Package Insert: Information for the Patient

Apadin 1 mg/ml eye drops in solution.

Olopatadina

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 read 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 even if they have the same symptoms as you, 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 is Apadin and what it is used for

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

3.How to use Apadin

4.Possible adverse effects

5.Storage of Apadin

6.Contents of the package and additional information

Apadin is indicated for the treatment of the symptoms of seasonal allergic conjunctivitis.

Seasonal allergic conjunctivitis.Some elements (called allergens) such as pollen, household dust or animal hair can cause allergic reactions that lead to itching and redness as well as inflammation of the surface of their eyes.

Olopatadine belongs to the group of medications usedfor the treatment of eye allergic conditions. It acts by reducing the intensity of the allergic reaction..

No useApadin

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

Do not useApadinif you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Olopatadine.

Remove your contact lenses from your eyes before using Olopatadine.

Children

Do not use Apadin in children under 3 years old. Do not administer this medication to children under 3 years old because there are no data to indicate that it is safe and effective in children under 3 years old.

Use of Apadin with other medications

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

If you are using another eye drop or ointment, wait at least 5 minutes between the application of each medication. Eye ointments should be administered last.

Pregnancy, breastfeeding, and fertility

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.

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

Driving and operating machinery

Immediately after applying Apadin, you may notice that your vision is blurry. Do not drive or operate machinery until this effect has disappeared.

Apadin contains benzalkonium chloride

This medication contains 0.5 mg of benzalkonium chloride in each 5 ml, which is equivalent to 0.1 mg/ml.

Apadin's preservative, benzalkonium chloride, can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove your contact lenses before using this medication and wait 15 minutes before reinserting them.

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

Apadin contains disodium dodecahydrate hydrogen phosphate

This medication contains 16.72 mg of phosphates (in 63.05 mg of disodium dodecahydrate hydrogen phosphate) in each 5 ml bottle, which is equivalent to 3.34 mg/ml.

If you have severe damage to the cornea (the transparent layer of the front part of the eye), treatment with phosphates, in rare cases, may cause blurry vision due to calcium accumulation.

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

The recommended dose is one drop in one eye or in both eyes, twice a day - in the morning and in the afternoon.

Use this amount unless your doctor tells you otherwise. Only apply Apadin in both eyes if your doctor has instructed you to do so. Follow the treatment for the period of time indicated by your doctor.

OnlyApadin should be used as eye drops.

Usage Instructions

12

?Take the Apadin bottle and stand in front of a mirror.

?Wash your hands.

?Take the bottle and unscrew the cap.

?After removing the cap, the plastic ring seal must be removed before use.

?Hold the bottle, upside down, between your thumb and index finger.

?Incline your head back. Gently separate your eyelid from your eye with a finger, until a pouch forms, in which the drop should fall (Figure 1).

?Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.

?Do not touch your eye, eyelid, nearby areas or other surfaces with the dropper, as the drops remaining in the bottle could become infected.

?Gently press the base of the bottle to allow one drop of Apadin to fall each time.

?Do not squeeze the bottle, as it is designed for a gentle pressure on the base to be sufficient (Figure 2).

?If drops are applied in both eyes, repeat the previous steps for the other eye.

?Tighten the cap on the bottle immediately after using the product.

?Use one bottle before opening the next.

?If a drop falls outside the eye, try again.

If you use more Apadin than you should

You can remove it by washing your eyes with warm water. Do not apply more drops until the next application.

If you forget to use Apadin

Apply one drop as soon as you remember and continue with your regular dosing schedule.

However, if it is almost time for your next dose, do not apply the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for the missed dose.

If you interrupt treatment with Apadin

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

If you have any other questions 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 observed with Olopatadina:

Frequent: may affect up to 1 in 10 people

Eye effects: eye pain, eye irritation, dry eye, abnormal sensation in the eye, eye discomfort

General effects: headache, fatigue, dry nose, bad taste in the mouth

Rare: may affect up to 1 in 100 people

Eye effects:blurred, decreased, or abnormal vision, corneal alteration, inflammation of the eye surface with or without damage to the surface, conjunctival infection or inflammation, eye discharge, light sensitivity, increased tear production, eye itching, eye redness, abnormality in the eyelid, itching, redness, swelling, or crust on the eyelid.

General effects:diminished or abnormal perception of stimuli, dizziness, runny nose, dry skin, skin inflammation.

Unknown frequency: (cannot be estimated from available data)

Eye effects:swelling in the eye, corneal swelling, change in pupil size

General effects:difficulty breathing, increased allergic symptoms, facial swelling, numbness, generalized weakness, nausea, vomiting, paranasal sinus infection, skin redness and itching.

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

Reporting 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 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 thesafety 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 and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

To prevent infections, discard the bottle four weeks after it has been opened for the first time and use a new bottle. Note the opening date in the space provided on the label of each bottle and box.

Do not use this medication if you notice any change in color or odor.

Medications should not be thrown away 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 containers and medications you no longer need. By doing so, you will helpto protectthe environment.

Composition of Apadin

• The active principle is olopatadine. Each milliliter of solution contains 1 mg of olopatadine (as hydrochloride).
• The other components are benzalkonium chloride, hydrochloric acid (E507) (pH adjustment), disodium dodecahydrogenephosphate (E339), sodium chloride, sodium hydroxide (E524) (pH adjustment), and water for injection preparations.

Appearance of the product and contents of the packaging

Apadin is a transparent and colorless (a solution), practically particle-free liquid.

It is presented in a packaging that contains a 5 ml low-density polyethylene (LDPE) opaque bottle with an LDPE dropper and a high-density polyethylene (HDPE) screw cap with a safety closure.

Packaging

1 x 5 ml (1 bottle, which contains 5 ml of solution).

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

TIEDRA FARMACÉUTICA, S.L.

C/ Colón, 7, 30510 Yecla (Murcia)

Spain

Responsible manufacturer:

actrevo GmbH

Großer Burstah 25, 20457 Hamburg

Germany

DRUGSRUS Ltd.,

5 Sandridge Close, Harrow, Middlesex, HA1 1XD,

United Kingdom

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

ES: Apadin 1mg/ml eye drops in solution

Last review date of this leaflet:04/2023.

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