In this manual :
1. WHAT IS PANSORAL, gel for oral application AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING PANSORAL, gel for oral application?
3. HOW TO USE PANSORAL, gel for oral application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE PANSORAL, gel for oral application?
6. ADDITIONAL INFORMATION
1. WHAT IS PANSORAL, gel for oral application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
PREPARATIONS FOR STOMATOLOGY/OTHER AGENTS FOR LOCAL TREATMENT (A01AD11).
(A: Digestive system and metabolism).
This medicine is recommended for the short-term adjunctive treatment of pain associated with inflammatory and ulcerative conditions of the oral mucosa.
2. WHAT DO YOU NEED TO KNOW BEFORE USING PANSORAL, gel for oral application?
List of information needed before taking the medicine
Not applicable.
Never use PANSORAL, gel for oral application in the following cases:
- history of allergy to salicylated drugs (aspirin..),
- in children under 6 years of age.
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DENTAL SPECIALIST.
Precautions for use; special warnings
Take care with PANSORAL, gel for oral application:
Special warnings
THIS MEDICINE IS INTENDED FOR ADULTS ONLY.
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If there is no improvement after a few days, consult your dental specialist. Indeed, an irritation due to your prosthesis can require an adaptation of this one and the application of this treatment constitutes only a gesture of waiting.
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CAUTION, THIS MEDICATION CONTAINS 39 G OF ALCOHOL PER 100 g.
Precautions for use
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE OPINION OF YOUR DENTAL SPECIALIST.
Interactions with other drugs
Use of other medications
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a known effect: Alcohol.
3. HOW TO USE PANSORAL, gel for oral application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
This medicine is for adults only.
For strict topical use. Gingival application.
Clean and dry denture appliances before application.
On average, 1 to 4 applications (the value of a hazelnut of gel) per day.
In case of permanent prosthesis: apply a pea-sized amount of gel to the incisors or molars opposite the painful gum.
In case of provisional prosthesis: put the gel on the part of the appliance corresponding to the extractions.
Once in the mouth, the gel spreads evenly with temperature and chewing.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines, PANSORAL, gel for oral application is likely to have undesirable effects, although not everyone is subject to them.
- Hypersensitivity reactions to salicylated drugs,
- Risk of irritation due to the presence of alcohol.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE PANSORAL, gel for oral application?
Keep out of the reach and sight of children.
Do not use PANSORAL, gel for oral application after the expiry date stated on the box.
The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does PANSORAL gel for oral application contain?
The active ingredients are
Choline salicylate ........................................................................................................................ 8.700 g
Cetalkonium chloride ................................................................................................................... 0.010 g
For 100 g of gel for oral application.
The other components are:
96 percent ethyl alcohol, glycerol, methyl cellulose, 32 percent sodium hydroxide solution, star anise essential oil, purified water.
Pharmaceutical form and content
What is PANSORAL, gel for oral application and what does it contain?
This medicine is presented as a mouth gel.
Box of 1 tube of 3, 5, 12, 15 or 30 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE-BILLANCOURT
Operator
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Manufacturer
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.
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