Instructions for use Otofix ear drops solution 16.65 g bottle 15 ml
Composition
active ingredient: phenazone, lidocaine hydrochloride;
1 g of solution contains phenazone 40 mg and lidocaine hydrochloride 10 mg;
excipients: sodium thiosulfate, ethanol 96%, purified water, glycerin.
Dosage form
Ear drops, solution.
Main physicochemical properties: transparent solution, from colorless to yellowish-brown.
Pharmacotherapeutic group
Drugs used in otology. Analgesics and anesthetics in combination.
ATX code S02D A30.
Pharmacological properties
Pharmacodynamics.
Otofix is a combination medicine that contains phenazone and lidocaine.
Phenazone is a pyrazolone derivative that has analgesic and anti-inflammatory properties.
Lidocaine is a local analgesic of the amide group. The combination of phenazone with lidocaine provides a synergistic analgesic/anti-inflammatory effect.
Pharmacokinetics.
The absorption of any component of the drug through the skin has not been studied. Absorption is almost non-existent.
Systemic absorption of this solution is not expected (in the absence of damage to the eardrum).
The drug's effect (reducing eardrum pain and reducing inflammation) begins 5 minutes after instillation. The pain syndrome almost completely disappears after 15–30 minutes.
Indication
Local symptomatic treatment of certain painful conditions of the middle ear with an intact tympanic membrane in children from 1 month of age and adults with:
· otitis media in the acute period;
Phlyctenulosis viral otitis (post-influenza);
· barotraumatic otitis.
Contraindication
- Hypersensitivity to the active substances, any components of the medicinal product or to amide local anaesthetic medicinal products.
- Perforation of the eardrum of traumatic or infectious origin (see section "Special instructions for use").
Interaction with other medicinal products and other types of interactions
There is no data on possible interactions.
Application features
Before starting treatment with the drug, it is recommended to check for perforation of the eardrum. If the eardrum is perforated, instillation of the drug into the ear may lead to contact of the drug with the structures of the middle ear and cause adverse reactions in these tissues.
The medicine contains an active substance that may cause positive results in anti-doping tests.
Use during pregnancy or breastfeeding
No consequences of using the drug during pregnancy are expected, since systemic exposure to phenazone and lidocaine is insignificant.
Under normal conditions of use, phenazone and lidocaine do not penetrate into breast milk. If necessary, Otofix can be used during pregnancy or breastfeeding after consulting a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
Otofix does not affect the ability to drive or operate potentially dangerous machinery.
Method of administration and doses
For children aged 1 month and older and adults, instill 4 drops 2-3 times a day into the external auditory canal of the ear in which pain is felt, lightly pressing on the elastic part of the dropper.
The course of treatment should not exceed 10 days. After this period of use, the treatment should be reviewed.
Method of application
For use in the ear.
In order to prevent unpleasant sensations as a result of contact of the skin of the ear canal with the cold solution, the bottle should be warmed in the hands before using the medicine.
Instructions for use:
- unscrew the bottle cap;
- screw the dropper onto the cap;
- remove the protective cap from the dropper;
- turn the bottle upside down and gently squeeze the dropper until a drop forms;
- press again until you get the required number of drops;
- after use, replace the dropper back with the white cap.
Children.
There are no data on the safety and efficacy of the drug Otofix in children under 1 month of age.
Use in children aged 1 month and over after consultation and on the recommendation of a doctor.
Overdose
When using the drug at the recommended dosage, no overdose was observed.
Adverse reactions
The adverse reactions listed below are classified according to organ system and frequency of occurrence.
From the organs of hearing and balance: local reactions: allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rashes.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua/.
Expiration date
3 years.
The shelf life after first opening the bottle is 6 months.
Storage conditions
Keep out of reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Packaging
15 ml (16.65 g) of solution in a glass bottle; 1 bottle together with a dropper applicator in a cardboard box
Vacation category
Without a prescription.
Producer
JSC "Sopharma".
Location of the manufacturer and address of its place of business
16 Ilienskoe Shose St., Sofia, 1220, Bulgaria.
2800, Sandanski, Industrial Zone, Bulgaria.
