AZELASTINE VIR 0.5 mg/ml EYE DROPS SOLUTION

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

Azelastine Vir contains the active ingredient azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines).

Antihistamines prevent the effects of substances like histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.

Azelastine 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 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.

You should consult your doctor if your symptoms worsen or do not improve after 2 days.

Azelastine is not suitable for the treatment of ocular infections.

2. What you need to know before you start using Azelastine Vir

Do not use Azelastine Vir:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Azelastine Vir

• 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 notable improvement despite using Azelastine.
• If you wear contact lenses.

Children and adolescents

For the treatment of ocular disorders caused by hay fever (seasonal allergic conjunctivitis): Do not give this medicine to children under 4 years of age, as the safety and efficacy have not been established.

For the treatment of ocular disorders caused by allergy (perennial allergic conjunctivitis): Do not give this medicine to children under 12 years of age, as the safety and efficacy have not been established.

Using Azelastine Vir with other medicines

Although it is not known whether azelastine can be affected by other medicines, tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

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

Driving and using machines

After using azelastine, your vision may be blurred for a short time. If this happens, wait until your vision returns to normal before driving or using machines.

Azelastine Vir contains benzalkonium chloride

This medicine contains 0.00375 mg of benzalkonium chloride in each drop, equivalent to 0.125 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Azelastine Vir

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Remember:

Azelastine 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, in the morning and at night.

If you expect to be exposed to pollen, you can take the normal dose of azelastine 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, 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.

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

Instructions for the proper use of Azelastine Vir

To facilitate the application of the eye drops, it may be helpful to sit in front of a mirror so you can see what you are doing.

1. Wash your hands.
2. Gently clean the area around your eyes to remove any moisture (Scheme 1)
3. Remove the cap from the bottle and check that the dropper is clean.
4. Gently pull your lower eyelid down (Scheme 2).
5. Place one drop carefully into the middle of the lower eyelid (Scheme 3). Make sure the dropper does not touch the eye.
6. Release your lower eyelid and gently press the inner corner of your eye against the bridge of your nose (Scheme 4). Keeping your finger pressed against your nose, blink slowly a few times to spread the drop across the surface of your eye.
7. Wipe away any excess medicine with a tissue.
8. Repeat this procedure in the other eye.

Scheme 1 Scheme 2 Scheme 3 Scheme 4

Duration of treatment

If possible, you should use Azelastine Vir regularly until your symptoms have disappeared.

Do not use Azelastine Vir for more than 6 weeks.

If you use more Azelastine Vir than you should

If you have accidentally administered too much azelastine in your eyes, you are unlikely to have any problems. But if you are concerned, consult your doctor. In case of accidental ingestion, consult your doctor immediately, or go to the emergency department of the nearest hospital or call the Toxicology Information Service Telephone (91) 562 04 20, indicating the medicine and the amount administered.

If you forget to use Azelastine Vir

Use your eye drops as soon as you remember and administer the next dose at the usual time.

Do not use a double dose to make up for forgotten doses.

If you stop using Azelastine Vir

If you stop using Azelastine Vir, your symptoms will probably come back.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These effects include:

• Common (may affect up to 1 in 10 patients): Mild irritation (itching, stinging, tearing) in the eyes after using Azelastine. These effects should not last long.
• Uncommon (may affect up to 1 in 100 patients): Bitter taste in the mouth. This effect should disappear quickly, especially if you have a drink.
• Rare (may affect up to 1 in 10,000 patients): Allergic reaction (rash and itching).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azelastine Vir

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

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date is the last day of the month stated.

After opening:Do not use this medicine if the bottle has been open for more than 28 days.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Azelastine Vir

The active substance is azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg of azelastine hydrochloride.

The other ingredients are benzalkonium chloride, disodium edetate, hypromellose (E464), liquid sorbitol (crystallizable) (E420i), sodium hydroxide (E524) (for pH adjustment), and water for injections.

Appearance of the product and pack contents

Azelastine Vir is a colorless and transparent solution.

Azelastine Vir is presented in a plastic bottle with a dropper.

One bottle contains 6 ml of eye drops solution.

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

Kymos Pharma Services, S.L.

Parc Tecnològic del Vallès

Ronda de Can Fatjó, 7B

08290 Cerdanyola del Vallès (Barcelona)

Spain

Date of last revision of this package leaflet:June 2019

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