NOTICE
ANSM - Updated: 19/07/2017
Name of the drug
CANTABILINE 400 mg tablets
Hymecromone
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is CANTABILINE 400mg tablet and when is it used?
2. What information do you need to know before you take CANTABILINE 400mg tablets?
3. How to take CANTABILINE 400mg, tablet?
4. What are the possible side effects?
5. How to store CANTABILINE 400mg, tablet?
6. Contents of the package and other information.
1. WHAT CANTABILINE 400 mg tablet is AND WHAT IT IS USED FOR
Pharmacotherapeutic group: DRUG-BASED DRUG DISCHARGE
This medicine is recommended in case of pain related to digestion.
2. BEFORE YOU TAKE CANTABILINE 400 mg tablet?
Do not take CANTABILINE 400 mg tablets:
· if you are allergic to hymecromone or any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking CANTABILINE 400 mg tablet.
children
Not applicable.
Other medicines and CANTABILINE 400 mg tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
CANTABILINE 400 mg tablets with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice or pharmacist before taking this medicine.
Driving and using machines
Not applicable.
CANTABILINE 400 mg tablet contains <{name the excipient (s)}>
Not applicable.
3. HOW TO TAKE CANTABILINE 400 mg tablet?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Reserved for adults.
The recommended dose is 1 tablet at the beginning of the main meals.
If you take more CANTABILINE 400 mg tablet than you should
Possible overdose may result in aggravation of adverse effects.
If you take more CANTABILINE 400 mg tablet than you should, talk to your doctor or pharmacist
If you forget to take CANTABILINE 400 mg tablet
Not applicable.
If you stop taking CANTABILINE 400 mg tablet
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, CANTABILINE 400 mg tablets can cause side effects, although not everybody gets them:
· diarrhea,
· possibility of allergic reactions with rash of the urticaria type, difficulty breathing, edema, blood pressure drop that may progress to anaphylactic shock.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE CANTABILINE 400 mg tablet?
Keep this medicine out of the sight and reach of children.
Do not use CANTABILINE 400 mg tablets after the expiry date which is stated on the package.
No special conditions of conservation.
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What CANTABILINE 400 mg tablets contain
· The active substance is:
Hymecromone ................................................. .................................................. ..................... 400 mg
For a tablet.
· The other components are:
Wheat starch, gelatin, alginic acid, talc, magnesium stearate.
What CANTABILINE 400 mg tablets contain and contents of the pack
This medicine comes in tablet form. Box of 20, 30 or 200 tablets.
Marketing Authorization Holder
CEDEPHARM
1 BIS, RIVER COMMANDER STREET
94210 LA VARENNE SAINT-HILAIRE
Operator of the marketing authorization
DB PHARMA
1 BIS, RIVER COMMANDER STREET
94210 LA VARENNE SAINT-HILAIRE
Maker
FAMAR LYON
29, AVENUE CHARLES DE GAULLE
69230 SAINT GENIS LAVAL
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
December 2015
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).