KAMILLAN

KAMILLAN liquid

Important notes (mandatory information)

Kamillan, liquid. Active ingredient: camomile flower-yarrow herb extract. Areas of application: to support gastrointestinal function; to support skin function; to support the function of the mucous membranes in the mouth and throat area. Warning: Contains 50% alcohol by volume!

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kamillan, liquid for internal use in adults, for external use and application to the mucous membrane in adults and adolescents aged 12 and over
Active ingredient: camomile flower-yarrow herb extract
Traditional herbal medicinal product

Read the entire package leaflet carefully before you start taking/using this medicine, because it contains important information. Always take/use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 5 days, consult your doctor.

What this package leaflet contains

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

1. WHAT IS KAMILLAN AND WHAT IS IT USED FOR?

Kamillan is a traditional herbal medicinal product used to support gastrointestinal function; to support skin function; to support the function of the mucous membranes in the mouth and throat area. This medicine is a traditional medicinal product that is registered exclusively on the basis of long-standing use for the area of application. If symptoms of illness such as gastrointestinal complaints that persist for a longer period of time or recur periodically, as well as inflammation or open injuries to the skin or mucous membranes occur, a doctor should be consulted. If you do not feel better or if you feel worse after 5 days, consult your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING/USING KAMILLAN?

Kamillan must not be taken/used if you are allergic to camomile, yarrow or other members of the daisy family as well as any of the other ingredients of this medicine listed in section 6. Camomile preparations are not suitable for use on the eyes or as a bowel wash.

Warnings and precautions

Please talk to your doctor or pharmacist before taking/using Kamillan.

Special care should be taken when taking/using Kamillan

If symptoms persist or recur for more than 5 days, a doctor should be consulted. If the skin or mucous membrane changes (redness, swelling or pain) or the general condition changes, a doctor should also be consulted. During internal use of Kamillan, you should refrain from additional alcohol consumption.

Children

Kamillan should not be used externally or on the mucous membrane in children under 12 years of age, as there is insufficient research available. Kamillan should not be taken by children and adolescents under 18 years of age, as there is insufficient data for internal use.

Taking/using Kamillan together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Studies with Kamillan on interactions with other medicines have not been conducted.

Pregnancy and breast-feeding

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 taking/using this medicine. Safety during pregnancy and breast-feeding has not been sufficiently studied. Taking during pregnancy and breast-feeding is not recommended.

Driving and using machines

No special precautions are required.

Kamillan contains alcohol and macrogolglycerol hydroxystearate (Ph. Eur.)

This medicine contains 50% alcohol by volume. If the dosage instructions are followed, up to 2.0 g of alcohol are consumed with each dose (2.5-5 ml of Kamillan with the measuring cup). A health risk exists, among others, for people with liver disease, alcoholics, epileptics, patients with organic brain disease, pregnant women, breast-feeding women and children. The effect of other medicines may be impaired or enhanced. Macrogolglycerol hydroxystearate (Ph. Eur.) can cause irritation when applied to the skin and mucous membranes and gastrointestinal upset and diarrhoea when ingested.

3. HOW SHOULD KAMILLAN BE TAKEN/USED?

Always take/use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is

Usual dose for adults and adolescents aged 12 and over:

• Gargling: to support the function of the mucous membranes in the mouth and throat area: 5 ml of Kamillan with the measuring cup in a glass of lukewarm water (approx. 150 ml) several times a day as needed.
• Brushing the gums and skin: to support the function of the mucous membranes in the mouth and throat area and to support skin function: apply a few drops of Kamillan diluted in water with a brush or cotton swab.
• Skin rinses, partial baths, compresses: to support skin function: approx. 7.5-15 ml with the measuring cup in 1 litre of lukewarm water.

Use in children under 12 years of age is not recommended.

Usual dose for adults:

• For oral administration: to support gastrointestinal function: 1-3 times a day approx. 2.5-5 ml of Kamillan with the measuring cup in water or tea.

Use in adolescents under 18 years of age is not recommended.

People with impaired liver or kidney function

There is insufficient data for specific dosage recommendations in the case of impaired liver or kidney function.

Duration of use:

• Internal use: The duration of use is limited to 2 weeks. Please observe the information under Precautions.
• External use: Kamillan should not be used externally for more than 1 week at a time, as it can dry out the skin and cause non-specific irritation due to its alcohol content.

Please talk to your doctor or pharmacist if you have the impression that the effect of Kamillan is too strong or too weak.

If you have taken/used more Kamillan than you should

In the event of accidental overdose, treatment can be continued with the correct dosage if no symptoms occur. If symptoms occur, a doctor should be consulted.

If you forget to take/use Kamillan

Do not take/use twice the amount to make up for a forgotten dose. You can continue treatment with the correct dosage.

If you stop taking/using Kamillan

Treatment can be interrupted or ended prematurely.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Not known (frequency cannot be estimated from the available data)

Allergic reactions may occur, including hypersensitivity to other members of the daisy family, up to and including severe allergic reactions (asthma, circulatory collapse, anaphylactic shock).

Reporting of side effects

If you experience 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, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD KAMILLAN BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "Use by:". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening: The shelf life after opening is 6 months. Preparations derived from plants tend to become cloudy or flocculate during prolonged storage, especially when exposed to temperature fluctuations. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kamillan contains

The active ingredient is: extract of camomile flowers and yarrow herb. 10 ml (equivalent to 9.4 g) of liquid contain: 10 ml of extract (1:5.5-5.9) from a mixture of camomile flowers and yarrow herb in a ratio of 2.4:1, extraction agent: ethanol 96 % : Purified water : 10 % ammonia solution : Macrogolglycerol hydroxystearate (52.1:50.8:1:0.25).

What Kamillan looks like and contents of the pack

The brown to brown-green liquid is available in brown glass bottles with a dropper, screw cap and measuring cup in 10 ml, 50 ml, 100 ml, 200 ml and 1000 ml only in pharmacies. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Tel.: +49 30 71094-4200
Fax: +49 30 71094-4250

This package leaflet was last revised in May 2016.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: camomile flower-yarrow herb extract. Areas of application: to support gastrointestinal function; to support skin function; to support the function of the mucous membranes in the mouth and throat area. Warning: Contains 50% alcohol by volume!