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Gripp-Heel® Summary of Product Characteristics

Tablets Injection solution Compositions: Tablets: 301.5 mg contains: Active ingredients: Aconitum napellus D4 120 mg, Byronia D4 60 mg, Eupatorium perfolia- tum D3 30 mg, Lachesis D12 60 mg, Phosphorus D5 30 mg. Excipients: Magnesium stearate 1.5 mg. Contains lactose! Injection solution: 1 ampoule (= 1.1 g) contains: Active ingredients: Aconitum napellus D3 4.4 mg, Bryonia D3 2.2 mg, Lachesis D11 2.2 mg, Eupatorium perfoliatum D2 1.1 mg, Phosphorus D4 1.1 mg. Excipients: Sodium chloride 9.8 mg, Water for injections 1089 mg. Indications: Tablets, injection solution: For the relief of symptoms related to colds and influenza-like illnesses, such as aches and pains, fever, drowsiness, cough and headache. 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, injection solution: 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. Interactions with other medication: 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. 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. 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 administration: Gripp-Heel, Solution for injection 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 (9674): Packs containing 50 and 250 tablets. Injection solution (8549): Packs containing 5, 10, 50 and 100 ampoules of 1.1 ml.