KAMILLOSAN

KAMILLOSAN ointment

Important notes (mandatory information)

Kamillosan Ointment. Active ingredient: Chamomile flower dry extract. Areas of application: for skin and mucous membrane inflammations. The ointment is also suitable for use in the anal and genital area, including for the treatment of hemorrhoids.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kamillosan Ointment, for use in infants from 4 weeks, children and adults
Active ingredient: Chamomile flower dry extract 4.3 mg/g, 1 g of ointment contains as active ingredient: Dry extract from chamomile flowers (15-25:1) 4.3 mg Extractant: Ethanol 95.4% (V/V), (containing 0.22% sodium acetate trihydrate and 0.12% sodium hydroxide)
Herbal medicinal product

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you. 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 is in this package leaflet

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

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

Kamillosan Ointment is a herbal medicinal product for external use in inflammatory skin and mucous membrane changes. Kamillosan Ointment is used for skin and mucous membrane inflammations. The ointment is also suitable for use in the anal and genital area, including for the treatment of hemorrhoids.

2. WHAT SHOULD YOU CONSIDER BEFORE USING KAMILLOSAN OINTMENT?

Kamillosan Ointment must not be used if you are hypersensitive (allergic) to:

• Chamomile and other composite flowers, e.g. mugwort, yarrow, arnica, chrysanthemum, daisy
• Wool wax
• or any of the other ingredients of Kamillosan Ointment.

Warnings and precautions

Do not use Kamillosan Ointment in the eye area due to the risk of irritation. If there is no improvement within 3 days or if there are signs of a bacterial infection (e.g. purulent skin changes), a doctor should be consulted. Note: If you treat the genital or anal area with Kamillosan Ointment, the auxiliary substance Vaseline may reduce the tear resistance of condoms made of latex when used at the same time. The safety of condoms may be impaired as a result.

Children

Kamillosan Ointment is not recommended for infants under 4 weeks due to insufficient studies in newborns.

Use of Kamillosan Ointment together with other medicines

Inform your doctor or pharmacist if you are using, have recently used or intend to use other medicines, even if they are non-prescription medicines. No interactions with other medicines are known to date.

Pregnancy and breast-feeding

Do not use Kamillosan Ointment on the nipples during breast-feeding. Ask your doctor or pharmacist for advice before using any medicine.

Driving and operating machinery

No special precautions are required.

Kamillosan Ointment contains wool wax and butylhydroxytoluene, which can cause localized skin irritation (e.g. contact dermatitis). Butylhydroxytoluene can also cause irritation to the eyes and mucous membranes.

3. HOW TO USE KAMILLOSAN OINTMENT?

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, use as follows: Apply thinly to the affected skin/mucous membrane areas several times a day.

Duration of use

The duration of use depends on the type, severity and course of the disease. Do not use Kamillosan Ointment for more than 14 days without medical advice. If there is no improvement within 3 days or if there are signs of a bacterial infection (e.g. purulent skin changes), a doctor should be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Kamillosan Ointment is too strong or too weak.

If you have used more Kamillosan Ointment than you should

No case of overdose has been reported in connection with the use of Kamillosan Ointment.

If you forget to use Kamillosan Ointment

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

If you have any further questions about 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 Compositae family (composite flowers, e.g. mugwort, yarrow, arnica, chrysanthemum, daisy) due to so-called cross-reactions or in case of hypersensitivity to ingredients of the ointment base (see section 2 "Contraindications" and section 6 "Other ingredients"). Severe allergic reactions (shortness of breath, swelling of the face, circulatory collapse, allergic 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 be taken if you are affected

If you experience any of the above symptoms, please stop using Kamillosan Ointment and contact your doctor immediately.

Reporting of side effects

If you get 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, 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 about the safety of this medicine.

5. HOW TO STORE KAMILLOSAN OINTMENT?

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: Do not store above 30°C. Note on shelf life after opening: Kamillosan Ointment should not be used for more than 12 months after opening the tube.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kamillosan Ointment contains

1 g of ointment contains as active ingredient: Dry extract from chamomile flowers (15-25:1) 4.3 mg Extractant: Ethanol 95.4% (V/V) (containing 0.22% sodium acetate trihydrate and 0.12% sodium hydroxide). The other ingredients are: Highly dispersed silicon dioxide, wool wax (contains butylhydroxytoluene), yellow Vaseline, glycerol, purified water, perfumes.

What Kamillosan Ointment looks like and contents of the pack

Kamillosan Ointment is a yellowish to pale greenish ointment. Kamillosan Ointment is available in aluminium tubes containing 20g, 40g and 100g.

Pharmaceutical entrepreneur and manufacturer

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

This package leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Chamomile flower dry extract. Areas of application: for skin and mucous membrane inflammations. The ointment is also suitable for use in the anal and genital area, including for the treatment of hemorrhoids.