Insert - Relestat - UK, Ireland - For MoH Submission

^r6. Contents of the pack and other information What Relestat contains

- The active substance is epinastine hydrochloride. One ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride.

edetate, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide/hydrochloric acid (to adjust pH) and purified water.

What Relestat looks like and contents of the pack

Relestat is a clear and colourless eye drops solution in a plastic bottle with a screw-cap. When unopened, each bottle is about half full and contains 5 ml of solution.

Each pack contains 1 bottle..............

Marketing Authorisation Holder and Manufacturer

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

This medicinal product is authorised in the Member States of the EEA under the following names:

This leafletwas last revised in June 2014.

^ALLERGAN

72322MD140F

Read all ofthis leaflet carefully beforeyou start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

¹ - 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 signs of illness 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.

What is in this leaflet

1. What Relestat is and what it is used for '2. WhatyouneedtoknowbeforeyouuseRelestat '3. HowtouseRelestat

4.    Possible side effects

5.    HowtostoreRelestat

6.    Contents of the pack and other information

1.    WhatRelestat is and what it is used for

Relestat is an anti-allergic medicine.

It is an eye drops solution used to treat the symptoms of seasonal allergic conjunctivitis, ¹ a seasonal allergic disease affecting the eye. The main symptoms treated by Relestat include watery eyes and eyes or eyelids which are itchy, red or swollen.

2.    Whatyouneed toknow before you use Relestat Do not use Relestat:

• ifyou are allergic to epinastine hydrochloride or anyofthe other ingredients of this medicine (listed in Section 6).

¹ Warnings and precautions

Talk to your doctor or pharmacist before using Relestat.

•    if you wear soft contact lenses: you must remove them before using the Relestat eye drops. After using Relestat, wait at least 15 minutes before putting your lenses back in. See also in Section 2, “Relestat contains benzalkonium chloride"

•    ifyou havetouseanyothereyedropsduringtreatmentwith Relestat: leave at least 10 minutes between putting in Relestat and the other drops.

¹ Other medicines and Relestat

Tell your doctor or pharmacist if you are using, have recently used or might use any

other medicines.

If you have to use any other eye drops during treatment with Relestat, please see

above under “Warnings and precautions" inthis section.

Pregnancyand breast-feeding

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Breast-feeding

It is not known whether Relestat passes into breast milk. Ask your doctor or pharmacist for advice before using this medicine during breast-feeding.

i Driving and using machines

Your sight may become blurred for a short time just after using Relestat. You should not drive or use machines until yoursight is clear again.

Relestat contains benzalkonium chloride

Relestat contains a preservative, called benzalkonium chloride, that can discolour soft contact lenses and may cause eye irritation.

Artwork created at 100%

Drop all keylines and notes before printing Part Number: 72322MD140F Drawing Number: 0106901

INSERT, TYPE B 3/4, PENCIL EELD,

BB8mm x BSSmm EELDEB TE 114mm x B3mm 0106901

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Use in children

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

Usein adults and adolescents (12 yearsof age and older)

The recommended dose is 1 drop in each eye that needs treatment, twice a day, for example in the morning and in the evening.

You should use Relestat every day that you experience eye symptoms during the allergy season but for no longer than 8 weeks.

Instructions for use

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first begin to use it. Apply your eye drops in the following way:

1.    Wash your hands. Tilt your head back and look at the ceiling.

2.    Gently pull the lower eyelid down until there is a small “pocket.

3.    Turn the bottle upside down and squeeze itto release one drop into each eye that needs treatment.

4.    Let go of the lower lid, and close your eye for 30 seconds.

If a drop misses your eye, try again.

¹ To avoid contamination of the solution in the bottle, do not let the tip of the dropper ¹ touch your eye or anything else.

Replace and tighten the cap straight after use.

Wipe off any excess liquid from your cheek with a clean tissue.

The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist..............

Ifyou use more Relestatthan you should

¹ If you use more drops of Relestat than you should, it is unlikely to cause you any harm. Putyour nextdrop(s) in atthe usual time. If you are worried, talktoyour doctor or pharmacist.

If you forget to use Relestat

If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then, use your next dose at the usual time and continue with your normal routine.

' Do not use a double dose to make up for a forgotten dose.

Ifyou stop using Relestat

Relestat should be used as advised by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

^r4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. None of the side effects are likely to be serious; most side effects are likelyto be mild and only affectthe eye.

If the following happens, stop using Relestat and contact your doctor immediately or go to your nearest hospital:

¹ • asthma (an allergic disease affecting the lungs that causes breathing difficulties) The following side effects may also occur:

Common (mayaffectuptol in 10people)

•    burning sensation or irritation ofthe eye (mostly mild)

Uncommon (mayaffectuptol in 100people)

General side effects:

•    headache

•    swelling and irritation inside the nose, which may cause a runny or blocked nose and sneezing

•    unusual taste in your mouth

Side effects affecting the eye:

•    red eyes i • dry eyes

•    itchy eyes

•    difficulty in seeing clearly

•    discharge from the eyes

Patients have also reported thefollowing side effects:

•    increased tear production

•    eye pain

i Reporting of side effects

Ifyou get anyside effects, talktoyour doctor or pharmacist. This includes anypossible side effects not listed inthis leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

i IMB Pharmacovigilance Earlsfort Terrace IRL- Dublin2 Tel:+3531 6764971 Fax: +3531 6762517 Website: www.imb.ie e-mail: imbpharmacovigilance@imb.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. HowtostoreRelestat

Keepthis medicine out ofthe sight and reach of children.

Do not use this medicine afterthe expirydate which is stated on the label of the bottle and on the box after EXP

¹ Do not use this medicine if you notice that the eye drops have shown signs of deterioration, for example change in colour, and take the productbacktoyour pharmacist.

Do not store above 25°C.

Keep the bottle in the box in order to protect from light.

, You must throw away the bottle 28 days after you first opened it, even if there are still some drops left. This will guard against infection. To help you remember, write downthe date thatyou opened it inthe space onthe box.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.