pack insert - WALA Arzneimittel

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
Echinacea Mund- und Rachenspray
Anthroposophical medicinal product for use in inflammation of the mouth and throat
Indications
according to the anthroposophical understanding of humankind and nature.
Indications include:
Harmonisation of the astral organisation in the oropharyngeal region in acute and chronic
inflammatory conditions of the mucous membranes and the tonsils and in lymphatic
diathesis.
Contraindications:
In principle, Echinacea Mund- und Rachenspray should not be used in children under 4
years of age.
What must be observed during pregnancy?
Due to the component sage, Echinacea Mund- und Rachenspray should not be used during
pregnancy.
This medicinal product should not be used in the case of hypersensitivity to donor animal
protein, any of the active substances or excipients or to other plants of the Compositae
family.
In principle, Echinacea Mund- und Rachenspray may not be used in progressive systemic
diseases such as tuberculosis, leukoses (leukaemia or leukamoid diseases), collagen
diseases (inflammatory diseases of the connective tissue), multiple sclerosis, AIDS, HIV
infection (infection with the AIDS virus), chronic viral diseases and autoimmune diseases
(diseases against the body‘s own tissue).
Precautions for use and warnings:
In the case of visible pus on the tonsils accompanied by recurrence of an often one-sided
sore throat, difficulty opening the mouth and fever, if there are inflamed joints or in the case
of any other persisting or unclear complaints, a doctor must be consulted.
What must be observed during lactation?
Due to the component sage, Echinacea Mund- und Rachenspray should only be used during
lactation following a consultation with a doctor.
Contains 18% alcohol by volume
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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
Interactions with other medicines: None known.
Dosage and method of administration:
Unless otherwise directed, apply the spray to the gums, tonsils or lymphatic ring twice a
week, in acute cases up to twice daily, spraying 2 to 3 times per application.
Duration of use:
The treatment of an acute condition should be completed after 2 weeks. If no improvement
occurs within 2 to 5 days, a doctor must be consulted.
Echinacea Mund- und Rachenspray should not be used for longer than 2 weeks.
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 after
using preparations containing formulations of pale 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.
Composition:
10 g of oromucosal spray, solution contain:
Active substances:
Argentum nitricum Dil. D13 aquos. (HAB, Method 5b)
Calendula officinalis e floribus LA 20% (HAB, Method 12c)
Echinacea pallida ex herba LA 20% (HAB, Method 12c)
Eucalyptus globulus e foliis ferm 33d Dil. D1 (HAB, Method 33d)
Gingiva bovis Gl Dil. D4 (HAB, Method 41b)
Gingiva bovis Gl Dil. D8 (HAB, Method 41b)
Salvia officinalis e foliis LA 20% (HAB, Method 12c)
Tonsillae palatinae bovis Gl Dil. D4 (HAB, Method 41a)
Tonsillae palatinae bovis Gl Dil. D8 (HAB, Method 41a)
0.1 g
1.0 g
1.0 g
0.1 g
0.1 g
0.1 g
1.0 g
0.1 g
0.1 g
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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
(The ingredients 1, 6 and 9 are potentised together in three steps, the ingredients 1, 4-6, 8
and 9 the last step.)
Excipients: Ethanol 96%, carbon dioxide as propellant, sodium chloride, sodium hydrogen
carbonate, purified water.
Dosage form and package size: 50 ml oromucosal spray, solution
Pharmaceutical Company/Manufacturer:
WALA Heilmittel GmbH
73085 Bad Boll/Eckwälden
GERMANY
Telephone: +49 (0)7164 930-0
Fax: +49 (0)7164 930-297
[email protected]
www.wala.de
Last updated: 10/2013
Container is under pressure. Flammable! Protect from exposure to sunlight and temperatures
above 50 °C. Do not open by force or burn even when empty. Do not spray into open flame
or on to very hot surfaces. Keep away from ignition sources – do not smoke.
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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.