NOTICE
ANSM - Updated on : 18/03/2025
Product name
CEMAUKOR 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 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.
What does this leaflet contain?
1. What is CEMAUKOR 1% topical gel and what is it used for?
2. What do I need to know before using CEMAUKOR 1% topical gel?
3. How should CEMAUKOR 1% topical gel be used?
4. What are the possible side effects?
5. How should CEMAUKOR 1% topical gel be stored?
6. Package contents and other information.
1. WHAT IS CEMAUKOR 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 CEMAUKOR 1%, gel for local application?
Never use CEMAUKOR 1% topical gel:
- If you are allergic to pramocaine, local anaesthetics or any of the other ingredients listed in section 6;
Do not apply to the nose or eyes.
Warnings and precautions
Consult your doctor or pharmacist before using CEMAUKOR 1%, gel for local application.
Administration of this product does not dispense with specific treatment of other anal diseases.
Treatment should be short-term. If symptoms do not subside rapidly, it is essential to consult your doctor.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Children and teenagers
Not applicable.
Other medicinal products and CEMAUKOR 1%, gel for local application
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CEMAUKOR 1% topical gel with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
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.
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Sportsmen
Warning: this product contains an active ingredient which may induce a positive reaction in tests carried out during doping controls.
Driving vehicles and operating machinery
Not applicable.
CEMAUKOR 1%, gel for topical application contains propylene glycol.
This medicine contains 6g propylene glycol (E1520) per 30g tube of gel. Propylene glycol (E1520) may cause skin irritation.
3. HOW DO I USE CEMAUKOR 1%, topical gel?
Always use this product exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
The recommended dose is 1 application morning and evening to the painful area.
Method and route of administration
Rectal route.
Applied locally or with a compress.
Duration of treatment
Treatment should be of short duration.
If you have used more CEMAUKOR 1%, gel for topical application than you should have
In the event of accidental oral ingestion of CEMAUKOR 1%, topical gel, nausea, vomiting, diarrhea and drowsiness may occur. In this case, please contact your doctor.
If you forget to use CEMAUKOR 1%, topical gel
Not applicable.
If you stop using CEMAUKOR 1%, gel for topical application
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not always occur in everyone.
Allergies and irritation may occur.
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: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE CEMAUKOR 1%, gel for topical application?
Keep out of sight and reach of children.
Do not use this product 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 CEMAUKOR 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 CEMAUKOR 1% topical gel 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
Bouchara-Recordati
Tour Hekla
52 Avenue Du General De Gaulle
92800 Puteaux
Marketing authorization holder
LABORATOIRES BOUCHARA-RECORDATI
TOUR HEKLA
52 AVENUE DU GENERAL DE GAULLE
92800 PUTEAUX
Manufacturer
Benta Lyon
29 Avenue Charles De Gaulle
69230 St Genis Laval
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.