Prospect: information for the patient

Afluón 0.5 mg/ml, eye drops in solution

Azelastina hydrochloride

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

-In this prospect, Afluón 0.5 mg/ml, eye drops in solution, is referred to as Afluón.

Content of the prospect

1. What Afluón is and for what it is used.
2. What you need to know before starting to use Afluón.
3. How to use Afluón.
4. Possible adverse effects.
5. Storage of Afluón.
6. Contents of the package and additional information.

Afluón contains the active ingredient, azelastine hydrochloride, which belongs to a group of medicines known as antiallergics (antihistamines).

Antihistamines prevent the effects of substances such as histamine that 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 above.

Afluón is 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.

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

Afluón is not suitable for the treatment of eye infections.

Do not use Afluón:

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

Warnings and precautionsConsult 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 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 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 medication to children under 4 years of age, as safety and efficacy have not been established.

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

Use of Afluón with other medications

Although it is unknown whether Afluón may be affected by other medications, inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

Driving and operating machinery:

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

Afluón contains benzalkonium chloride:

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

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you experience a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication 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:

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, morning and night.

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

Allergic conjunctivitis (perennial non-seasonal)

• Use in adults and children aged 12 years and older.
• The normal dose is one drop in each eye, morning and night.

If your symptoms are severe, your doctor may increase the dose to one drop in each eye up to four times a day.

The relief of allergic conjunctivitis symptoms should be observed within 15-30 minutes.

Instructions for the proper use of Afluón

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 remaining 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 in the middle of your lower eyelid (Scheme 3). Make sure the dropper does not touch your 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 pressing your nose, blink slowly a few times to spread the drop across the surface of your eye.
7. Wipe away any excess medication with a tissue.
8. Repeat this process in the other eye.

Scheme 1 Scheme 2 Scheme 3 Scheme 4

Treatment duration

Try to use Afluón regularly until your symptoms have disappeared.

Do not use Afluón for more than 6 weeks.

If you use more Afluón than you should

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

If you forget to use Afluón

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 missed doses.

If you interrupt treatment with Afluón

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

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

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

These effects include:

• Frequent (may affect 1 in 10 patients): Mild irritation (burning, itching, tearing) in the eyes after using Afluón. These effects should not last long.
• Infrequent (may affect 1 in 100 patients): Bitter taste in the mouth. This effect should disappear quickly, especially if you drink a soft drink.
• Very rare (may affect 1 in 10,000 patients): Allergic reaction (rash and itching).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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.

Do not use this medication after the expiration date that appears on the bottle label and in the box. The expiration date is the last day of the month indicated.

Once opened:Do not use this medication when the bottle has been opened after a period exceeding 4 weeks. This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medication containers. By doing so, you will help protect the environment.

Composition of Afluón

The active ingredient is azelastine hydrochloride0.05% (0.5 mg / ml).Each drop contains 0.015 mg of azelastine hydrochloride.

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

Appearance of the product and contents of the package

Afluón is a colorless and transparent solution.

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

Tubilux Pharma S.p.A.

Via Costarica 20/22

00071 Pomezia (Rome)

Italy

Phone: +39 (0) 691183 1

Fax: +39 (0) 691183 410

e-mail:[email protected]

For more information about this medication, please contact the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

This medication 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

Last review date of this leaflet:March 2024