OTOAKUT

Posology The single dose for adults and adolescents aged 15 years and older is 5 drops. The single dose can be administered 3 to 4 times a day every 6 to 8 hours. The use of OtoAkut is only intended for short-term symptomatic pain relief.

If the pain does not subside within 2 days, the treatment should be reconsidered. The same applies to an intensification of the symptoms during treatment. The usual duration of treatment is 5 days. The duration of treatment is unlimited under medical supervision.

Paediatric population For toddlers and children up to 14 years of age, the single dose is 2 to 3 drops. The single dose can be administered 3 to 4 times a day every 6 to 8 hours. Method of administration For auricular use only. OtoAkut should be used at body temperature (content briefly warmed up by holding the bottle in the hand.

). OtoAkut is administered into the auditory canal of the affected ear when the patient is lying on the side with the affected ear upwards. One drop at a time is released by briefly and lightly squeezing the bottle. The lateral position is then maintained for about 15 minutes so that the ear drops can act on the eardrum.

The ear is loosely closed by packing it with cotton wool, which should be removed at the end of treatment.

Adverse reactions are listed below by system organ class and frequency.

Very rare (<1/10,000):

Immune system disorders: Hypersensitivity reactions such as skin reactions or nettle rash Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Before the beginning of treatment with the medicinal product, it is recommended to check if there is perforation of the tympanic membrane. If the tympanic membrane is perforated, intra-auricular administration may lead to contact of the product with middle ear structures and cause undesirable effects in these tissues.

The product should not be used in the presence of a perforated tympanic membrane, which would include the presence of a myringotomy, in case of penetration of the active substances into the middle ear, risking ototoxicity. The patient should be advised that treatment should be stopped, and medical advice sought, if ear discharge develops during the course of treatment, which may indicate perforation.

If symptoms do not improve within 2 days or worsen rapidly or significantly at any time, the therapy should be re-evaluated. Methemoglobinemia has been reported following the topical use of local anaesthetics. Caution should be exercised in patients who are susceptible to methemoglobinemia, including infants under 3 months of age and patients with haemoglobinopathies or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Patients should be advised to avoid letting OtoAkut come into contact with eyes or nose. If contact occurs, the eyes or nose should be rinsed out immediately with plenty of water. If orally ingested by mistake, local numbness of the tongue and oral cavity may occur.

This may lead to difficulty in swallowing. In this case the oral cavity should be rinsed out immediately with plenty of water and medical advice should be searched. Paediatric population A medical examination is required before using this medicinal product in children under the age of 3 years.

g. contact dermatitis), or irritation to the eyes and mucous membranes.

g. medicinal products containing metamizole, isopropylaminophenazone, propyphenazone or phenazone) or to medicinal products containing phenylbutazone • Perforation of the tympanic membrane (eardrum) or inflammation of the ear canal with injured skin.

• Certain metabolic diseases (hepatic porphyria, congenital glucose-6-phosphate dehydrogenase deficiency)