34

Euphorbium compositum Summary of Product Characteristics

Nasal spray Oral drops Compositions: Nasal spray: 100 g containing: Active ingredients: Euphorbium D4 1,0000 g, Luffa operculata D2 1,0000 g, Pulsatilla pratensis D2 1,0000 g, Argentum nitricum D10 1,0000 g, Hepar sulfuris D10 1,0000 g, Hydrargyrum biiodatum D8 1,0000 g. Excipients: Disodium phosphate dihydrate 0,0200 g, Sodium chloride 0,8800 g, Sodium dihydrogen phosphate dihydrate 0,0628 g, Water for injections 93,0372 g. In isotonic sodium chloride solution. Oral drops: 100 g containing: Active ingredients: Argentum nitricum D10 1,0 g, Hepar sulfuris D10 1,0 g, Hydrargyrum biiodatum D8 1,0 g, Luffa operculate D6 1,0 g, Euphorbium D3 1,0 g, Pulsatilla pratensis D2 1,0 g. Excipients: Ethanol (96 per cent) 27,2 g, Water, purified 66,8 g, Contains 35 vol-% alcohol. Indications: Nasal spray, oral drops: Rhinitis of various origins including infectious, allergic (e.g. hay fever), and rhinitis sicca. Acute or chronic sinusitis. Contraindications: Nasal spray, oral drops: Known allergy (hypersensitivity) to one or more of the ingredients. Special warnings and special precautions for use: Nasal spray: None. Oral drops: This medicinal product contains 35 vol.-% ethanol (alcohol). Side effects: Nasal spray: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. In isolated cases transient local reactions or irritation of the nasal mucosa have been reported. Oral drops: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. Interactions with other medication: Nasal spray, oral drops: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Nasal spray, oral drops: 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: Nasal spray, oral drops: No effects on the ability to drive and use machines have been reported, and none are expected due to the homeopathic dilutions. Dosage: Nasal spray: Standard Dosage: Adults (and children 12 years and older): 1 2 sprays into each nostril 3 5x daily. Pediatric: 2 5 years: 1 spray into each nostril 3 5x daily; 6 11 years: 1 spray into each nostril 3 5x daily. Acute or Initial Dosage: Adults (and children 12 years and older): 1 2 sprays into each nostril every ½ to 1 hr. for the first day up to 8x, and then continue with standard dosage. Pediatric: 2 5 years: 1 spray into each nostril every ½ to 1 hr. for the first day up to 6x, and then continue with standard dosage; 6 11 years: 1 spray into each nostril every½ to 1 hr. for the first day up to 8x, and then continue with standard dosage. Method of Administration: For each application, spray the recommended dosage into each nostril. For hygienic reasons it is not recommended to share the use of the same product with others. Oral drops: Standard Dosage: Adults (and children 12 years and older): 10 drops 3x daily. Paediatric: Below 2 years: 3 drops 3x daily; 2-5 years: 5 drops 3x daily; 6-11 years: 7 drops 3x daily. Acute or Initial Dosage: Adults (and children 12 years and older): 10 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. Paediatric: Below 2 years: 3 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage; 2-5 years: 5 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage; 6-11 years: 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. Overdose: Nasal spray, oral drops: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Nasal spray (9965): Atomiser without propellant, 20 ml. Oral drops (9957): Drop bottles containing 30 and 100 ml.