NOTICE
ANSM - Updated on : 03/12/2021
Product name
DIOSMETITE VIATRIS 3 g, powder for drinkable suspension in sachet
Diosmectite
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet and what is it used for?
2. What do I need to know before taking DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet?
3. How should DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet, be taken?
4. What are the possible side effects?
5. How to store DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet?
6. Package contents and other information.
1. WHAT IS DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER INTESTINAL ADSORBENTS - ATC code: A07BC05.
This medicine contains the active substance diosmectite.
Diosmectite is a purified natural clay that covers the digestive mucosa. This medicine is indicated for the treatment of
- acute diarrhea in children over 2 years of age , as a complement to oral rehydration, and in adults ;
- chronic (long-lasting) diarrhea in adults;
- pain associated with functional bowel disease in adults.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet?
Never take DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet :
- if you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6 ;
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
Warnings and precautions
Infants and children under 2 years of age: DIOSMECTITE VIATRIS should not be used.
In children over 2 years of age: DIOSMECTITE VIATRIS should only be used for the treatment of acute diarrhoea (7 days maximum), in association with the early administration of oral rehydration solution (ORS). Chronic use of DIOSMECTITE VIATRIS should be avoided.
Adults: Prolonged or repeated use of DIOSMECTITE VIATRIS is not recommended without medical advice.
Talk to your doctor or pharmacist before taking DIOSMECTITE VIATRIS :
- if you have a history of severe constipation.
Consult your doctor:
- in case of acute diarrhea, if your symptoms do not improve or worsen after 3 days of treatment;
- if digestive pain is associated with fever or vomiting.
Children
DIOSMECTITE VIATRIS is reserved for children over 2 years of age, for the treatment of acute diarrhoea. It should be administered in association with the early administration of oral rehydration solution (ORS) to avoid dehydration. The duration of treatment should not exceed 7 days.
Additional dietary measures
This treatment is a complement to dietary rules:
- rehydrate with plenty of salty or sweet drinks, to compensate for fluid losses due to diarrhea (the average daily water intake for adults is 2 liters);
- continue to eat during diarrhea, excluding certain foods, particularly raw vegetables and fruit, green vegetables, spicy dishes, and iced foods or drinks;
- give preference to grilled meats and rice.
Other drugs and DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet
Taking this medicine may reduce the absorption of other medicines taken at the same time. No medication should be taken at the same time as DIOSMECTITE VIATRIS.
If possible, DIOSMECTITE VIATRIS should be taken more than 2 hours apart from other medications.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet is not recommended during pregnancy and breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
No studies on the ability to drive vehicles and use machines have been performed. However, the expected effect is nil or negligible.
DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet contains laspartam (E 951) and glucose.
This medicine contains 16 mg daspartam per sachet.
Laspartam contains a source of phenylalanine. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by the accumulation of phenylalanine which cannot be eliminated properly.
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
3. HOW DO I TAKE DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet?
Always take DIOSMECTITE VIATRIS exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Treatment of acute diarrhoea :
Children aged 2 and over: 4 sachets a day for 3 days, then 2 sachets a day for 4 days.
Adults:
On average 3 sachets a day for 7 days. In practice, the dosage may be doubled at the start of treatment.
Other indications
Adults:
An average of 3 sachets a day.
Method and route of administration
Oral administration.
The contents of the sachet must be suspended just before use.
Children:
The contents of the sachet can be diluted in a 50 ml bottle of water, or mixed with a semi-liquid food such as porridge, compote, purée or "petit-pot".
Adults:
The contents of the sachet can be diluted in half a glass of water.
If you have taken more DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet, than you should have :
Taking too much DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet may cause constipation, which usually disappears when the dose is reduced or treatment stopped. Consult your doctor or pharmacist.
If you forget to take DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet:
Do not take a double dose to make up for the one you forgot to take.
If you stop taking DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
Undesirable effects which may occur with DIOSMECTITE VIATRIS are listed below in order of frequency.
Common (may occur in up to 1 in 10 people)
- Constipation
Uncommon (may occur in up to 1 in 100 people)
- Rash
- Vomiting
Rare (may occur in up to 1 in 1,000 people)
- Urticaria
Unknown frequency (cannot be estimated on the basis of available data)
- Allergic reaction which may manifest itself as reddening of the skin, itching, swelling of the face and throat, difficulty in breathing, malaise, collapse.
If you experience any of these signs, you should seek medical advice immediately.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and sachet. The expiration date refers to the last day of this month.
No special storage precautions.
Do not dispose of any medicine in the drain or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet, contains
- The active substance is :
Diosmectite.......................................................................................................................... 3 g
per sachet.
- The other components are :
Aspartam (E 951), glucose monohydrate, vanillin.
What DIOSMECTITE VIATRIS 3 g, powder for drinkable suspension in sachet, is and what it contains
This medicine comes in sachet form. Boxes of 18, 30 or 60 sachets.
Not all presentations may be marketed.
Marketing authorization holder
OY SIMCERE EUROPE LTD
VOLTTIKATU 5
70700 KUOPIO
FINLAND
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
or
OY MEDFILES Ltd
VOLTTIKATU 5, VOLTTIKATU 8
KUOPIO FI-70210
FINLAND
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
