Prospecto: information for the user

Opatanol 1mg/ml eye drop solution

olopatadina

Read the entire prospect carefully before starting to use thismedicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1.What isOpatanoland for what it is used

2.What you need to knowbefore starting to useOpatanol

3.How to useOpatanol

4.Possible adverse effects

5.Storage ofOpatanol

6.Contents of the package and additional information

Opatanolis indicated for the treatment of the signs and symptoms of seasonal allergic conjunctivitis.

Seasonal allergic conjunctivitis.Some substances (called allergens) such as pollen, household dust or animal hair can cause allergic reactions that lead to itching and redness as well as inflammation of the surface of their eyes.

Opatanol belongs to the group of medications usedfor the treatment of allergic eye conditions. It acts by reducing the intensity of the allergic reaction.

Do not useOpatanol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Opatanol.

Remove your contact lenses from your eyes before using Opatanol.

Children

Do not use Opatanol in children under 3 years old. Do not administer this medication to children under 3 years old because there is no data to indicate that it is safe and effective in children under 3 years old.

Other medications and Opatanol

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you are using another eye drop or ointment, wait at least 5 minutes between the application of each medication.The ointments should be administered last.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use Opatanol if you are breastfeeding, consult your doctor before using this medication.

Driving and operating machines

Immediately after applying Opatanol, you may notice that your vision is blurry. Do not drive or use machines until this effect has disappeared.

Opatanol contains benzalkonium chloride

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

Opatanol's preservative, benzalkonium chloride, can be absorbed by soft contact lenses and may alter the color of the lenses. Remove your contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front part of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in your eye after using this medication.

Opatanol contains disodium dodecahydrate hydrogen phosphate

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

If you have severe damage to the cornea (the transparent layer of the front part of the eye), treatment with phosphates, in rare cases, may cause blurry vision due to calcium accumulation.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one drop in one eye or in both eyes, twice a day - in the morning and in the afternoon.

Use this amount unless your doctor tells you otherwise. Opatanol should only be applied in both eyes if your doctor has instructed you to do so. Follow the treatment for the period of time indicated by your doctor.

Opatanol should only be used as eye drops.

SEE BACK FOR MORE INFORMATION

Turn the package insert over.

How to use Opatanol(continued)

12

Amount to use

See front of package insert

• Take the Opatanol bottle and stand in front of a mirror.
• Wash your hands.
• Take the bottle and unscrew the cap.
• After removing the cap, the plastic ring seal must be removed before use.
• Hold the bottle, upside down, between your thumb and index finger.
• Incline your head back. Gently separate your eyelid from your eye with a finger, until a pouch forms, in which the drop should fall (Figure 1).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch your eye, eyelid, nearby areas or other surfaces with the dropper, as the drops remaining in the bottle could become infected.
• Gently press the base of the bottle to allow one drop of Opatanol to fall each time.
• Do not squeeze the bottle, it is designed for a gentle pressure on the base to be sufficient (Figure 2).
• If drops are applied in both eyes, repeat the above steps for the other eye.
• Tighten the cap on the bottle immediately after use.

If a drop falls outside the eye, try again.

If you use more Opatanol than you should

You can remove it by rinsing your eyes with warm water. Do not apply more drops until the next application.

If you forget to use Opatanol

Apply one drop as soon as you remember and continue with your regular dosing schedule. However, if it is almost time for your next dose, do not apply the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for the missed doses.

If you interrupt treatment with Opatanol

Do not stop using this medication without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed with Opatanol:

Frequent (may affect up to 1 in 10 people)

Eye Effects

Eye pain, eye irritation, dry eye, abnormal sensation in the eye, eye discomfort.

General Effects

Headache, fatigue, dry nose, bad taste in the mouth.

Rare (may affect up to 1 in 100 people)

Eye Effects

Blurred, decreased, or abnormal vision, corneal alteration, inflammation of the eye surface with or without damage to the surface, conjunctival infection or inflammation, eye discharge, light sensitivity, increased tear production, eye itching, eye redness, abnormality in the eyelid, itching, redness, swelling, or crust on the eyelid.

General Effects

Decreased or abnormal perception of stimuli, dizziness, runny nose, dry skin, skin inflammation.

Unknown Frequency (cannot be estimated from available data)

Eye Effects

Eye swelling, corneal swelling, pupil size change.

General Effects

Difficulty breathing, increased allergic symptoms, facial swelling, numbness, generalized weakness, nausea, vomiting, paranasal sinus infection, skin redness and itching.

In rare cases, some patients with severe injury to the transparent layer at the front of the eye (the cornea) have developed dark spots on the cornea due to calcium accumulation during treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

To prevent infections, you must discard the bottle four weeks after having opened it for the first time and use a new bottle. Note the opening date in the space provided on the label of each bottle and box.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Opatanol

• The active ingredient is olopatadine. Each milliliter of solution contains 1mg of olopatadine (as hydrochloride).
• The other components are benzalkonium chloride, sodium chloride,disodium dihydrogen phosphate dodecahydrate (E339), hydrochloric acid (E507) and/or sodium hydroxide (E524) and purified water.

Appearance of the product and contents of the container

Opatanol is a transparent and colorless (a solution) liquid that is presented in a container that contains a 5ml bottle or three plastic bottles of 5ml with a screw cap.

Only some container sizes may be commercially available.

Holder of the marketing authorizationof commercialization

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Manufacturing N.V.

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Siegfried El Masnou, S.A.

Camil Fabra 58

El Masnou

08320 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu