KAMILLOSAN Wund- u.Heilbad

Important notes (mandatory information)

Kamillosan Wound and Healing Bath. Active ingredient: Extract from chamomile flowers (1 : 4.0-4.5). Areas of application: For use as compresses, rinses and baths for skin and mucous membrane inflammations. As a sitz bath for inflammatory diseases of the anal and genital area, for itching at the anal outlet (pruritus ani), for relieving discomfort from hemorrhoids, anal fissures, anal eczema and perianal eczema, after operations in the anogenital area, for aftercare of vaginal surgical wounds and episiotomies

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


Instructions for use: Information for users
Kamillosan Wound and Healing Bath
100 %
Bath additive
Chamomile flower extract

For use in adults and children aged 6 and over.
100 ml (corresponding to 97 g) contain as active ingredient: Extract from chamomile flowers (1 : 4.0-4.5) 97 g
Extraction agent: Ethanol 38.5 % (m/m) (containing 1.36 % sodium acetate trihydrate, 0.45 % sodium ascorbate and 0.41 % sodium hydroxide)
Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always 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 notice any side effects, contact 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 even worse after 3 days,contact your doctor.

What this package leaflet contains

1. WHAT IS KAMILLOSAN WOUND AND HEALING BATH AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING KAMILLOSAN WOUND AND HEALING BATH?
3. HOW TO USE KAMILLOSAN WOUND AND HEALING BATH?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE KAMILLOSAN WOUND AND HEALING BATH?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS KAMILLOSAN WOUND AND HEALING BATH AND WHAT IS IT USED FOR?

Kamillosan Wound and Healing Bath is a herbal medicine.
It is a bath additive for use in inflammatory skin conditions.
For use as compresses, rinses and baths for skin and mucous membrane inflammations.
As a sitz bath
- for inflammatory diseases of the anal and genital area
- for itching at the anal outlet (pruritus ani)
- for relieving discomfort from hemorrhoids, anal fissures, anal eczema and perianal eczema
- after operations in the anogenital area
- for aftercare of vaginal surgical wounds and episiotomies

2. WHAT SHOULD YOU CONSIDER BEFORE USING KAMILLOSAN WOUND AND HEALING BATH?

Kamillosan Wound and Healing Bath must not be used if you
are hypersensitive (allergic) to chamomile and other daisy family members, e.g. mugwort, yarrow, arnica, chrysanthemum, daisy.

Warnings and precautions
The preparation should not be used in the eye and eye area or for aerosol inhalation due to possible irritation. Chamomile preparations are not suitable for use as a bowel rinse. In individual cases, allergic reactions up to and including anaphylactic shock can occur. Also because of the alcohol (ethanol) content, the preparation should not be used for bowel irrigation.

Children
There are no adequate studies on the use of this medicine in infants and toddlers. For this reason and because of the alcohol content, Kamillosan Wound and Healing Bath should not be used in children under 6 years of age.

Use of Kamillosan Wound and Healing Bath together with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines, even if they are not prescription medicines. No interactions are known to date.

Pregnancy and breast-feeding
To date, no evidence of risks during pregnancy and breast-feeding has emerged from the widespread use of chamomile as a food and medicine. Kamillosan Wound and Healing Bath should not be used during pregnancy and breast-feeding without consulting a doctor because of the alcohol content. Kamillosan Wound and Healing Bath must be removed from the area of the nipples before breastfeeding newborns.

Driving and ability to operate machinery
No special precautions are required. Kamillosan Wound and Healing Bath contains 42.8 vol.-% alcohol.

3. HOW TO USE KAMILLOSAN WOUND AND HEALING BATH?

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.

Unless otherwise prescribed by your doctor, the usual application is

For compresses and rinses: 45 ml (1 1/2 measuring cups) per 1 liter of water.
For partial and sitz baths: 30 ml (1 measuring cup) per 1 liter of water.

The enclosed measuring cup must be used for the exact dosage of Kamillosan Wound and Healing Bath.
Kamillosan Wound and Healing Bath should usually be used 1-2 times a day. The bathing time for partial and sitz baths should not exceed 5-10 minutes.

Type of application
Kamillosan Wound and Healing Bath is used to prepare compresses, rinses, partial and sitz baths. Kamillosan Wound and Healing Bath is intended for external use only.

For compresses, the diluted solution should be applied in the form of compresses soaked with the diluted solution. The individually most pleasant temperature is recommended as the bath temperature.

Use in children
Kamillosan Wound and Healing Bath must not be used in children under 6 years of age.

Duration of use
The duration of use of Kamillosan Wound and Healing Bath depends on the type, severity and course of the disease. In principle, Kamillosan Wound and Healing Bath can be used until the symptoms subside. Please always observe the information under section 2 "What should you consider before use", as well as the information under section 4 "Side effects". If there is no improvement within 3 days, extensive inflammation or signs of bacterial infection (e.g. purulent skin lesions), a doctor should be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Kamillosan Wound and Healing Bath is too strong or too weak.

If you have used more Kamillosan Wound and Healing Bath than you should

If you have used more than you should, the side effects listed below may be more severe.

If you have forgotten to use Kamillosan Wound and Healing Bath

Do not use twice the amount if you have used too little or forgotten the previous application, but continue using as prescribed by your doctor or as described in the instructions for use.

If you have taken Kamillosan Wound and Healing Bath orally

Accidental oral ingestion of larger amounts of Kamillosan Wound and Healing Bath, especially in children, can lead to alcohol poisoning. In this case, there is a risk to life, which is why a doctor must be consulted immediately. 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 have side effects, although not everybody gets them.

Possible side effects
Hypersensitivity reactions are possible, even in people with hypersensitivity to other plants from the daisy family (daisy family, e.g. mugwort, yarrow, arnica, chrysanthemum, daisy) due to so-called cross-reactions. Severe allergic reactions (shortness of breath, facial swelling, circulatory collapse, anaphylactic shock) have been reported in the event of contact with mucous membranes, especially in the case of improper use of liquid chamomile preparations. The frequency cannot be estimated from the available data. Significant side effects or signs to watch out for, and measures to take if affected If you experience any signs such as skin redness, possibly combined with itching, please stop using Kamillosan Wound and Healing Bath and consult your doctor so that he/she can decide on the severity and any further measures that may be necessary.

Reporting of side effects
If you notice any side effects, contact your doctor or pharmacist or the medical professional. 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, Dept. 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 TO STORE KAMILLOSAN WOUND AND HEALING BATH?

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 Wound and Healing Bath should not be used for more than 12 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kamillosan Wound and Healing Bath contains

100 ml (corresponding to 97 g) contain as active ingredient: Extract from chamomile flowers (1 : 4.0-4.5) 97 g Extraction agent: Ethanol 38.5 % (m/m) (containing 1.36 % sodium acetate trihydrate, 0.45 % sodium ascorbate and 0.41 % sodium hydroxide)
Other ingredients: none

What Kamillosan Wound and Healing Bath looks like and contents of the pack
Kamillosan Wound and Healing Bath is a brownish, clear to slightly cloudy liquid. The natural flocculations or precipitations that sometimes occur in plant extracts have no influence on the effectiveness of the preparation. Kamillosan Wound and Healing Bath is available in packs of 250 ml (N1) and 500 ml (N2) bath additive.

Pharmaceutical entrepreneur and manufacturer
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Telephone (06172) 888-01
Telefax (06172) 888-2740
Email: medinfo@medapharma.de

This leaflet was last revised in August 2014.

Source: Information from the package leaflet
Status: 08/2015
Active ingredient: Extract from chamomile flowers (1 : 4.0-4.5). Areas of application: For use as compresses, rinses and baths for skin and mucous membrane inflammations. As a sitz bath for inflammatory diseases of the anal and genital area, for itching at the anal outlet (pruritus ani), for relieving discomfort from hemorrhoids, anal fissures, anal eczema and perianal eczema, after operations in the anogenital area, for aftercare of vaginal surgical wounds and episiotomies