This medication is a single-use gel. It is recommended in some constipation and as a preparation for certain tests (sigmoidoscope) in children and infants.
For warnings, precautions for use and contraindications, please consult the instructions for use.
This medication is a single use gel. It is recommended in certain constipations and as preparation for certain exams (rectoscopy).
Occasional constipation :
It may be related to a recent change in lifestyle (travel). The drug can be an aid in short treatment. Any recent constipation unexplained by the change in the mode of ive, any constipation accompanied by pain, fever, swelling of the belly must seek the advice of the doctor.
Chronic constipation (long-term constipation):
It can be linked to two causes:
The treatment includes among others :
The cannula can be lubricated to facilitate introduction.
IN ALL CASES STRICTLY COMPLY WITH YOUR DOCTOR'S ORDER
The active substance of the drug Bébégel is :
Glycerol 3,900 g
For a single-dose container
The other components are :
Gelatin, drinking water.
Never use BEBEGEL, rectal gel in a single-dose container in the following case:
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Warning with the drug Bébégel :
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
It is useful to take advice from your doctor or pharmacist.
Special case of the child : In children, the treatment of constipation is based on lifestyle and dietetic measures: in particular using the right amount of water with infant milk powders, a diet rich in vegetable products, addition of fruit juice.
Treatment with a rectal laxative without medical advice is contraindicated (regular use can hinder the normal functioning of the defecation reflex).
Precautions for use
To avoid possible interactions with other medicines, you should systematically report this treatment to your doctor or pharmacist. It is best to avoid the use of this medication in cases of hemorrhoidal flare, anal fissure or ulcerative colitis.
In case of doubt do not hesitate to seek the advice of your doctor.
Taking or using other medications:
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SYSTEMICALLY REPORT ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR PHARMACIST.
Pregnancy and breast feeding :
This medication should be used with caution during pregnancy and breastfeeding.
In general, you should ask your doctor or pharmacist for advice before taking any medicine.
Box of 6 single-dose containers
Summary of product characteristics (ANSM)
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
BEBEGEL, rectal gel in single dose container
Glycerol
Read this leaflet carefully before you start using 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 a physician.
· 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.
In this notice :
1. WHAT IS BEBEGEL, rectal gel in a single-dose container AND WHAT IT IS USED FOR?
2. BEFORE YOU USE BEBEGEL, rectal gel in single dose containers?
3. HOW TO USE BEBEGEL, rectal gel in single dose container?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BEBEGEL, rectal gel in single dose container?
6. ADDITIONAL INFORMATION
1. WHAT IS BEBEGEL, rectal gel in a single-dose container AND WHAT IT IS USED FOR?
Not applicable.
This medication is a single use gel. It is recommended in certain constipations and as preparation for certain examinations (rectoscopy).
2. BEFORE YOU USE BEBEGEL, rectal gel in single dose containers?
List of information needed before taking the medication
Not applicable.
Never use BEBEGEL, rectal gel in a single dose container in the following case:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of BEBEGEL, rectal gel in a single-dose container.
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 BEBEGEL, rectal gel in single dose container:
Caution
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
Occasional constipation:
It may be related to a recent change in lifestyle (travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation):
It can be linked to two causes:
· a disease of the intestine that requires treatment by the physician,
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· an increase in dietary intakes of products of vegetable origin (green vegetables, raw vegetables, wholemeal bread, fruits ...)
· an increase in the consumption of water and fruit juices,
· an increase in physical activities (sports, walking ...),
· a rehabilitation of the defecation reflex,
· sometimes, adding sound to the diet.
It is helpful to seek advice from your doctor or pharmacist.
Special case of the child:
In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right amount of water with infant milk powders, a diet rich in vegetable products, addition of Juice.
Treatment with rectal laxatives without medical advice is contraindicated (regular intake may interfere with the normal functioning of the defecation reflex).
Precautions for use
In order to avoid possible interactions with other medicines, this treatment should be reported to your doctor or pharmacist.
It is best to avoid the use of this medication in case of hemorrhoidal outbreak, annular fissure or ulcerative colitis. In case of doubt, do not hesitate to ask your doctor for advice.
Interaction with other medicines
Taking or using other medicines:
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR 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
This medication should be used with caution during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE BEBEGEL, rectal gel in single dose container?
Not applicable.
Dosage
The cannula can be lubricated to facilitate insertion.
Adults and children over 6 years :
A dose 5 to 30 minutes before the chosen time to go to the saddle to renew once in the half hour or the following hour in case of constipation rebel.
Children from 2 to 6 years :
A dose 5 to 30 minutes before the chosen time to go to the saddle.
infants
Consult your doctor.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
If you have used more BEBEGEL, rectal gel in a single dose container you should:
Excessive use may exacerbate adverse effects.
Instructions for omission of one or more doses
Not applicable.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· sensation of anal burns.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE BEBEGEL, rectal gel in single dose container?
Keep out of the reach and sight of children.
Do not use BEBEGEL, rectal gel in a single-dose container after the expiry date which is stated on the outer packaging.
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.
Full list of active substances and excipients
What does BEBEGEL contain, rectal gel in single dose containers?
The active substance is :
Glycerol ................................................. .................................................. ....................................... 3,900 g
For a single-dose container.
The other components are :
Gelatin, drinking water.
Pharmaceutical form and content
What is BEBEGEL, rectal gel in a single-dose container and contents of the pack?
This medication is in the form of a rectal gel. Box of 6 unidose containers.
40-44 WASHINGTON STREET
75008 PARIS
40-44 Washington Street
75008 PARIS
MEDA MANUFACTURING
AVENUE JF KENNEDY
33700 MERIGNAC
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.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Not applicable.
Rectal Laxative
glycerol
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
BABEGEL: rectal gel; box of 6 unidose containers of 5 g.
-
Laboratory Meda Pharma
| unidose | |
| Glycerol | 3.9 g |
Usual dosage:
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