NOTICE
ANSM - Updated on : 28/01/2022
Product name
CARBOSYLANE, capsule
Activated charcoal, Simeticone
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine in strict accordance with the information provided 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 after 10 days.
What does this leaflet contain?
1. What is CARBOSYLANE, capsule and what is it used for?
2. What do I need to know before taking CARBOSYLANE, capsule?
3. How should CARBOSYLANE capsules be taken?
4. What are the possible side effects?
5. How should CARBOSYLANE capsules be stored?
6. Package contents and other information.
1. WHAT IS CARBOSYLANE, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class ATC code: A07BA51, INTESTINAL ANTIFLATULENT/ADSORBENT
This medicine is indicated for adults and children over 6 years of age in the symptomatic treatment of dyspeptic conditions (difficult digestion) and meteorism (intestinal bloating).
You should consult your doctor if you do not feel any improvement or if you feel less well after 10 days of treatment.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CARBOSYLANE, capsule?
Never take CARBOSYLANE, capsule :
- if you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine, as listed in section 6.
- in children under 6 years of age, due to the risk of a false route.
Warnings and precautions
If you are taking any other medical treatment, take CARBOSYLANE, capsule at a distance (more than 2 hours if possible).
Ask your doctor or pharmacist before taking CARBOSYLANE, capsule.
Children
Not applicable.
Other drugs and CARBOSYLANE, capsule
As CARBOSYLANE may reduce the absorption of other drugs, these should be taken at a distance from CARBOSYLANE (more than 2 hours if possible).
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CARBOSYLANE, capsule with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
This medicine should only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can judge whether it is necessary to continue treatment.
This medicine may be prescribed during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
3. HOW DO I TAKE CARBOSYLANE, capsule?
Dosage
For adults and children over 6 years of age.
This medicine is presented in the form of a gastro-soluble blue capsule (whose active ingredients are released in the stomach) and a red capsule (whose active ingredients are released in the stomach).stomach) and a gastro-resistant red capsule (whose active ingredients are released in the intestine) to be taken simultaneously.
The recommended dosage is 3 doses (one dose = 1 red capsule + 1 blue capsule) per day.
Always take this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Method of administration
Oral administration.
One unit dose (red capsule + blue capsule) to be taken simultaneously with a glass of water.
Frequency of administration
Take preferably before or after main meals.
Duration of treatment
Duration of treatment varies according to symptomatology.
If you have taken more CARBOSYLANE, capsule than you should have :
At high doses, black stools may occur.
Consult your doctor or pharmacist immediately.
If you forget to take CARBOSYLANE, capsule:
Do not take a double dose to make up for the one you forgot to take.
If you stop taking CARBOSYLANE, capsule :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
- dark discoloration of stools may occur,
- cases of allergic reactions (urticaria, generalized allergic reaction) have been reported following administration of CARBOSYLANE, capsule.
- gastrointestinal disorders (pain, vomiting, discomfort, constipation or diarrhea) have been reported following administration of CARBOSYLANE, capsule.
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 CARBOSYLANE, capsule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
No special storage precautions.
Do not dispose of any medicine with your 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 CARBOSYLANE capsules contain
- The active ingredients are :
Activated charcoal..................................................................................................................... 140 mg
Simeticone........... 45 mg
For one blue or red capsule.
- Other ingredients are : Sorbitan oleate, polysorbate 80
Blue capsule shell: gelatin, indigotine (E132), titanium dioxide (E171)
Red capsule shell: gelatin, erythrosine (E127), titanium dioxide (E171), indigotine (E132)
Gastro-resistant coating of red capsule: cellulose acetate phthalate, diethyl phthalate.
What CARBOSYLANE capsules are and what they contain
This medicine comes in capsule form. Boxes of 48 (24 doses), 60 (30 doses), 96 (48 doses), 192 (96 doses).
Not all presentations may be marketed.
Marketing authorization holder
LABORATOIRES GRIMBERG SA
44, Avenue Georges Pompidou
92300 LEVALLOIS-PERRET
Marketing authorization holder
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES
RUE VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
Manufacturer
LABORATOIRES GRIMBERG
ZA DES BOUTRIES
RUE VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
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]
{MM/YYYY}
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.