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Engystol® Summary of Product Characteristics
Tablets Injection solution Compositions: Tablets: 1 tabl. contains: Active ingredients: Sulfur D4 37.5 mg, Sulfur D10 37.5 mg, Vincetoxicum hirundinaria D6 75.0 mg, Vincetoxicum hirundinaria D10 75.0 mg, Vincetoxicum hirundinaria D30 75.0 mg. Excipients: Magnesium stearate 1.5 mg. Contains lactose! Injection solution: 1 ampoule of 1.1 ml (=1.1 g) contains: Active ingredients: Sulfur D4 3.30 mg, Sulfur D10 3,30 mg, Vincetoxicum hirundinaria D6 6.60 mg, Vincetoxicum hirundinaria D10 6.60 mg, Vincetoxicum hirundinaria D30 6.60 mg. Excipients: Sodium chloride 8.78 mg, Water for injections 1.073.60 mg. Indications: Tablets, injection solution: To reduce severity and duration of symptoms in viral infections, particularly in colds and influenza-like illnesses by supporting the immune system during or in upcoming flu season. Contraindications: Tablets, 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. Injection solution: None. 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 (eg. rash, pruritus or erythema) and gastrointestinal complaints (eg. abdominal pain or discomfort) have been reported. Injection solution: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. In isolated cases transient reactions (e.g. skin allergies, redness/swelling at the injection site) have been reported. Interaction with other medicaments: Tablets, injection solution: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Tablets, 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. Dosage: Tablets: Standard dosage: Adults (and children 12 yrs. and older): 1 tablet 3x daily. 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. 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. 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. 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: Injection solution may be administered by the s.c., i.d., i.m. or i.v. route. Overdose: Tablets, injection solution: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Tablets (9830): Packs containing 50 and 250 tablets. Injection solution (8546): Packs containing 5, 10, 50 and 100 ampoules of 1.1 ml.