In this manual :
1. WHAT IS OXYBOLDINE, effervescent tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING OXYBOLDINE, effervescent tablet
3. HOW DO I TAKE OXYBOLDINE, effervescent tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE OXYBOLDINE, effervescent tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS OXYBOLDINE, effervescent tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Cholagogue-choleretic
This medicine is recommended as an adjunct treatment for difficult digestion.
2. WHAT YOU SHOULD KNOW BEFORE TAKING OXYBOLDINE, effervescent tablet
List of information needed before taking the medicine
Not applicable.
Never take OXYBOLDINE, effervescent tablet
- Hypersensitivity to oxyboldine or any of its components.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE
Precautions for use; special warnings
Be careful with OXYBOLDINE, effervescent tablet:
Precautions for use
- USE WITH CAUTION in cases of biliary tract obstruction or severe liver disease.
- This medicine contains 470 mg of sodium per tablet. To be taken into account in patients who are controlling their dietary intake of sodium.
- In case of diarrhoea or abdominal pain, stop treatment and CONSULT YOUR DOCTOR.
IF IN DOUBT, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST
Interactions 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 drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy and breastfeeding. If you discover that you are pregnant, consult your doctor, who is the only person who can decide whether you should continue treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notorious effect: Sodium salts: 1 tablet contains 470 mg of sodium.
3. HOW TO TAKE OXYBOLDINE, effervescent tablet
Instructions for proper use
Not applicable.
Dosage, Method 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 trouble.
Mode and route of administration
Oral use.
Frequency of administration
1 to 3 tablets per day at mealtimes or at the time of disturbances.
Duration of treatment
If symptoms worsen or persist, consult your doctor.
DO NOT USE FOR PROLONGED PERIODS WITHOUT MEDICAL ADVICE.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Do not take a double dose to make up for the one you missed.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, OXYBOLDINE, effervescent tablet is likely to have side effects, although not everyone is susceptible.
- risk of diarrhea at high doses,
- rare cases of skin reactions have been reported.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE OXYBOLDINE, effervescent tablet?
Keep out of the reach and sight of children.
Do not use OXYBOLDINE effervescent tablets after the expiry date stated on the box.
Store in a dry place.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does OXYBOLDINE effervescent tablet contain?
The active ingredients are
Boldine ............................................................................................................................................ 0.5 mg
Sodium sulphate anhydrous ............................................................................................................... 54.0 mg
Sodium dihydrogen phosphate ................................................................................................... 132.0 mg
For one effervescent tablet.
Other components are: sodium benzoate, aniseed oil, tartaric acid, anhydrous citric acid, sodium bicarbonate.
1 tablet contains 470 mg of sodium.
Pharmaceutical form and content
What is OXYBOLDINE, effervescent tablet and what does it contain?
Effervescent tablet in tube. Box of 2 tubes of 12 tablets or 2 tubes of 18 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Operator
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Manufacturer
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
or
A. NATTERMANN ET CIE GMBH
NATTERMANNALLEE I
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