Opatanol

Package leaflet: Information for the user

Opatanol 1 mg/mL eye drops, solution

olopatadine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Opatanol is and what it is used for

Opatanol is indicated for the treatment of signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Certain substances (allergens) such as pollen, house dust, or animal fur can trigger allergic reactions, causing itching, redness, and sometimes swelling of the eye surface.
Opatanol is a medicine for the treatment of allergic eye conditions. It works by reducing the intensity of the allergic reaction.

2. What you need to know before using Opatanol

Do not use Opatanol

• If you are allergic (hypersensitive) to olopatadine or to any of the other ingredients of this medicine (listed in section 6).
• Do not use Opatanol if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Opatanol.
If you wear contact lenses, you must remove them before using Opatanol.
Children
Do not use Opatanol in children under 3 years of age. Do not give this medicine to children under 3 years of age, as there are no data confirming that it is safe and effective in children below 3 years of age.
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 ophthalmic ointments, wait at least 5 minutes between using one medicine and the next. Ointments should be used last.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Opatanol if you are breastfeeding: consult your doctor before using this medicine.
Driving and using machines
You may experience blurred vision for a period of time after using Opatanol. Do not drive or operate machinery until this effect has passed.
Opatanol contains Benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride per 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 cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience any unusual sensation, burning or pain in the eye after using this medicine, speak with your doctor.
Opatanol contains Disodium phosphate dodecahydrate
This medicine contains 16.72 mg of phosphate buffer (in 63.05 mg of disodium phosphate dodecahydrate) per 5 ml bottle, which is equivalent to 3.34 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Opatanol

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one drop in the eye/each eye, twice daily—morning and evening.
Use this dose unless your doctor has advised you otherwise. Instil Opatanol in
both eyes only if specifically prescribed by your doctor. Use the product for the length of time
specified by your doctor.
Opatanol is intended for ophthalmic use only.
TURN THE PAGE FOR FURTHER INFORMATION
Turn the page.
How to use Opatanol (continued)

1 2
How much to use (see previous page)

• Take the Opatanol bottle and a mirror.
• Wash your hands.
• Take the bottle and unscrew the cap.
• After removing the cap, if the safety ring has loosened, remove it before using the product.
• Hold the bottle upside down between your thumb and middle finger.
• Tilt your head backward. Gently pull down the lower eyelid with a clean finger to create a pouch between the eyelid and the eye. The drop should be instilled into this pouch (Figure 1).
• Bring the tip of the bottle close to your eye. Use the mirror if it helps.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip to avoid contaminating the remaining drops in the bottle.
• Gently press the base of the bottle to release one drop of Opatanol at a time.
• Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is needed (Figure 2).
• If instilling drops into both eyes, repeat the same procedure for the other eye.
• Immediately replace the cap after use, screwing it back on securely.

If a drop misses the eye, try again.
If you use more Opatanol than you should
Rinse it away with lukewarm water. Do not instil the eye drops again until it is time for your next scheduled dose.
If you forget to use Opatanol
Instil one drop as soon as possible, then return to your regular dosing schedule. However, if it is almost time for your next dose, do not take the missed dose and resume your normal dosing schedule. Do not use a double dose to make up for a forgotten dose.
If you stop using Opatanol
Do not stop treatment with this medicine without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been observed with Opatanol:

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

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

Uncommon (may affect up to 1 in 100 people)
Eye disorders
Blurred vision, reduced or abnormal vision, corneal disorder, inflammation of the surface of the eye with or without damage, conjunctivitis (inflammation or infection of the conjunctiva), eye discharge, sensitivity to light, increased tear production, eye itching, eye redness, eyelid abnormalities, itching, redness, swelling, or crusting of the eyelid.

General side effects
Abnormal or reduced sensitivity, dizziness, runny nose, dry skin, skin inflammation.

Not known (frequency cannot be estimated from the available data)
Eye disorders
Eye swelling, corneal swelling, change in pupil size.

General side effects
Shortness of breath, worsening of allergy symptoms, facial swelling, somnolence, generalized weakness, nausea, vomiting, sinusitis, skin redness and itching.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (cornea) developed opaque spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Opatanol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the carton, following "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The bottle should be discarded 4 weeks after first opening to prevent possible infections, and a new bottle should be used.
Please record the date of opening in the designated space (i) on the label of the bottle and on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

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.

Description of the appearance of Opatanol and contents of the pack
Opatanol is a clear, colourless liquid (solution) supplied in a pack containing one bottle of 5 mL or three plastic bottles of 5 mL 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

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

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

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: + 421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/