olopatadine: package leaflet

Opatanol 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.

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

Do not use Opatanol
- If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6).
- You should not use Opatanol if you are breast-feeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Opatanol.

You should remove contact lenses that are in your eyes before using Opatanol.

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

Other medicines and Opatanol
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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Opatanol if you are breast-feeding, 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 Opatanol. Do not drive or use machines until this has worn off.

Opatanol contains Benzalkonium chloride

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

The preservative in Opatanol, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

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.

Opatanol contains Disodium Phosphate Dodecahydrate

This medicine contains 16.72 mg phosphates (in 63.05 mg disodium phosphate dodecahydrate) in each bottle of 5 ml, which is equivalent to 3.34 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.

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 Opatanol in both eyes if your doctor told you to. Use it for as long as your doctor told you to.

Opatanol should only be used as an eye drop.

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How to use Opatanol (continued)

How much to use see side 1

• Get the Opatanol bottle and a mirror.
• Wash your hands.
• Take the bottle and twist off the cap.
• After cap is removed, if the tamper evident snap collar is loose, remove before using the product.
• 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 a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).
• Bring the bottle tip 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 Opatanol at a time.
• Don’t squeeze the bottle, it is designed so that just a gentle press on the bottom is needed (picture 2).
• If you use drops in both eyes, repeat the steps for your other eye.
• Put the bottle cap back on firmly immediately after use.

If a drop misses your eye, try again.

If you use more Opatanol 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 Opatanol
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 Opatanol
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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been seen with Opatanol:

Common (may affect up to 1 in 10 people)
Effects in the eye
Eye pain, eye irritation, dry eye, abnormal eye sensation, eye discomfort.

General side effects
Headache, fatigue, dry nose, bad taste.

Uncommon (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, generalized 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 bottle and the box after ‘EXP’.
The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

You should 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 throw away 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.

What Opatanol contains
- The active substance is olopatadine. Each mL of solution contains 1 mg of olopatadine (as hydrochloride).
- The other ingredients are benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), hydrochloric acid (E507) and/or sodium hydroxide (E524) and purified water.

What Opatanol looks like and contents of the pack
Opatanol is a clear and colourless liquid (a solution) supplied in a pack containing either one 5 ml bottle or three 5 ml plastic bottles with screw caps.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50
България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28
Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111
Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: + 421 2 5542 5439
Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.emea.europa.eu/