• Pansoral Gel 15g

Pansoral Gel 15g

Indications: This drug is recommended for the short-term adjunctive treatment of pain associated with inflammatory and ulcerative conditions of the oral mucosa.

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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).

Therapeutic indications

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.

Contra-indications

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.

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.

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.

Sports

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.

Expiry date

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.

Storage conditions

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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