79SUMMARY OF PRODUCT CHARACTERISTICS

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. Dosage: Tablets: Unless otherwise prescribed: Standard dosage: Adults (and children 12 yrs. and older): 1 tablet 3× daily. Pediatric: below 2 yrs.: 1 tablet 1× daily. 2 5 yrs.: 1 tablet 1 2× daily. 6 11 yrs.: 1 tablet 2× daily. Acute or initial dosage: Adults (and children 12 yrs. and older): 1 tablet every ½ to1 hr., up to 12× daily, and then continue with standard dosage. Pediatric: below 2 yrs.: 1 tablet every 1 to 2 hrs., up to 4× daily, and then continue with standard dosage. 2 5 yrs.: 1 tablet every 1 to 2 hrs., up to 6× daily, and then continue with standard dosage. 6 11 yrs.: 1 tablet every 1 to 2 hrs., up to 8× daily, and then continue with standard dosage. Method of administration: Preferably allow the tablet to dissolve in the mouth, and then swallow. For children it is possible to crush the tablet and add to a small amount of water. This medicine should be taken away from meals. Solution for Injection: unless otherwise prescribed: Standard dosage: Adults (and children 12 yrs. and older): 1 ampoule 1 to 3× weekly. Pediatric: 2 5 yrs.: ½ ampoule 1 to 3x weekly. 6 11 yrs.: ⅔ of an ampoule 1 to 3× weekly. Acute or initial dosage: Adults (and children 12 yrs. and older): 1 ampoule daily, and then continue with standard dosage. Pediatric: 2 5 yrs.: ½ ampoule daily, and then continue with standard dosage. 6 11 yrs.: ⅔ of an ampoule daily, and then continue with standard dosage. Method of administration: Solution for Injection: may be administered by the s.c., i.a., i.d., i.m. or i.v. route. Ointment, Gel: Unless otherwise prescribed: Standard dosage: Adults (and children 12 yrs. and older): apply 2× daily, or more often if needed. Paediatric: below 2 yrs.: apply 2× daily, or more often if needed. 2 5 yrs.: apply 2× daily, or more often if needed. 6 11 yrs.: apply 2× daily, or more often if needed. Method of administration: for external use only. Apply generously to the affected area. Traumeel® may be applied using mild compression bandaging and/or occlusive bandaging. Drops: unless otherwise prescribed: Standard dosage: Adults (and children 12 yrs. and older): 10 drops 3× daily. Pediatric: below 2 yrs.: 3 drops 3× daily. 2 5 yrs.: 5 drops 3× daily. 6 11 yrs.: 7 drops 3× daily. Acute or initial dosage: Adults (and children 12 yrs. and older): 10 drops every ½ to 1 hr., up to 12× daily, and then continue with standard dosage. Pediatric: below 2 yrs.: 3 drops every ½ to 1 hr., up to 12× daily, and then continue with standard dosage. 2 5 yrs.: 5 drops every ½ to 1 hr., up to 12× daily, and then continue with standard dosage. 6 11 yrs.: 7 drops every ½ to 1 hr., up to 12× daily, and then continue with standard dosage. Method of administration: This medicine should be taken away from meals. For children, add drops to a small amount of water. Duration of use: Tablets, Solution for Injection, Drops: As this product contains Echinacea, individual evaluation is recommended before prescribing this product for periods longer than 8 weeks. Overdose: Tablets, Solution for Injection, Drops: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Ointment, Gel: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions and external use. Package sizes: Tablets: Packs containing 50 and 250 tablets. (9753) Solution for Injection: Packs containing 5, 10, 50 and 100 ampoules of 2.2 ml. (8561) Ointment: Tubes containing 50 and 100 g of ointment. (9932). Gel: Tubes containing 50 and 100 g of gel. (9934) Drops: Drop bottles containing 30 and 100 ml. (9804).

Version 2016