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Luffeel® Summary of Product Characteristics

Tablets Nasal spray Compositions: Tablets: 301.5 mg contains: Active ingredients: Arsenum iodatum D8 25 mg, Lobelia inflata D6 25 mg, Luffa operculata D12 25 mg, Aralia racemosa D1 25 mg. Excipients: Lactose monohydrate 200 mg, Magnesium stearate 1.5 mg. Contains lactose! Nasal spray: 100 g contains: Active ingredients: Histaminum D12 5 g, Histaminum D30 5 g, Histaminum D200 5 g, Luffa operculata D4 10 g, Luffa operculata D12 10 g, Luffa operculata D30 10 g, Sulfur D12 5 g, Sulfur D30 5 g , Sulfur D200 5 g, Thryallis glauca D4 10 g, Thryallis glauca D12 10 g, Thryallis glauca D30 10 g. Excipients: Benzalkonium chloride solution 0.02 g, Disodium phosphate dihydrate 0.02 g, Sodium chloride 0.72 g, Sodium dihydrogen phosphate dihydrate 0.0628 g, Water purfied 9.1772 g. Preserved with benzalko- nium chloride 0,01 %. Indications: Tablets: Allergic rhinitis, particularly hay fever during pollen season. May also be used to support the preventative management of these conditions. Nasal spray: Allergic rhinitis, particularly hay fever. Contraindications: Tablets, Nasal spray: 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. Nasal spray: Luffeel, Nasal spray con- tains benzalkonium chloride. May cause irritation of the nasal mucosa. Side effects: Tablets: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. In isolated cases transient skin reactions have been reported. 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. Interactions with other medication: Tablets, Nasal spray: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Tablets, Nasal spray: 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 the pregnancy and lactation. No adverse effects have so far been reported. Effects on ability to drive and use machines: Tablets, Nasal spray: 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. Preventative (Prophylactic) Dosage: For patients in whom allergy symptoms recur annually, start with the standard dosage one month before the allergy season and continue until two weeks after the end of the critical season. 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 a small amount of water. This medicine should be taken away from meals. Nasal spray: Standard Dosage: Adults (and children 12 yrs. and older): 1 2 sprays into each nostril 3 5x daily. Pediatric: 2 5 yrs.: 1 spray into each nostril 3 5x daily. 6 11 yrs.: 1 spray into each nostril 3 5x daily. Acute or Initial Dosage: Adults (and children 12 yrs. 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 yrs.: 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 yrs.: 1 spray into each nostril every ½ to 1 hr. for the first day up to 8x, and then continue with standard dosage. Method of administration: For each appli- cation, spray the recommended dosage into each nostril. For hygienic reasons it is not recommended to share the use of the same product with others. Overdose: Tablets, Nasal spray: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Tablets (9831): Packs containing 50 and 250 tablets. Nasal spray (9864): Atomiser without propellant, 20 ml.