NOTICE
ANSM - Last updated: 01/10/2010
Name of the medicinal product
ODDIBIL 250 mg coated tablet
framed
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 ODDIBIL 250 mg, coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE ODDIBIL 250 mg, coated tablet?
3. HOW TO TAKE ODDIBIL 250 mg coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ODDIBIL 250 mg, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS ODDIBIL 250 mg, coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Herbal medicines.
Therapeutic indications
Traditionally used to facilitate the elimination functions of the body.
2. BEFORE YOU TAKE ODDIBIL 250 mg, coated tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take ODDIBIL 250 mg, coated tablet:
If you are hypersensitive to the active substance or to any of the other ingredients of ODDIBIL 250 mg, coated tablet.
If you are allergic (hypersensitive) to peanut oil or soybean, due to the presence of peanut oil.
Precautions for use; special warnings
Take special care with ODDIBIL 250 mg, coated tablet:
Special warnings
This drug contains peanut oil and can cause severe allergic reactions.
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Use of this medication is not recommended in patients with fructose intolerance, glucose or galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Precautions for use
Tell your doctor if you have gall bladder stones.
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 - Breastfeeding
It is best not to use this medication during pregnancy;
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
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:
Lactose, sucrose, peanut oil.
3. HOW TO TAKE ODDIBIL 250 mg coated 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.
1 tablet, 4 times a day.
Method and route of administration
Oral use.
Frequency and timing of administration of the drug
Take one tablet before each of the main meals and one tablet at bedtime.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
If you forget to take ODDIBIL 250 mg, coated tablet:
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, ODDIBIL 250 mg, coated tablet is likely to have side effects, although not everyone is subject to it.
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 ODDIBIL 250 mg, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use ODDIBIL 250 mg coated tablets after the expiry date which is stated on the carton.
Storage conditions
No special storage conditions.
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 ODDIBIL 250 mg, coated tablet contain?
The active substance is :
Fumeterre (aqueous dry extract of aerial flowering parts) ........................................ 250 mg
For a coated tablet.
The other components are :
Cellulose powder, lactose monohydrate, magnesium stearate, sucrose, calcium carbonate, talc, anhydrous colloidal silica, gum arabic, titanium dioxide, beta-carotene, peanut oil, gelatin, starch, white beeswax, wax carnauba, DL-alpha tocopherol, ascorbyl palmitate.
Pharmaceutical form and content
What does ODDIBIL 250 mg, coated tablet contain?
This medication is in the form of a coated tablet. Box of 40.
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
BIOPHELIA LABORATORY
11, RUE DE MONTBAZON
37260 MONTS
or
LABORATOIRES RHONE POULENC RORER GMBH
NATTERMANNALLEE 1
D- 50829 KOLN
or
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.