route of administration
Oral administration.
Immediately before use, the contents of the sachet should be dissolved in liquid to form a suspension.
In children over 2 years of age: The contents of a 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 fruits, purees, or ready-made baby meals.
In adults: The contents of a sachet may be dissolved in half a glass of water.
Use of a higher than recommended dose of Smecta
Taking a higher than recommended dose of Smecta may cause severe constipation or formation of a bezoar, i.e. accumulation of undigested material in the gastrointestinal tract.
If a higher than recommended dose of Smecta has been taken, consult a physician.
Missed dose of Smecta
Do not take a double dose to make up for a missed dose.
If there are any further doubts concerning the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following symptoms, stop taking
Smecta and contact your 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 occurrence of the above-mentioned adverse reactions is unknown (cannot be estimated from the available data).

Other adverse reactions 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Smecta

Keep 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 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 packaging and other information

What Smecta contains

The active substance is: dioctahedral smectite (aluminosilicate). One sachet contains 3 g of dioctahedral smectite in the form of aluminosilicate.
Other excipients are: glucose monohydrate, sodium saccharin, orange flavour*, vanilla flavour**
* Orange flavour: (maltodextrin, sucrose, gum arabic (E 414), mono- and diglycerides of fatty acids esterified with mono- and diacetyl 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, presented 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

French Marketing Authorisation Numbers (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 Authorisation Number: 279/22