Otirelax

• Short description
• How to use

• • Otirelax is for topical symptomatic treatment and pain relief in:
  • acutely unperforated middle ear inflammation;
  • viral inflammation of the ear for influenza;
  • go to barotrauma.

• CONTENT
  What OTIRELAX contains - The active substances are: phenazone and lidocainе hydrochloride; - The excipients are: sodium thiosulfate, ethanol 96%, purified water, sodium hydroxide for pH adjustment (as 1 molar solution) and glycerol.

  Method of use
  The recommended dose is: 4 drops, 2 or 3 times daily in the affected ear. To avoid the unpleasant contact of the ear with the cold solution, warm the vial before use between your hands. The duration of treatment should not exceed 10 days. If discomfort continues, consult a doctor. There is no age restriction.

• General information
• Ingredients

• Package leaflet: Information for the patient

  OTIRELAX 4 g/100 g + l g/100 g ear drops, solution

  Phenazone / Lidocainе hydrochloride

  Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

  - Keep this leaflet. You may need to read it again.

  - If you have any further questions, ask your pharmacist.

  - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  - You must talk to a doctor if you do not feel better or if you feel worse after 10 days.

  What is in this leaflet

  1. What OTIRELAX is and what it is used for

  2. What you need to know before you use OTIRELAX

  3. How to use OTIRELAX

  4. Possible side effects

  5. How to store OTIRELAX

  6. Contents of the pack and other information

  1. What OTIRELAX is and what it is used for

  
  OTIRELAX is intended for local, symptomatic treatment and relief of pain in the following:  

  - acute unperforated inflammation of the middle ear;  

  - middle ear inflammation as a complication after flu;  

  - barotraumatic otitis (as a result of diving or air travel).  

  You must talk to a doctor if you do not feel better or if you feel worse after 10 days.

  2. What you need to know before you use OTIRELAX

  Do not use OTIRELAX:

  - if you are allergic to phenazone, lidocainе or any of the other ingredients of this medicine  

  (listed in section 6);

  -if you have perforated ear drum.

  Warnings and precautions

  Talk to your doctor or pharmacist before using OTIRELAX.

  If you have perforated ear drum membrane this medicine may cause side effects in the middle ear and  

  in this case, as a precautionary measure before using OTIRELAX, it is recommended to visit a doctor to check if your ear drum is intact.

  In case of sudden hearing loss or ear discharge, which may be signs of a pierced eardrum membrane, do not use OTIRELAX and contact 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, drink and alcohol  

  There are no special requirements.

  Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

  your doctor or pharmacist for advice before taking this medicine.

  Driving and using machines

  The use of this medicine does not affect the ability to drive and use machines.

  OTIRELAX contains glycerol.

  3. How to use OTIRELAX

  Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  The recommended dose is: 4 drops, 2 or 3 times daily in the affected ear.

  To avoid the unpleasant contact of the ear with the cold solution, warm the vial before use between your hands.

  The duration of treatment should not exceed 10 days. If discomfort continues, consult a doctor.

  There is no age restriction.

  Instructions for use:

  • Wash your hands before applying this medicine;

  • Lie on one side or tilt your sick ear upwards;

  • Pull the earlobe back and forth for adults or down and back for the children to ensure that the drops fall into the ear;

  • Place the drops in the ear;

  • Hold your head in a tilted position for about 5 minutes.

  To avoid pollution, avoid touching the tip of the applicator-dropper ear or other surfaces. Do not rinse the applicator-dropper, but clean it with a little sterile cotton. Close the bottle well after each applying of the medicine.

  If you use more OTIRELAX than you should

  If you have used more of the required dose of the medicine, talk to your doctor or pharmacist.

  If you forget to use OTIRELAX

  Do not use a double dose to make up for a forgotten one.

  If you stop using OTIRELAX

  If you have any further questions on 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.

  Ear disorders

  Rare side effects: local allergic reactions (itching, maculopapular rash), auditory canal hyperaemia.

  If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

  Reporting of side effects

  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

  Bulgarian Drug Agency

  Address: 8, Damyan Gruev Str. 1303 Sofia, Bulgaria;  

  Phone: +359 2 890 34 17,  

  website: www.bda.bg;  

  Email: bda@bda.bg.  

  By reporting side affects you can help provide more information on the safety of this medicine.

  5. How to store OTIRELAX

  Keep this medicine out of reach of children.

  Store below 25°С in the original package.

  Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

  Shelf life after first opening – 28 days.

  Do not use this medicine if you notice visible signs of product quality damage.

  Do not throw away any medicines via wastewater or household waste. Ask your pharmacists how to throw away medicines you no longer use. These measures will help protect the environment.

  6. Contents of the pack and other information

  What OTIRELAX contains

  - The active substances are: phenazone and lidocainе hydrochloride;

  - The excipients are: sodium thiosulfate, ethanol 96%, purified water, sodium hydroxide for pH adjustment (as 1 molar solution) and glycerol.

  What OTIRELAX looks like and contents of the pack

  OTIRELAX is packaged in a card box containing a white, opaque, low density polyethylene bottle of nominal capacity 15 ml enclosed with a dropper applicator consisting of: a dropper (white, opaque, made of polyethylene low pressure) and a screw cap, fitted with a protective ring (white, opaque, made of high-pressure polyethylene).

   

  Marketing Authorisation Holder

  Fortex Nutraceuticals Ltd.

  10, Prohladen kat Street,  

  1362 Sofia, Bulgaria

   

  Manufacturer

  S.C. Rompharm Company SRL

  1A, Eroilor Street,

  Otopeni 075100, Romania

   

  The leaflet was last revised in December 2017.

   

• What OTIRELAX contains

  - The active substances are: phenazone and lidocainе hydrochloride;

  - The excipients are: sodium thiosulfate, ethanol 96%, purified water, sodium hydroxide for pH adjustment (as 1 molar solution) and glycerol.

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