Package leaflet: Information for the patient

Dynexan 20 mg/g gingival/oral mucosa gel

Lidocaine hydrochloride
Read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor, dentist or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you want more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor, dentist or nurse. See section 4.
Consult your doctor or dentist if you do not notice improvement or if you notice worsening of symptoms after 2 days and the underlying cause is unknown.

Contents of this leaflet:

What Dynexan is and what it is used for
What you need to know before using Dynexan
How to use Dynexan
Possible side effects
How to store Dynexan
Contents of the pack and other information

1. What Dynexan is and what it is used for

Dynexan contains the active substance lidocaine hydrochloride, a substance that numbs the skin and mucous membranes locally (local anaesthesia).
Dynexan is used for the short-term symptomatic treatment of pain in the oral mucosa, gums and lips in adults, adolescents and children from the age of 6 years.

2. What you need to know before using Dynexan

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 amide-type local anesthetics (e.g. prilocaine, mepivacaine).

Warnings and precautions
Consult your doctor, dentist or pharmacist before using Dynexan if you have severe underlying conditions, such as heart disease or severe liver or kidney diseases.
Exercise caution when consuming hot food or drinks within 45 minutes after application to prevent choking, biting the tongue or burns.
Children
Do not administer this medicine to children under 6 years of age.
Other medicines and Dynexan
Inform your doctor, dentist or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor, dentist or pharmacist for advice before using this medicine.
Dynexan should not be used during pregnancy unless clearly necessary.
Lidocaine is excreted in breast milk in small amounts. At therapeutic doses of Dynexan, effects on breastfed infants are not expected.
Driving and using machines
Dynexan has no known effects on the ability to drive or operate machinery.
Dynexan contains 1 mg of benzalkonium chloride per 1 g of gel
Irritant, may cause skin reactions.

3. How to use Dynexan

Use this medicine exactly as instructed by your doctor, dentist, or pharmacist. If you have any doubts, consult your doctor, dentist, or pharmacist.

Adults and adolescents
The recommended dose for adults and adolescents is a quantity of gel equal to approximately 0.2 g (4 mg of lidocaine hydrochloride) applied 4 to 8 times daily.

Use in children
In children from 6 years of age, the dose should be approximately 0.2 g of gel (4 mg of lidocaine hydrochloride) up to 4 times daily.

How to apply the gel
Gingival/oral mucosa use
Dynexan should be applied to the affected areas and gently massaged to promote penetration.
In case of dentures or new dental appliances, a thin layer of Dynexan should be applied to the affected areas.
If symptoms persist for more than 2 days and the underlying cause is unknown or unclear, consult a doctor or dentist.

If you use more Dynexan than you should
To date, no cases of poisoning due to overdose, accidental ingestion, or errors with Dynexan have been reported. If you think you have used more Dynexan than you should, contact your doctor or dentist immediately.

If you have any questions about the use of this medicine, consult your doctor, dentist, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dynexan may very rarely cause allergic reactions, in most cases an acute hypersensitivity reaction up to shock (anaphylactic shock). If you develop an allergic reaction, stop using Dynexan and seek immediate medical attention.

Other possible side effects
Very rare: may affect up to 1 in 10,000 people

Local skin reactions, e.g. burning sensation, swelling, redness, itching, urticaria, contact dermatitis, rash, pain
Taste disturbances
Numbness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, dentist or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dynexan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening the tube, the product is valid for 3 months.

6. Package contents and other information

What Dynexan contains

The active substance is lidocaine hydrochloride.
1 g of gel contains 20 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate).
The other components are benzalkonium chloride, fennel fruit oil, glycerol, guar gum, partially dementholated peppermint oil, liquid paraffin, peppermint oil, sodium saccharin, anhydrous colloidal silica, star anise oil, thymol, titanium dioxide (E171), white soft paraffin, purified water.

Description of the appearance of Dynexan and contents of the pack
Dynexan is a white, ointment-like gingival/oromucosal gel.
The tube contains 10 g of gingival/oromucosal gel.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Chemische Fabrik Kreussler & Co. GmbH
Rheingaustrasse 87-93
65203 Wiesbaden
Germany

Sole Distributor
Pasquali srl
Viale Belfiore 41
50144 Florence
Italy
Tel.: 055 4219341
Email: [email protected]

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: LidocainKreussler 20 mg/g Gel zur Anwendung am Zahnfleisch/in der Mundhöhle
Italy, Poland: Dynexan
Luxembourg: Dynexan
Netherlands: Dynexan Gel 20 mg/g, gel voor oromucosaal gebruik
Spain: Dynexan 20 mg/g gel bucal