Prospect: Information for the Patient

Dynexan 20 mg/g Oral Gel

Lidocaine Hydrochloride

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Follow exactly the administration instructions for the medication contained in this prospect or those indicated by your doctor, dentist, or pharmacist.
• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, dentist, or pharmacist, even if they do not appear in this prospect. 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.

1.What is Dynexan and for what it is used
2.What you need to know before starting to use Dynexan
3.How to use Dynexan
4.Possible adverse effects
5.Storage of Dynexan
6.Contents of the package and additional information

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

Dynexan is used for the symptomatic treatment of short duration, of pain in the oral mucosa, in the gum and in the lips in adults, adolescents and children aged 6 years and above.

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

Do not use Dynexan:

• if you are allergic to lidocaine hydrochloride or to any of the other ingredients of this medicine (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 serious underlying diseases, for example heart disease or severe liver or kidney disease.

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

Children

Do not administer this medicine to children under 6 years old.

Other medicines and Dynexan

Inform your doctor, dentist or pharmacist if you are using, have used recently or may need to use any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, dentist or pharmacist before using this medicine. Dynexan should not be used during pregnancy, unless strictly necessary.

Lidocaine is excreted in breast milk in small amounts.

No adverse effects are anticipated in infants breastfed at therapeutic doses of Dynexan.

Driving and operating machinery

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

Dynexan contains benzalkonium chloride

This medicinecontains 1 mg of benzalkonium chloride in each gram of gel.Benzalkonium chloride may cause local irritation.

Follow exactly the medication administration instructions contained in this leaflet or those 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 gel amount the size of a pea (approx. 0.2 g of gel (4 mg of lidocaine hydrochloride)).

Use in children

For children aged 6 and above, the dosage should be up to 4 times a day of a gel amount the size of a pea (approx. 0.2 g of gel (4 mg of lidocaine hydrochloride)).

How to administer

Oral route.

Apply Dynexan to the painful areas and massage gently.

In case of wearing dentures or dental appliances, administer 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 take 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, speak with your doctor or dentist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Other possible adverse effects

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, dentist or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and the tube after CAD. 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.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Dynexan

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

Appearance of the product and contents of the packaging

Dynexan is a white, gel-like buccal paste.

Tubes containing 10g of buccal gel

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer
Chemische Fabrik Kreussler & Co. GmbH
Rheingaustr. 87-93
65203 Wiesbaden
Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany: LidocainKreussler 20 mg/g Gel for application to the gum tissue/oral cavity

Spain: Dynexan 20mg/g buccal gel

Italy, Poland: Dynexan

Luxembourg: Dynexan Gel

Netherlands: Dynexan Gel 20 mg/g, gel for oromucosal use

Revision date of this leaflet:

December 2018

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/