27

Neurexan® Summary of Product Characteristics

Tablets Oral drops Compositions: Tablets: 1 tablet contains: Active ingredients: Avena sativa D2 0.6 mg, Coffea arabica D12 0.6 mg, Passiflora incarnata D2 0.6 mg, Zincum isovalerianicum D4 0.6 mg. Excipients: Lactose monohydrate 300 mg, Magnesium stearate 1.5 mg. Contains lactose. Oral drops: 100 g contain: Active ingredients: Avena sativa D2 0.06 g, Coffea arabica D12 0.06 g, Passiflora incarnata D2 0.06 g, Zincum isovalerianicum D4 0.06 g. Excipients: Ethanol 96% (V/V) 31.34 g; water, purified 68.42 g. Indications: Tablets, oral drops: : Nervous restlessness and sleep disturbances. Contraindications: Tablets, oral drops: 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. Oral drops: This medicinal product contains 36 vol.-% ethanol (alcohol). Side effects: Tablets: Allergic (hypersensitivity) skin reactions may occur in very rare cases (i.e. affects less than 1 in 10,000 users). Due to the homeopathic nature of Neurexan tablets a temporary worsening in symptoms (initial aggravation) is possible but harmless. Oral drops: Due to the homeopathic nature of Neurexan drops a temporary worsening in symptoms (initial aggravation) is possible but harmless. Interactions with other medication: Tablets, oral drops: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Tablets, 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: Tablets, 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: 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. Oral 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 children 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. Overdose: Tablets, oral drops: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Tablets (9519): Packs containing 50 and 250 tablets. Oral drops (9880): Packs containing 30 ml and 100 ml.