OTIRELAX ear drops 15ml
Phenazone / Lidocaine hydrochloride
1. What OTIRELAX is and what it is used for
OTIRELAX is intended for local, symptomatic treatment and pain relief in:
- acute imperforate inflammation of the middle ear;
- viral inflammation of the ear during flu;
- barotrauma otitis (as a result of diving or traveling by plane).
If after 10 days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you use OTIRELAX
Do not use OTIRELAX:
- if you are allergic to: phenazone, lidocaine or any of the other ingredients of this medicine (listed in point 6);
- if you have a perforated eardrum.
Warnings and precautions
Talk to your doctor or pharmacist before using OTIRELAX.
If you have a perforated eardrum, this medicine can cause unwanted effects in the middle ear, and therefore, in case of doubt, before treatment with OTIRELAX as a preventive measure, ask your doctor to check whether your eardrum is intact.
In case of sudden hearing loss or in the presence of discharge from the ear, which may be signs of a ruptured eardrum, do not use OTIRELAX and consult a doctor.
Other medicines and OTIRELAX
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
OTIRELAX with food, drinks and alcohol
There are no special requirements.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Administration of this medicine does not affect the ability to drive or operate machinery.
OTIRELAX contains glycerol.
3. How to use OTIRELAX
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is: 4 drops in the affected ear, 2 or 3 times a day.
To avoid unpleasant contact of the cold solution with the ear, warm the vial between the hands before use.
The maximum duration of treatment with OTIRELAX is 10 days. Consult a doctor if symptoms persist after this time.
There is no age limit.
Instructions for use:
• Wash your hands before applying this medicine;
• Lie on one side or tilt the affected ear upwards;
• Pull the pinna up and back in adults or down and back in children to ensure the drops get into the ear;
• Put the drops in the ear;
• Keep your head in an inclined position for about 5 minutes.
To prevent contamination, avoid touching the tip of the dropper applicator to the ear or other surfaces. Do not rinse the dropper applicator, but clean it with a little sterile cotton. Close the bottle tightly after each administration of the medicine.
If you have used more than the required dose of OTIRELAX
If you have used more than the required dose of the medicinal product, consult your doctor or pharmacist.
If you forget to use OTIRELAX
Do not take a double dose to make up for a missed dose.
If you have stopped using OTIRELAX
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Disorders of the ear
Rare: local allergic reactions (itching, maculo-papular rash), hyperemia of the auditory canal.
If any of the side effects become serious, or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Medicines Executive Agency, ul. "Damyan Gruev", №8, 1303 Sofia, phone: +359 2 890 34 17, website: www.bda.bg. By reporting side effects, you can help get more information about the safety of this medicine.
5. How to store OTIRELAX
Keep out of the reach of children.
To be stored below 25°C, in the original packaging.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date corresponds to the last day of the specified month.
Shelf life after first opening – 28 days.
Do not use this medicine if you notice visible signs of product deterioration.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Otirelax contains
- The active substances are: phenazone and lidocaine hydrochloride;
- Excipients are: sodium thiosulphate, ethanol 96%, purified water, sodium hydroxide for pH adjustment (as 1 molar solution) and glycerol.
What OTIRELAX looks like and what it contains
OTIRELAX is packed in a cardboard box containing a white, opaque bottle of low-pressure polyethylene, with a nominal volume of 15 ml, closed with an applicator-dropper, consisting of: a dropper (white, opaque, made of low-pressure polyethylene) and a screw cap, equipped with a protective ring (white, opaque, made of high-pressure polyethylene).
License holder
Fortex Nutraceuticals Ltd
St. Cool corner 10
Sofia 1362, Bulgaria
Manufacturer
SC Rompharm Company SRL
1A, Eroilor Street,
Otopeni 075100, Romania