NOTICE
ANSM - Updated on : 20/03/2023
Product name
PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for local application
Pramocaine hydrochloride
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. 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.
What does this leaflet contain?
1. What is PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, topical gel and what is it used for?
2. What do I need to know before using PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application?
3. How do I use PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application?
4. What are the possible side effects?
5. How should PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1% topical gel be stored?
6. Package contents and other information
1. WHAT IS PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: local anesthetic - ATC code: D04AB07
This drug contains a local anesthetic.
It is recommended for certain anal pathologies accompanied by pain or itching, particularly haemorrhoids.
2. WHAT DO I HAVE TO KNOW BEFORE USING PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for local application?
Never use PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, topical gel.
- if you are allergic to pramocaine, local anaesthetics or any of the other ingredients listed in section 6;
- in the event of oral endoscopic examinations.
Do not apply to the nose or eyes.
Warnings and Precautions
Ask your doctor, pharmacist or nurse before using PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL.
Administration of this product does not dispense with specific treatment of other anal diseases.
Treatment should be of short duration. If symptoms do not subside rapidly, it is essential to consult your doctor.
Children and adolescents
Not applicable.
Other medicinal products and PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for local application
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application with food, drink and alcohol
Not applicable.
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.
In the human species, no malformative effects have been reported following the use of local anesthetics. However, epidural administration of local anesthetics may cause adverse effects in pregnant women and newborns. As a result, it is not recommended for use during pregnancy and breastfeeding.
Driving and use of machinery
Not applicable.
PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application contains propylene glycol.
This medicine contains 6 g propylene glycol (E1520) per 30 g tube of gel. Propylene glycol (E1520) may cause skin irritation.
3. HOW TO USE PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
The recommended dose is 1 application morning and evening to the painful area.
Rectal route.
Apply locally or with a compress.
Treatment should be short-term.
If you have used more PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application than you should have
In the event of accidental oral ingestion of PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL, nausea, vomiting, diarrhea and drowsiness may occur. In this case, please contact your doctor.
If you forget to use PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application
Do not take a double dose to make up for the one you have forgotten to take.
If you stop using PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Possibility of allergy, irritation.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, topical gel contains
- The active substance is :
Pramocaine hydrochloride.................................................................................................. 1 g
For 100 g of gel.
- The other components are :
Propylene glycol (E1520), hypromellose, purified water.
What PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1%, gel for topical application is and what it contains
This medicine is a gel for topical application.
It comes in tubes containing 30 g of gel.
Box of 1 tube with cannula.
Marketing authorization holder
biogaran
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
biogaran
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
BENTA LYON
29 avenue Charles de Gaulle
69230 SAINT GENIS LAVAL
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed later by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website