DYNEXAN 20 mg/g BUCAL GEL

Introduction

Package Leaflet: Information for the Patient

Dynexan 20 mg/g Oral Gel

Lidocaine Hydrochloride

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, dentist, or pharmacist.
• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, dentist, or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor or dentist if it worsens or does not improve after 2 days and the underlying cause is unknown.

Contents of the Package Leaflet:

1. What is Dynexan and what is it used for
2. What you need to know before using Dynexan
3. How to use Dynexan
4. Possible side effects
5. Storage of Dynexan
6. Contents of the pack and further information

1. What is Dynexan and what is it used for

Dynexan contains the active ingredient lidocaine hydrochloride, a substance for local numbing (local anesthesia) of the skin and mucous membranes.

Dynexan is used for the short-term symptomatic treatment of pain in the oral mucosa, gums, and lips in adults, adolescents, and children from 6 years of age.

You should consult a doctor or dentist if it worsens or does not improve after 2 days and the underlying cause is unknown.

2. What you need to know before using Dynexan

Do not use Dynexan:

• if you are allergic to lidocaine hydrochloride or any of the other components of this medication (listed in section 6).
• if you are allergic to local anesthetics of the amide type (e.g., prilocaine, mepivacaine).

Warnings and precautions

Consult your doctor, dentist, or pharmacist before starting to use Dynexan if you have severe underlying diseases, e.g., heart disease or severe liver or kidney disease.

Within 45 minutes after application, you should be cautious when consuming hot drinks or food to avoid asphyxiation, biting, or burns on the tongue.

Children

Do not administer this medication to children under 6 years of age.

Other medications and Dynexan

Tell your doctor, dentist, or pharmacist if you are using, have recently used, or might use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor, dentist, or pharmacist before using this medication. Dynexan should not be used during pregnancy unless strictly necessary.

Lidocaine is excreted in breast milk in small amounts.

At therapeutic doses of Dynexan, no effects on breastfed infants are expected.

Driving and using machines

Dynexan has no known effect on the ability to drive and use machinery.

Dynexan contains benzalkonium chloride

This medication contains 1 mg of benzalkonium chloride per gram of gel.Benzalkonium chloride may cause local irritation.

3. How to use Dynexan

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, dentist, or pharmacist. In case of doubt, ask your doctor, dentist, or pharmacist.

Adults and adolescents

The recommended dose for adults and adolescents is 4-8 applications per day of a pea-sized amount of gel (approx. 0.2 g of gel (4 mg of lidocaine hydrochloride)).

Use in children

For children from 6 years of age, the dosage should be up to 4 times a day, a pea-sized amount of gel (approx. 0.2 g of gel (4 mg of lidocaine hydrochloride)).

How to administer

Oral route.

Apply Dynexan to the painful areas and gently massage.

If you wear dentures or dental appliances, apply a thin layer of Dynexan to the affected areas.

If symptoms persist for more than 2 days and the underlying cause is unknown, you should consult a doctor or dentist.

If you use more Dynexan than you should

So far, no cases of intoxication due to overdose, accidental ingestion, or errors with Dynexan have been reported. If you think you have used more Dynexan than you should, talk to your doctor or dentist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor, dentist, or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Very rarely, Dynexan may cause allergic reactions, in the most severe cases, an acute hypersensitivity reaction that can cause shock (anaphylactic shock). If you develop an allergic reaction, stop using Dynexan and seek medical attention immediately.

Other possible side effects

Very rare: may affect up to 1 in 10,000 people

• Local skin alterations, e.g., burning sensation, swelling, redness, itching, urticaria, contact dermatitis, exanthema, pain
• Alteration of taste
• Numbness

Reporting side effects

If you experience any side effects, consult your doctor, dentist, or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dynexan

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton and tube after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

After opening the tube, the validity period is 3 months.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dynexan

• The active ingredient is lidocaine hydrochloride.
• 1 g of gel contains 20 mg of lidocaine hydrochloride (as lidocaine hydrochloride 1 H2O).
• The other components (excipients) are benzalkonium chloride, glycerol, guar gum, partially demetholized peppermint oil, liquid paraffin, peppermint oil, sodium saccharin, anhydrous colloidal silica, thymol, soft white petrolatum, purified water.

Appearance and packaging of the product

Dynexan is a white gel-like paste in the form of an oral gel.

Tubes containing 10 g of oral gel

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturerChemische Fabrik Kreussler & Co. GmbH Rheingaustr. 87-93 65203 Wiesbaden Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: LidocainKreussler 20 mg/g Gel zur Anwendung am Zahnfleisch/in der Mundhöhle

Spain: Dynexan 20 mg/g oral gel

Italy, Poland: Dynexan

Luxembourg: Dynexan Gel

Netherlands: Dynexan Gel 20 mg/g, gel voor oromucosaal gebruik

Date of the last revision of this package leaflet:

March 2025

Detailed and up-to-date information on this medication can be found on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/