EPAR update

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Olopatadine 1mg/ml eye drops, solution

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

•    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, gets serious, 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 Olopatadine is and what it is used for

2.    What you need to know before you use Olopatadine

3.    How to use Olopatadine

4.    Possible side effects

5.    How to store Olopatadine

6.    Contents of the pack and other information

. WHAT OLOPATADINE IS AND WHAT IT IS USED FOR

Olopatadine is used for the treatment of signs and symptoms of seasonal allergic conjunctivitis.

Allergic conjunctivitis: Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness, as well as swelling of the surface of your eye.

Olopatadine is a medicine for treatment of allergic conditions of the eye. It works by reducing the intensity of the allergic reaction.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OLOPATADINE

Do not use Olopatadine:

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

Warnings and precautions

Talk to your doctor or pharmacist before using Olopatadine.

You should remove the contact lenses that are in your eyes before using Olopatadine. Children

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

Other medicines and Olopatadine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are using other eye drops or eye ointment medicines, leave at least 5 minutes between each medicine. Eye ointments should be administered last.

Pregnancy, breast-feeding and fertility

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

You should not use Olopatadine if you are breastfeeding. Ask your doctor for advice before using this medicine.

Driving and using machines

You may find that your vision is blurred for a time just after you use Olopatadine. Do not drive or use machines until this has worn off.

Olopatadine contains benzalkonium chloride

Benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses, therefore contact with soft contact lenses should be avoided. If you wear contact lenses you should remove contact lenses prior to application and wait at least 15 minutes before putting your lenses back in.

3. HOW TO USE OLOPATADINE

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

The recommended dose is one drop in the eye or eyes, twice a day - morning and evening. Use this much unless your doctor tells you to do differently. Only use Olopatadine in both eyes if your doctor told you to. Use it for a long as your doctor told you to. Only use Olopatadine as an eye drop.

Instructions on using Olopatadine

•    Get the Olopatadine bottle and a mirror.

•    Wash your hands.

•    Take the bottle and twist off the cap.

•    Hold the bottle, pointing down, between your thumb and middle finger.

•    Tilt your head back. Pull down your eyelid with a clean finger, until there is between the eyelid and your eye. The drop will go in here.

•    Bring the bottle top close to the eye. Use the mirror if it helps.

•    Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops left in the bottle.

•    Gently press on the base of the bottle to release one drop of Olopatadine at a time.

• Don’t squeeze the bottle, it is designed so that just a gentle press on the bottom is needed.

•    If you use drops in both eyes, repeat the steps for your other eye.

•    Put the bottle cap back on firmly immediately after use.

•    Use up one bottle before opening the next bottle.

•    If a drop misses your eye, try again.

If you use more Olopatadine than you should

Rinse it all out with warm water. Do not put in any more drops until it’s time for your next regular dose.

If you forget to use Olopatadine

Use a single drop as soon as you remember, and then go back to your regular dosing routine. However, if it is almost time for your next dose, skip the missed dose before going back to your regular dosing routine. Do not use a double dose to make up for the one missed.

If you stop using Olopatadine

Do not stop using this medicine without first speaking to your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been seen with olopatadine:

Common side effects (may affect up to 1 in 10 people)

Effects in the eye: eye pain or swelling, eye irritation, dry eye, abnormal eye sensation, eye discomfort

General side effects: headache, fatigue, dry nose, bad taste.

Uncommon side effects (may affect up to 1 in 100 people)

Effects in the eye: blurred, reduced or abnormal vision, corneal disorder, eye surface inflammation with or without surface damage, inflammation or infection of the conjunctiva, eye discharge, sensitivity to light, increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling or crusting of the eyelid.

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

Not known (frequency cannot be estimated from the available data)

Effects in the eye: eye swelling, corneal swelling, change in pupil size.

General side effects: shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalised weakness, nausea, vomiting, sinus infection, skin redness and itching.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

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 via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLOPATADINE

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

Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the label (EXP). The expiry date refers to the last day of that month.

You must throw away the bottle four weeks after you first opened it, to prevent infections, and use a new bottle. Write down the date you opened it in the space on each bottle label and box.

Do not use this medicine if you notice a change in colour or smell.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olopatadine contains:

•    The active substance is olopatadine 1mg/ml (as hydrochloride).

•    The other ingredients are benzalkonium chloride; hydrochloric acid (E507) (for pH adjustment); disodium phosphate dodecahydrate (E339); sodium chloride; water for injections.

What Olopatadine looks like and contents of the pack:

Clear to almost clear colourless solution, practically free from particles.

5 ml opaque LDPE bottle with LDPE dropper and HDPE tamper-proof screw-cap.

1 x 5 ml (1 bottle, which contains 5 ml of solution).

Marketing Authorisation Holder and Manufacturer

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

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

Cyprus and Poland: OLOPATADINE Zentiva,

United Kingdom: Olopatadine Zentiva 1 mg/ml eye drops solution Czech Republic: OLOPATADINE Zentiva 1 mg/ml Bulgaria: OnonaTagnH 3eHTHBa 1 mg/ml KanKH 3a onn, pa3TBop

EPAR update

Romania: OLOPATADINA Zentiva 1mg/ml picaturi oftalmice, solute This leaflet was last revised in 07/2014