DYNEXIDIN

DYNEXIDIN Forte 0.2% solution

Important notes (mandatory information)

Dynexidin Forte 0.2%. Active ingredient: Chlorhexidine bis(D-gluconate). Areas of application: for reducing bacteria in the oral cavity, as supportive treatment for mechanical cleaning in the case of bacterial inflammation of the gums and oral mucosa, as well as after surgical interventions on the periodontium and in the case of restricted oral hygiene capability.

For risks and side effects, read the package insert and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Dynexidin Forte 0.2% 2 mg/g solution
Active ingredient: Chlorhexidine bis(D-gluconate)

Dear patient!
Please read the following 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 success, Dynexidin Forte must be used as prescribed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after a few days, you must consult a dentist or doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS DYNEXIDIN FORTE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING DYNEXIDIN FORTE?
3. HOW SHOULD DYNEXIDIN FORTE BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD DYNEXIDIN FORTE BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS DYNEXIDIN FORTE AND WHAT IS IT USED FOR?

Dynexidin Forte is a disinfectant mouth and throat therapeutic. Dynexidin Forte is used temporarily to reduce bacteria in the oral cavity, as supportive treatment for mechanical cleaning in the case of bacterial inflammation of the gums and oral mucosa, as well as after surgical interventions on the periodontium and in the case of restricted oral hygiene capability.

2. WHAT SHOULD YOU CONSIDER BEFORE USING DYNEXIDIN FORTE?

Dynexidin Forte must not be used:

• if you are hypersensitive (allergic) to chlorhexidine (synonym for chlorhexidine bis(D-gluconate)) or any of the other ingredients.
• in the case of poorly perfused tissue in the oral cavity.
• on the eardrum.
• on the eye and in the eye area.
• in the case of open wounds and ulcers in the oral cavity (ulcerations).
• in infants and toddlers under 2 years of age (due to age-related lack of control of the swallowing reflex and risk of laryngospasm).

Special care should be taken when using Dynexidin Forte if you have exfoliating, scaly changes in the oral mucosa.

Pregnancy and breastfeeding

Ask your doctor, dentist or pharmacist for advice before taking/using any medicine. There is insufficient experience with the use of chlorhexidine, the active ingredient in Dynexidin Forte, during pregnancy and breastfeeding. Therefore, if you are pregnant or breastfeeding, you should only use Dynexidin Forte with special caution.

Use of Dynexidin Forte with other substances

Chlorhexidine is rendered ineffective by sucrose (saccharose), as well as by polysorbate 80 and insoluble magnesium, zinc and calcium salts. The effectiveness of Dynexidin Forte is reduced by soaps and other anionic substances, which are also generally contained in toothpastes.

Warnings and other information about certain ingredients

Macrogolglycerol hydroxystearate can cause skin irritation.

3. HOW SHOULD DYNEXIDIN FORTE BE USED?

Always use Dynexidin Forte exactly as described in this package leaflet. Please ask your dentist, doctor or pharmacist if you are not sure. If you want to use Dynexidin Forte for a longer period of time, please ask your dentist, doctor or pharmacist. Unless otherwise prescribed by your dentist or doctor, rinse your mouth with Dynexidin Forte two to three times a day after meals and brushing your teeth. To do this, first rinse your mouth thoroughly with water after brushing your teeth to remove any remaining toothpaste. Then rinse for about 1 minute with at least 10 ml of undiluted Dynexidin Forte. Then spit out Dynexidin Forte - the solution should not be swallowed. Do not rinse your mouth again with water afterwards, as this could reduce the effect of Dynexidin Forte. The solution should not be used for longer than 6 weeks without medical or dental advice.

If you have used more Dynexidin Forte than you should

In the case of intended use, the amounts of chlorhexidine absorbed by the skin or mucous membrane can be detoxified by the human organism without any toxic signs. In the case of local overdose on the skin and mucous membrane, Dynexidin Forte can be removed by rinsing with water. Accidental swallowing is harmless.

If you forget to use Dynexidin Forte or stop using it

The therapy may be unsuccessful and the bacterial colonisation of the oral cavity may spread again.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Dynexidin Forte can have side effects, although not everybody gets them. The following side effects have been observed with chlorhexidine-containing medicines.

Rarely (1 to 10 out of 1,000 treated patients), there may be a short-term impairment of taste sensitivity, a temporary numbness of the tongue and temporary discolouration of the tongue as well as teeth and restorations (these are e.g. fillings).

With unknown frequency (cannot be estimated from the available data), hypersensitivity reactions to the ingredients of Dynexidin Forte, temporary superficial, non-bleeding desquamation of the oral mucosa and anaphylactic reactions (up to and including anaphylactic shock) may occur.

Constant use of Dynexidin Forte without mechanical cleaning can promote bleeding of the gums.

Reporting of side effects

If you get any side effects, talk to your doctor 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 to provide more information about the safety of this medicine.

5. HOW SHOULD DYNEXIDIN FORTE BE STORED?

Keep all medicines out of the reach of children.

Notes and information on shelf life

The expiry date of this pack is printed on the container and the folding box (only available with the 300 ml pack). Please do not use this pack after this date.

Special precautions for storage

None.

Shelf life after opening

Dynexidin Forte can be stored for 3 months after the container has been opened for the first time.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dynexidin Forte contains

The active ingredient is chlorhexidine bis(D-gluconate) (synonym: chlorhexidine digluconate, often abbreviated as chlorhexidine, abbreviated as CHX): Dynexidin Forte contains 0.2 g of active ingredient per 100 g. The other ingredients are: glycerol, macrogolglycerol hydroxystearate (Ph. Eur.), mint oil, peppermint oil, purified water.

What Dynexidin Forte looks like and contents of the pack

Dynexidin Forte is a clear, colourless solution in a 300 ml PET bottle with measuring cup and package leaflet in a folding box. Dynexidin Forte is available for dental practices as a 5l PET canister (with separate pump and measuring cup).

Pharmaceutical entrepreneur and manufacturer

Chemische Fabrik Kreussler & Co. GmbH
Rheingaustraße 87-93
D-65203 Wiesbaden
Telephone: 0611-9271-0
Telefax: 0611-9271-111
www.kreussler.com
E-mail: infoSkreussler.com

This package leaflet was last revised in March 2016.

Source: Information from the package leaflet
Status: 10/2019
Active ingredient: Chlorhexidine bis(D-gluconate). Areas of application: for reducing bacteria in the oral cavity, as supportive treatment for mechanical cleaning in the case of bacterial inflammation of the gums and oral mucosa, as well as after surgical interventions on the periodontium and in the case of restricted oral hygiene capability.