Dinexan
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How to use Dinexan
Package Leaflet: Information for the Patient
Dynexan, 20 mg/g, gel for oral cavity use
Lidocaine hydrochloride
Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, dentist, or pharmacist.
- Keep this leaflet, you may need to read it again.
- If you need advice or additional information, consult a pharmacist.
- If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, dentist, or pharmacist. See section 4.
- If after 2 days there is no improvement or the patient feels worse, they should contact their doctor or dentist.
Table of Contents of the Leaflet
- 1. What is Dynexan and what is it used for
- 2. Important information before using Dynexan
- 3. How to use Dynexan
- 4. Possible side effects
- 5. How to store Dynexan
- 6. Contents of the pack and other information
1. What is Dynexan and what is it used for
Dynexan contains the active substance lidocaine hydrochloride, a substance used for local anesthesia of the skin and mucous membranes.
Dynexan is used for short-term, symptomatic treatment of pain in the oral mucosa, gums, and lips in adults, adolescents, and children from 6 years of age.
2. Important information before using Dynexan
When not to use Dynexan:
Warnings and precautions
Before starting to use Dynexan, the patient should discuss it with their doctor, dentist, or pharmacist if they have a severe illness, e.g., heart disease or severe liver or kidney disease.
Care should be taken when consuming hot beverages or food within 45 minutes of applying the gel to avoid choking, biting the tongue, or burns.
Children
This medicine should not be given to children under 6 years of age.
Dynexan and other medicines
The patient should tell their doctor, dentist, or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, dentist, or pharmacist before using this medicine.
Dynexan should not be used during pregnancy unless absolutely necessary.
Lidocaine passes into breast milk in small amounts. When using Dynexan in therapeutic doses, no effect on the breastfed child is expected.
Driving and using machines
The effect of Dynexan on the ability to drive and use machines is not known.
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 the package leaflet for the patient or as directed by a doctor, dentist, or pharmacist. If in doubt, the patient should consult their doctor, dentist, or pharmacist.
Adults and adolescents
The recommended dose for adults and adolescents is a pea-sized amount of gel [about 0.2 g of gel (lidocaine hydrochloride 4 mg)] used 4 to 8 times a day.
Children
In children from 6 years of age, a pea-sized amount of gel [about 0.2 g of gel (lidocaine hydrochloride 4 mg)] should be used up to 4 times a day.
Method of administration
Administration to the oral mucosa.
Dynexan should be applied to painful areas and gently rubbed in.
If the patient has a new dental appliance, a thin layer of Dynexan should be applied to the painful areas.
If the patient's symptoms persist for more than 2 days and the cause is unknown, they should consult their doctor, dentist, or pharmacist.
Overdose 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 they have taken too much Dynexan, they should contact their doctor or dentist immediately.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, dentist, or pharmacist.
4. Possible side effects
Like all medicines, Dynexan can cause side effects, although not everybody gets them.
Dynexan may very rarely cause allergic reactions, in the most severe cases leading to a severe hypersensitivity reaction, including anaphylactic shock.
In case of an allergic reaction, the use of Dynexan should be stopped and immediate medical attention should be sought.
Other possible side effects:
Very rare: may occur in up to 1 in 10,000 people
- Local skin reactions, e.g., burning, swelling, redness, itching, hives, contact dermatitis, rash, pain
- Taste changes
- Numbness.
Reporting side effects
If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, dentist, or pharmacist. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.
5. How to store Dynexan
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or tube after EXP.
The expiry date refers to the last day of the month.
Batch number - lot number, EXP - expiry date.
No special precautions for storage.
After first opening the package, the shelf life is: 3 months.
6. Contents of the pack 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)
- The other ingredients are: benzalkonium chloride, glycerol, purified water, liquid paraffin, white petrolatum, colloidal anhydrous silica, thymol, sodium saccharin, guar gum, dill apiol, star anise oil, peppermint oil with reduced menthol content, spearmint oil.
What Dynexan looks like and contents of the pack
Dynexan is a gel for oral cavity use, which looks like a white ointment.
The tube contains 10 g of gel for oral cavity use.
Marketing authorization holder and manufacturer
Chemische Fabrik Kreussler & Co. GmbH
Rheingaustrasse 87-93
65203 Wiesbaden
Germany
Phone: ++49 (611) 9271-0
Fax: ++49 (611) 9271-111
e-mail: [email protected]
This medicine 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
Italy, Poland: Dynexan
Luxembourg: Dynexan Gel
Netherlands: Dynexan Gel 20 mg/g, gel voor oromucosaal gebruik
Spain: Dynexan 20 mg/g gel bucal
Date of last revision of the leaflet:
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- ImporterChemische Fabrik Kreussler Co.GmbH
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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