NOTICE
ANSM - Last updated: 21/02/2011
Name of the medicinal product
AFTAGEL, oral gel
Lidocaine Hydrochloride, Zinc Sulphate
framed
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.
Review summary
In this notice :
1. WHAT IS AFTAGEL, oral gel AND WHAT IT IS USED FOR?
2. BEFORE YOU USE AFTAGEL, oral gel?
3. HOW TO USE AFTAGEL, oral gel?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE AFTAGEL, oral gel?
6. ADDITIONAL INFORMATION
1. WHAT IS AFTAGEL, oral gel AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Local anesthetic
Stomatological preparation
(A. digestive system and metabolism)
Therapeutic indications
Local treatment of limited inflammatory lesions of the buccal mucosa and canker sores.
2. BEFORE YOU USE AFTAGEL, oral gel?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use AFTAGEL, mouth gel if: you have a history of allergy to local anesthetics (lidocaine).
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 AFTAGEL, oral gel:
Special warnings
Do not use for long periods.
Precautions for use
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or 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.
Sport
The attention of athletes is drawn to the fact that this specialty contains an active principle which can induce a positive reaction of the tests performed during doping controls.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of AFTAGEL, oral gel
List of excipients with known effect: Propylene glycol.
3. HOW TO USE AFTAGEL, oral gel?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
After thoroughly washing your hands, apply the gel to your finger and gently massage the painful mouth.
Wash hands after application.
To be renewed if necessary.
Method and route of administration
LOCAL WAY
Symptoms and Instructions for Overdose
If you used more AFTAGEL, mouth gel than you should:
Consult your doctor or pharmacist.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, AFTAGEL, oral gel is likely to have side effects, although not everyone is subject to it: local reactions (irritations or sensitization) possible.
DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR OR PHARMACIST.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE AFTAGEL, oral gel?
Keep out of the reach and sight of children.
Expiration date
Do not use AFTAGEL, mouth gel after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C.
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.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does AFTAGEL contain, mouth gel?
The active substances are:
Lidocaine Hydrochloride ............................................... .................................................. ............. 0.60000 g
Sulphate of zinc ............................................... .................................................. ............................ 0.50000 g
For 100 ml of buccal gel.
The other components are:
Excipients: glycerol, hydroxyethylcellulose, strawberry flavor LC 15096, sodium saccharin, clove essential oil, cochineal red A (E 124), purified water.
Pharmaceutical form and content
What is AFTAGEL, oral gel and contents of the pack?
This medication is in the form of an oral gel. Tube of 15 ml
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77000 MELUN
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77000 MELUN
Maker
FRENCH PHARMACEUTICAL COOPERATION
2 RUE DE LA SAUSSAIE
77310 SAINT-FARGEAU PONTHIERRY
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.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.
