OTIPAX salt 15ml
OTIPAX salt. 15 ml.
LEAFLET: PATIENT INFORMATION
OTIPAX 4 g / 100 g + 1 g / 100 g ear drops, solution
Phenazone / Lidocaine hydrochloride
OTIPAX 4 g / 100 g + 1 g / 100 g ear drops, solution
Phenazone/Lidocaine 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, pharmacist or nurse has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor, pharmacist or nurse.
This also includes any possible side effects not described in this leaflet. See item 4.
If after 10 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Otipax is and what it is used for
2. What you need to know before you use Otipax
3. How to use Otipax
4. Possible side effects
5. How to store Otipax
6. Contents of the package and additional information
1. WHAT OTIPAX IS AND WHAT IT IS USED FOR
Otipax is intended for local symptomatic treatment and pain relief in: acute non-perforated inflammation of the middle ear;
viral ear inflammation in influenza;
barotrauma otitis.
2. BEFORE YOU USE OTIPAX
Do not use Otipax
if you are allergic (hypersensitive) to phenazone or lidocaine, or to any of the other ingredients of Otipax.
if you have a perforated eardrum (See Take special care with Otipax)
Take special care when using Otipax
If you have a perforated eardrum, this medicine can cause unwanted effects in the middle ear, and therefore, in cases of doubt, before treatment with Otipax 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 Otipax and consult a doctor.
Use of other drugs
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Pregnancy, lactation and fertility
Ask your doctor or pharmacist before using any medicine. Otipax can be used in pregnant and lactating women if necessary.
Driving and using machines
Not applicable.
Important information about some of the ingredients of Otipax
Contains glycerol.
3. HOW TO USE OTIPAX
Always use Otipax exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual 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 Otipax is 10 days. Consult a doctor if symptoms persist after this time.
There is no age limit.
Instructions for use:
Unscrew the cap from the vial.
Screw the dropper onto the vial,
Remove the protective cap from the dropper.
Turn the bottle upside down and gently press the dropper until 1 drop is formed.
Repeat squeezing until 4 drops are obtained.
Screw the white dropper cap back on after use.
If you have used more than the required dose of Otipax
If you have used more than the required dose of the medicinal product, consult your doctor or pharmacist.
However, according to the data on good tolerability of Otipax ear drops, there are no concerns about overdose even in cases of excessively frequent or higher doses of use
If you forget to use Otipax
Do not take a double dose to make up for a missed dose.
If you have any further questions related to the use of this product, please ask your doctor or pharmacist.
If you have stopped using Otipax
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, Otipax 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 side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Phone: +359 2 8903417
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5.HOW TO STORE OTIPAX
Keep out of the reach of children.
To be stored below 30°C, away from sunlight.
Do not use Otipax for more than 1 month (30 days) after first opening.
Do not use Otipax after the expiry date stated on the label and carton. The expiration date corresponds to the last day of the specified month.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION
What Otipax contains
The active substances are: phenazone and lidocaine hydrochloride.
The other ingredients are: sodium thiosulphate, ethanode, glycerol and purified water.
What Otipax looks like and contents of the pack
Vial 15 ml (yellow glass, type III) containing 16 g of solution, closed with (LDPE) with seal (LDPE) and dropper (polyethylene/vinyl acetate) with stopper (LDPE).
License holder
BIOCODEX, France.
Manufacturer
BIOCODEX, France.
Leaflet last revised: November 2017.
