Hexoral solution for gargling

Hexetidine, the active ingredient in Hexoral, has a broad spectrum of activity against bacterial pathogens of mouth and throat infections.

Application

1. What is Hexoral and what is it used for?

Hexetidine, the active ingredient in Hexoral, has a broad spectrum of activity against bacterial pathogens of mouth and throat infections. Fungal diseases in the mouth and throat, especially thrush, are also effectively combated by Hexoral.

Hexoral is suitable for the short-term supportive treatment of
non-febrile inflammations in the mouth and throat
sore throat in mild, non-febrile colds
gum inflammation, bleeding gums, pressure sores in denture wearers
mouth sores and minor injuries.
Gum inflammation, bleeding gums, pressure sores in denture wearers
Mouth sores and minor injuries in the mouth area
You should use Hexoral under medical supervision for the following conditions, which may also cause fever:
Tonsillitis, pharyngitis, angina
Gum or mouth inflammation. Oral mucosa inflammation, aphthae (painful inflamed areas of the mucous membrane of the gums, oral cavity or tongue)
Prevention and treatment of infections during surgical procedures (e.g. tooth extraction or mandel surgery).
Treatment of fungal diseases, especially thrush
Control of bad breath in severe diseases of the mouth and throat (e.g. tumours)
Oral hygiene in severe general diseases

For use in children from 3 years of age, adolescents and adults.

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How is it applied?

What is Hexoral and what is it used for?

Hexetidine, the active ingredient in Hexoral, has a broad spectrum of activity against bacterial pathogens of mouth and throat infections. Fungal diseases in the mouth and throat, especially thrush, are also effectively combated by Hexoral.

Hexoral is suitable for short-term supportive treatment of

• Non-febrile inflammation of the mouth and throat
.
• Sore throat in mild, non-feverish colds
.
• Gum inflammation, bleeding gums, pressure points in denture wearers
.
• Mouth sores as well as minor injuries in the mouth area
.

For the following conditions, where fever may also occur, Hexoral should only be used under medical supervision:

• Tonsillitis, pharyngitis, angina
.
• Inflammation of the gums or oral mucosa, aphthae (painful inflamed areas of the mucous membrane of the gums, the oral cavity or the tongue)
.
• Prevention and treatment of infections during surgical procedures (e.g. tooth extraction or tonsillectomies)
.
• Treatment of fungal diseases, especially thrush
.
• Fighting bad breath in severe diseases of the mouth and throat (e.g. tumours)
.
• Mouth hygiene in severe general diseases
.

For use in children from 3 years, adolescents and adults.

What should you pay attention to before taking it?

What should you be aware of before using Hexoral?

Hexoral must not be used,

.

• If you are allergic to hexetidine, azorubin, levomenthol, eucalyptus oil or any of the other ingredients of this medicine listed in section 6.
.
• Because of the content of levomenthol in patients with bronchial asthma or other
  respiratory diseases associated with pronounced hypersensitivity of the airways. Inhalation of Hexoral in this case can lead to shortness of breath or trigger an asthma attack.
• for infants,
  toddlers and children under 3 years of age.
• in persons for whom it can be assumed that the mouth rinsing solution may be swallowed.
• for ulcers and erosive, scaly changes of the oral mucosa.

Warnings and precautions.
Please talk to your doctor, dentist or pharmacist before using Hexoral.
If you have accidentally swallowed large amounts of Hexoral, nausea will occur. A significant uptake into the bloodstream is therefore not to be assumed.

Hexoral is for topical use only and must not be swallowed.
Hexoral must not be placed in the eye, around the eye or in the ear canal.

Long-term treatment with Hexoral is not recommended, as shifts in the flora of the oral cavity may occur.

Use of Hexoral with other medicines.
Inform your doctor, dentist or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

The active ingredient hexetidine is inactivated by soaps and other anionic substances, which are usually also contained in toothpaste.
These should therefore not be done at the same time, but before rinsing the mouth with Hexoral. Rinse your mouth thoroughly with water between brushing your teeth and using Hexoral.

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

There is insufficient experience or research on the safety of using Hexoral during pregnancy and lactation. Therefore, you should only use Hexoral with special care and not exceed the recommended dosage.

Driving ability and ability to operate machinery.
Hexoral has no or negligible effect on the ability to drive and use machines.

Hexoral contains ethanol (alcohol) and azorubin.
This medicinal product contains 5.4% alcohol by volume.
Azorubin may cause allergic reactions.

How should the medicine be taken?

How to use Hexoral?

Always use this medicine exactly as described in this leaflet or as your doctor, dentist or pharmacist has told you.... Check with your doctor, dentist or pharmacist if you are not sure.
Adults and adolescents aged 12 and over
In the morning and evening, rinse the oral cavity or gargle in the throat for about 30 seconds with 1 tablespoon of undiluted Hexoral and then spit it out. For individual inflammation sites, you can also apply the solution directly with swabs. Avoid swallowing the solution.
Children 3 to 12 years
Dab the affected areas with a Hexoral-soaked cotton swab (do not wipe or rub) in the morning and evening after meals. Use a maximum of 3 times a day.
Children aged 3 to 6 years should only be treated with Hexoral if ordered by a doctor.

Olderly patients
Specific recommendations for dosage in elderly patients are not available. Unless otherwise prescribed by a doctor or dentist, the dosage given for adults applies.

Method of use
For rinsing or gargling.
Hexoral is used undiluted after meals. For it to work properly, you should not eat or drink for the next few minutes.
Hexoral must not be mixed with other medicines.
For local treatment in the mouth, Hexoral can also be applied to the diseased areas with cotton buds or swabs.
Hexoral is only suitable for use in the mouth and throat and must not be swallowed. Therefore, Hexoral should only be used if the patient can suppress the swallowing reflex and is able to spit out the solution after rinsing or gargling.

Duration of use
Do not use Hexoral for more than 10 days without medical or dental advice. The total duration of treatment is determined by the attending doctor or dentist.
If symptoms persist after 15 days of treatment, consult a doctor or dentist again.

If you have used more Hexoral than you should
Notify a doctor immediately!
Hexoral must not be swallowed (in large quantities and intentionally). The active ingredient hexetidine is only absorbed by the body in small quantities.
No cases of poisoning following the intended use of Hexoral have been reported to date. There is no evidence that excessive use of Hexoral increases the risk of hypersensitivity reactions.
If Hexoral is used inappropriately, e.g. swallowing, vomiting may occur. The uptake of larger amounts of active substance is therefore unlikely. However, symptoms of alcohol intoxication may occur.

If you forget to use Hexoral
Do not use twice the amount if you have forgotten to use it before.

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

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

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What are the possible side effects?

How should Hexoral be stored?

Do not store above 30 °C. Do not freeze. Store the bottle in the outer carton to protect the contents from light.
If this is not done, small dot-shaped deposits may appear on the wall of the bottle, but these do not affect the efficacy and tolerability of Hexoral.
Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the outer carton. The expiry date refers to the last day of the month indicated.

Shelf life after opening: 6 months

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 should Hexoral be stored?

Do not store above 30 °C. Do not freeze. Store the bottle in the outer carton to protect the contents from light.
If this is not done, small dot-like deposits may appear on the wall of the bottle, but these will not affect the efficacy and tolerability of Hexoral.
Keep this medicine out of the reach of children.

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

Shelf life after opening: 6 months

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 Hexoral contains

The active substance is: hexetidine. 100 ml solution contains 100 mg hexetidine (0.1 % solution).
The other ingredients are: purified water, ethanol 96 %, polysorbate 80, citric acid monohydrate, saccharin sodium, levomenthol, azorubin (E 122), eucalyptus oil, sodium calcium edetate, sodium hydroxide.

What Hexoral looks like and contents of the pack
Solution for use in the oral cavity
Hexoral is a clear, red mouthwash and is available in 200 ml glass bottles and 400 ml PET bottles.
Not all pack sizes may be placed on the market.