DYNEXAN

DYNEXAN mouth gel

Important notes (mandatory information)

Dynexan Mouth Gel. Active ingredient: Lidocaine hydrochloride 1 H2O. Areas of application: Pain-relieving gel based on lidocaine hydrochloride. For the temporary, symptomatic treatment of pain in the oral mucosa, gums and lips.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Dynexan Mouth Gel
2 % gel
Active ingredient: Lidocaine hydrochloride 1 H2O

Dear patient!
Please read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, in order to achieve the best possible treatment results, Dynexan Mouth Gel must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If acute symptoms do not improve after a few days, you must consult a dentist or doctor.

This package leaflet contains

1. WHAT IS DYNEXAN MOUTH GEL AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING DYNEXAN MOUTH GEL?
3. HOW TO USE DYNEXAN MOUTH GEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DYNEXAN MOUTH GEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS DYNEXAN MOUTH GEL AND WHAT IS IT USED FOR?

Dynexan Mouth Gel is a pain-relieving gel based on lidocaine hydrochloride. For the temporary, symptomatic treatment of pain in the oral mucosa, gums and lips.

2. WHAT YOU NEED TO KNOW BEFORE USING DYNEXAN MOUTH GEL?

2.1 Dynexan Mouth Gel must not be used

in case of hypersensitivity to any of the ingredients or to other local pain relievers (local anaesthetics) of the acid amide type

2.2 Special care must be taken when using Dynexan Mouth Gel

in patients with severe disorders of the stimulus formation and conduction system of the heart, acute decompensated heart failure and severe kidney and liver diseases. Although the absorption of the active ingredient into the body after application of Dynexan Mouth Gel is significantly lower than with anaesthesia with this substance, general effects cannot be completely ruled out in the case of severely damaged oral mucosa.

Pregnancy and breast-feeding

Tell your dentist or doctor before treatment with Dynexan Mouth Gel if you are pregnant or planning to become pregnant. You should not use Dynexan Mouth Gel if you are pregnant or breast-feeding unless your doctor considers it clearly necessary.

Warnings and other notes on certain ingredients

Benzalkonium chloride can cause skin irritation.

2.3 Interactions with other medicines

Due to the local application and the amount used, clinically relevant interactions are very unlikely. However, it is generally possible that the pain-relieving effect of other local pain relievers (local anaesthetics) could be enhanced. The interactions with other medicines (antiarrhythmics, ß-receptor blockers) otherwise known for lidocaine are of no significance when Dynexan Mouth Gel is applied locally to the oral mucosa.

3. HOW TO USE DYNEXAN MOUTH GEL?

If symptoms do not improve within one week or if unclear symptoms occur, a dentist or doctor should be consulted.

3.1 Type of application

Gel for use in the oral cavity

3.2 Dosage instructions for adults

Apply a pea-sized amount of Dynexan Mouth Gel (corresponding to approx. 0.2 g gel or 4 mg lidocaine) to the painful areas in the oral cavity 4-8 times a day and massage the gel in gently. A total dose of 40 mg lidocaine should not be exceeded. If pain occurs when inserting dentures or braces, apply Dynexan Mouth Gel thinly to the affected areas. When Dynexan Mouth Gel is used from cylinder ampoules by the dentist, the gel is applied to the alveoli and gum pockets using a special cannula.

Children;

Toddlers and infants

Use a maximum of a pea-sized amount (dosage individually according to age and weight) in children, toddlers and infants 4 times a day.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Dynexan Mouth Gel can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Very rare:

• Local allergic and non-allergic reactions e.g.:
  • Burning
  • Swelling
  • Redness
  • Itching
  • Urticaria
  • Contact dermatitis
  • Exanthema
  • Pain
• Changes in taste
• Numbness
• anaphylactic reactions and shock reactions with accompanying symptoms

Unknown side effects

If you notice any side effects not listed in this package leaflet, please inform your dentist, doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, dentist or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DYNEXAN MOUTH GEL?

Dynexan Mouth Gel is a medicine. Keep it out of the reach of children.

5.1 Notes and information on shelf life

The expiry date of this pack is printed on the container and the folding box. Do not use this pack after this date.

5.2 Special precautions for storage

Store the cylinder ampoules protected from light and not above 25 °C.

5.3 Shelf life after opening

Dynexan Mouth Gel should be used within 3 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

6.1 Composition

1 g gel contains as active ingredient: Lidocaine hydrochloride 1 H2O 20 mg
other ingredients: Benzalkonium chloride, bitter fennel oil, glycerol, guar galactomannan, mint oil, liquid paraffin, peppermint oil, saccharin sodium, highly dispersed silicon dioxide, star anise oil, thymol, titanium dioxide, white petroleum jelly, purified water.

6.2 What Dynexan Mouth Gel looks like and contents of the pack

Dynexan Mouth Gel is available in packs of 1 tube with 10 g gel and in packs of 1 tube with 30 g gel for use in the oral cavity.
Dynexan Mouth Gel is available in packs of 4 cylinder ampoules each containing 1.7 g gel.

6.3 Pharmaceutical entrepreneur and manufacturer

Chemische Fabrik Kreussler & Co. GmbH
Rheingaustraße 87-93
D - 65203 Wiesbaden
www.kreussler.com
E-mail: info@kreussler.com

This package leaflet was last revised in July 2015.

Source: Information from the package leaflet
Status: 04/2017
Active ingredient: Lidocaine hydrochloride 1 H2O. Areas of application: Pain-relieving gel based on lidocaine hydrochloride. For the temporary, symptomatic treatment of pain in the oral mucosa, gums and lips.