Pansoral ORAL GEL TUBE 15 G

PANSORAL GEL BUCCAL TUBE 15 G View larger

3400936075764

Pierre Fabre Pierre Fabre

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.

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For warnings, precautions for use and against-indications, please refer to the user manual.

Description

Pansoral Oral Gel is a short-term adjunctive treatment of pain associated with inflammatory and ulcer of the oral mucosa.

Contents:   15g

composition:   Choline sallicylate 8.7g, chloride cetalkonium 0.01gpour 110g. Excipients: ethyl alcohol, glycerol, cellulose, sodium hydroxide solution, star anise essential oil, purified water.

Manual :   clean and dry the prosthetic devices before applying. On average 1-4 applications the value of a dab of gel per day. Once in the mouth, the gel spreads evenly under the effect of temperature and mastication.

Warnings about medications

Attention, the drug is not a product like any other. Read the package leaflet before ordering. Do not let drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug

VIDAL OF THE FAMILY

Pansoral

Analgesic oral preparation

choline salicylate, ketalkonium chloride

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

PANSORAL: gel for oral application; 15 g tube.
-

Laboratory Pierre Fabre Medicine

COMPOSITION (summary)
p 100 g
Choline salicylate 8.6 g
Ketalkonium chloride 10 mg
Alcohol 39 g

INDICATIONS (summary)
This buccal gel contains an analgesic (choline salicylate) and an antiseptic (cetalkonium chloride).
It is used to relieve the pain of canker sores and inflammations of the mouth and gums.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medicinal product contains significant amounts of alcohol .
PREGNANCY AND BREAST-FEEDING (summary)
This medicine may be used during pregnancy or lactation.
DIRECTIONS FOR USE AND DOSAGE (summary)
Place a gel pea directly on the painful gum or prosthesis (in case of temporary prosthesis). Once in the mouth, the gel spreads evenly under the effect of temperature and mastication.

Usual dosage:

  • Adult: 1 to 4 applications per day.
TIPS (summary)
The use of this medicine should not be used as a substitute for careful, regular brushing of teeth after each meal.
In case of irritation of the gums by a prosthesis (dentures), do not hesitate to consult your dentist quickly.
POSSIBLE ADVERSE EFFECTS (summary)
Tingling associated with the alcohol contained in the gel.
Allergic reaction .


GLOSSARY (summary)


alcohol
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even at 60o) is a better antiseptic than alcohol at 90o.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


analgesic
Medication that works against pain. Analgesics act either directly on the centers of pain in the brain or by blocking the transmission of pain to the brain.
Synonym: analgesic.


antiseptic
A substance that locally destroys bacteria, reducing their numbers and preventing their proliferation. Some antiseptics are also active on microscopic fungi and viruses.


mouth ulcers
Very painful lesion of the mouth, having the appearance of a yellowish or gray spot, slightly hollowed out. Healing is usually spontaneous after a few days.
Stress, fatigue and certain foods (walnuts, hazelnuts, gruyere, citrus fruits ...) can cause a surge of canker sores. In very rare cases, canker sores may be due to disease or drug therapy.


inflammations
Natural reaction of the organism against an element recognized as foreign. It manifests itself locally by redness, heat, pain or swelling.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


salicylates
A family of drugs, the best known of which is acetylsalicylic acid (aspirin).

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 16/03/2017

Name of the medicinal product

Pansoral, oral application gel

Choline salicylate, Cetalkonium chloride

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

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.

What is in this leaflet?

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?

Pharmacotherapeutic group: PREPARATIONS FOR STOMATOLOGY / OTHER AGENTS FOR LOCAL TREATMENT - ATC code: A 01AD11 (A: Digestive tract and metabolism).

This medication is recommended for the treatment of short duration of pain related to the inflammatory and ulcerative states of the oral mucosa (small oral wounds).

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:

Not applicable.

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

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE-BILLANCOURT

Marketing Authorization Operator

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

Maker

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]

Other

Detailed information on this medicine is available on the ANSM website (France).

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