Package Insert: Information for the User

Epinastine Hydrochloride 0.5 mg/mL Eye Drops Solution

Epinastine Hydrochloride

Read this entire 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 to you alone, 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 Relestat and for what it is used

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

3. How to use Relestat

4. Possible adverse effects

5. Storage of Relestat

6. Contents of the package and additional information

Relestat is an antiallergic medication.

Relestat is a solution eye drop used for the treatment of symptoms of seasonal allergic conjunctivitis, a seasonal allergic disease that affects the eye. The main symptoms treated by Relestat include tearing and itching, redness or swelling of the eyes or eyelids.

No use Relestat

• If you are allergic to epinastine hydrochloride 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 Relestat:

• If you wear contact lensesYou must remove them before using Relestat. Wait at least 15 minutes before putting them back in. See also section 2, “Relestat contains benzalkonium chloride”.
• If you need to use any other eye drops during treatment with Relestat: wait at least 10minutes between its application and the application of other eye drops.

Other Medications and Relestat

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

If you need to use any other eye drops during treatment with Relestat follow the instructions included in “Warnings and Precautions” in this section.

Pregnancy and Breastfeeding

Pregnancy

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

Breastfeeding

The passage of Relestat to breast milk is unknown. Consult your doctor or pharmacist before using this medication during the breastfeeding period.

Driving and Operating Machines

You may experience temporary blurred vision after using Relestat. Do not drive or operate machines until your vision returns to normal.

Relestat contains benzalkonium chloride and phosphates

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

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 in.

Benzalkonium chloride may cause eye 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.

This medication contains 23.75 mg of phosphate in each 5 ml of solution, equivalent to 4.75 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 blurred vision due to calcium accumulation (See section 4).

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

Use in children

Relestat should not be used in children under 12 years old.

Use in adults and adolescents (over 12 years old)

The recommended dose is one drop in each eye that needs treatment, twice a day; for example, in the morning and at night.

You must use Relestat every day you have symptoms during the allergy season but never for more than 8 weeks.

Instructions for use

Do not use this container if the security seal on the neck of the bottle is broken before its first use. Apply the drops in the following way:

1. Wash your hands. Tilt your head back and look up.
2. Separate your lower eyelid gently until a small space is left.
3. Turn the bottle back and press it to let one drop fall into the eye that needs treatment.
4. Release your lower eyelid and keep your eye closed for 30 seconds.

If the drop falls outside the eye, try again.

To avoid contamination of the solution, avoid letting the tip of the container touch the eye or any other surface.

Put the cap back on and close the container immediately after using it.

Wipe away any excess liquid on your cheek with a clean tissue.

The correct application of the drops is very important. If in doubt, consult your doctor or pharmacist.

If you use more Relestat than you should

If you use more drops of Relestat than you should,it is unlikely to cause any harm. Apply the next drop at the usual time. If you are concerned, talk to your doctor or pharmacist.

If you forgot to use Relestat

If you forgot a dose,apply it as soon as you remember, unless it is already time for your next dose, in which case you should discard the missed dose. Then use your next dose at the usual time and continue with your regular schedule.

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

If you interrupt the treatment with Relestat

Relestat should be used as advised by your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is unlikely that any of these side effects will be serious; most of them will be mild and only affect the eye.

If any of these situations occur, stop using Relestat and contact your doctor immediately or go to the nearest hospital:

• Asthma (an allergic disease that affects the lungs and causes breathing difficulties)
• If you experience symptoms of angioedema (swelling of the face, tongue, or throat; difficulty swallowing; urticaria and difficulty breathing)

The following side effects may also occur:

Frequent(may affect up to1 in 10 people)

• Burning or irritation sensation in the eye (usually mild)

Rare(may affect up to 1 in 100 people)

General side effects:

• Headache
• Nasal congestion, runny nose, and sneezing due to nasal swelling and irritation
• Unusual taste in the mouth

Eye side effects:

• Redness of the eyes
• Dryness of the eyes
• Itching of the eyes
• Difficulty seeing clearly
• Eye discharge

Unknown(frequency cannot be estimated from available data):

• Increased tear production
• Pain in the eye
• Allergic reaction affecting the eyes
• Swelling of the eyes
• Swelling of the eyelids
• Skin rash and redness

Other side effects reported with phosphate-containing eye drops

This medicinecontains 23.75 mg of phosphate in each 5 ml of solution, equivalent to 4.75 mg/ml.

If you suffer from severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation (See section 2).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 of the container and on the box after EXP.The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the eye drops show signs of deterioration, for example, a change in color, and return the product to your pharmacist.

Do not store at a temperature above25ºC.

Store the bottle inside its box to protect it from light.

Discard the bottle 28 days after opening it, even if there are some drops left. This will protect you from infections.To help you remember, note the opening date on the box.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Relestat

• The active ingredient is epinastine hydrochloride. Each milliliter of eye drop solution contains 0.5 mg of epinastine hydrochloride.
• The other components are benzalkonium chloride (preservative), disodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide/hydrochloric acid (to adjust pH), and purified water.

Appearance of the product and contents of the package

Relestat is a transparent and colorless eye drop solution contained in a plastic bottle with a screw cap. Before opening, each bottle is filled to half its capacity, and contains 5 ml of solution. Each package contains one bottle.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid,

Spain

Responsible for manufacturing:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

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

Last review date of this leaflet: January 2021

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