NOTICE
ANSM - Last updated: 27/03/2017
Name of the medicinal product
CARBOLEVURE ADULTS, capsule
Dehydrated yeast, Activated charcoal
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 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 experience no improvement or feel less well after 2 days.
What is in this leaflet?
1. What is CARBOLEVURE ADULTS, capsule and in which cases it is used?
2. What should be known before taking CARBOLEVURE ADULTS, capsule?
3. How to take CARBOLEVURE ADULTS, capsule?
4. What are the possible side effects?
5. How to store CARBOLEVURE ADULTS, capsule?
6. Package contents and other information.
1. WHAT CARBOLEVURE ADULTS, capsule AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - ATC code: intestinal adsorbant / substitution flora
This medication is indicated for adults:
· in case of difficult digestion, especially with intestinal bloating
· in addition to rehydration and / or dietary measures, in supplementary symptomatic treatment of diarrhea.
2. BEFORE YOU TAKE CARBOLEVURE ADULTS, capsule?
Never take CARBOLEVURE ADULTS, capsule:
· if you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before taking CARBOLEVURE ADULTS, capsule .
Take special care with CARBOLEVURE ADULTS, capsule:
Special warnings
In case of diarrhea, you should consult your doctor in the following cases:
· in the absence of improvement after 2 days of treatment,
· in case of fever, vomiting,
· in the presence of blood or mucus in the stools,
· in case of intense thirst, sensation of dry tongue. Indeed, these signs show a beginning of dehydration, that is to say a large loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done either orally or intravenously.
Precautions for use
· In case of bloating, flatulence, avoid dry vegetables (lentils, flageolets, peas ...) as well as certain green vegetables (cabbage, Brussels sprouts, chard ...).
· In case of diarrhea, it is necessary to:
o Rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (the average adult daily water intake is 2 liters).
o Feeding time diarrhea,
§ excluding certain intakes and especially raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.
§ favoring grilled meats, rice.
IN CASE OF DOUBT DO NOT HESITATE TO CONSULT YOUR DOCTOR OR YOUR PHARMACIST.
Children and Youth
Not applicable.
Other drugs and CARBOLEVURE ADULTS, capsule .
As this medication may decrease the absorption of other drugs, they should be administered at a distance (more than 2 hours if possible).
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CARBOLEVURE ADULTS, capsule with food and beverages and alcohol
Not applicable.
Pregnancy and breast feeding
It is best not to use this medication during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
In general, during pregnancy and breast-feeding you should always seek advice from your doctor or pharmacist before taking any medicine.
Driving and using machines
Not applicable.
CARBOLEVURE ADULTS, capsule contains
Not applicable.
3. HOW TO TAKE CARBOLEVURE ADULTS, capsule?
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.
Dosage
Reserved for adults only.
Oral use.
The recommended dose is 3 capsules per day.
Swallow the capsules as they are with a glass of water.
Method and route of administration
Oral use.
Frequency of Administration
The capsules should be swallowed without opening them with a glass of water, preferably outside meals.
If you take more CARBOLEVURE ADULTS, capsule than you should have
Immediately consult your doctor or pharmacist.
Taking high doses of Carbolevure may result in mild constipation. Treatment will be symptomatic. Ask your doctor or pharmacist.
If you forget to take CARBOLEVURE ADULTS, capsule
Not applicable.
If you stop taking CARBOLEVURE ADULTS, capsule
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. In particular, a dark coloration of the stool may appear.
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 CARBOLEVURE ADULTS, capsule?
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 package after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C.
Do not throw any medicines into drains or rubbish. 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 CARBOLEVURE ADULTS contains, capsule
· The active substances:
Live dehydrated yeast containing a minimum of 10 8 Saccharomyces cerevisiae cells per gram ........................................................................................................... 108.5 mg
Activated charcoal ....................................................... ............................ .......... 109.0 mg
For a capsule.
· The other components are:
Polyvidone K 30, colloidal silica.
Composition of the capsule shell:
o head: black iron oxide - titanium dioxide - gelatin.
o Body: erythrosin - red iron oxide - titanium dioxide - gelatin .
What is CARBOLEVURE ADULTS, capsule and contents of the pack
This medication is in the form of a capsule. Box of 20, 30, 40 or 60 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Marketing Authorization Operator
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
PROGIPHARM ESTABLISHMENT
RUE DU LYCEE
45500 GIEN
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).