Label: information for the user

Otix eye drops in solution

Dexamethasone sodium phosphate/polymyxin B sulfate/trimethoprim

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What Otix is and for what it is used

2. What you need to know before starting to use Otix

3. How to use Otix

4. Possible adverse effects

5. Storage of Otix

6. Contents of the package and additional information

Otix belongs to the group of medications called combinations of dexamethasone and anti-infectives. It contains a glucocorticosteroid, dexamethasone phosphate (sodium) and two antibiotics, polymyxin B sulfate and trimethoprim.

The trimethoprim-polymyxin B association has a spectrum of activity that covers gram-positive and gram-negative germs that can grow in the external ear. The corticosteroid-antimicrobial association produces a reduction of inflammation in the external auditory canal while combating the existing infection or preventing overinfection in inflammatory processes.

Otix is indicated for acute external otitis caused by germs sensitive to the trimethoprim-polymyxin B association in adults and children over 2 years old.

Before prescribing this medication, your doctor will have examined your eardrums to ensure they are not perforated.

Do not use Otix:

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have a perforated or damaged eardrum.
• If you have chronic or acute middle ear infection (otitis media).
• If you have a viral, fungal, or tuberculosis infection of the external ear canal.

• Warnings and precautions. This medication should only be applied to the ear. Do not ingest or inject. If symptoms of itching (urticaria) or allergy (including hives, itching, or respiratory problems) occur once treatment has begun, it is recommended to discontinue medication and consult your doctor.
• When applying the medication, avoid contact between the dropper and the ear and fingers to prevent possible contamination.
• With the use of this medication, you may become more sensitive to other infections. Consult your doctor if symptoms and signs persist after one week of treatment. Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may occur after interrupting intensive or long-term treatment with Otix. Consult your doctor before discontinuing treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir.

Children

It is not recommended to use Otix in children under 2 years of age due to a lack of data in these patients.

Other medications and Otix

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Since no systemic absorption is expected after otic application, it is very unlikely to interact with systemic medications. No interaction studies have been conducted.

It is not recommended to administer other medications in the ear at the same time. If multiple medications need to be administered via this route, it is recommended to administer them separately.

Inform your doctor if you are using ritonavir, as it may cause an increase in dexamethasone levels in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate the use of this medication if you are pregnant.

Breastfeeding

Your doctor will evaluate the use of this medication if you are breastfeeding.

Driving and operating machinery

Given the administration route and usage conditions, it is unlikely that this medication will affect your ability to drive vehicles or operate machinery. No data is available.

This medication contains 0.1 mg of benzalkonium chloride in each bottle.

Follow exactly the medication administration instructions provided by your doctor. If you are unsure, ask your doctor or pharmacist again.

Otic route (administer in the ear).

The recommended dose is 4 drops 3-4 times a day in the affected ear for a minimum of 7 days. If symptoms persist after this period, consult your doctor.

Use in children over 2 years

No dose adjustment is necessary in this patient group.

ATTENTION: It is essential to follow the instructions in the "Preparation of the solution" section when removing the product packaging. The prepared solution will be used during treatment, following the indications in the "Correct administration guidelines" section. If you have any doubts about preparing the solution, consult your pharmacist.

Preparation of the solution.

To prepare the solution, operate with precision and cleanliness, following the instructions below:

INSTRUCTIONS

Correct administration guidelines.

Once the solution has been prepared according to the instructions, remove the cap and tilt your head to one side so that the affected ear is facing upwards. Let the drops fall into the affected ear canal with the help of the dropper. Avoid contact between the dropper and the ear and fingers to prevent possible contamination. Keep your head tilted for at least 30 seconds to allow the drops to penetrate the ear and not come out. Close the bottle after each application and keep it perfectly closed.

If you use more Otix than you should

Due to the characteristics of this preparation, intended for topical use, it is not expected to experience intoxication phenomena with the use of this medication, even in the event that the patient inadvertently instilled the product without reconstituting it.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Otix

Apply a single dose as soon as you remember, and continue with the next dose scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen.

Do not use a double dose to compensate for the missed doses.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

With the use of Otix, the following adverse effects may appear, for which the frequency is unknown:

• Overgrowth of non-susceptible microorganisms, particularly fungi, in which case the medication will be discontinued and appropriate measures will be taken.
• Allergic reactions that will require discontinuation of treatment.
• Local reactions (irritation).
• Toxicity in the ear.
• Endocrine problems: excessive hair growth (particularly in women), weakness and muscle wasting, purple striae on the body skin, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and body and facial swelling and weight gain (Cushing's syndrome) (see section 2, "Warnings and Precautions").

Corticosteroids may mask the clinical symptoms of infection or sensitization. The side effects characteristic of corticosteroids are not expected due to the specific conditions of use in the ear.

See also Important Information about some of the components of Otix.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Protect from light.

After preparing the solution, it can be stored for 15 days at room temperature.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Otix

• The active principles are dexamethasone (as sodium phosphate), trimethoprim, and polymyxin B (as sulfate).
• The other components are benzalkonium chloride, sulfuric acid, sodium chloride, sodium hydroxide (E 524), tribasic sodium citrate, polysorbate 80, citric acid, and purified water.

Prepared solution: Each ml contains 1 mg of dexamethasone (as sodium phosphate), 1 mg of trimethoprim, and 10,000 IU of polymyxin B (as sulfate).

Appearance of the product and contents of the packaging

Polyethylene bottle with a dropper containing two solutions (upper and lower) to prepare 5 ml of transparent and colorless solution.

The upper chamber (1 ml) is made of low-density polyethylene and the lower chamber (4 ml) is made of high-density polyethylene.

Holder of the marketing authorization

M4 PHARMA, S.L.

C/ Tánger, 86

08018 Barcelona, Spain

Responsible for manufacturing

Tubilux Pharma S.p.A.

C/ Via Costarica, 20 / 22 00071

Pomezia (RM) – ITALY

Date of the last review of this leaflet:January 2018

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/