TRAUMEEL® PRODUCT MONOGRAPH78

12 SUMMARY OF PRODUCT CHARACTERISTICS

Compositions: Tablets: 1 tablet containing: Active ingredients: Achillea millefolium D3 15.0 mg; Aconitum napellus D3 30.0 mg; Atropa belladonna D4 75.0 mg; Hepar sulfuris D8 30.0 mg; Matricaria recutita D3 24.0 mg; Mercurius solubilis Hahnemanni D8 30.0 mg; Symphytum officinale D8 24.0 mg; Bellis perennis D2 6.0 mg; Calendula officinalis D2 15.0 mg; Echinacea D2 6.0 mg; Echinacea purpurea D2 6.0 mg; Hamamelis virginiana D2 15.0 mg; Hypericum perforatum D2 3.0 mg; Arnica montana D2 15.0 mg. Excipients: Lactose monohydrate 6.0 mg; Magnesium stearate 1.5 mg. Contains lactose! Please see package insert! Solution for Injection: 1 ampoule of 2.2 ml (= 2.2 g) contains: Active ingredients: Achillea millefolium D3 2.20 mg; Matricaria recutita D3 2.20 mg; Symphytum officinale D6 2.20 mg; Aconitum napellus D2 1.32 mg; Atropa belladonna D2 2.20 mg; Bellis perennis D2 1.10 mg; Calendula officinalis D2 2.20 mg; Echinacea D2 0.55 mg; Echinacea purpurea D2 0.55 mg; Hypericum perforatum D2 0.66 mg; Hepar sulfuris D6 2.20 mg; Mercurius solubilis Hahnemanni D6 1.10 mg; Hamamelis virginiana D1 0.22 mg; Arnica montana D2 2.20 mg. Excipients: Sodium chloride 19.4 mg, Water for injections 2179.1 mg. Ointment: 100 g containing: Active ingredients: Achillea millefolium D4 0.090 g; Aconitum napellus D4 0.050 g; Arnica montana D4 1.500 g; Atropa belladonna D4 0.050 g; Bellis perennis D4 0.100 g; Calendula officinalis D4 0.450 g; Echinacea D4 0.150 g; Echinacea purpurea D4 0.150 g; Hamamelis virginiana D4 0.450 g; Hepar sulfuris D6 0.025 g; Hypericum perforatum D6 0.090 g; Matricaria recutita D4 0.150 g; Mercurius solubilis Hahnemanni D6 0.040 g; Symphytum officinale D4 0.100 g. Excipients: Paraffin, liquid 9.342 g; Cetostearyl alcohol (type A), emulsifying 8.007 g; Paraffin, white soft 9.342 g; Water, purified 60.579 g; Ethanol (96%) 9.335 g; Preserved with 12.7 vol.-% alcohol. Gel: 100 g containing: Active ingredients: Achillea millefolium D0 0.090 g; Aconitum napellus D1 0.050 g; Arnica montana D3 1.500 g; Atropa belladonna D1 0.050 g; Bellis perennis D0 0.100 g; Calendula officinalis D0 0.450 g; Echinacea D0 0.150 g; Echinacea purpurea D0 0.150 g; Hamamelis virginiana D0 0.450 g; Hepar sulfuris D6 0.025 g; Hypericum perforatum D6 0.090 g; Matricaria recutita D0 0.150 g; Mercurius solubilis Hahnemanni D6 0.040 g; Symphytum officinale D4 0.100 g. Excipients: Water, purified 74.652 g; Ethanol (96%) 18.653 g; Carbomers (Carbopol 980NF) 1.000 g; Sodium hydroxide solution 18% (m/m) 2.300 g; Contains 24.4 vol.-% alcohol. Purified water, ethanol 96% (V/V), carbomers, sodium hydroxide solution 18% m/m. Drops: 100 g containing: Active ingredients: Aconitum napellus D3 10.0 g; Atropa belladonna D4 25.0 g; Symphytum officinale D8 8.0 g; Achillea millefolium D3 5.0 g; Calendula officinalis D2 5.0 g; Echinacea D2 2.0 g; Echinacea purpurea D2 2.0 g; Hamamelis virginiana D2 5.0 g; Hypericum perforatum D2 1.0 g; Matricaria recutita D3 8.0 g; Hepar sulfuris D8 10.0 g; Mercurius solubilis Hahnemanni D8 10.0 g; Arnica montana D2 5.0 g; Bellis perennis D2 2.0 g. Excipients: Water, purified 2.0 g; Contains 35 vol.-% alcohol. Indications: Tablets, Solution for Injection, Ointment, Gel, Drops: The medicinal product is used for the treatment of various inflammatory conditions including injuries, especially of the musculoskeletal system. 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. Side effects: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. Tablets: In isolated cases transient skin reactions have been reported. Solution for Injection: In isolated cases transient allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) have been reported. Ointment: In isolated cases transient skin reactions have been reported. Gel: In isolated cases transient skin reactions (eg. rash, itchiness) have been reported. Drops: In isolated cases transient allergic skin reactions have been reported. Interactions with other medication: Tablets: None have been reported, and none are expected due to the homeopathic dilutions. Solution for Injection, Drops: No interactions have been reported, and none are expected due to the homeopathic dilutions. Ointment, Gel: No interactions have been reported, and none are expected due to the homeopathic dilutions and external use. Pregnancy and lactation: For this product no clinical data on pregnancy and lactation are available. Homeopathic dilutions of the substances present in this medicinal product are not known to be harmful during pregnancy and lactation. No adverse effects have so far been reported.

TRAUMEEL® FORMULATIONS AND DOSING RECOMMENDATIONS Traumeel®: Tablets Solution for Injection Ointment Gel Drops

This is the master version of the Traumeel® Summary of Product Characteristics (SmPC). For local adaptation and approval, please refer to your local Traumeel® SmPC.