Camillosan mouth spray, 30 ML

1 What is Kamillosan mouth spray and what is it used for?

Kamillosan - Mouth Spray is a herbal wound treatment with the active ingredients of an ethanolic extract of camomile flowers, peppermint oil and aniseed oil and is intended for use in the oral cavity.

Kamillosan contains a natural camomile extract for the treatment of catarrh in the mouth and throat and for oral hygiene measures. The camomile extract contains water- and fat-soluble components that have an anti-inflammatory, pain-relieving and germicidal (anti-bacterial and anti-fungal) effect.

Aniseed oil contained in Kamillosan also has a germicidal effect. The main active ingredient in peppermint oil is menthol in addition to menthol esters. As an alcohol, menthol has pronounced germicidal effects in addition to weak anaesthetic properties; it has a local cooling effect and deodorising effect. The good flavour and the local cooling effect are perceived as pleasant in inflammatory diseases of the mouth and throat.

Kamillosan can be used for all inflammatory changes in the oral cavity and throat, such as
- Periodontitis and gum inflammation
- Discomfort after tooth extraction and when changing teeth
- Mucosal irritation due to dentures
- Catarrh of the oral cavity and pharynx
- Preventive mouth and throat disinfection and as a mouth and throat deodorant.

2 What do you need to consider before using Kamillosan mouth spray?

Kamillosan mouth spray must not be used
- if you are hypersensitive (allergic) to the active ingredients or any of the other ingredients of Kamillosan Mouth Spray.
- if you have a known allergy to camomile or other composite plants, to aniseed oil or its main component anethole or to peppermint oil
- in infants and children under 10 years of age.

Special care is required when using Kamillosan mouth spray,
for alcoholics. In this case, Kamillosan is not suitable as the mouth spray contains 25% alcohol by volume.

If you have not used Kamillosan for a long time, the spray tube may become blocked in rare cases. Please hold the spray tube briefly under warm water and do not tamper with the spray tube yourself.

No special precautions need to be taken when using Kamillosan mouth spray with other medicines.

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.

You do not need to take any special precautions when using Kamillosan Oral Spray together with food and drink.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicines.
Kamillosan should not be used without medical supervision during pregnancy and breastfeeding.
Camomile is used in many different ways in humans. No indications of risks during pregnancy and breastfeeding have been observed. Similarly, there are no restrictions on the proper use of aniseed oil during pregnancy or breastfeeding at the recommended dosage. There are no data on the use of peppermint oil during pregnancy and breastfeeding.

Ability to drive and operate machinery
Kamillosan has no influence on the ability to drive and use machines.

Important information about certain other ingredients of Kamillosan mouth spray
Kamillosan contains 25 % alcohol by volume.

3 How should Kamillosan mouth spray be used?

Always use Kamillosan exactly as directed by your doctor. Please ask your doctor or pharmacist if you are unsure.

Unless otherwise prescribed, spray the inflamed areas of the mouth or throat 3 times a day with two sprays each (two sprays correspond to a single dose of 0.14 ml).

Do not spray into the nose.

The duration of use is individual and depends on how quickly the symptoms subside.

How to use the spray head:
1. please do not bend the spray tube of the spray head forwards upwards.
2. swivel the spray tube sideways to the left or right into a horizontal position
3. remove the air from the pump system by pumping several times before the first application. Now you can use Kamillosan according to the dosage instructions.

If you have used a larger amount of Kamillosan mouth spray than you should
you do not need to take any special precautions.

It is known that excessive inhalation of menthol-containing products can cause potentially reversible adverse effects such as vomiting, abdominal pain, drowsiness and heart problems (cardiac problems) due to volatile menthol.

4 What side effects are possible?

Like all medicines, Kamillosan can cause side effects, although not everybody gets them.

Please tell your doctor or pharmacist if any of the side effects listed significantly affect you or if you notice any side effects not listed in this leaflet.

Rare: less than 1 in 1000, but more than 1 in 10,000 people treated.
Very rare: 1 or less in 10,000 people treated, including isolated cases.

Diseases of the immune system:
(very rare) Hypersensitivity reaction to camomile, cross-reactions to allergens of composite plants (e.g. mugwort, yarrow, chrysanthemums or daisies); severe allergic reactions when applied to mucous membranes (asthma, facial oedema, circulatory collapse, allergic shock).

Diseases of the respiratory tract, chest and mediastinum:
(rare) coughing fit due to inhalation of peppermint oil (menthol).

5 How should Kamillosan Oral Spray be stored?

Keep the medicine out of the reach of children.

Do not use the medicine after the expiry date which is stated on the outer carton and the container. The expiry date refers to the last day of the month.
Kamillosan can be used for one year after the bottle has been opened for the first time.

The medicine must not be disposed of in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION

The active ingredients of 1 ml solution are
370.5 mg ethanolic chamomile flower extract (1:4.0 - 4.5), 18.5 mg peppermint oil and 7.0 mg aniseed oil. A single dose corresponds to 0.28 ml (= 2 sprays of 0.14 ml each).
The other ingredients are
Ethanol, propylene glycol, sodium dodecyl sulphate, saccharin sodium 0.6 mg, vanillin, citric acid, macrogol glycerol ricinoleate, flavourings and purified water.water.