Package leaflet: Information for the user

DIOSMECTAL 3 g powder for oral suspension in sachets

Diosmectite
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DIOSMECTAL is and what it is used for
What you need to know before taking DIOSMECTAL
How to take DIOSMECTAL
Possible side effects
How to store DIOSMECTAL
Contents of the pack and other information

1. WHAT DIOSMECTAL IS AND WHAT IT IS USED FOR

Diosmectal is a purified and standardized natural clay.
Diosmectal coats the mucosa and protects it by enhancing mucus resistance and binding to pathogens,
bacteria, viruses, and toxins.
DIOSMECTAL is used for the treatment:

Of pain associated with intestinal functional disorders in adults
Of acute diarrhoea in children over 2 years of age, as an adjunct to oral rehydration therapy with saline solutions, and in adults.
Of chronic diarrhoea (long-term diarrhoea) in adults

Consult your doctor if you do not feel better or if you feel worse. Prolonged or repeated use of Diosmectal is not recommended without medical advice.

2. WHAT YOU SHOULD KNOW BEFORE USING DIOSMECTAL

Do not use DIOSMECTAL
If you are allergic to the active substance (diosmectite) or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIOSMECTAL.
Your doctor will recommend that fragile patients and children take hydrating solutions to prevent
dehydration, and, if necessary, will prescribe intravenous administration of fluids and electrolytes.

Inform your doctor if you have previously experienced severe constipation.
In acute diarrhoea, prolonged use of DIOSMECTAL should be avoided. Consult your doctor:
if pain is associated with high fever or vomiting

Additional dietary instructions:

Ensure adequate rehydration with sweet and salty drinks to compensate for fluid loss due to diarrhoea (the average daily water requirement in adults is 2 litres)
Maintain food intake while diarrhoea persists, but avoid certain foods, especially raw vegetables and fruit, leafy green vegetables, spicy dishes, as well as iced foods or drinks
Prefer grilled meat and rice

Other medicines and DIOSMECTAL
The adsorbent properties of this product may interfere with the absorption of other substances.
Therefore, other medications should not be taken at the same time as diosmectite. Inform your doctor
or pharmacist if you are taking, or have recently taken, any other medicines.

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor
or pharmacist before taking this medicine.
The use of Diosmectal is not recommended during pregnancy and breastfeeding.
Your doctor will prescribe Diosmectal only if clearly necessary.

Driving and using machines
No studies are available on the ability to drive or operate machinery. However, no effect is expected.

DIOSMECTAL contains glucose and sucrose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact him/her before taking this medicine.

DIOSMECTAL contains ethanol
This medicine contains 0.3 mg of alcohol (ethanol) per dose. This amount corresponds to less than 0.0075 ml of beer or 0.003 ml of wine.
The small amount of alcohol in this medicine will not produce any significant effects.

3. HOW TO TAKE DIOSMECTAL

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment of acute diarrhoea
Dosage
Adults:
The recommended dose is 9 g per day, equivalent to 3 sachets per day. The daily dose may be
doubled at the beginning of treatment.
Children over 2 years of age:
The recommended dose is 6 g per day, equivalent to 2 sachets per day.
The dosage may be doubled at the beginning of an episode of acute diarrhoea.
DIOSMECTAL must not be used in children under 2 years of age.
Duration of treatment
Do not exceed 7 days of treatment.
Treatment of other conditions
Dosage
Adults
The recommended dose is 9 g per day, equivalent to 3 sachets per day.
Method and route of administration:
Oral use
The contents of the sachet must be mixed into a suspension shortly before use.
Adults: the contents of the sachet may be mixed with half a glass of water.
Children: the contents of the sachet may be mixed into a suspension in a 50 ml bottle of water,
to be administered at intervals throughout the day, or mixed with a semi-liquid food, such as
broth, compote, purée, or infant foods.
Take this medicine exactly as stated in this leaflet or as prescribed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
If you take more DIOSMECTAL than you should
Excessive intake of Diosmectal may cause constipation. Constipation usually resolves when
treatment is discontinued or the dose is reduced.
If you forget to take DIOSMECTAL
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The reported side effects are generally mild and transient and include:
Common side effects (may affect up to 1 in 10 people)
Constipation
Uncommon side effects (may affect up to 1 in 100 people)
Rash
Rare side effects (may affect up to 1 in 1,000 people)
Urticaria (itchy rash)
Side effects with unknown frequency (frequency cannot be estimated from the available data)
Symptoms of an allergic reaction such as skin redness, itching, swelling, difficulty breathing, feeling faint or collapse.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DIOSMECTAL

Keep this medicine out of the 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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What DIOSMECTAL contains
Active substance: diosmectite.
Other components: sodium saccharin, glucose monohydrate, vanilla flavour*, orange flavour**.
*composition of vanilla flavour: maltodextrin, sucrose, glyceryl triacetate (E1518), silicon dioxide (E551), ethyl alcohol, soybean lecithin (E322), vanilla flavourings
**composition of orange flavour: maltodextrin, sucrose, arabic gum (E414), mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E472e), silicon dioxide (E551), orange flavourings

Description of the appearance of DIOSMECTAL and packaging contents
Oral suspension powder in sachets.
DIOSMECTAL is available in different pack sizes containing:

30 sachets
20 sachets
10 sachets Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ipsen Consumer HealthCare Srl
Via G. Stephenson 43/A
20157 Milan, Italy

Manufacturer
Beaufour Ipsen Industrie
Rue Ethe Virton
28100 Dreux
France