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Lymphomyosot® Summary of Product Characteristics

Tablets Drops Injection solution Compositions: Tablets: 1 tablet = 301.5 mg containing: Active ingredients: Araneus diadematus D6 15.0 mg, Calcium phosphoricum D12 15.0 mg, Equisetum hiemale D4 15.0 mg, Ferrum iodatum D12 30.0 mg, Fumaria officinalis D4 15.0 mg, Gentiana lutea D5 15.0 mg, Geranium robertianum D4 30.0 mg, Juglans regia ssp. regia D3 15.0 mg, Levothyroxinum D12 15.0 mg, Myosotis arvensis D3 15.0 mg, Nasturtium officinale D4 30.0 mg, Natrium sulfuricum D4 15.0 mg, Pinus sylvestris D4 15.0 mg, Scrophularia nodosa D3 15.0 mg, Smilax D6 15.0 mg, Teucrium scorodonia D3 15.0 mg, Veronica officinalis D3 15.0 mg. Excipients: Magnesium stearate 1,5 mg. Contains lactose! Drops: 100 g containing: Active ingredients: Araneus diadematus D6 5.0 g, Calcium phosphoricum D12 5.0 g, Equisetum hiemale D4 5.0 g, Ferrum iodatum D12 10.0 g, Fumaria officinalis D4 5.0 g, Gentiana lutea D5 5.0 g, Geranium robertianum D4 10.0 g, Juglans regia ssp. regia D3 5,0 g, Levothyroxinum D12 5.0 g, Myosotis arvensis D3 5.0 g, Nasturtium officinale D4 10.0 g, Natrium sulfuricum D4 5.0 g, Pinus sylvestris D4 5.0 g, Scrophularia nodosa D3 5.0 g, Smilax D6 5.0 g, Teucrium scorodonia D3 5.0 g, Veronica officinalis D3 5.0 g, Excipients: Contains 35 vol.-% alcohol. Injection solution: 1.1 g containing: Active ingredients: Araneus diadematus D6 0.55 mg, Calcium phos- phoricum D12 0.55 mg, Equisetum hiemale D4 0.55 mg, Ferrum iodatum D12 1.10 mg, Fumaria officinalis D4 0.55 mg, Gentiana lutea D5 0.55 mg, Geranium robertianum D4 1.10 mg, Juglans regia ssp. regia D3 0.55 mg, Levothyroxinum D12 0.55 mg, Myosotis arvensis D3 0.55 mg, Nasturtium officinale D4 1.10 mg, Natrium sulfuricum D4 0.55 mg, Pinus sylvestris D4 0.55 mg, Scrophularia nodosa D3 0.55 mg, Smilax D6 0.55 mg, Teucrium scorodonia D3 0.55 mg, Veronica officinalis D3 0.55 mg. Excipients: Sodium chloride 10.3 mg, water for injections 1089 mg. Indications: Tablets, Drops, injection solution: Improvement of lymphatic drainage, the non-specific immune defense, and condi- tions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema. Contraindications: Tablets, Drops, 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. Drops: This medicinal product contains 35 vol.-% ethanol (alcohol). Injection solution: None. Side effects: Tablets: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. Drops, injection solution: Like all medicinal products, this homeopathic medicinal product can cause side effects, alt- hough not everybody gets them. In isolated cases transient allergic skin reactions have been reported. Interactions with other medication: Tablets, injection solution: No interactions have been reported, and none are expected due to the homeopathic dilutions. Drops: This medicine has no or negligible influence on the ability to drive and use machines. Pregnancy and lactation: Tablets, Drops, 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. Drops: This medicine has no or negligible influence on the ability to drive and use machines. 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. Drops: Standard dosage: Adults (and children 12 yrs. and older): 10 drops 3x daily. Pediatric: Below 2 yrs.: 3 drops 3x daily. 2 5 yrs.: 5 drops 3x daily. 6 11 yrs.: 7 drops 3x daily. Acute or initial dosage: Adults (and child- ren 12 yrs. and older): 10 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. Pediatric: Below 2 yrs.: 3 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. 2 5 yrs.: 5 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. 6 11 yrs.: 7 drops every ½ to 1 hr., up to 12x 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. 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 administration: Lymphomyosot, Solution for injection may be administered by the s.c., i.d., i.m. or i.v. route. Overdose: Tablets, Drops, injection solution: No cases of overdose have been reported, and none are expected due to the homeo- pathic dilutions. Package sizes: Tablets (9832): Packs containing 50, 100 and 250 tablets. Drops (9780): Drop bottles containing 30 ml and 100 ml. Injection solution (8553): Packs containing 5, 10, 50 and 100 ampoules of 1.1 ml each.