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Spascupreel® Summary of Product Characteristics

Tablets Injection solution Suppositories Compositions: Tablets: 1 tablet contains: Active ingredients: Aconitum napellus D6 60 mg, Amanita muscaria D4 15 mg, Ammonium bromatum Trit. D4 30 mg, Atropinum sulfuricum D6 30 mg, Citrullus colocynthis D4 30 mg, Cuprum sulfuricum D6 15 mg, Gelsemium sempervirens D6 30 mg, Magnesium phosphoricum D6 30 mg, Matricaria recutita D3 15 mg, Passiflora incarnata D2 15 mg, Veratrum album D6 30 mg; Excipients: Magnesium stearate 1.5 mg; contains lactose. Injection solution: 1 ampoule of 1,1 ml (=1,1 g) contains: Active ingredients: Aconitum napellus D6 2.20 mg, Amanita muscaria D4 0.55 mg, Ammonium bromatum D4 1.10 mg, Atropinum sulfuricum D6 1.10 mg, Citrullus colocynthis D4 1.10 mg, Cuprum sulfuricum D6 0.55 mg, Gelsemium sempervirens D6 1.10 mg, Magnesium phosphoricum D6 1.10 mg, Matricaria recutita D3 0.55 mg, Passiflora incarnata D2 0.55 mg, Veratrum album D6 1.10 mg; Excipients: Sodium chloride 10.4 mg, water for injections 1089.0 mg. Suppositories: 1 suppository = 2.0 g containing: Active ingre- dients: Aconitum napellus D5 2.20 mg, Amanita muscaria D3 0.55 mg, Ammonium bromatum D3 1.10 mg. Atropinum sulfuricum D5 1.10 mg, Citrullus colocynthis D3 1.10 mg, Cuprum sulfuricum D5 0.55 mg, Gelsemium sempervirens D5 1.10 mg, Magnesium phosphori- cum D6 1.10 mg, Matricaria recutita D2 0.55 mg, Passiflora incarnata D1 0.55 mg, Veratrum album D5 1.10 mg; Excipients: Hard fat 1989.0 mg. Indications: Tablets, Injection solution, Suppositories: Spasms of the smooth musculature of the gastrointestinal and the urogenital tract. Contraindications: Tablets, Injection solution, Suppositories: 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, Suppositories: None. Side effects: Tablets: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. Injection solution, Suppositories: Like all medicinal products, homeopathic medicines can cause side effects in isolated cases, such as transient allergic reactions. The frequency of these effects is not known. Interactions with other medication: Tablets, Injection solution, Suppositories: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Tablets, Injection solution, Suppositories: 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, Suppositories: 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 to1 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 administ- ration: Spascupreel, Solution for injection may be administered by the s.c., i.d., i.m. or i.v. route. Suppositories: Standard dosage: Adults (and children 12 yrs. and older): 1 suppository 3x daily. Pediatric: 6 11 yrs.: 1 suppository 2x daily. Acute or initial dosage: Adults (and children 12 yrs. and older): 1 suppository every 2 hrs. up to 6x daily, and then continue with standard dosage. Pediatric: 6 11 yrs.: 1 suppository every 2 hrs. up to 4x daily, and then continue with standard dosage. Method of administration: Insert suppository into the rectum. Overdose: Tablets, Injection solution, Suppositories: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Tablets (9749): Packs containing 50 and 250 tablets. Injection solution (8558): Packs containing 5, 10, 50 and 100 ampoules of 1.1 ml each. Suppositories (9573): Packs containing 12 and 60 suppositories of 2.0 g