APADIN 1 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Apadin 1 mg/ml eye drops in solution.

Olopatadine

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Apadin and what is it used for

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

Allergic conjunctivitis.Some 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.

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

2. What you need to know before you start using Apadin

Do not useApadin

If you are allergic(hypersensitive) to olopatadina or any of the other ingredients of this medicine (listed in section 6).

Do not use Apadin if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before you start using Olopatadina.

You should remove your contact lenses before using Olopatadina.

N

Do not use Apadin in children under 3 years of age. Do not give this medicine to children under 3 years of age because there is no data to indicate that it is safe and effective in children under 3 years of age.

Using Apadin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using this medicine.

Do not use Apadin if you are breastfeeding. Talk to your doctor before using this medicine.

Driving and using machines

Immediately after applying Apadin, you may notice that your vision is blurred. Do not drive or use machines until this effect has disappeared.

Apadin contains benzalkonium chloride

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

The preservative in Apadin, 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 medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride can cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer on the front of the eye). Talk to your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

A

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

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

3. How to use Apadin

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are not sure, talk to 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 gives you other instructions. You should only apply Apadin to both eyes if your doctor has told you to do so. Continue the treatment for the period of time indicated by your doctor.

Olopatadina should only be used as eye drops.

Instructions for use

1 2

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

? Wash your hands.

? Hold the bottle and unscrew the cap.

? After removing the cap, you must remove the plastic ring from the seal before using.

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

? Tilt your head back. Gently pull down your lower eyelid to form a pocket, where the drop should fall (Figure 1).

? Bring the tip of the bottle close to your eye. You may find it helpful to look in the mirror.

? Do not touch your eye, eyelid, or surrounding areas with the dropper, because the drops that remain in the bottle could become infected.

? Gently press the base of the bottle to release one drop of Apadin at a time.

? Do not squeeze the bottle, it is designed so that a gentle pressure on the base is enough (Figure 2).

? If you are applying drops to both eyes, repeat the above steps for the other eye.

? Replace the cap on the bottle immediately after use.

? Use one bottle before opening the next one.

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

If you use more Apadin than you should

You can rinse your eyes with lukewarm 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 next scheduled dose.

However, if it is almost time for your next dose, do not apply the missed dose. Continue with your next scheduled dose. Do not apply a double dose to make up for the missed dose.

If you stop using Apadin

Do not stop using this medicine without talking to your doctor first.

If you have any further questions about the use of this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed with Olopatadina:

Common: 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

Uncommon: may affect up to 1 in 100 people

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

General effects:decreased or abnormal sensation, dizziness, runny nose, dry skin, skin inflammation.

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

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

General effects: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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Apadin

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

Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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

Do not use this medicine if you notice any change in the color or smell.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Apadin

• The active ingredient is olopatadine. Each ml of solution contains 1 mg of olopatadine (as hydrochloride).
• The other ingredients are benzalkonium chloride, hydrochloric acid (E507) (pH adjuster), disodium hydrogen phosphate dodecahydrate (E339), sodium chloride, sodium hydroxide (E524) (pH adjuster), and water for injections.

Appearance and pack contents

Apadin is a clear and colorless liquid (a solution), practically free of particles.

It comes in a pack containing a 5 ml bottle of low-density polyethylene (LDPE) with a dropper of LDPE and a screw cap of high-density polyethylene (HDPE) with a child-resistant closure.

Packs

1 x 5 ml (1 bottle, containing 5 ml of solution).

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

TIEDRA FARMACÉUTICA, S.L.

C/ Colón, 7, 30510 Yecla (Murcia)

Spain

Manufacturer:

actrevo GmbH

Großer Burstah 25, 20457 Hamburg

Germany

DRUGSRUS Ltd.,

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

United Kingdom

This medicine is authorised in the Member States of the European Economic Area under the following names:

ES: Apadin 1mg/ml eye drops in solution

Date of last revision of this package leaflet: 04/2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es