Afluon 0.5 mg/ml eye drops solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Afluón 0,5 mg/ml, eye drops solution

Azelastine hydrochloride

Read the entire leaflet carefully before you start using this medicine, as 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• In this leaflet, Afluón 0,5 mg/ml, eye drops solution, is referred to as Afluón.

Package leaflet contents

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

1. What Afluón is and what it is used for

Afluón contains the active substance azelastine hydrochloride, which belongs to a group of medicines known as antiallergic agents (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.

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

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

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

Afluón is not suitable for the treatment of ocular infections.

2. What you need to know before using Afluón

Do not use Afluón:

• 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 Afluón

• If you are unsure whether your eye symptoms are caused by an allergy. In particular, if only one eye is affected; if your vision has worsened; or if you have eye pain without nasal symptoms, you may have an infection rather than an allergy.
• If symptoms worsen or last longer than 48 hours without significant improvement despite using Afluón.
• If you wear contact lenses.

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 safety and efficacy have not been established.

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

Using Afluón with other medicines

Although it is not known whether Afluón may be affected by other medicines, inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

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

Driving and use of machines:

After using Afluón, your vision may become blurred for a short period of time. If this occurs, wait until your vision has cleared before driving or operating machinery.

Afluón contains benzalkonium chloride:

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

Benzalkonium chloride can be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, particularly if you have dry eye or other corneal conditions (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use Afluón

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Remember:

Afluón should only be applied to the eyes.

The recommended dose is:

Ocular disorders caused by hay fever (seasonal allergic conjunctivitis)

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

If you anticipate exposure to pollen, you may administer the usual dose of Afluón before going outdoors as a preventive measure.

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

• For use in adults and children aged 12 years and older.
• The usual 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 allergic conjunctivitis symptoms should occur within 15–30 minutes.

Instructions for the proper use of Afluón

To make it easier to apply the eye drops, it may be helpful at first to sit in front of a mirror so you can see what you are doing.

1. Wash your hands.
2. Gently clean around your eyes to remove any moisture (Scheme 1).
3. Unscrew the cap from the bottle and check that the dropper is clean.
4. Gently pull down your lower eyelid (Scheme 2).
5. Carefully place one drop into the middle part 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). While keeping your finger pressed against the nose, blink slowly several times to spread the drop over the entire surface of the eye.
7. Gently wipe away any excess medication 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 Afluón regularly until your symptoms have disappeared.

Do not use Afluón for longer than 6 weeks.

If you use more Afluón than you should

If you have administered too much Afluón into your eyes, you are unlikely to experience problems. However, if you are concerned, consult your doctor. In case of accidental ingestion, contact your doctor immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medication and the amount taken.

If you forget to use Afluón

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

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

If you stop using Afluón

If you stop using Afluón, your symptoms will likely return.

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

4. Possible adverse effects

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

These effects include:

• Common (may affect up to 1 in 10 people): Mild eye irritation (stinging, itching, tearing) after using Afluón. 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 drink a beverage.
• Very rare (may affect up to 1 in 10,000 people): Allergic reaction (rash, 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Afluón

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

Do not use this medicine after the expiry date stated on the label of the bottle and the outer carton. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Afluón

The active substance is azelastine hydrochloride 0.05% (0.5 mg/mL). Each drop contains 0.015 mg of azelastine hydrochloride.

The other components are benzalkonium chloride, disodium edetate, hypromellose, liquid sorbitol (crystallizable) (E420i), sodium hydroxide (E524), and water for injection.

Appearance of the product and contents of the container

Afluón is a clear, colourless solution.

Afluón is supplied in a plastic bottle with a dropper. A bottle contains 6, 8 or 10 mL of ophthalmic solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The 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]

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

This medicinal product is authorized in EEA Member States under the following names:

Germany: Allergodil Augentropfen

Austria, Denmark, Italy, The Netherlands: Allergodil

Finland, Sweden: Lastin

Portugal: Allergodil

Spain: Afluon

United Kingdom, Ireland: Optilast

Date of the most recent revision of this leaflet: March 2024