Prospecto: information for the patient

Azelastina Abamed 0.5 mg/mL eye drop solution

Azelastina hydrochloride

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

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

1. What isAzelastina Abamedand for what it is used

2. What you need to know before starting to useAzelastina Abamed

3. How to useAzelastina Abamed

4. Possible adverse effects

5. Storage ofAzelastina Abamed

6. Contents of the package and additional information

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

Azelastina Abamedis 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 Abamedis 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 Abamed is not recommended for treating eye infections.

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

No use AzelastinaAbamed:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Azelastina Abamed 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.

- your symptoms worsen or last more than 48 hours without significant improvement, despite usingAzelastina Abamed.

- you are taking other non-prescription medicines.

- 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 eye disorders caused by hay fever (seasonal allergic conjunctivitis): Do not administer this medicine to children under 4 years of age, as its safety and efficacy have not been established.

For the treatment of eye disorders caused by an allergy (perennial non-seasonal allergic conjunctivitis): Do not administer this medicine to children under 12 years of age, as its safety and efficacy have not been established.

Other medicines and Azelastina Abamed

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

The effect of Azelastina Abamed on other medicines is unknown.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine

Driving and operating machinery

After using Azelastina Abamed your vision may become blurred for a short period of time. If this happens, wait for your vision to recover before driving or operating machinery.

Azelastina Abamed contains benzalkonium chloride, which may:

• cause eye irritation
• alter 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 reinserting them.

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

The recommended dose is:

Allergic conjunctivitis caused by hay fever (seasonal allergic conjunctivitis)

- Use in adults and children aged 4 years and older.

- The normal dose is one drop in each eye in the morning and in the evening.

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

Allergic conjunctivitis (perennial non-seasonal allergic conjunctivitis)

- Use in adults and children aged 12 years and older.

- The normal dose is one drop in each eye in the morning and in the evening.

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 Abamed regularly, if possible, until your symptoms have disappeared.

Remember:

1. • Do not use Azelastina Abamed for more than 6 weeks.

• Azelastina Abamed should only be applied to the eyes.

Instructions for the proper use of Azelastina Abamed:

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.

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

If you estimate that the action of Azelastina Abamed is too strong or too weak, inform your doctor or pharmacist.

If you use more Azelastina Abamed than you should

If you have administered too muchAzelastina Abamedin your eyes, you are unlikely to have problems, but if you are concerned, consult your doctor.

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

If you forgot to use Azelastina 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 compensate for the missed doses.

If you interrupt treatment with Azelastina Abamed

If you stop using Azelastina Abamed, your symptoms are likely to return.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

Frequent(may affect between 1 and 10 of every 100 treated patients):

• Mild eye irritation (burning, itching, tearing) in the eyes after use. These effects should not last long.

Infrequent(may affect between 1 and 10 of every 1,000 treated patients):

• Bitter taste in the mouth. This effect should disappear quickly, especially if you drink a refreshing beverage.

Very Rare(may affect fewer than 1 of every 10,000 treated patients):

• Allergic reaction (rash and itching).

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

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

Do not usethis medication afterthe expiration date that appears on the bottle (after CAD.:). The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGREpointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Azelastina Abamed

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

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

Appearance of the product and contents of the packaging

Azelastina Abamed is an colorless, transparent solution.

Azelastina Abamed is presented in a plastic bottle with a dropper inside a cardboard box. Each bottle contains 6 ml of eye drop solution.

Holder of the marketing authorization:

Qualix Pharma, S.L

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Spain

Responsible for manufacturing:

Labiana Pharmaceuticals, S.L.U.

c/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

Spain

Date of the last review of this leaflet:March 2018

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/