Azelastine Abamed 0.5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Azelastina Abamed 0.5 mg/ml eye drops, solution

Azelastine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Azelastina Abamed is and what it is used for
2. What you need to know before using Azelastina Abamed
3. How to use Azelastina Abamed
4. Possible side effects
5. How to store Azelastina Abamed
6. Contents of the pack and other information

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

Azelastine belongs to a group of medicines known as antiallergic agents called antihistamines. Antihistamines prevent the effects of substances such as histamine, which the body produces as part of an allergic reaction. Azelastine has been shown to reduce ocular inflammation.

Azelastina Abamed is used for the treatment and prevention of eye disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children aged 4 years and older.

Azelastina Abamed is also used for the treatment of eye disorders caused by allergies to substances such as house dust mites or animal dander (perennial allergic conjunctivitis) in adults and children aged 12 years and older.

Azelastina Abamed is not recommended for the treatment of ocular infections.

You should consult a doctor if your condition worsens or does not improve after 2 days of treatment.

2. What you need to know before using Azelastina Abamed

Do not use Azelastina Abamed:

• 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 unsure whether your eye symptoms are caused by an allergy. In particular, if symptoms affect only one eye, if your vision has worsened, or if you have eye pain without nasal symptoms, this may indicate an infection rather than an allergy.

• symptoms worsen or last longer than 48 hours without significant improvement, despite using Azelastina Abamed.

• you are taking other medicines without a prescription.

• you wear contact lenses. It is advised not to wear contact lenses until the signs and symptoms of allergic conjunctivitis have resolved.

Children and adolescents

For the treatment of ocular 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 ocular disorders caused by 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is unknown whether Azelastina Abamed may be affected by other medicines.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Azelastina Abamed contains benzalkonium chloride, which may:

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

It is recommended to:

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

3. How to use Azelastine Abamed

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to use your medicine.

The recommended dose is:

Eye disorders caused by hay fever (seasonal allergic conjunctivitis)

• For use in adults and children aged 4 years and older.
• The normal dose is one drop in each eye in the morning and at night.

If exposure to pollen is expected, a normal dose of Azelastine Abamed may be administered before going outdoors as a preventive measure.

Eye disorders caused by allergy (perennial non-seasonal allergic conjunctivitis)

• For use in adults and children aged 12 years and older.
• 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.

Reminder:

1. • Do not use Azelastine Abamed for longer than 6 weeks.

• Azelastine Abamed should only be applied to the eyes.

Instructions for proper use of Azelastine Abamed:

To facilitate the administration of the eye drops, it may be helpful during the first few times to sit in front of a mirror so that you can see what you are doing.

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

If you feel that the effect of Azelastina Abamed is too strong or too weak, tell your doctor or pharmacist.

If you use more Azelastina Abamed than you should

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

In case of accidental ingestion, seek immediate medical advice from your doctor, the nearest hospital emergency department, or call the Toxicology Information Service (91) 562 04 20, indicating the medication and the amount taken.

If you forget to use Azelastina Abamed

Use your eye drops as soon as you remember, and then take the next dose at your usual scheduled time.

Do not use a double dose to make up for a missed dose.

If you stop using Azelastina Abamed

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

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

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

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

Very rare (may affect fewer than 1 in every 10,000 treated patients):

• allergic reaction (rash and itching).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azelastine Abamed

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

No special storage conditions are required.

After opening the bottle, the eye drops should be used within 4 weeks. Discard any remaining solution. Record the date of opening in the space provided on the label of each bottle and on the carton.

Do not use this medicine after the expiry date stated on the bottle (after EXP.:). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azelastina Abamed

• The active substance is azelastine hydrochloride. Each millilitre 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, liquid sorbitol (crystallized) 70%, sodium hydroxide and water for injection.

Appearance of the product and contents of the container

Azelastina Abamed is a colourless, transparent solution.

Azelastina Abamed is supplied in a plastic bottle with a dropper, contained within a cardboard box. Each bottle contains 6 ml of eye drops.

Marketing Authorisation Holder:

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Spain

Manufacturer responsible for manufacturing:

Labiana Pharmaceuticals, S.L.U.

c/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

Spain

Date of the most recent revision of this leaflet: March 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/