NOTICE
ANSM - Last updated: 23/06/2016
Name of the medicinal product
BEDELIX powder for oral suspension in sachet
Montmorillonite Beidellitique
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the 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 talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
What is in this leaflet?
1. What is BEDELIX powder for oral suspension in sachets and in which cases it is used?
2. What information should I know before BEDELIX powder for oral suspension in sachets ?
3. How to BEDELIX powder for oral suspension in sachets ?
4. What are the possible side effects?
5. How to store BEDELIX powder for oral suspension in sachets ?
6. Package contents and other information.
1. WHAT IS BEDELIX Powder for oral suspension in sachets AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER INTESTINAL ADSORBENTS -
ATC code: A07BC05
This medicine works by protecting the walls (mucous membranes) of your stomach and your intestine.
This medication is used as a symptomatic treatment for functional colopathies, ie to treat symptoms related to a functional disease of the colon (a condition that affects the proper functioning of the intestine).
2. BEFORE YOU TAKE BEDELIX, powder for oral suspension in sachets?
Do not take BEDELIX powder for oral suspension in sachets :
· If you are allergic (hypersensitive) to the active substance (beidellitic montmorillonite) or to any of the other ingredients of this medication mentioned in section 6.
· If you suffer from an illness causing a narrowing of your digestive tract.
Warnings and Precautions
Talk to your doctor or pharmacist before taking BEDELIX powder for oral suspension in sachets.
If your doctor has told you about an intolerance to some sugars, contact the doctor before taking this medicine.
Be careful with BEDELIX:
If you are on dialysis, it means that your kidneys are not working and they will have difficulty removing the aluminum hydroxide contained in this medicine. In this case, you should not take this medicine for an extended period of time without talking to your doctor.
The use of this medication is not recommended in patients with glucose and galactose malabsorption syndrome.
Other drugs and BEDELIX powder for oral suspension in sachet
You should take BEDELIX and another medication in order to avoid decreasing the effectiveness of the other treatment.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BEDELIX powder for drinkable suspension in sachets with food and beverages
You should take BEDELIX between meals or a little before.
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
BEDELIX powder for oral suspension in sachet contains: Glucose.
3. HOW TO TAKE BEDELIX powder for oral suspension in sachets?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
In general, the usual oral dose is:
· Adults: 3 sachets per day on average.
· Children:
o before 2 years: ½ sachet 1 to 2 times a day;
o 2 to 5 years: ½ sachet 2 to 3 times a day;
o from 5 to 10 years: 1 sachet 2 times a day.
You should dissolve the contents of a sachet in half a glass of water or mix it with a semi-liquid food such as porridge, compote, puree, etc.
If your doctor has recommended that you use BEDELIX rectally:
In this case, take 1 to 3 sachets of BEDELIX 1 to 3 times a day.
You must dissolve the contents of the sachet (s) in 100 ml of lukewarm water. Then insert the suspension obtained in the rectum with an enema bulb.
Frequency of Administration
You should take BEDELIX preferably between meals or a little before.
Duration of treatment
Your doctor will tell you how long you should take this medication. If you have any further questions on the use of this medication, ask your doctor or pharmacist.
If you take more BEDELIX powder for oral suspension in a sachet than you should:
Immediately consult your doctor or pharmacist. Possible overdose in children may result in vomiting.
If you forget to take BEDELIX, powder for oral suspension in sachet :
Not applicable.
If you stop taking BEDELIX, powder for oral suspension in sachets :
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Reported adverse reactions include skin rash, angioedema, itching and hives.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE BEDELIX powder for oral suspension in sachets?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not throw any medication into drains < or with household garbage>. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What BEDELIX contains, powder for oral suspension in sachets
· The active substance (s) is (are):
Montmorillonite beidellitique ................................................ .............................................. 3,000 g
for a sachet of 3.925 g
· The other components are: Aluminum hydroxide gel and magnesium carbonate coded, licorice extract, vanillin, saccharin sodium and hydrated glucose.
What is BEDELIX powder for oral suspension in sachets and contents of the pack
This medication is in the form of a whitish powder contained in a sachet. Box of 30, 60 or 100 sachets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
IPSEN Pharma
65 quai Georges Gorse
92100 Boulogne-Billancourt
Marketing Authorization Operator
IPSEN Pharma
65 quai Georges Gorse
92100 Boulogne-Billancourt
Maker
BEAUFOUR IPSEN INDUSTRIE
Rue Ethe Virton
28100 DREUX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).