KAMILLOSAN

KAMILLOSAN Concentrate

Important notes (mandatory information)

Kamillosan Concentrate, liquid. Areas of application: for inhalation in the case of inflammatory diseases and irritation of the respiratory tract, as an additive for moist compresses, rinses or washes in the case of inflammatory skin and mucous membrane diseases including the oral cavity and gums, as an additive to partial and sitz baths or rinses in the case of inflammations in the anal area and in the genital area and for ingestion in the case of spasmodic and inflammatory diseases in the gastrointestinal tract. Warning: Contains 42.8% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR USERS

Kamillosan Concentrate, liquid for use in adults and children aged 6 and over
Active ingredients: camomile flower extract 98.91g + camomile oil 0.19 g/100 g

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as instructed 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 notice any side effects, consult your doctor or pharmacist or the medical professional. 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 7 days, consult your doctor.

What this package leaflet contains

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

1. WHAT IS KAMILLOSAN CONCENTRATE AND WHAT IS IT USED FOR?

Kamillosan Concentrate is a herbal medicine for use in gastrointestinal complaints, in inflammations in the mouth and throat, in catarrhal diseases of the upper respiratory tract and for external use in inflammatory skin changes. Kamillosan Concentrate is used for inhalation in the case of inflammatory diseases and irritation of the respiratory tract, as an additive for moist compresses, rinses or washes in the case of inflammatory skin and mucous membrane diseases including the oral cavity and gums, as an additive to partial and sitz baths or rinses in the case of inflammations in the anal area and in the genital area and for ingestion in the case of spasmodic and inflammatory diseases in the gastrointestinal tract.

2. WHAT SHOULD YOU CONSIDER BEFORE USING KAMILLOSAN CONCENTRATE?

Kamillosan Concentrate must not be used if you are allergic to camomile and other composite plants, e.g. mugwort, yarrow, arnica, chrysanthemum, daisy and/or one of the other ingredients of Kamillosan Concentrate listed in section 6. Not for ingestion, mouthwash and inhalation in the case of alcoholism. Do not use in children under 6 years of age.

Warnings and precautions

Due to its alcohol content, Kamillosan Concentrate should only be used internally after consultation with a doctor in the case of liver disease, epilepsy and brain damage. Camomile preparations are not suitable for use as a bowel irrigation. In individual cases, allergic reactions up to and including anaphylactic shock can occur. Also because of the alcohol content (ethanol), the preparation should not be used for bowel irrigation. Kamillosan Concentrate should not be used directly in the eye area because of possible irritation. Inhalation should only be carried out by means of steam inhalation, not with nebulisers.

Children

There are no sufficient studies on the use of this medicine in children and infants. Children under 6 years of age must not use Kamillosan Concentrate. Due to the alcohol content of Kamillosan Concentrate, it is particularly important to ensure correct dilution when used internally in children aged 6 and over. Only give Kamillosan Concentrate to children under 12 years of age after consulting a doctor.

Use of Kamillosan Concentrate together with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or intend to take other medicines, even if they are non-prescription medicines. The alcohol content in Kamillosan Concentrate can impair or enhance the effect of other medicines.

Pregnancy and breast-feeding

To date, no evidence of risks during pregnancy and breast-feeding has emerged from the widespread use of camomile as a food and medicine. Due to its alcohol content, Kamillosan Concentrate should not be used during pregnancy and breast-feeding without consulting a doctor. Before breast-feeding, Kamillosan Concentrate must be removed from the area of the nipples. Ask your doctor or pharmacist for advice before using any medicine.

Driving and operating machinery

No special precautions are required.

Kamillosan Concentrate contains macrogolglycerol hydroxystearate, which can cause stomach upset and diarrhoea when ingested and irritation when applied to the skin and mucous membranes. Kamillosan Concentrate contains 42.8% alcohol by volume. If the dosage instructions are followed, up to 2 g of alcohol are consumed with each dose (5 ml). A health risk exists, among other things, for people with liver disease, alcoholics, epileptics, people with brain damage, pregnant women and children.

3. HOW IS KAMILLOSAN CONCENTRATE USED?

Always 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.

Type of use:

• For inhalation: Inhale 20 ml of Kamillosan Concentrate in approx. 1 litre of hot water 1 to several times a day for 10 minutes.
• For mouthwash and gargling: 5 ml in 1 glass (100 ml) of warm water 3 times or several times a day as required.
• For compresses, washes and rinses: 45 ml (1½ measuring cups) in 1 litre of water 1 to several times a day.
• For sitz and partial baths: 30 ml (1 measuring cup) in 1 litre of water 1 to several times a day.
• For ingestion: Up to 4 times a day in 1 cup (100 ml) of warm water: Adults: 5 ml,

  Children

  Children aged 6 — 12: 3 — 4 ml. Children over 12 years of age: 5 ml. Children under 12 years of age must not take Kamillosan Concentrate without medical advice.

It is essential to ensure correct dilution. A dosing aid (35 ml) is enclosed with the 30 ml pack size for use of the correct dose and a measuring cup (530 ml) is enclosed with the 100 ml, 250 ml and 1000 ml pack sizes.

Use in children

There are no sufficient studies on the use of this medicine in children and infants, therefore Kamillosan Concentrate must not be used in children under 6 years of age.

How should you use Kamillosan Concentrate + Inhaler?
When using the Kamillosan Inhaler, ensure that the hook lock is securely in place. Only transport the filled device by the handles. Ensure that the inhaler is standing securely (risk of scalding)! Do not allow children to inhale without supervision! Inhalation should only be carried out by means of steam inhalation.

Duration of use

The duration of use of Kamillosan Concentrate depends on the type, severity and course of the disease. Kamillosan Concentrate can generally be used until the symptoms subside. Please also refer to the information in section 2 "What should you consider before use" and the information in section 4 "Side effects". If there is no improvement within 7 days or if symptoms recur periodically, if there are large-scale inflammations or if there are purulent skin changes, a doctor should be consulted immediately.

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

If you have used more Kamillosan Concentrate than you should

Accidental oral ingestion of larger amounts of Kamillosan Concentrate can lead to alcohol poisoning in children. In this case, there is a risk to life, which is why a doctor must be consulted immediately. If you experience any symptoms, please talk to your doctor or pharmacist.

If you forget to use Kamillosan Concentrate

Do not use twice the amount if you have forgotten to use it before. Continue treatment as prescribed or as described in this package leaflet.

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.

Possible side effects

Hypersensitivity reactions are possible, even in people with hypersensitivity to other plants from the composite family (composite plants, e.g. mugwort, yarrow, arnica, chrysanthemum, daisy) due to so-called cross-reactions. Severe allergic reactions (shortness of breath, swelling of the face, circulatory collapse, anaphylactic shock) have been reported in the case of contact with mucous membranes, especially in the case of improper use of liquid camomile preparations. The frequency cannot be estimated on the basis of the available data.

Significant side effects or signs to watch out for, and measures to be taken if affected

If you experience any signs such as skin redness, possibly combined with itching, please stop using Kamillosan Concentrate and contact your doctor immediately.

Reporting of side effects

If you notice any side effects, consult 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 to provide more information on the safety of this medicine.

5. HOW SHOULD KAMILLOSAN CONCENTRATE 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 container and the folding box. 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: Kamillosan Concentrate should not be used for longer than 12 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kamillosan Concentrate contains

100 g of liquid contain as active ingredients: Extract (1:4.04.5) from camomile flowers: Camomile ray florets (both Matricaria recutita L.) (4.7:1) 98.91 g Extractant: Ethanol 38.5% (m/m) (containing 1.36% sodium acetate trihydrate, 0.45% sodium ascorbate and 0.41% sodium hydroxide), camomile oil 0.19 g. The other ingredients are: Macrogolglycerol hydroxystearate, dissolved in ethanol 96%.

What Kamillosan Concentrate looks like and contents of the pack

Kamillosan Concentrate is a brownish, clear to slightly cloudy liquid with a characteristic camomile smell. The natural flocculation or precipitation that sometimes occurs in plant extracts has no influence on the effectiveness of the preparation. Kamillosan Concentrate is available in bottles containing 30 ml, 100 ml (N1), 250 ml (N2) and 1000 ml of Kamillosan Concentrate and in 100 ml (N1) of Kamillosan Concentrate + Inhaler.

Pharmaceutical entrepreneur and manufacturer

MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Telephone (06172) 88801
Telefax (06172) 8882740
Email: medinfo@medapharma.de

This package leaflet was last revised in October 2015.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for inhalation in the case of inflammatory diseases and irritation of the respiratory tract, as an additive for moist compresses, rinses or washes in the case of inflammatory skin and mucous membrane diseases including the oral cavity and gums, as an additive to partial and sitz baths or rinses in the case of inflammations in the anal area and in the genital area and for ingestion in the case of spasmodic and inflammatory diseases in the gastrointestinal tract. Warning: Contains 42.8% alcohol by volume!