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Echinacea compositum Summary of Product Characteristics

Tablets Injection solution Compositions: Tablets: 1 tablet contains: Active ingredients: Bryonia D4 0.3 mg, Echinacea D2 0.9 mg, Lachesis D10 0.3 mg, Matricaria recutita D6 0.3 mg, Phytolacca americana D4 0.3 mg, Rhus toxicodendron D4 0.3 mg, Thuja occidentalis D4 0.3 mg, Hepar sulfuris D8 0.3 mg. Excipients: Lactose monohydrate 299.7 mg, Magnesium stearate 1.5 mg. Injection solution: 1 ampoule = 2.2 g contains: Active ingredients: Acidum arsenicosum D8 22 mg, Aconitum napellus D3 22 mg, Argentum nitricum D8 22 mg, Arnica montana D4 22 mg, Baptisia tinctoria D4 22 mg, Bryonia D6 22 mg, Cortisonum aceticum D13 22 mg, Echinacea D5 22 mg, Eupatorium perfoliatum D6 22 mg, Euphorbium D6 22 mg, Gelsemium sempervirens D6 22 mg, Hepar sulfuris D10 22 mg, Hydrargyrum bichloratum D8 22 mg, Lachesis D10 22 mg, Phosphorus D8 22 mg, Phytolacca americana D6 22 mg, Pulsatilla pratensis D8 22 mg, Rhus toxicodendron D4 22 mg, Sanguinaria canadensis D5 22 mg, Sulfur D8 22 mg, Thuja occidentalis D8 22 mg, Zincum metallicum D10 22 mg. Excipients: Sodium chloride 18.5 19.7 mg, Water for injections 1716 mg. Indications: Tablets, Injection solution: Stimulation of the body s intrinsic defense system in cases of inflammations and infections of all tissues and organs. Contraindications: Tablets, injection solution: Known allergy (hypersensitivity) to one or more of the ingredients. 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. Injection solution: None. Side effects: Tablets, injection solution: None have been reported. Interactions with other medication: Tablets, injection solution: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Tablets, injection solution: For this product no clinical data on pregnancy and lactation are available. Homeopathic dilutions of the substances present in this medicament are not known to be toxic during pregnancy and lactation. No adverse effects have so far been reported. Effects on ability to drive and use machines: Tablets, injection solution: No effects on the ability to drive and use machines have been reported, and none are expected due to the homeopathic dilutions. Dosage: Tablets: Standard Dosage: Adults (and children 12 yrs. and older): 1 tablet 3x daily. Pediatric: Below 2 yrs.: 1 tablet 1x daily. 2 5 yrs.: 1 tablet 1 2x daily. 6 11 yrs.: 1 tablet 2x daily. Acute or Initial Dosage: Adults (and children 12 yrs. and older): 1 tablet every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. Pediatric: Below 2 yrs.: 1 tablet every 1 to 2 hrs., up to 4x daily, and then continue with standard dosage. 2 5 yrs.: 1 tablet every 1 to 2 hrs.: up to 6x daily, and then continue with standard dosage. 6 11 yrs.: 1 tablet every 1 to 2 hrs., up to 8x 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. Injection solution: Standard dosage: Adults (and children 12 yrs. and older): 1 ampoule 1 to 3x weekly. Pediatric: 2 5 yrs.: ½ ampoule 1 to 3x weekly. 6 11 yrs.: ⅔ of an ampoule 1 to 3x 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 administrati- on: Echinacea comp., Solution for injection may be administered by the s.c., i.d., i.m. or i.v. route. Overdose: Tablets, injection solution: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Tablets (9820): Packs containing 50 and 250 tablets. Injection solution (52729): Packs containing 5, 10, 50 and 100 ampoules of 2.2 ml.