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Oteel Summary of Product Characteristics

Ear drops Compositions: Ear drops: 1 vial (0.45 ml) contains: Active ingredients: Achillea millefolium D3 0.99 mg, Matricaria recutita D3 0.99 mg, Symphytum officinale D6 0.99 mg, Aconitum napellus D2 0.954 mg, Atropa bella-donna D2 0.99 mg, Bellis perennis D2 0.495 mg, Calendula officinalis D2 0.99 mg, Echinacea D2 0.2475 mg, Echinacea purpurea D2 0.2475 mg, Hypericum perforatum D2 0.297 mg, Hepar sulfuris D6 0.99 mg, Mercurius solubilis Hahnemanni D6 0.495 mg, Hamamelis virginiana D1 0.099 mg, Arnica montana D2 0.99 mg. Excipients: Sodium chloride 3.46-3.75 mg, Water for injections 440.2350 mg. Indications: Ear drops: Local (external) supportive treatment of earaches in general, as in conditions such as otitis media and/or inflammations of the external ear. Contraindications: Ear drops: Known allergy (hypersensitivity) to one or more of the ingredients. Special warnings and special precautions for use: Ear drops: None. Side effects: Ear drops: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybo- dy gets them. Interactions with other medication: Ear drops: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Ear drops: For this product no clinical data on pregnancy and lactation are available. Homeopathic dilu- tions 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: Ear drops: No effects on the ability to drive and use machines have been reported, and none are expected due to the homeopathic dilutions. Dosage: Ear drops: Standard Dosage: Adults (and children 12 yrs. and older): 3 4 drops 4x daily, or more often if needed. Pediatric: Below 2 yrs.: 1 2 drops 4x daily as directed [consult a healthcare professional before use]. 2 5 yrs.: 2 drops 4x daily, or more often if needed. 6 11 yrs.: 3 drops 4x daily, or more often if needed. Method of administration: For external use only. Instill into the external ear canal. Instructions for use: 1. Only open the vial directly before use. 2. Separate the vial by turning and pulling off the strip. 3. Warm the vial to body temperature by holding it in the palm of your hand for about one minute. 4. To open twist the upper part of the vial. 5. Tilt the head sideways. Instill the fluid into the ear canal by pressing lightly on the upper part of the vial. Close the ear canal with

some cotton wool in order to prevent the fluid from flowing back out. 6. Discard remaining contents of vial after each application. Overdose: Ear drops: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions and external use. Package sizes: Ear drops (12737): Available in packages of 10 sterile vials of 0.45 ml each.