Adult: Max 4 applications per day
Pansoral Oral Gel is a short-term adjunctive treatment of pain associated with inflammatory and ulcer of the oral mucosa.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Pansoral Gel buccal is a short-term adjunctive treatment for pain associated with inflammatory and ulcerative conditions of the oral mucosa .
The oral mucosa includes the tongue, the floor of the tongue, the gums, the internal surface of the cheeks and lips, the palate and the soft palate. Just like the skin, which it is very close to in terms of constitution, it is exposed to all kinds of aggressions, whether bacterial, viral, fungal (fungi), physical, chemical or thermal and can be the seat of a extremely varied pathology.
choline sallicylate 8.7g, cetalkonium chloride 0.01g for 110g. Excipients: ethyl alcohol, glycerol, methylcellulose, sodium hydroxide solution, star anise essential oil, purified water.
How to use: clean and dry prosthetic devices before application. On average, 1 to 4 applications of the value of a small amount of gel per day. Once in the mouth, the gel spreads evenly under the effect of temperature and chewing.
15g
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 - Last updated: 16/03/2017
Pansoral, oral application gel
Choline salicylate, Cetalkonium chloride
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the 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 talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
1. What is PANSORAL, oral application gel, and when is it used?
2. What information should be known before using PANSORAL, oral gel?
3. How to use PANSORAL, mouth gel?
4. What are the possible side effects?
5. How to store PANSORAL, oral gel?
6. Package contents and other information.
1. WHAT IS PANSORAL, oral application gel AND WHAT IT IS USED FOR?
You should talk to your doctor if you do not feel better or feel less well.
2. BEFORE YOU USE PANSORAL, gel for oral application?
Never use PANSORAL, mouth gel:
· If you are allergic (hypersensitive) to the active ingredients or to any of the other ingredients of this medication mentioned in section 6, especially if you have a history of allergy to salicylates (aspirin ...).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DENTAL SPECIALIST.
Warnings and Precautions
Talk to your doctor or pharmacist before using PANSORAL, oral gel .
If there is no improvement within a few days, consult your dental specialist. Indeed, an irritation due to your prosthesis may require an adaptation of it and the application of this treatment is only a gesture of waiting.
WARNING THIS MEDICINAL PRODUCT CONTAINS 39 g ALCOHOL PER 100 g.
children
THIS MEDICINE IS RESERVED FOR ADULTS.
Other medicines and PANSORAL, gel for oral application
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
PANSORAL, gel for oral application with food and beverages
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
PANSORAL, oral gel contains alcohol.
3. HOW TO USE PANSORAL, gel for oral application?
Strict local use. Gingival application.
Clean and dry prostheses before application.
On average, 1 to 4 applications (of the value of a hazelnut gel) per day.
In the case of permanent prostheses : deposit the value of a pea of gel on the incisors or molars opposite the painful gingiva.
In the case of temporary prostheses : place the gel on the part of the apparatus corresponding to the extractions.
Once in the mouth, the gel spreads evenly under the effect of temperature and mastication.
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Use in children
This medication is for adults only.
If you have used more PANSORAL, oral application gel than you should:
Not applicable.
If you forget to use PANSORAL, mouth gel:
If you stop using PANSORAL, oral gel:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Hypersensitivity reactions to salicylates.
Risk of irritation due to alcohol.
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 PANSORAL, gel for oral application?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What PANSORAL contains, gel for oral application
· The active substances are:
Choline Salicylate ............................................... .................................................. ............ 8,700 g
Ketalkonium chloride ............................................... .................................................. ....... 0.010 g
For 100 g of gel for oral application.
· The other components are:
96 percent ethanol, glycerol, methylcellulose, 32 percent sodium hydroxide solution, essential oil of badiane, purified water.
What is PANSORAL, oral application gel and contents of the pack?
This medication is in the form of an oral gel. Box of 1 tube of 3, 5, 12, 15 or 30 g.
Not all pack sizes may be marketed.
Marketing Authorization Holder
45 PLACE ABEL GANCE
92100 BOULOGNE-BILLANCOURT
Marketing Authorization Operator
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
PIERRE FABRE MEDICAMENT PRODUCTION
45 PLACE ABEL GANCE
92100 BOULOGNE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
Analgesic oral preparation
choline salicylate, ketalkonium chloride
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
PANSORAL: gel for oral application; 15 g tube.
-
Laboratory Pierre Fabre Medicine
p 100 g | |
Choline salicylate | 8.6 g |
Ketalkonium chloride | 10 mg |
Alcohol | 39 g |
Usual dosage: