Package Insert: Information for the User

Azelastina MABO 0.5 mg/mL, Eye Drop Solution

Azelastine hydrochloride 0.05% (0.5 mg/mL)

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

• 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 for 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 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 MABO and how is it used?

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

3. How to use Azelastina MABO

4. Possible adverse effects

5. Storage of Azelastina MABO

6. Contents of the package and additional information

Azelastina MABO contains azelastine, which belongs to a group of medicines known as 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 MABO 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 above.

Azelastina MABO 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 above.

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

Do not use Azelastina MABO:

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

Inform your doctor or pharmacist if this is the case.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Azelastina MABO

• If you are unsure whether 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 Azelastina MABO.
• If you are taking other non-prescription medications.
• If you use contact lenses.

It is recommended not to use contact lenses until the signs and symptoms of allergic conjunctivitis have disappeared.

Using Azelastina MABO with other medications

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

The effect of Azelastina MABO on other medications is unknown.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

You may experience blurred vision immediately after applying Azelastina MABO. Do not drive or operate machinery until this effect has disappeared.

Azelastina MABO contains Benzalkonium Chloride

This medication contains 0.75 mg of benzalkonium chloride in each bottle.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases. Consult your doctor if you experience a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Important: If you are not sure of the correct dose or how to use this medication, consult your doctor or pharmacist.

Allergic eye disorders caused by hay fever (seasonal allergic conjunctivitis)

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

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

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

• Use in adults and children aged 12 years and older.
• The recommended 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.

You should use Azelastina MABO regularly until your symptoms have disappeared.

If you stop using Azelastina MABO, your symptoms are likely to recur.

Remember:

• Do not use Azelastina MABO for more than 6 weeks.
• Azelastina MABO should only be applied to the eyes.

Instructions for the proper use of Azelastina MABO

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 remaining moisture (Scheme 1).
3. Remove the cap from the bottle and check that the dropper is clean.
4. Slowly pull your lower eyelid down (Scheme 2).
5. Place a drop carefully in the middle of your lower eyelid (Scheme 3). Make sure the dropper does not touch your 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 pressing your nose, blink slowly a few times to spread the drop across the surface of your eye.
7. Wipe away any excess medication with a tissue.
8. Repeat this procedure in the other eye.

Scheme 1Scheme 2 Scheme 3 Scheme 4

If you use more Azelastina MABO than you should

If you have applied too much Azelastina MABO to your eyes, you are unlikely to have any problems. In general, overdosing does not cause any adverse effects. However, if you have applied an excessive amount of the product and are concerned about this, consult your doctor.

In case of 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 administered, or go to the nearest hospital emergency room

If you forgot to use Azelastina MABO

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

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

Like all medications, Azelastina MABO may produce adverse effects, although not everyone will experience them. These adverse effects are usually not severe.

These effects include:

• Frequent (may affect up to 1 in 10 people): Mild irritation (burning, itching, tearing) in the eyes after using Azelastina MABO. 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 beverage.
• Very rare (may affect up to 1 in 10,000 people): Allergic reaction (rash and itching).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed 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.

No special storage conditions are required.

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.

Once opened:Do not use Azelastina MABO when the bottle has been opened after a period exceeding 4 weeks.

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

Composition of Azelastina MABO

• The active ingredient is azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg of azelastine hydrochloride.
• The other components are benzalkonium chloride, sodium edetate, hypromellose (E-464), liquid crystallizable sorbitol (E-420i), sodium hydroxide (E-524) to adjust pH, and water for injectable preparations.

Appearance of the product and contents of the packaging

Azelastina MABO is a colorless and transparent solution.

Azelastina MABO is presented in a plastic bottle with a dropper. A bottle contains 6 ml.

Holder of the marketing authorization

MABO-FARMA. S.A.

Calle Rejas 2, 1st floor

28821 Coslada(Madrid)

Spain

Responsible for manufacturing

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

.

28802, Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: June 2015

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/