Otofix ear droops 15 ml.

1. What Otofix is ​​and what it is used for

This medicinal product is intended for the local symptomatic treatment and relief of pain in the following non-perforated middle ear conditions:

acute middle ear inflammation (acute otitis media);

viral ear inflammation associated with influenza;

otitis due to barotrauma.

2. What you need to know before you use Otofix

Do not use Otofix:

if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);

if you have a perforated eardrum (ruptured eardrum).

Warnings and precautions

If you have a perforated eardrum, this medicine may cause adverse effects in the middle ear. As a precautionary measure, ask your doctor to check that your eardrum is intact before starting treatment with Otofix.

In the event of sudden hearing loss or ear discharge (which may be signs of a perforated eardrum), do not use Otofix and consult a doctor.

Other medicines and Otofix

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Driving and using machines

Otofix does not affect your ability to drive or use machines. Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Otofix may be used by pregnant and breastfeeding women, if necessary.

3. How to use Otofix

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure about anything, ask your doctor or pharmacist.

Otofix is ​​a medicinal product intended for instillation into the ears.

Do not use in the nose or eyes!

Do not take by mouth!

To avoid the unpleasant sensation of the cold solution coming into contact with the ear, warm the bottle between your hands before use.

Dosage:

The usual dose is 4 drops into the affected ear, 2 or 3 times daily.

The maximum duration of treatment is 10 days. Consult a doctor if symptoms persist beyond this period.

There is no age restriction.

Instructions for use

Unscrew the cap from the bottle.

Screw the dropper onto the bottle in place of the cap.

Remove the protective cap from the dropper.

Turn the bottle upside down and gently squeeze the dropper until a drop forms.

Continue squeezing until the required number of drops is obtained.

Replace the white protective cap on the dropper after use. If you have applied more than the required dose of Otofix

There have been no reports of overdose cases when Otofix is ​​used correctly.

If you have missed a dose of Otofix

Do not apply a double dose to make up for a missed dose.

If you have any further questions regarding 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.

Rare – affects up to 1 in 1,000 people

Local allergic reactions – itching, rash, or redness of the ear canal.

5. How to store Otofix

Keep out of the reach and sight of children.

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.

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

You may use Otofix for up to 6 months after opening the bottle.

Do not dispose of medicines via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Contents of the pack and other information

What Otofix contains

The active substances are: phenazone and lidocaine hydrochloride.

The other ingredients are: sodium thiosulfate, ethanol, glycerol, and purified water.

What Otofix looks like and contents of the pack

A clear, colourless to yellow-brown solution.

15 ml of solution in 15 ml brown glass bottles. The bottles are closed with polyethylene screw caps featuring a tamper-evident ring and a seal.

A dropper applicator is used to dose the medicinal product; it is attached to the bottle after the pack is opened for the first time.

One bottle with a dropper and a package leaflet in a cardboard box.