Package Insert: Information for the Patient

Azelastina POS 0.5 mg/mL, Eye Drops Solution

Azelastine Hydrochloride

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given 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 package insert. See section 4.

1. What is Azelastina POS and what it is used for.

2. What you need to know before starting to use Azelastina POS.

3. How to use Azelastina POS.

4. Possible adverse effects.

5. Storage of Azelastina POS.

6. Contents of the package and additional information.

Azelastina POS contains the active ingredient azelastine hydrochloride, which belongs to a group of medicines known as antiallergics (antihistamines). Antihistamines prevent the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.

Azelastina POS is used for the treatment and prevention of ocular disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children aged 4 years and older.

Azelastina POS is also used for the treatment of ocular disorders caused by allergies to substances such as house dust mites or pet hair (perennial allergic conjunctivitis) in adults and children aged 12 years and older.

Azelastina POS is not suitable for the treatment of eye infections.

Do not use this medication:

• If you are allergic to azelastine hydrochloride or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication:

• If you are not sure that your eye symptoms are caused by an allergy. In particular, if they only affect one eye; if your vision has worsened; or if you have eye pain and no nasal symptoms, it may be an infection rather than an allergy.
• If your symptoms worsen or last more than 48 hours without significant improvement despite using this medication.
• If you use contact lenses.

Children and adolescents

For the treatment of eye disorders caused by hay fever (seasonal allergic conjunctivitis):

Do not administer this medication to children under 4 years of age, as safety and efficacy have not been established.

For the treatment of eye disorders caused by an allergy (perennial allergic conjunctivitis):

Do not administer this medication to children under 12 years of age, as safety and efficacy have not been established.

Using Azelastina POS with other medications

Although it is unknown whether this medication may be affected by other medications, inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

Driving and operating machinery

After using this medication, you may experience temporary blurred vision. Wait until your vision is clear before driving or operating machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Remember:

• This medication should only be applied to the eyes.

The recommended dose is:

Eye disorders caused by hay fever (seasonal allergic conjunctivitis)

• Use in adults and children aged 4 years and older.
• The usual dose is one drop in each eye, in the morning and at night.

If you anticipate exposure to pollen, you can administer the usual dose of this medication as a preventive measure before going outside.

Eye disorders caused by an allergy (perennial allergic conjunctivitis, non-seasonal)

• Use in adults and children aged 12 years and older.
• The usual dose is one drop in each eye, in the morning and at night.

If your symptoms are severe, your doctor may increase the dose to one drop in each eye up to four times a day.

The relief of symptoms of allergic conjunctivitis should be observed within 15-30 minutes.

How to use Azelastina POS

Wash your hands.

Take a clean cloth and gently wipe the area around your eyes to remove any remaining moisture

Step 1:

Remove the cap before each application. Before the first application of Azelastina POS, hold the container vertically with the tip down and press the base until the first drop appears in the nozzle. Now the container is ready for use.

Step 2:

Hold the container with the dropper down, with your thumb pressing the shoulder of the container and the rest of your fingers on the base.

Step 3:

Support the hand holding the container with the one that is free, as shown.

Step 4:

Tilt your head slightly back, pull your lower eyelid down gently, and press the base of the container firmly and quickly. This will activate the mechanism for the release ofonedrop. Thanks to the special technique of the COMOD valve system, the size and speed of the drop are identical, regardless of the pressure applied. During application, avoid contact between the tip of the container and the eye or skin. Close your eyes slowly to allow the liquid to distribute evenly over the surface of the eye.

Step 5:

After applying Azelastina POS, release your lower eyelid and press your finger on the corner of your eye near the nose (see image). While doing this, blink several times to distribute the drop evenly over the surface of the eye. Then, remove any excess medication.

Step 6:

After application, replace the cap immediately. Check that the tip of the dropper is dry.

Duration of treatment

Use this medication regularly until your symptoms have disappeared, if possible.

Do not use this medication for more than 6 weeks.

If you use more Azelastina POS than you should

If you have accidentally used too much Azelastina POS in your eyes, you are unlikely to have problems. However, if you are concerned, consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Azelastina POS

Use your eye drops as soon as you remember and apply the next dose at your usual time. Do not use a double dose to make up for the missed dose.

If you interrupt treatment with Azelastina POS

If you stop using this medication, your symptoms are likely to return.

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

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

These effects include:

Frequent (may affect up to 1 in 10 people):Mild irritation (burning, itching, tearing) in the eyes after using this medication. These effects should not last long.

Infrequent (may affect up to 1 in 100 people):Bitter taste in the mouth. This effect should disappear quickly, especially if you drink a soda.

Very rare (may affect up to 1 in 10,000 people): Allergic reaction (such as rash and itching).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products 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 label of the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Once opened:Azelastina POS can be used for up to 12 weeks after the first opening with proper care.

Do not use this medication if you observe that the seal of the carton box is broken before the first use.

Do not store above 25 ° C.

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

Composition of Azelastina POS

The active ingredient is azelastine hydrochloride 0.05% (0.50 mg/ml). Each drop of approximately 30 µl contains 0.015 mg of azelastine hydrochloride.

The other components are disodium edetate, hypromellose, sorbitol, sodium hydroxide (pH adjustment) and water for injections.

Appearance of the product and contents of the packaging

Azelastina POS is a colourless and transparent solution that is presented in a 10 ml multidose container with a gas-free pump system and a stopper.

Each box contains 1 multidose container with a gas-free pump system and a stopper.

Holder of the Marketing Authorization

BRILL PHARMA, S.L.

Munner, 8

08022 Barcelona

(Spain)

Responsible for manufacturing

URSAPHARM Arzneimittel GmbH,

Industriestraße,

66129 Saarbrücken,

Germany

Date of the last review of this leaflet:September 2017

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