OLOPATADINE JUTA 1 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Olopatadina JUTA 1 mg/ml Eye Drops Solution

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

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

Contents of the Package Leaflet

1. What Olopatadina JUTA is and what it is used for
2. What you need to know before using Olopatadina JUTA
3. How to use Olopatadina JUTA
4. Possible side effects
5. Storage of Olopatadina JUTA
6. Package Contents and Additional Information

1. What Olopatadina JUTA is and what it is used for

This medication is indicated for the treatment of signs and symptoms of seasonal allergic conjunctivitis.

In allergic conjunctivitis, certain elements (called allergens) such as pollen, house dust, or animal hair can cause allergic reactions that lead to itching and redness, as well as inflammation of the surface of your eyes.

This medication works by reducing the intensity of the allergic reaction.

2. What you need to know before using Olopatadina JUTA

Do not use Olopatadina JUTA

• If you are allergic to olopatadine or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

If you wear contact lenses, you must remove thembefore using this medication (see section 3).

Children

Do not use this medication in children under 3 years of age. Do not administer this medication to children under 3 years of age, as there is no data indicating that it is safe and effective in children under 3 years of age.

Using Olopatadina JUTA with other medications

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

If you are using another eye drop or ointment, wait at least 5 minutes between applying each medication. Ointments should be applied last.

Pregnancy, Breastfeeding, and Fertility

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

Do not use this medication if you are breastfeeding; consult your doctor before using this medication.

Driving and Using Machines

You may experience blurred vision immediately after applying this medication. Do not drive or use machines until this effect has disappeared.

Olopatadina JUTA contains benzalkonium chloride

• This medication contains 0.1 mg of benzalkonium chloride per unit volume.
• Benzalkonium chloride can be absorbed by soft contact lenses, altering their color.
• Remove contact lenses before using this medication and wait 15 minutes before putting them back.
• Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

This medication contains less than 23 mg of sodium (1 mmol) per unit volume; it is essentially "sodium-free".

3. How to use Olopatadina JUTA

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended doseis one drop in one eye or both eyes, twice a day: in the morning and in the evening.

Use this amount unless your doctor gives you other instructions. This medication should only be applied to both eyes if your doctor has indicated it. Follow the treatment for the period of time indicated by your doctor.

Remember that this medication should only be applied to the eyes.

Instructions for the proper use of Olopatadina JUTA:

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

1 2

• Wash your hands and remove any contact lenses.
• Take the bottle and unscrew the cap.
• After removing the cap, remove the plastic ring from the seal if it is loose.
• The plastic ring of the seal should not be broken before the first use.
• Hold the bottle, upside down, between your thumb and index finger.
• Tilt your head back. Gently separate the eyelid from the eye with one finger, until a pocket forms between the eyelid and your eye, where the drop should fall (Figure 1).
• Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
• Do not touch the eye, eyelid, or surrounding areas with the dropper, as the drops remaining in the bottle may become infected.
• Gently press the base of the bottle to release one drop of the medication at a time.
• Do not squeeze the bottle; it is designed so that gentle pressure on the base is sufficient (Figure 2).
• If you are applying drops to both eyes, repeat the above steps for the other eye.
• Screw the cap back on the bottle immediately after using the product.
• If a drop falls outside the eye, try again.

If you use more Olopatadina JUTA than you should

You can rinse your eyes with warm water. Do not apply more drops until the next scheduled application.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medication and the amount used.

If you forget to use Olopatadina JUTA

Apply one drop as soon as you remember and continue with the next dose of your regular schedule. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular schedule. Do not apply a double dose to make up for missed doses.

If you stop using Olopatadina JUTA

Do not stop using this medication without consulting your doctor first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The side effects that have been observed during the use of this eye drop are:

Common(may affect up to 1 in 10 people):

• Eye pain, eye irritation, dry eye, abnormal sensation in the eye, eye discomfort.
• Headache, fatigue, dry nose, bad taste in the mouth.

Uncommon(may affect up to 1 in 100 people):

• Blurred vision, decreased or abnormal vision, corneal disorder, inflammation of the eye surface with or without damage to the surface, conjunctival infection or inflammation, eye discharge, sensitivity to light, increased tear production, eye itching, eye redness, eyelid abnormality, itching, redness, swelling, or crust on the eyelid.
• Decreased or abnormal perception, dizziness, runny nose, dry skin, skin inflammation.

Frequency not known(cannot be estimated from available data):

• Eye swelling, corneal swelling, change in pupil size.
• Difficulty breathing, increased allergic symptoms, facial swelling, numbness, general weakness, nausea, vomiting, sinus infection, redness, and itching of the skin.

In very rare cases, some patients with severe damage to the transparent layer on the front of the eye (the cornea) have developed dark spots on the cornea due to calcium accumulation during treatment.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olopatadina JUTA

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle (after EXP). The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

To avoid infections, you must discard the bottle four weeks after first opening it and use a new bottle. Write the opening date on the space provided on the label of each bottle and on the box.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Olopatadina JUTA Composition

• The active ingredient is olopatadine. Each milliliter of solution contains 1 mg of olopatadine (as hydrochloride).
• This medication contains 0.5 mg of benzalkonium chloride per 5 ml, which is equivalent to a concentration of 0.1 mg/ml.

• The other components are sodium chloride, disodium hydrogen phosphate dodecahydrate, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Product Appearance and Package Contents

Olopatadina JUTA is a colorless, transparent solution presented in a package containing a 5 ml bottle or three 5 ml plastic bottles with a screw cap.

Only certain package sizes may be marketed.

Marketing Authorization Holder:

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

Manufacturer:

Juta Pharma GmbH

Gutenbergstr. 13

24941 Flensburg

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Olopatadin JUTA 1 mg/ml Augentropfen, Lösung

Denmark: Olopatadin JUTA

United Kingdom: Olopatadine USV 1 mg/ml eye drops, solution

Date of the last revision of this package leaflet: September 2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/