Package Insert: Information for the Patient

Ibis 6 mg/ml Eye Drops Solution

Bilastine

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What Ibis is and for what it is used

2.What you need to know before starting to use Ibis

3.How to use Ibis

4.Possible adverse effects

5.Storage of Ibis

6.Contents of the package and additional information

This medication contains bilastine, which belongs to a group of medications called antihistamines. Antihistamines work by preventing the effects of a substance called histamine that the body produces as part of an allergic reaction.

This medication is used to treat the signs and symptoms of eye disorders that occur withseasonal allergic conjunctivitisin adults.

This medication is also used to treat the signs and symptoms of eye disorders caused by an allergy to substances such as house dust mites or animal hair(perennial allergic conjunctivitis)in adults.

Do not use Ibis

- if you are allergic to bilastine or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ibis if during treatment you experience any adverse effects, such as eye irritation, pain, redness, or changes in vision, or if your condition worsens. It may be necessary to interrupt treatment.

After administering the Ibis antiallergic eye drop into the conjunctival sac of the eye, your visual acuity may decrease for a few minutes due to the formation of spots.

In the case of inflammation, including allergic conjunctivitis, consult your ophthalmologist if you can use contact lenses despite the symptoms.

Children and adolescents

This medication is only indicated for adults.

Do not administer this medication to children and adolescents because its efficacy and safety have not yet been studied in these groups.

Other medications and Ibis

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

If you are using other eye medications, leave at least 5 minutes between each medication.

Ophthalmic creams must be administered last.

Pregnancy, breastfeeding, and fertility

Ibis can be used during 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 machines

After instillation of this medication, temporary blurred vision or other visual changes may occur that affect your ability to drive or operate machines. Wait until your vision is clear before driving or operating machinery.

Contact lenses

The use of this medication does not affect the properties of contact lenses. You can continue to use contact lenses during use of this medication.

Remove your contact lenses before applying the eye drop and do not put them back on until 15 minutes after administration.

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

The recommended dose for adults is one drop in each affected eye once a day.

This medication can be used for a maximum of 8 weeks. Your doctor will decide and advise you on how long you should use it based on your situation.

For ocular use only.

Administration Form

1. Always wash your hands and dry them with a clean towel before administering this medication.
2. Gently clean your eyelids if there is discharge by rubbing the eyelid with the eye closed from the inner to the outer part with a cotton swab moistened with warm water.
3. Open the bottle and avoid contact between the tip of the dropper and your eye or any other surface: the drops and droppers must remain clean.
4. Tilt your head back, or lie down, and look up (Figure 1). Using your finger, pull the lower eyelid down (Figure 2).
5. Look up and press to let one drop fall into the eye.
6. Release the lower eyelid and keep the eye closed for a while to distribute the drop over the eye surface (Figure 3).
7. Repeat the previous action in the other eye if necessary.

To avoid contamination during the use of this medication, do not touch any surface (eyelids, areas around the eye, or other surfaces) with the tip of the dropper and dry the tip of the dropper after use with a clean paper tissue to eliminate any residual liquid.

If you use more Ibis than you should

You can rinse it with warm water. In case of doubt, consult your doctor. Also, in case of overdose or accidental ingestion, you can consult the Toxicological Information Service Tel.: 91 562 04 20.

If you forgot to use Ibis

Do not use a double dose to compensate for the missed doses.

If you forget to apply the drop on time, apply the missed drop as soon as possible and then return to your usual dosing schedule.

If you interrupt treatment with Ibis

Treatment with this medication should be carried out as regularly as possible until symptoms improve. If you stop using Ibis while still exposed to allergens, you can expect symptoms typical of an allergy to reappear.

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

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

The following adverse effects have been reported.

Adverse effects that are infrequent (may affect up to 1 in 100 people):

Alteration of taste (dysgeusia), headache.

Dry eye, ocular secretion, eye irritation, increased tear production, eye discomfort.

If one of the adverse effects described above occurs, stop using this medication and consult your doctor directly. The mentioned adverse effects are usually mild and disappear quickly in all cases. Therefore, no specific measures are required.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish 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.

Do not use this medication after the expiration date that appears on the label or on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After the first opening of the bottle:do not use this medication if the bottle has been open for more than 2 months.

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

Composition of Ibis

• The active principle is bilastine 6 mg/ml.

One drop contains 0.2 mg of bilastine.

• The other components are hydroxypropyl betadex, methylcellulose, sodium hyaluronate, glycerol (E 422), sodium hydroxide 1 N (for pH adjustment), and water for injectable preparations.

Appearance of the product and contents of the package

Ibis are transparent and colorless eye drops, contained in a 1 LDPE white multidose vial that contains 5 ml of preservative-free solution, with a white HDPE dropper and a safety anti-manipulation cap system.

Package size: 1 vial of 5 ml.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare

L-1611 Luxembourg

Local representative:

Laboratorios Menarini, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona), Spain

Responsible manufacturer

FAMAR Health Care Services Madrid, S.A.U.

Avenida Leganés, 62

28923 Alcorcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany: Bilaxten 6 mg/ml Augentropfen, Lösung;

Austria: Olisir 6 mg/ml Augentropfen, Lösung;

Belgium: Bellozal 6 mg/ml eye drops, solution;

Croatia: Nixar 6 mg/ml eye drops, solution;

Cyprus: Bilaz 6mg/mlophthalmicdrops;

Slovenia: Bilador 6 mg/ml eye drops, solution;

Spain: Ibis 6 mg/ml eye drops in solution;

Estonia: Opexa;

France: Bilaska 6 mg/ml eye drops in solution;

Greece: Bilaz;

Hungary: Lendin 6 mg/ml eye drops;

Ireland: Drynol 6 mg/ml eye drops, solution;

Italy: Olisir 6 mg/ml eye drops, solution;

Latvia: Opexa 6 mg/ml eye drops, solution;

Lithuania: Opexa 6 mg/ml eye drops, solution;

Luxembourg: Bellozal 6 mg/ml eye drops, solution;

Malta: Gosall 6 mg/ml eye drops, solution;

Poland: Clatra;

Portugal: Lergonix 6 mg/ml eye drops, solution;

Czech Republic: Xados;

Slovakia: Omarit 6 mg/ml eye drops;

Romania: Borenar 6 mg/ml eye drops, solution.

Last review date of thisleaflet:June 2022

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