Opatanol 1 mg/ml eye drops solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Opatanol 1mg/ml eye drops, solution

olopatadine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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 the signs and symptoms of seasonal allergic conjunctivitis.

Allergic conjunctivitis. Certain substances (called allergens), such as pollen, house dust, or animal hair, can cause allergic reactions leading to itching, redness, and inflammation of the surface of the eyes.

Opatanol belongs to a group of medicines used for the treatment of allergic eye disorders. 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).
• You must not use Opatanol if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Opatanol.

You must remove your contact lenses before using Opatanol.

Children

Do not use Opatanol in children under 3 years of age. Do not administer this medicine to children under 3 years of age, as there are no data indicating that it is safe and effective in children under 3 years.

Other medicines and Opatanol

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

If you are using another eye drop or ophthalmic ointment, wait at least 5 minutes between applying each medicine. Ophthalmic ointments should be administered last.

Pregnancy, breastfeeding and fertility

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

You must not use Opatanol if you are breastfeeding; consult your doctor before using this medicine.

Driving and using machines

Immediately after applying Opatanol, you may experience blurred vision. Do not drive or operate machinery until this effect has passed.

Opatanol contains benzalkonium chloride

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

The preservative in Opatanol, benzalkonium chloride, can be absorbed by soft contact lenses and may change their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal disorders (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

Opatanol contains disodium hydrogen phosphate dodecahydrate

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

If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, lead to blurred vision due to calcium accumulation.

3. How to use Opatanol

Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one drop in one or both eyes, twice daily – in the morning and in the evening.

Use this amount unless your doctor has given you other instructions. Opatanol should only be applied to both eyes if your doctor has specifically instructed you to do so. Continue treatment for the period of time indicated by your doctor.

Opatanol should only be used as eye drops.

FOR MORE INFORMATION SEE THE REVERSE SIDE

Turn over the leaflet.

How to use Opatanol (continued)

Amount to use

See the front of the leaflet

• Take the Opatanol bottle and position yourself in front of a mirror.
• Wash your hands.
• Take the bottle and unscrew the cap.
• After removing the cap, remove the plastic seal ring before first use.
• Hold the bottle upside down between the thumb and middle finger.
• Tilt your head backwards. Gently pull down the eyelid with one finger to form a pouch, into which the drop should fall (Figure 1).
• Bring the tip of the bottle close to the eye. Using a mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip, as this could contaminate 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 gentle pressure on the base is sufficient (Figure 2).
• If applying drops to both eyes, repeat the above steps for the other eye.
• Immediately after use, securely screw the cap back onto the bottle.

If a drop misses the eye, try again.

If you use more Opatanol than you should

You can remove it by rinsing your eyes with lukewarm water. Do not apply any further drops until the next scheduled dose.

If you forget to use Opatanol

Apply one drop as soon as you remember and continue with your next dose according to your usual schedule. However, if it is almost time for your next dose, do not take the missed dose; instead, continue with your next scheduled dose. Do not use a double dose to make up for a missed dose.

If you stop using Opatanol

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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.

Uncommon (may affect up to 1 in 100 people)

Eye effects

Blurred, reduced or abnormal vision, corneal disorder, inflammation of the surface of the eye with or without surface damage, conjunctival infection or inflammation, eye discharge, light sensitivity, increased tear production, eye itching, eye redness, eyelid abnormality, itching, redness, swelling or crusting of the eyelid.

General effects

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

Frequency not known (cannot be estimated from available data)

Eye effects

Eye swelling, corneal swelling, change in pupil size.

General effects

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

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

Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Opatanol

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

Do not use this medicine after the expiry date stated on the bottle and carton, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

To prevent infection, discard the bottle four weeks after first opening and use a new bottle. Record the date of opening in the space provided on the label of each bottle and carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Opatanol

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

Appearance of the product and contents of the pack

Opatanol is a clear, colourless liquid (a solution) supplied in a pack containing one 5 ml bottle or three 5 ml plastic bottles with a screw cap.

Only certain 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 N.V.
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder.

Date of the latest review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu