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 containing the active ingredients of an ethanolic chamomile flower extract, peppermint oil and aniseed oil, and is intended for use in the oral cavity.

Kamillosan contains a natural chamomile extract for the treatment of catarrh in the mouth and throat and for oral hygiene. The chamomile extract contains water- and fat-soluble components which have anti-inflammatory, pain-relieving and germicidal (bacteria- and fungus-inhibiting) effects.

The aniseed oil contained in Kamillosan also has germicidal properties. Peppermint oil contains menthol as its main active ingredient, alongside menthol esters. As an alcohol, menthol exhibits pronounced germicidal effects alongside mild anaesthetic properties; it has a locally cooling effect and acts as a deodorant. The pleasant taste and local cooling effect are found to be soothing in cases of inflammatory conditions of the mouth and throat.

You can use Kamillosan for all inflammatory conditions in the oral cavity and throat, such as:
- periodontitis and gingivitis
- Discomfort following tooth extraction and during tooth replacement
- Mucosal irritation caused by dentures
- Catarrh of the mouth and throat
- As a preventative measure for disinfecting the mouth and throat, and as a mouth and throat deodorant.

2. What should you bear in mind 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 in Kamillosan mouth spray.
- if you have a known allergy to camomile or other composite flowers, to aniseed oil or its main constituent anethole, or to peppermint oil
- in infants and children under 10 years of age.

Particular caution is required when using Kamillosan mouth spray
in people with alcoholism. In this case, Kamillosan is not suitable, as the mouth spray contains 25% by volume of alcohol.

If you have not used Kamillosan for a long time, the spray nozzle may, in rare cases, become blocked. Please hold the spray nozzle briefly under warm water; do not attempt to clear the nozzle yourself.

No special precautions are required when using Kamillosan mouth spray in conjunction with other medicines.

Please inform your doctor or pharmacist if you are taking or using any other medicines, or have recently taken or used any, even if they are over-the-counter medicines.

No special precautions are required when using Kamillosan mouth spray with food and drink.

Pregnancy and breastfeeding
Always ask your doctor or pharmacist for advice before taking any medicines.
You should not use Kamillosan during pregnancy or whilst breastfeeding without medical supervision.
Chamomile has a wide range of uses in humans. To date, no evidence of risks during pregnancy or breastfeeding has been observed. Similarly, when used correctly, there are no restrictions on the use of aniseed oil during pregnancy or breastfeeding at the recommended dosage. There are no data available regarding the use of peppermint oil during pregnancy and breastfeeding.

Driving and operating machinery
Kamillosan has no effect on your ability to drive or operate machinery.

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

3. How should Kamillosan mouth spray be used?

Always use Kamillosan exactly as instructed by your doctor. Please check with your doctor or pharmacist if you are not entirely sure.

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

Do not spray into the nose.

The duration of treatment varies from person to person and depends on when the symptoms subside.

To use the spray head:
1. Please do not bend the spray tube of the spray head upwards towards you.
2. Swivel the spray tube sideways to the left or right into a horizontal position
3. Before using for the first time, remove any air from the pump system by pumping several times. You can now use Kamillosan in accordance with the dosage instructions.

If you have used more Kamillosan mouth spray than you should have
you do not need to take any special precautions.

It is known that excessive inhalation of products containing menthol may cause reversible, undesirable 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 listed side effects significantly affect you, or if you notice any side effects not listed in this leaflet.

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

Immune system disorders:
(very rare) Hypersensitivity reaction to camomile; cross-reactions to allergens from the Asteraceae family (e.g. mugwort, yarrow, chrysanthemums or daisies); severe allergic reactions following application to mucous membranes (asthma, facial oedema, circulatory collapse, anaphylactic shock).

Diseases of the respiratory tract, chest and mediastinum:
(rare) Coughing fits caused by inhalation of peppermint oil (menthol).

5. How should Kamillosan mouth spray be stored?

Keep this medicine out of the reach of children.

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

Do not dispose of this medicine in waste water or household waste. Ask your pharmacist how to dispose of this medicine when you no longer need it. This helps to protect the environment.

6. FURTHER INFORMATION

The active ingredients in 1 ml of solution are
370.5 mg of ethanolic chamomile flower extract (1:4.0 – 4.5), 18.5 mg of peppermint oil and 7.0 mg of 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, sodium saccharin 0.6 mg, vanillin, citric acid, macrogol glycerol ricinoleate, flavourings and purified water.