AZELASTINE MABO 0.5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Azelastina MABO 0.5 mg/ml, Eye Drops Solution

Azelastina Hydrochloride 0.05% (0.5 mg/ml)

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

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

Azelastina MABO contains azelastine, which belongs to a group of medications called 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.

Azelastina MABO 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.

Azelastina MABO 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.

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

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

Do not use Azelastina MABO:

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

If this is the case, inform your doctor or pharmacist.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Azelastina MABO

• 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 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 Azelastina MABO.
• You are taking other medications without a medical prescription.
• 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

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

It is unknown if Azelastina MABO may be affected by other medications.

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 Using Machines

You may notice blurred vision immediately after applying Azelastina MABO. Do not drive or use machines 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 their color. Remove contact lenses before using this medication and wait 15 minutes before putting them back.

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

3. How to use Azelastina MABO

Follow 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 what the correct dose is or how to use this medication, consult your doctor or pharmacist.

Ocular disorders caused by hay fever (seasonal allergic conjunctivitis)

• Use in adults and children from 4 years of age.
• 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.

Ocular disorders caused by allergy (perennial allergic conjunctivitis)

• Use in adults and children from 12 years of age.
• 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.

If possible, you should use Azelastina MABO regularly until your symptoms have disappeared.

If you stop using Azelastina MABO, your symptoms will likely 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 the first few times, 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. Carefully place one drop in 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 pressing on the nose, blink slowly a few times to spread the drop across the entire surface of the eye.
7. Wipe away any excess medication with a tissue.
8. Repeat this procedure in the other eye.

Scheme 1 Scheme 2 Scheme 3 Scheme 4

If you use more Azelastina MABO than you should

If you have administered too much Azelastina MABO to your eyes, you will likely not have any problems. Generally, overdosing does not produce side effects. However, if you have applied an excessive amount of product and are concerned about this, consult your doctor.

In case of 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 administered, or go to the Emergency Department of the nearest hospital.

If you forget 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 make up for missed doses.

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

4. Possible Side Effects

Like all medications, Azelastina MABO can cause side effects, although not everyone will experience them. Side effects are usually not serious.

These effects include:

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect 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 Azelastina MABO

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 shown 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 for more than 4 weeks.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients are benzalkonium chloride, disodium edetate, hypromellose (E-464), sorbitol liquid (crystallizable) (E-420i), sodium hydroxide (E-524) to adjust pH, and water for injectable preparations.

Appearance of the Product and Package Contents

Azelastina MABO is a colorless and transparent solution.

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

Marketing Authorization Holder

MABO-FARMA. S.A.

Vía de los Poblados 3,

Building 6, 28033, Madrid,

Spain.

Manufacturer

MEIJI PHARMA SPAIN, S.A.

Avenida de Madrid, 94,

28802, Alcalá de Henares (Madrid)

Spain

Date of the Last Revision of this Package Leaflet: June 2015

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/