AFLUON 0.5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Afluon 0.5 mg/ml, Eye Drops Solution

Azelastine Hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• In this package leaflet, Afluon 0.5 mg/ml, Eye Drops Solution, is referred to as Afluon.

Contents of the Package Leaflet

1. What is Afluon and what is it used for.
2. What you need to know before you start using Afluon.
3. How to use Afluon.
4. Possible side effects.
5. Storage of Afluon.
6. Contents of the pack and further information.

1. What is Afluon and what is it used for

Afluon contains the active ingredient azelastine hydrochloride, which belongs to a group of medicines called antiallergics (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.

Afluon 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.

Afluon 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.

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

Afluon is not suitable for the treatment of ocular infections.

2. What you need to know before you start using Afluon

Do not use Afluon:

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

Warnings and precautionsTalk to your doctor or pharmacist before you start using Afluon

• 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 Afluon.
• If you wear contact lenses.

Children and adolescents

For the treatment of ocular disorders caused by hay fever (seasonal allergic conjunctivitis): Do not give this medicine to children under 4 years of age, as the safety and efficacy have not been established.

For the treatment of ocular disorders caused by allergy (perennial allergic conjunctivitis): Do not give this medicine to children under 12 years of age, as the safety and efficacy have not been established.

Using Afluon with other medicines

Although it is not known if Afluon can be affected by other medicines, tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy and Breast-feeding

If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines:

After using Afluon, your vision may be blurred for a short time. If this happens, wait until your vision returns to normal before driving or using machines.

Afluon contains benzalkonium chloride:

This medicine contains 0.00375 mg of benzalkonium chloride in each drop, equivalent to 0.00375 mg / 0.03 ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medicine 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). Talk to your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Afluon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Remember:

Afluon should only be applied to the eyes.

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 the normal dose of Afluon 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 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.

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

Instructions for the proper use of Afluon

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 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. Place one drop carefully into 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 pressed against your nose, blink slowly a few times to spread the drop across the entire surface of the eye.
7. Wipe away any excess medicine with a tissue.
8. Repeat this procedure in the other eye.

Scheme 1 Scheme 2 Scheme 3 Scheme 4

Duration of treatment

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

Do not use Afluon for more than 6 weeks.

If you use more Afluon than you should

If you have administered too much Afluon to your eyes, you are unlikely to have any problems. But if you are concerned, talk to your doctor. In case of accidental ingestion, consult your doctor immediately, with the emergency department of the nearest hospital, or call the Toxicology Information Service Telephone (91) 562 04 20, indicating the medicine and the amount administered.

If you forget to use Afluon

Use your eye drops as soon as you remember and administer the next dose at the usual time.

Do not use a double dose to make up for forgotten doses.

If you stop using Afluon

If you stop using Afluon, your symptoms will probably come back.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These effects include:

• Common (may affect up to 1 in 10 people): Mild irritation (itching, stinging, tearing) in the eyes after using Afluon. 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.
• Rare (may affect up to 1 in 10,000 people): Allergic reaction (rash and itching).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Afluon

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

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date is the last day of the month stated.

After opening:Do not use this medicine if the bottle has been open for more than 4 weeks. This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Afluon

The active substance 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, sorbitol liquid (crystallizable) (E420i), sodium hydroxide (E524), and water for injection.

Appearance and packaging of the product

Afluon is a colorless and transparent solution.

Afluon is presented in a plastic bottle with a dropper. One bottle contains 6, 8 or 10 ml of eye drops solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

Tubilux Pharma S.p.A.

Via Costarica 20/22

00071 Pomezia (Rome)

Italy

Tel: +39 (0) 691183 1

Fax: +39 (0) 691183 410

e-mail: [email protected]

You can ask for more information about this medicine from the local representative of the Marketing Authorisation Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5ª planta

08011 - Barcelona

This medicine is authorized in the EEA Member States with the following names:

Germany:Allergodil Augentropfen

Austria, Denmark, Italy, Netherlands:Allergodil

Finland, Sweden:Lastin

Portugal:Allergodil

Spain:Afluon

United Kingdom, Ireland:Optilast

Date of last revision of this package leaflet:March 2024