AZELASTINE POS 0.5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Azelastine POS 0.5 mg/ml, Eye Drops Solution

Azelastine Hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Azelastine POS is and what it is used for.
2. What you need to know before taking Azelastine POS.
3. How to use Azelastine POS.
4. Possible side effects.
5. Storage of Azelastine POS.
6. Package Contents and Additional Information.

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

Azelastine POS contains the active ingredient azelastine hydrochloride, which belongs to a group of medications 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.

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

Azelastine POS is also used for the treatment of ocular disorders caused by allergy to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children from 12 years of age.

Azelastine POS is not suitable for the treatment of ocular infections.

2. What you need to know before taking Azelastine POS

Do not use this medication:

• If you are allergic to azelastine hydrochloride or any of the other components 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 ocular symptoms are caused by an allergy. In particular, if they only affect one eye; if your vision has worsened; or if you have ocular 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 wear contact lenses.

Children and Adolescents

For the treatment of ocular 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 ocular disorders caused by 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 Azelastine POS with Other Medications

Although it is not known if this medication can be affected by other medications, inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy and Breastfeeding

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

Driving and Using Machines

After using this medication, temporary blurred vision may occur. If this happens, wait until your vision is clear before driving or using machines.

3. How to Use Azelastine POS

Follow the administration instructions for this medication as 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:

Ocular disorders caused by hay fever (seasonal allergic conjunctivitis)

• Use in adults and children from 4 years of age.
• The normal dose is one drop in each eye, morning and night.

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

Ocular disorders caused by allergy (perennial allergic conjunctivitis)

• Use in adults and children from 12 years of age.
• The normal dose is one drop in each eye, morning and night.

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

Relief from the symptoms of allergic conjunctivitis should be observed within 15-30 minutes.

How to Use Azelastine POS

Wash your hands.

Take a clean cloth and gently clean the eye contour to remove any moisture

Step 1:

Remove the cap before each application. Before the first application of Azelastine POS, hold the container vertically with the tip downwards and press the base until the first drop appears on the nozzle. The container is now ready for use.

Step 2:

Hold the container with the dropper downwards, so that your thumb presses the shoulder of the container and the rest of your fingers are on the base.

Step 3:

Rest the hand holding the container COMOD on the free hand, as represented.

Step 4:

Tilt your head slightly backwards, gently pull down the lower eyelid, and press the base of the container firmly and quickly. This activates the mechanism for the release of one drop. Thanks to the special valve technique of the COMOD 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 so that the liquid is distributed evenly over the eye surface.

Step 5:

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

Step 6:

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

Duration of Treatment

If possible, you should use this medication regularly until your symptoms have disappeared.

Do not use this medication for more than 6 weeks.

If you use more Azelastine POS than you should

If you have administered too much Azelastine POS to your eyes, you are unlikely to have problems. But if you are concerned, consult your doctor.

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

If you forget to use Azelastine 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 forgotten doses.

If you stop using Azelastine POS

If you stop using this medication, your symptoms will likely recur.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

These effects include:

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

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

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

Reporting Side Effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Azelastine POS

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the label and carton after EXP. The expiration date is the last day of the month indicated.

Once opened: With proper care, Azelastine POS can be used for up to 12 weeks after the first opening.

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

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Azelastine 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 Package Contents

Azelastine POS is a colorless and transparent solution presented in a 10 ml multidose container with a gas-free pump system and a cap.

Each carton contains 1 multidose container with a gas-free pump system and a cap.

Marketing Authorization Holder

BRILL PHARMA, S.L.

Munner, 8

08022 Barcelona

(Spain)

Manufacturer

URSAPHARM Arzneimittel GmbH,

Industriestraße,

66129 Saarbrücken,

Germany

Date of the Last Revision of this Package Leaflet:September 2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es