Summary of Product Characteristics (SmPC) - Traumeel ointment
1 NAME OF THE MEDICINAL PRODUCT
Traumeel Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g contain:
Active Ingredient Final Dilution
Achillea millefolium 3 X Aconitum napellus 4 X Atropa belladonna 4 X Hepar sulfuris 9 X Matricaria recutita 2 X Mercurius solubilis Hahnemanni 9 X Symphytum officinale 7 X Bellis perennis 3X Calendula officinalis 2X Echinacea angustifolia 2X or Echinacea pallida 2X, or a mixture of both species
Echinacea purpurea 2X Hamamelis virginiana 2X Hypericum perforatum 9X Arnica montana 4X
Excipients with known effect:
Contains cetostearyl alcohol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment
Traumeel ointment is white to yellow-white.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition to relieve symptoms such as pain and swelling which may result from minor injuries such as sprains, muscular strains and bruising
4.2 Posology and method of administration
For external use only.
Posology
Adults, elderly and children over 2 years of age:
Apply a thin layer to the affected area 2 times daily and gently massage into the skin until absorbed. Can be applied up to 4 times daily if needed.
Method of Administration
The hands should be washed before and after applying the ointment.
Duration of use
If the condition worsens, or if symptoms do not improve within 7 days, a doctor or qualified healthcare practitioner should be consulted.
(See Section 4.4. Special warnings and precautions for use)
4.3 Contraindications
Hypersensitivity to the active substances, plants of the Asteraceae (Compositae) family or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Do not use on broken, sore, red or irritated skin. Avoid contact with the eyes and mucous membranes. Discontinue use if redness, irritation or dry skin occurs.
If joint pain accompanied by swelling of the joint, redness or fever occurs, a doctor should be consulted.
There is a possible risk of allergic/hypersensitivity reactions in sensitive or atopic patients. Those patients should consult their doctor before using Traumeel.
Do not exceed the stated dose.
Paediatric population
This product is not recommended for use in children under 2 years of age.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies.
The use of this product during pregnancy and lactation should be avoided unless under the guidance of a doctor.
Studies on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed. However Traumeel is not expected to have any influence on the ability to drive and use machines.
4.8 Undesirable effects
There have been a small number of post marketing reports, as shown in Table 1. The frequency of these effects is not known.
Table 1: Tabulated list of adverse reactions
| System Organ Class (SOC) | Preferred Term (PT) |
| Cardiac disorders | Tachycardia, Cardiovascular disorder |
| Ear and labyrinth disorders | Vertigo |
| General disorders and administration site conditions | Swelling, Application site eczema, Application site erythema, Application site pruritus, Feeling abnormal, Inflammation, Oedema peripheral, Fatigue, Pain |
| Infections and infestations | Application site pustules |
| Nervous system disorders | Formication, Headache, Hypoaesthesia |
| Respiratory, thoracic and mediastinal disorders | Throat tightness |
| Skin and subcutaneous tissue disorders | Erythema, Pruritus, Rash, Blister, Exanthem, Urticaria, Dermatitis contact, Skin irritation, Skin swelling, Skin burning |
If other adverse effects are experienced a doctor or pharmacist should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
No cases of overdose have been reported. Symptomatic and supportive measures should be taken as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Liquid paraffin
Cetostearyl alcohol (type A)
White soft paraffin
Water purified
Ethanol (96%)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
5 years.
Shelf-life after first opening: 12 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions. Store in the original container.
6.5 Nature and contents of container
Aluminium tubes with a protective lacquer in-and outside closed with a screw cap, in a cardboard box
Pack size: 25, 50 or 100 g ointment
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Biologische Heilmittel Heel GmbH
Dr. Reckeweg Strasse 2-4
D - 76532 - Baden Baden
Germany
Tel : 00 49 72 21 501 00
Fax : 00 49 72 21 501 485
e-mail : info@heel.de
8 MARKETING AUTHORISATION NUMBER(S)
NR 08927/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/06/2014
10 DATE OF REVISION OF THE TEXT
21/12/2015