Relestat

Package Leaflet: Information for the User

Relestat, 0.5 mg/ml, eye drops, solution
Epinastine hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Relestat and what is it used for
• 2. Important information before using Relestat
• 3. How to use Relestat
• 4. Possible side effects
• 5. How to store Relestat
• 6. Contents of the pack and other information

1. What is Relestat and what is it used for

Relestat, eye drops, solution is an antiallergic medicine (anti-allergic), used to treat the symptoms of seasonal allergic conjunctivitis. Relestat is used to treat the following symptoms: eye watering, itching, redness or swelling of the eyes or eyelids.

2. Important information before using Relestat

When not to use Relestat

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

Warnings and precautions

Before starting to use Relestat, you should talk to your doctor or pharmacist.

• If you wear soft contact lenses; lenses should be removed before using Relestat, eye drops. After using the drops, wait at least 15 minutes before putting the lenses back in. See also section 2: "Relestat contains benzalkonium chloride".
• If you need to use other eye drops during treatment with Relestat, leave at least 10 minutes between using Relestat and the other eye drops.

Relestat and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take. If you need to use other eye drops during treatment with Relestat, see the section "Warnings and precautions" in this section.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Breastfeeding
It is not known whether Relestat passes into breast milk. Before using this medicine while breastfeeding, ask your doctor or pharmacist for advice.

Driving and using machines

For a short time after using Relestat, your vision may be blurred. Do not drive or use machines until your vision is clear.

Relestat contains benzalkonium chloride and phosphates

This medicine contains 0.5 mg of benzalkonium chloride in every 5 ml of solution, which corresponds to 0.1 mg/ml. Relestat contains a preservative called benzalkonium chloride, which may be absorbed by soft contact lenses and may change the color of soft contact lenses. Before using Relestat, eye drops, remove your soft contact lenses (also called hydrophilic lenses). After using the drops, wait at least 15 minutes before putting the lenses back in. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging or pain in the eye after using this medicine, contact your doctor. This medicine contains 23.75 mg of phosphates in every 5 ml of solution, which corresponds to 4.75 mg/ml. In very rare cases, during treatment in some patients with severe damage to the transparent layer on the front of the eye (cornea), phosphates may cause corneal clouding due to calcium accumulation (see section 4).

3. How to use Relestat

This medicine should always be used exactly as your doctor has instructed you. If you are not sure, ask your doctor or pharmacist.

Use in children

Relestat should not be used in children under 12 years of age.

Use in adults and adolescents (12 years of age and older)

The recommended dose of Relestat is one dropinto each affected eye twice a day, for example in the morning and in the evening. Relestat should be used every day in the eye with symptoms during the allergy season, but not for more than 8 weeks.

Method of administration

Do not use the medicine if the protective cap on the bottle neck is damaged before the first opening. The drops should be administered as follows:

1.

Before opening the bottle, wash your hands. Tilt your head back and look up at the ceiling.

2.

Gently pull down the lower eyelid of the affected eye to form a small pocket.

3.

Turn the bottle upside down and squeeze it to release one drop into the pocket formed in the eye that needs treatment.

4.

Release the lower eyelid and close your eye for 30 seconds. If the drop does not get into your eye, try again. To avoid contaminating the solution in the bottle, do not touch the tip of the dropper to your eye or any other surface. Immediately after use, replace and tighten the cap to close the bottle. Wipe away any excess solution from your cheek with a clean tissue. It is very important to administer the drops correctly into the treated eye. If you have any questions, ask your doctor or pharmacist.

Using more Relestat than you should

It is unlikely that using more Relestat than recommended will harm you. Administer the next dose at the normal time. If you are concerned, talk to your doctor or pharmacist.

Forgetting to use Relestat

If you miss a dose of Relestat, use one drop into each affected eye as soon as you remember, unless it is nearly time for the next dose. Do not use a double dose to make up for a forgotten dose.

Stopping the use of Relestat

Use Relestat as instructed by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Relestat can cause side effects, although not everybody gets them. You should not expect serious side effects. Most side effects are mild and affect only the eyes.

If you experience any of the following symptoms, stop using Relestat and contact your doctor or go to the nearest hospital immediately:

• asthma (an allergic reaction that affects the lungs and can cause difficulty breathing);
• if you experience symptoms of angioedema (swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing)

The following side effects may also occur:

Common (affects up to 1 in 10 people):

burning sensation or eye irritation (usually mild).

Uncommon (affects up to 1 in 100 people):

General disorders:

• headache;
• nasal congestion and irritation, which may cause a runny nose or stuffy nose and sneezing;
• unusual taste in the mouth.

Eye disorders:

• eye redness;
• dry eyes;
• eye itching;
• blurred vision;
• eye discharge.

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

• increased tearing;
• eye pain;
• allergic reaction of the eyes;
• eye swelling;
• eyelid swelling;
• skin rash and redness.

Other side effects reported with the use of eye drops containing phosphates

This medicine contains 23.75 mg of phosphates in every 5 ml of solution, which corresponds to 4.75 mg/ml. In very rare cases, during treatment in some patients with severe damage to the transparent layer on the front of the eye (cornea), phosphates may cause corneal clouding due to calcium accumulation (see section 2).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Relestat

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 label and carton after EXP. Do not use this medicine if you notice any signs of deterioration. Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. To prevent infection, discard the bottle after 28 days of first opening, even if there is still some medicine left. To help you remember the expiry date, write the date you opened the bottle on the carton. 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 other information

What Relestat contains

• The active substance is epinastine hydrochloride. 1 ml of solution contains 0.5 mg of epinastine hydrochloride.
• The other ingredients are: benzalkonium chloride (preservative), disodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide/hydrochloric acid (for pH adjustment), purified water.

What Relestat looks like and contents of the pack

Relestat is a clear and colorless solution in a plastic bottle with a screw cap. Each bottle is filled to about half and contains 5 ml of solution. Each pack contains one bottle.

Marketing authorization holder

AbbVie Sp. z o.o., ul. Postępu 21B, 02-676 Warsaw, tel. 22 372 78 00

Manufacturer

Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, Ireland

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

Date of last revision of the package leaflet: