NOTICE
ANSM - Updated on : 11/10/2022
Product name
RECTOPANBILINE GEL, rectal gel
Beef bile extract
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after several days.
What does this leaflet contain?
1. What is RECTOPANBILINE GEL, rectal gel and what is it used for?
2. What do I need to know before using RECTOPANBILINE GEL, rectal gel?
3. How do I use GEL RECTOPANBILINE, gel rectal?
4. What are the possible side effects?
5. How should GEL RECTOPANBILINE rectal gel be stored?
6. Package contents and other information.
1. WHAT IS RECTOPANBILINE GEL, rectal gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: Not applicable.
This medicine is a rectal laxative. It acts by triggering the defecation reflex.
It is recommended for certain types of constipation and as a preparation for certain examinations (rectoscopy).
2. WHAT DO I HAVE TO KNOW BEFORE USING RECTOPANBILINE GEL, rectal gel?
Never use RECTOPANBILINE GEL, rectal gel in the following cases:
- if you are allergic to ox bile extract or to any of the other ingredients listed in section 6,
- in children under twelve years of age without a doctor's prescription.
Warnings and Precautions
Talk to your doctor or pharmacist before using RECTOPANBILINE GEL, rectal gel.
Warning
DO NOT USE FOR PROLONGED PERIODS WITHOUT MEDICAL ADVICE.
Occasional constipation:
This may be due to a recent change in lifestyle (travel). The drug can be used as a short-term treatment. Any recent constipation unexplained by a change in lifestyle, or any constipation accompanied by pain, fever or swelling of the abdomen, should be referred to your doctor.
Chronic constipation (long-term constipation):
There are two possible causes:
- or an intestinal disease requiring medical attention,
- or an imbalance in bowel function due to dietary and lifestyle habits.
Treatment includes
- increasing dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit, etc.),
- increased consumption of water and fruit juices,
- increased physical activity (sports, walking, etc.),
- reeducation of the defecation reflex,
- sometimes adding bran to the diet.
Consult your doctor or pharmacist for advice.
Children
In children, treatment of constipation is based on lifestyle and dietary measures: in particular, using the right amount of water with infant milk powders, eating a diet rich in plant-based products, and adding fruit juices.
Treatment with rectal laxatives without medical advice is contraindicated (regular use may interfere with the normal functioning of the defecation reflex).
Precautions for use
This product should not be used in cases of hemorrhoidal crisis, anal fissure or ulcerative colitis.
Other drugs and GEL RECTOPANBILINE, rectal gel
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
RECTOPANBILINE GEL, rectal gel with food and drink
Not applicable.
Pregnancy and breast-feeding
Under normal conditions of use, this medicine may be used occasionally during pregnancy and breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
Not applicable.
RECTOPANBILINE GEL, rectal gel contains glycerol.
This medicine may have a mild laxative effect.
3. HOW TO USE RECTOPANBILINE GEL, rectal gel?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist.
Dosage
On average, the recommended dose is 1 to 2 doses per day, taken rectally a few minutes before the chosen time for exoneration.
If you have used more RECTOPANBILINE GEL, rectal gel than you should have
Not applicable.
If you forget to use RECTOPANBILINE GEL, rectal gel
Not applicable.
If you stop using RECTOPANBILINE GEL, rectal gel
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Sensation of anal burning .
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE RECTOPANBILINE GEL, rectal gel?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging after EXP. The expiration date refers to the last day of this month.
No special storage conditions.
Medicines must not be disposed of in the mains or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What RECTOPANBILINE GEL, rectal gel contains
- The active substance is :
Extract of buf bile................................................................................................. 0.0975 g
For one single-dose container.
- Other ingredients include gelatin, glycerol and purified water.
What RECTOPANBILINE GEL, rectal gel is and what it contains
This medicine comes in the form of a rectal gel. Box of 6 single-dose containers.
Marketing authorization holder
MEDA PHARMA
1 BIS PLACE DE LA DEFENSE TOUR TRINITY
92400 COURBEVOIE
Marketing authorization holder
VIATRIS MEDICAL
1 BIS PLACE DE LA DEFENSE TOUR TRINITY
92400 COURBEVOIE
Manufacturer
MEDA MANUFACTURING
AVENUE J.F. KENNEDY
33700 MERIGNAC
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.