In this manual :
1. WHAT IS ODDIBIL 250 mg, coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING ODDIBIL 250 mg, coated tablet
3. HOW DO I TAKE ODDIBIL 250 mg, coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE ODDIBIL 250 mg, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS ODDIBIL 250 mg, coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Herbal medicinal product.
Traditionally used to facilitate the elimination functions of the body.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ODDIBIL 250 mg, coated tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.
Never take ODDIBIL 250 mg, coated tablet:
If you are hypersensitive to the active substance or to any of the other components contained in ODDIBIL 250 mg, coated tablet.
If you are allergic (hypersensitive) to peanut oil or soya, due to the presence of peanut oil.
Precautions and special warnings
Take caution with ODDIBIL 250 mg, coated tablet:
Special warnings
This medicine contains peanut oil and may cause severe allergic reactions.
This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases).
The use of this medicine 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 gallbladder stones.
Interactions with other medicines
Taking or using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Lactation
It is preferable not to use this medicine during pregnancy;
If you discover that you are pregnant during treatment, consult your doctor as only he/she can judge the need to continue the 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 notable effect:
Lactose, sucrose, peanut oil.
3. HOW TO TAKE ODDIBIL 250 mg, coated 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.
1 tablet, 4 times a day.
Mode and route of administration
By mouth.
Frequency and timing of administration
Take one tablet before each main meal and one tablet at bedtime.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
If you forget to take ODDIBIL 250 mg, coated tablet:
Do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ODDIBIL 250 mg, coated tablet is likely to have side effects, although not everyone is susceptible.
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 ODDIBIL 250 mg, coated tablet
Keep out of the reach and sight of children.
Do not use ODDIBIL 250 mg, coated tablet after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of 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 ODDIBIL 250 mg, coated tablet contain?
The active substance is:
Fumitory (aqueous dry extract of the aerial flowering parts) ............................................................... 250 mg
For one coated tablet.
Other components are:
Powdered cellulose, lactose monohydrate, magnesium stearate, sucrose, calcium carbonate, talc, colloidal anhydrous silica, gum arabic, titanium dioxide, beta-carotene, peanut oil, gelatin, starch, white beeswax, carnauba wax, DL-alpha tocopherol, ascorbyl palmitate.
Pharmaceutical form and content
What does ODDIBIL 250 mg, coated tablet contain?
This medicine is presented as a coated tablet. Box of 40.
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
LABORATOIRE BIOPHELIA
11, RUE DE MONTBAZON
37260 MONTS
or
LABORATOIRES RHONE POULENC RORER GMBH
NATTERMANNALLEE 1
D- 50829 KOLN
or
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
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