Package leaflet: Information for the user

Dynexan, 20 mg/g, oral gel
Lidocaine hydrochloride
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your
doctor, dentist, or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, dentist, or pharmacist. See section 4.
If there is no improvement after 2 days, or if you feel worse, consult your doctor or dentist.

Contents of the 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 used for local anaesthesia of the skin and mucous membranes.
Dynexan is used for the short-term, symptomatic relief of pain in the oral mucosa, gums, and lips in adults, adolescents, and children aged 6 years and older.

2. Important information before using Dynexan

When not to use Dynexan:

if the patient is allergic to lidocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
if the patient is allergic to local anaesthetics of the amide type (e.g. prilocaine, mepivacaine).

Warnings and precautions
Before starting to use Dynexan, consult your doctor, dentist, or pharmacist if the patient suffers from a serious illness, such as heart disease, severe liver disease, or kidney disease.
Exercise caution when consuming hot drinks or food within 45 minutes after applying the gel to prevent choking, biting the tongue, or burns.
Children
This medicine should not be given to children under 6 years of age.
Dynexan and other medicines
Inform your doctor, dentist, or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, dentist, or pharmacist before using this medicine.
Dynexan should not be used during pregnancy unless absolutely necessary.
Lidocaine passes into human milk in small amounts. When Dynexan is used at therapeutic doses, no effect on breastfed infants is expected.
Driving and operating machinery
The effect of Dynexan on the ability to drive and operate machinery is unknown.
Dynexan contains 1 mg of benzalkonium chloride per 1 g of gel.
Benzalkonium chloride may cause local irritation.

3. How to use Dynexan
This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor, dentist, or pharmacist. If in doubt, consult your doctor, dentist, or pharmacist.
Adults and adolescents
The recommended dose for adults and adolescents is a pea-sized amount of gel [approximately 0.2 g of gel (lidocaine hydrochloride 4 mg)] applied 4 to 8 times daily.
Children
In children aged 6 years and older, a pea-sized amount of gel [approximately 0.2 g of gel (lidocaine hydrochloride 4 mg)] should be used up to 4 times daily.
Method of administration
Apply to the oral mucosa.
Dynexan should be applied to the painful area and gently rubbed in.
If the patient has a new dental appliance, a thin layer of Dynexan product should be applied to the sore areas.
If symptoms persist for more than 2 days and the cause is unknown, the patient should consult a doctor, dentist, or pharmacist.
Use of a higher than recommended dose of Dynexan
To date, no cases of poisoning due to overdose, accidental ingestion, or improper use of Dynexan have been reported. If the patient suspects having taken too much Dynexan, they should contact a doctor or dentist immediately.
If you have any further doubts regarding the use of this medicine, consult your doctor, dentist, or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Dynexan may very rarely cause allergic reactions, in the most severe cases progressing to a severe hypersensitivity reaction leading to shock (anaphylactic shock).
If an allergic reaction occurs, treatment with Dynexan should be discontinued immediately and urgent medical advice must be sought from a physician without delay.

Other possible adverse reactions:
Very rare: may affect up to 1 in 10,000 people

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, dentist or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Dynexan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or tube following EXP.
The expiry date refers to the last day of the stated month.
Lot - batch number, EXP - expiry date.
No special storage instructions for this medicine.
After first opening of the container, the period of usability is: 3 months.

6. Contents of the package 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 1 H 0).
Other components are: benzalkonium chloride, glycerol, purified water, liquid paraffin, white soft paraffin, anhydrous colloidal silicon dioxide, thymol, sodium saccharin, guar galactomannan, bitter caraway essential oil, star anise essential oil, peppermint essential oil with reduced menthol content, and peppermint oil.

What Dynexan looks like and contents of the pack
Dynexan is a gel for use in the oral cavity, appearing as a white ointment.
The tube contains 10 g of gel for use in the oral cavity.

Marketing Authorisation Holder and Manufacturer
Chemische Fabrik Kreussler & Co. GmbH
Rheingaustrasse 87-93
65203 Wiesbaden
Germany
Tel.: ++49 (611) 9271-0
Fax: ++49 (611) 9271-111
e-mail: [email protected]

This medicinal product is authorised 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 Gel
Netherlands: Dynexan Gel 20 mg/g, gel voor oromucosaal gebruik
Spain: Dynexan 20 mg/g gel bucal