pack insert

WALA Heilmittel GmbH 73087 Bad Boll/Eckwälden
Translation of the compulsory information of the Patient Information Leaflet compliant with
the requirements of the German Drug Law
Pati
e nt i
nform ati
on le afle t
Akne-Wasser
Cutaneous liquid
Anthroposophical medicinal product for use in acne
Indications
according to the anthroposophical understanding of humankind and nature.
Indications include:
Harmonisation of the astral organisation in the skin in circumscribed purulent-inflammatory
conditions, e.g. acne vulgaris, excessive secretion from the sebaceous glands (seborrhoea).
Contraindications:
This preparation should not be used in the case of hypersensitivity to any of the active
substances or excipients or to other plants of the Compositae family.
In principle, Akne-Wasser must not be used in progressive systemic diseases such as
tuberculosis, leukoses (leukaemia or leukaemoid diseases), collagen diseases (inflammatory
diseases of the connective tissue), multiple sclerosis, AIDS, HIV infection (infection with the
AIDS virus), chronic viral diseases or autoimmune diseases (diseases against the body‘s
own tissue).
Precautions for use and warnings:
In the case of persisting or unclear complaints, a doctor must be consulted.
Sufficiently documented experience for the use of this medicinal product in children is not
available. Therefore it should only be used in children under 10 years of age following a
consultation with a doctor.
What must be observed during pregnancy and lactation?
As all medicinal products, Akne-Wasser should only be used during pregnancy and lactation
following a consultation with a doctor.
Contains 15% alcohol by volume.
Interactions with other medicines: None known.
Dosage and method of administration:
Unless otherwise directed, apply undiluted with a cotton-wool ball twice daily and allow to
soak into the skin.
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WALA Heilmittel GmbH 73087 Bad Boll/Eckwälden
Duration of use:
The treatment duration of chronic conditions requires a consultation with a doctor.
Side effects:
Very rarely hypersensitivity reactions may occur. Skin rashes, itching, rarely swelling of the
face, shortness of breath, dizziness and fall in blood pressure have been observed for
medicinal products containing formulations of purple coneflower.
In such cases you should stop using this medicinal product and consult your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or a medical professional. This
includes any possible side effects not listed in this leaflet. You can also report side effects
directly via
Bundesinstitut für Arzneimittel und Medizinprodukte
Abt. Pharmakovigilanz
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.
Do not use this medicinal product after the expiry date stated on the recipient and the outer
packaging.
Use within 6 months after opening.
Composition:
10 g (10.2 ml) contain:
Active substances:
Aesculus hippocastanum e cortice, Decoctum LA 10% (HAB, Method 12k)
0.30 g
Anthyllis vulneraria ex herba LA 20% (HAB, Method 12c)
0.75 g
Bellis perennis ex herba LA 20% (HAB, Method 12c)
0.15 g
Calendula officinalis e floribus LA 20% (HAB, Method 12c)
0.75 g
Cutis feti bovis Gl Dil. D5 (HAB, Method 41b)
0.10 g
Echinacea pallida ex herba LA 20% (HAB, Method 12c)
0.25 g
Funiculus umbilicalis bovis Gl Dil. D5 (HAB, Method 41b)
0.10 g
Glandulae suprarenales bovis Gl Dil. D5 (HAB, Method 41a)
0.10 g
Placenta bovis Gl Dil. D5 (HAB, Method 41b)
0.10 g
Tropaeolum majus ex herba LA 20% (HAB, Method 12c)
0.50 g
(The ingredients 5 and 7-9 are potentised together in two steps.)
Excipients: Ethanol 94% (m/m), lactic acid, sodium chloride, sodium hydrogen carbonate,
purified water.
Dosage form and package size: 100 ml cutaneous liquid
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This document is the property of WALA Heilmittel GmbH. It may not be reproduced in part or in its entirety without permission.
WALA Heilmittel GmbH 73087 Bad Boll/Eckwälden
Pharmaceutical Company/Manufacturer:
WALA Heilmittel GmbH
73085 Bad Boll/Eckwälden
GERMANY
Telephone: +49 (0)7164 930-0
Fax: +49 (0)7164 930-297
info@wala.de
www.wala.de
Last updated: 08/2013
Shake before use!
Due to the processing of natural substances, Akne-Wasser may develop a slight cloudiness
or precipitation.
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This document is the property of WALA Heilmittel GmbH. It may not be reproduced in part or in its entirety without permission.