AZELASTINE ABAMED 0.5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Azelastine Abamed 0.5 mg/ml Eye Drops Solution

Azelastine Hydrochloride

Read the 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, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Azelastine belongs to a group of medications that are antiallergic and are called antihistamines. Antihistamines prevent the effects of substances like histamine, which the body produces as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.

Azelastine Abamed 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 Abamed 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 Abamed should not be used to treat ocular infections.

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

2. What you need to know before using Azelastine Abamed

Do not use Azelastine Abamed:

• 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 Azelastine Abamed if:

• You are not sure if 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.

• Your symptoms worsen or last more than 48 hours without notable improvement, despite using Azelastine Abamed.

• You are taking other medications without a prescription.

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

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 its 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 its safety and efficacy have not been established.

Other Medications and Azelastine Abamed

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

It is not known if Azelastine Abamed can 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

After using Azelastine Abamed, your vision may be blurred for a short period. If this happens, wait until your vision returns before driving or using machines.

Azelastine Abamed contains benzalkonium chloride, which may:

• cause ocular irritation
• change the color of soft contact lenses

It is recommended:

• to avoid contact with soft contact lenses
• to remove contact lenses before applying the eye drops and wait at least 15 minutes before putting them back in.

3. How to use Azelastine Abamed

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Remember to use your medication.

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 anticipate exposure to pollen, you can take a normal dose of Azelastine Abamed before going outside as a preventive measure.

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.

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

Remember:

1. Do not use Azelastine Abamed for more than 6 weeks.

• Azelastine Abamed should only be applied to the eyes.

Instructions for the proper use of Azelastine Abamed:

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.

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

If you think the effect of Azelastine Abamed is too strong or too weak, tell your doctor or pharmacist.

If you use more Azelastine Abamed than you should

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

In case of accidental ingestion, consult your doctor, the emergency department of the nearest hospital, or call the Toxicology Information Service (91) 562 04 20, indicating the medication and the amount administered.

If you forget to use Azelastine Abamed

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 forgotten doses.

If you stop using Azelastine Abamed

If you stop using Azelastine Abamed, your symptoms will likely return.

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 gets them.

The side effects that have been observed during the use of this eye drop are:

Common(may affect between 1 and 10 out of 100 patients treated):

• mild irritation (stinging, itching, tearing) in the eyes after use. These effects should not last long.

Uncommon(may affect between 1 and 10 out of 1000 patients treated):

• bitter taste in the mouth. This effect should disappear quickly, especially if you take a drink.

Rare(may affect less than 1 out of 1000 patients treated):

• allergic reaction (rash and itching).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Azelastine Abamed

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

No special storage conditions are required.

Once the bottle is opened, the eye drops should be used within 4 weeks. Discard any remaining solution. Write the opening date on the space provided on the label of each bottle and on the carton.

Do not use this medication after the expiration date shown on the bottle (after EXP.:). The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Azelastine Abamed

• The active ingredient is azelastine hydrochloride. Each milliliter of eye drops contains 0.5 milligrams of azelastine. Each drop of eye drops contains 0.015 mg of azelastine hydrochloride.

• The other components (excipients) are: benzalkonium chloride, disodium edetate, hypromellose, sorbitol liquid (crystallized) at 70%, sodium hydroxide, and water for injection.

Appearance of the Product and Package Contents

Azelastine Abamed is a clear, colorless solution.

Azelastine Abamed is presented in a plastic bottle with a dropper inside a cardboard box. Each bottle contains 6 ml of eye drops.

Marketing Authorization Holder:

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Spain

Manufacturer:

Labiana Pharmaceuticals, S.L.U.

c/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

Spain

Date of the Last Revision of this Package Leaflet:March 2018

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/