Chlorhexamed 1% - Gel for use in the oral cavity

Chlorhexamed Gel is a surface-active mouth and throat antiseptic (disinfectant) with a broad spectrum of activity and long-term effect against bacterial pathogens and a somewhat weaker activity against fungal diseases.

Application

1. What is Chlorhexamed 1% - Gel and what is it used for?

Chlorhexamed 1% - Gel is a surface-active oral and pharyngeal antiseptic (disinfectant) with a broad spectrum of activity and long-term effect against bacterial pathogens and a somewhat weaker activity against fungal diseases.

Chlorhexamed 1% gel is used exclusively in the oral cavity
for the prevention and temporary supportive treatment of bacterial gingivitis.
to support the healing phase after periodontal surgery (interventions on the periodontal apparatus)
in the case of restricted oral hygiene, e.g. as a result of orthodontic surgery.
as an additive to fluoride administration to prevent caries in high-risk patients and patients who suffer from dry mouth (xerostomia patients) or patients with dentures.

If you do not feel better or even worse after 3 weeks, contact your doctor.

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How is it applied?

What is Chlorhexamed Gel and what is it used for?

Chlorhexamed Gel is a surface-active mouth and throat antiseptic (disinfectant) with a broad spectrum of activity and long-term effect against bacterial pathogens and a somewhat weaker activity against fungal diseases.

Chlorhexamed Gel is used exclusively in the area of the oral cavity

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• For prevention and temporary supportive treatment of bacterial inflammation of the gums (gingivitis) and the oral mucosa
.
• to support the healing phase after periodontal surgery (procedures on the periodontium)
• With limited oral hygiene ability, e.g. as a result of orthodontic (orthodontic) treatments
.
• As an additive to fluoride administration for the prevention of caries in high-risk patients, such as patients suffering from dry mouth (xerostomia patients) or patients with dentures
.

If you do not feel better or even worse after 3 weeks, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before using Chlorhexamed Gel?
Chlorhexamed Gel must not be used,
- if you are allergic to chlorhexidine digluconate or any of the other ingredients listed in section 6. other ingredients of this medicinal product mentioned in section 6.
- in open wounds and ulcers in the oral cavity and in superficial non-bleeding exfoliation of the oral mucosa.
- in infants and young children under 2 years of age (risk of laryngospasm).
- in persons who cannot control swallowing properly (including children under 6 years of age).
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- in patients with bronchial asthma or other respiratory diseases associated with marked hypersensitivity of the airways. Inhalation of Chlorhexamed Gel may cause shortness of breath or trigger an asthma attack.

Warnings and precautions
Please talk to your doctor or pharmacist before using Chlorhexamed Gel.

Use Chlorhexamed Gel only in the mouth! You must not put Chlorhexamed Gel in the eye, around the eye or in the ear canal. In case of accidental contact with the eye or ear canal, rinse with plenty of water.

Chlorhexamed Gel should not be swallowed.

The use of Chlorhexamed Gel does not replace brushing the teeth.

Chlorhexamed Gel should not be used for longer than 3 weeks without interruption without a doctor's recommendation, as longer periods of use may cause discolouration of the tongue and teeth and taste disorders.
In special cases, e.g. intensive care for the manually disabled, preventive treatment can also be carried out over a longer period of time.

You can largely prevent eventual discolouration of teeth, tongue, fillings and dentures: Brush your teeth with a normal toothpaste at least 5 minutes before using Chlorhexamed Gel. Rinse your mouth thoroughly with water between brushing your teeth and using Chlorhexamed Gel (see "Using Chlorhexamed Gel with other medicines"). If necessary, reduce your consumption of strongly colouring foods and drinks, such as tea, coffee and red wine. Clean dentures with a commercial denture cleaner before using Chlorhexamed Gel.Discolouration that still occurs can be removed over time by intensive brushing. In stubborn cases by professional cleaning by the dentist, for full dentures by a special cleaner.

Stop using Chlorhexamed Gel and tell your dentist if you have pain or irritation in your mouth.

Stop using Chlorhexamed Gel and seek medical help immediately if you develop a rash, swelling of the lips, tongue, throat or face, or if you have difficulty breathing.

If symptoms persist or if the expected effect from use does not occur, be sure to consult a doctor.

Use Chlorhexamed Gel with other medicines
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

Chlorhexamed Gel is affected in its effect by anionic substances, which are usually a component of common toothpastes. Therefore, do not use them at the same time, but at least five minutes before using Chlorhexamed Gel (rinse mouth thoroughly with water between brushing teeth and using Chlorhexamed Gel).

Use Chlorhexamed Gel with food and drink
.Do not eat or drink any sugary foods or drinks immediately after using Chlorhexamed Gel, as these may otherwise impair the effect of Chlorhexamed Gel.

Pregnancy, breast-feeding and fertility
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.If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

There is insufficient experience or research on the safety of using Chlorhexamed Gel, during pregnancy and breast-feeding. Therefore, you should only use Chlorhexamed Gel with special care and after consulting your doctor.

Driving and ability to operate machinery
Chlorhexamed Gel has no or negligible effect on driving and ability to operate machinery.

Chlorhexamed Gel contains macrogol glycerol hydroxystearate as well as sodium.Macrogol glycerol hydroxystearate may cause skin irritation.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is almost "sodium-free".

How should the medicine be taken?

How to use Chlorhexamed Gel?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

The following information applies unless your doctor has prescribed the use of Chlorhexamed Gel differently.
Please follow the instructions for use, otherwise Chlorhexamed Gel may not work properly! Do not exceed the stated dosage.

The recommended dose is:

Adults
Apply the gel 2 to 3 times daily. The amount (approx. 1 - 2.5 cm gel) depends on the extent of the inflammation or the type of application.

For use in the oral cavity.

The teeth should be brushed at least 5 minutes before using Chlorhexamed Gel and then the oral cavity should be rinsed thoroughly with water (see section 2:
"Use of Chlorhexamed Gel with other medicines").

Apply a sufficiently large amount of gel after meals and brushing your teeth, e.g. with a cotton bud or, in the case of the 9 g tube, with the help of the applicator directly to the inflamed areas in the mouth. Let the gel work for about 1 minute. The gel should be spat out after this exposure time. Do not swallow the gel.

You can also use Chlorhexamed Gel like a toothpaste. To do this, put approx. 2 cm of gel on a moistened toothbrush and brush the teeth for at least 1 minute. Afterwards, the rest of the gel should be spat out but not rinsed with water.
Do not swallow the gel.

Children and adolescents
Children up to 6 years
The use and safety in children under 6 years of age has not yet been tested. Due to the risk of accidental swallowing or the menthol contained, Chlorhexamed Gel Version 04, 02/2016

must not be used in this age group (see section 2: "Chlorhexamed Gel must not be used").

Children from 6 years
The use in children between 6 and 12 years of age should only be carried out on the instructions of the doctor. Specific dosage recommendations for children 6 years and older are not available, the dosage is determined by the doctor.

Adolescents
Unless otherwise prescribed by the doctor, the dosage for adolescents 12 years and older is that given for adults.

Older patients ≥ 65 years
Specific recommendations on dosage in elderly patients are not available. The normal dose recommended for adults also applies to these groups of people, unless your doctor recommends otherwise.

Duration of use
The duration of treatment depends on the clinical picture and clinical course, and is up to 3 weeks. Consult your doctor if the inflammation has not improved after this time. Prolonged use of Chlorhexamed Gel should only be done after consulting your doctor.

Please talk to your doctor or pharmacist if you think that the effect of Chlorhexamed Gel is too strong or too weak.

If you have used more Chlorhexamed Gel than you should
Always use Chlorhexamed Gel exactly as described in this leaflet and do not exceed the stated dosage. If you have used a large amount of Chlorhexamed Gel, rinse your mouth with water and spit it out. Severe symptoms of poisoning are not known. If any discomfort occurs, consult a doctor if necessary.

Note to doctor/ healthcare professional
For overdose information, see the end of the leaflet.

If you forget to use Chlorhexamed Gel
Do not use twice the amount if you have forgotten to use it before. Continue the treatment according to the dosage instructions.

If you stop using Chlorhexamed Gel
In this case, no special measures are necessary.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Chlorhexamed Gel?

Do not store above 25°C.

Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton/container after "Use by". The expiry date refers to the last day of the month indicated.

Burns for 3 months after opening.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5 How to store Chlorhexamed 1% - Gel?

Do not store above 25°C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the container after "use by". The expiry date refers to the last day of the given month.

Stay for 3 months after opening.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Chlorhexamed Gel contains
- The active ingredient is: Chlorhexidine digluconate
1 g contains 10 mg chlorhexidine digluconate. A 1 cm gel strand is equivalent to 0.67 g gel
- The other ingredients are:
2-propanol, hydroxypropyl cellulose, sodium acetate trihydrate, macrogol glycerol hydroxystearate, purified water, menthol, peppermint oil.

What Chlorhexamed Gel looks like and contents of the pack
Chlorhexamed Gel is a clear colourless or lightly coloured gel for use in the oral cavity and is available in tubes of 9 g with applicator enclosed or 50 g.

Not all pack sizes may be marketed.