OPATANOL 1 mg/ml eye drops, solution

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 OPATANOL.

Ask your doctor for advice.

Take special care with OPATANOL...

• Do not use OPATANOL in children under the age of 3 years.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are using other eye drops at the same time as OPATANOL, follow the advice at the end of section 3.

Pregnant women
If you are pregnant, or might get pregnant, talk to your doctor before you use OPATANOL.

Breast feeding women
If you are breast feeding. Do not use OPATANOL, it may get into your milk.

Ask your doctor for advice before taking any 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.

Important information about some of the ingredients of OPATANOL
If you wear soft contact lenses. Do not use the drops while your contact lenses are in your eyes. Wait 10-15 minutes after using the eye drops before putting your lenses back into your eyes. A preservative in OPATANOL (benzalkonium chloride) can affect soft lenses.

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

The usual dose is?

onedrop 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.

Only use OPATANOL as an eye drop.

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3. HOW TO USE OPATANOL continued 1 2

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.
• 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.
• Use up one bottle before opening the next bottle.

If a drop misses your eye, try again.

If you use more OPATANOL than you should rinse it all out with warm water. Don?t 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 routine. Do not use a double dose to make up for the one missed.

If you are using other eye drops, wait at least five to ten minutes between putting in OPATANOL and the other drops.

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

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

Common side effects

These may affect up to 10 in every 100 people

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

Effects in the body: headache, fatigue, dry nose, bad taste

Uncommon side effects

These may affect up to 1 in every 100 people

Effects in the eye: blurred, reduced, or abnormal vision, corneal disorder, inflammation or infection of the conjunctiva, eye discharge, eye allergy, sensitivity to light, increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.

Effects in the body: abnormal or decreased sensation, dizziness, runny nose, dry skin, skin inflammation, redness, and itching.

Additional side effects that have been reported include:

Effects in the eye: change in pupil size

Effects in the body: shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinus infection

You can usually carry on taking the drops, unless the effects are serious.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use OPATANOL after the expiry date which is stated on the bottle and the boxafter ?Exp?. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

What OPATANOL CONTAINS

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

The other ingredients are: benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), and purified water. Tiny amounts of hydrochloric acid (E507) and/or sodium hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.

What OPATANOL looks like and the contents of the pack

OPATANOLis a clear liquid (a solution) supplied in a pack containing either one 5 ml plastic bottle or three 5 ml bottles with screw caps. Not all pack sizes may be marketed.

S.A. Alcon Couvreur N.V. Manufacturer Alcon Cusí. S.A. Camil Fabra 58 08320 El Masnou Manufacturer Rijksweg 14 B-2870 Puurs Belgium Spain The marketing authorisation holder Alcon Laboratories UK Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom

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

Lietuva Alcon Pharmaceuticals Ltd. atstovyb 370 5 2 314 756 BelgiëBelgiqueBelgien LuxembourgLuxemburg SA Alcon-Couvreur NV 32 03 890 27 11 BelgiëBelgiqueBelgien

359 2 950 15 65 Magyarország Alcon Hungária Gyógyszerkereskedelmi Kft. 36-1-463-9080

eská republika Alcon Pharmaceuticals Czech Republic s.r.o. 420 225 377 333 Nederland Alcon Nederland BV 31 0 183 654321

Danmark Alcon Danmark AS 45 3636 3434 Norge Alcon Norge AS 47 23 25 25 50

Deutschland Alcon Pharma GmbH 49 0761 1304-0 Österreich Alcon Ophthalmika GmbH 43 01 596 69 70

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Alcon Pharmaceuticals Ltd
+ 371 7 321 121

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