59CLINICAL SAFETY

DRUG INTERACTIONS

Traumeel® is not known to interact with any other medications or with any laboratory tests. Systemic use of Traumeel®, via either oral or parenteral administration, can be safely augmented by the application of Traumeel® in a topical dosage form.

CONTRAINDICATIONS

Tablets, Solution for Injection, Gel, Drops: Known allergy (hypersensitivity) to one or more of the ingredients, including plants of the daisy family (Asteraceae) such as Arnica montana (arnica), Calendula officinalis (pot marigold), Chamomilla recutita (chamomile), Echinacea (coneflower), Achillea millefolium (yarrow), Bellis perennis (daisy). Ointment: Known allergy (hypersensitivity) to one or more of the ingredients, including plants of the daisy family (Asteraceae) such as Arnica montana (arnica), Calendula officinalis (pot marigold), Chamomilla recutita (chamomile), Echinacea (coneflower), Achillea millefolium (yarrow), Bellis perennis (daisy) and emulsifying cetylstearyl alcohol.

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Tablets: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. As this product contains Echinacea, individual evaluation is recommended before prescribing this product in patients with immune system dysfunction, e.g. cases of progressive systemic disorders, autoimmune diseases, immunodeficiencies, immunosuppression and diseases of the white blood cell system. Solution for Injection: As this product contains Echinacea, individual evaluation is recommended before prescribing this product in patients with immune system dysfunction, e.g. cases of progressive systemic disorders, autoimmune diseases, immunodeficiencies, immunosuppression and diseases of the white blood cell system. Ointment: Cetylstearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Avoid contact with eyes, mucosae, open wounds or broken skin. Gel: Avoid contact with eyes, mucosae, open wounds or broken skin. Drops: This medicinal product contains 35 vol.-% ethanol (alcohol). As this product contains Echinacea, individual evaluation is recommended before prescribing this product in patients with immune system dysfunction, e.g. cases of progressive systemic disorders, autoimmune diseases, immunodeficiencies, immunosuppression and diseases of the white blood cell system.

Effects on ability to drive and use machines Tablets, Solution for Injection: No effects on the ability to drive and use machines have been reported, and none are expected due to the homeopathic dilutions. Ointment, Gel: Not applicable. Drops: This medicinal product has no or negligible influence on the ability to drive and use machines.