NOTICE
ANSM - Updated on: 12/07/2016
Name of the medicinal product
OXYBOLDINE, effervescent tablet
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Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS OXYBOLDINE, an effervescent tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE OXYBOLDINE, effervescent tablet?
3. HOW TO TAKE OXYBOLDINE, effervescent tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE OXYBOLDINE, effervescent tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS OXYBOLDINE, an effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Cholagogue-choleretic
Therapeutic indications
This medication is recommended as an adjunct to difficult digestions.
2. BEFORE YOU TAKE OXYBOLDINE, effervescent tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take OXYBOLDINE, effervescent tablet
· Hypersensitivity to oxyboldine or to any of its components.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Take special care with OXYBOLDINE, effervescent tablet:
Precautions for use
· USE WITH CAUTION in case of obstruction of the bile ducts or severe liver disease.
· This medicine contains 470 mg of sodium per tablet. To be taken into account in patients controlling their sodium dietary intake.
· In case of diarrhea or abdominal pain, stop treatment and CONSULT YOUR DOCTOR.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy and lactation. If you discover that you are pregnant, consult your doctor, alone can judge the need to continue treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect: sodium salts: 1 tablet contains 470 mg sodium.
3. HOW TO TAKE OXYBOLDINE, effervescent tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS.
Dissolve in a glass of water, 1 tablet, before the 3 main meals or at the time of the troubles.
Method and route of administration
Oral use.
Frequency of Administration
1 to 3 tablets per day at mealtime or at the time of the disorders.
Duration of treatment
If symptoms worsen or persist, consult your doctor.
DO NOT USE EXTENDEDLY WITHOUT MEDICAL ADVICE.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, OXYBOLDINE, an effervescent tablet is likely to have side effects, although not everyone is.
· risk of high-dose diarrhea,
· rare cases of skin reactions have been reported.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE OXYBOLDINE, effervescent tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use OXYBOLDINE, effervescent tablet after the expiry date stated on the carton.
Storage conditions
Keep away from moisture.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does OXYBOLDINE contain, effervescent tablet?
The active substances are:
Boldine ................................................. .................................................. ......................................... 0.5 mg
Anhydrous sodium sulfate .............................................. .................................................. 54.0 mg
Sodium dihydrogen phosphate ............................................... .................................................. .. 132.0 mg
For an effervescent tablet.
The other components are: sodium benzoate, anise essential oil, tartaric acid, anhydrous citric acid, sodium bicarbonate.
1 tablet contains 470 mg sodium.
Pharmaceutical form and content
What is OXYBOLDINE, effervescent tablet and contents of the pack?
Effervescent tube tablet. Box of 2 tubes of 12 tablets or 2 tubes of 18 tablets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Maker
DELPHARM GAILLARD
33 STREET OF INDUSTRY
74240 GAILLARD
or
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.