Relestat, 0.5 mg/ml, eye drops, solution.

• Keep this 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 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.

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

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

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”.
• if you have to use any other eye drops during treatment with Relestat: leave at least 10 minutes between putting in Relestat and the other drops.

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” in this section.

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.

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

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

Relestat contains a preservative, called benzalkonium chloride, that may be absorbed by soft contact lenses and and may change the colour of the contact lenses

If you wear soft contact lenses (also called hydrophilic lenses) you must remove them before using the Relestat eye drops. After using Relestat, you have to wait at least 15 minutes before putting your lenses back in.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

This medicine contains 23.75 mg phosphates in each 5 ml, which is equivalent to 4.75 mg/ml.

If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment (see section 4).

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

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.

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 it to 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.

To avoid contamination of the solution in the bottle, do not let the tip of the dropper 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.

If you use more drops of Relestat than you should, it is unlikely to cause you any harm. Put your next drop(s) in at the usual time. If you are worried, talk to your doctor or pharmacist.

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.

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.

This medicine contains 23.75 mg phosphates in each 5 ml which is equivalent to 4.75 mg/ml.

If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment (see section 2).

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 via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• The active substance is epinastine hydrochloride. One ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride.
• The other ingredients are benzalkonium chloride (a preservative), disodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide/hydrochloric acid (to adjust pH) and purified water.

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.