NOTICE
ANSM - Last updated: 19/12/2016
Name of the medicinal product
CARBOSYMAG, capsule
Activated carbon, siméticone, magnesium oxide
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine by following the instructions 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 your 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 CARBOSYMAG, capsule and in which cases it is used?
2. What information should be known before taking CARBOSYMAG capsule?
3. How to take CARBOSYMAG, capsule?
4. What are the possible side effects?
5. How to store CARBOSYMAG, capsule?
6. Package contents and other information.
1. WHAT CARBOSYMAG, capsule AND IN WHAT CASES IS IT USED?
Pharmaco-therapeutic group: Digestive tract and metabolism, ATC code: A07BA51.
This medication is indicated in stomach burns associated with bloating.
2. BEFORE YOU TAKE CARBOSYMAG, capsule?
Do not take CARBOSYMAG, capsule:
If you have severe kidney disease (kidney function failure).
Warnings and Precautions
Talk to your doctor or pharmacist before taking CARBOSYMAG capsule.
DO NOT TAKE THIS MEDICINE WITHOUT MEDICAL ADVICE in case of chronic dialysis.
This drug may decrease the effect of many medications. You should always report any other medications you are taking to your doctor or pharmacist. As a precaution, this drug should be taken at a distance from other medicines (2 hours apart if possible).
This medicine contains an azo coloring agent yellow orange S (E 110) and may cause allergic reactions.
In addition to the use of this medication, it is recommended to follow certain hygiene-dietetic rules:
· avoid going to bed immediately after meals,
· do not sleep flat (elevate the head of the bed to decrease the frequency of night reflux),
· avoid prolonged work, bend leaning forward (cleaning, gardening ...),
· avoid over-abundant meals.
Other medicines and CARBOSYMAG, capsule
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
CARBOSYMAG, capsule with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
This medication will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
This medication may be prescribed during breast-feeding.
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
No effect on the ability to drive and use machines is known or expected.
CARBOSYMAG, capsule contains orange yellow S (E 110) , an excipient with notorious effect.
3. HOW TO TAKE CARBOSYMAG, capsule?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
This medication is in the form of a green capsule (whose active ingredients are released into the stomach) and an orange capsule (whose active ingredients are released into the intestine) to be taken simultaneously.
The usual dosage is 3 doses (one dose = 1 green capsule + 1 orange capsule) per day.
Method and route of administration
Oral use.
Frequency of Administration
This medication should be taken before or after the main meals.
Duration of treatment :
The duration of treatment varies according to the symptomatology.
If you take more CARBOSYMAG, capsule than you should:
Ingestion of excessive doses of CARBOSYMAG may result in hypermagnesemia. Symptoms may include gastrointestinal pain, diarrhea, vomiting, drowsiness, respiratory depression or even cardiac arrest.
If you have taken CARBOSYMAG more than necessary, contact the nearest Poison Control Center or your doctor immediately.
If you forget to take CARBOSYMAG, capsule:
Do not take a double dose to make up for the missed dose .
If you stop taking CARBOSYMAG, 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 medication can cause side effects, although not everybody gets them.
· diarrhea,
· dark coloration of stools
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 CARBOSYMAG, 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. The expiry date refers to the last day of that month.
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 CARBOSYMAG contains, capsule
· The active substances are:
Green Capsule:
Activated charcoal ................................................ .................................................. 140.00 mg
Simethicone ................................................. .................................................. ...................... 45.00 mg
Heavy magnesium oxide .............................................. ................................................. 180 , 00 mg
for a green capsule
Orange Capsule:
Activated charcoal ................................................ .................................................. 140.00 mg
Simethicone ................................................. .................................................. ...................... 45.00 mg
for an orange capsule
· The other components are:
Green Capsule:
Composition of the capsule shell: quinoline yellow (E 104), indigo (E 132), titanium dioxide (E 171), gelatin.
Gastro-resistant orange capsule:
Capsule envelope composition: Erythrosine (E 127), S (E 110) orange-yellow, Titanium dioxide (E 171), Gelatin.
Composition of the gastro-resistant coating: cellulose acetate phthalate, diethyl phthalate.
What is CARBOSYMAG, capsule and contents of the pack
This medication is in the form of a capsule.
Box of 24 green capsules + 24 orange capsules in platelets (PVC / Aluminum), 48 green capsules + 48 orange capsules in platelets (PVC / Aluminum) or 96 green capsules + 96 orange capsules in platelets (PVC / Aluminum).
Not all pack sizes may be marketed.
Marketing Authorization Holder
LABORATOIRES GRIMBERG SA
19 RUE POLIVEAU
75005 PARIS
Marketing Authorization Operator
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES, STREET VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
Maker
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES, STREET VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
Names of the medicinal product in the Member States of the European Economic Area
[to be completed later by the holder]
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).