Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - opatanol

Document Subject

Generated Narrative: MedicinalProductDefinition mp5e88337560455eac655afab15013ce20

identifier: http://ema.europa.eu/identifier/EU/1/02/217/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Opatanol 1 mg/mL eye drops, solution

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5e88337560455eac655afab15013ce20

identifier: http://ema.europa.eu/identifier/EU/1/02/217/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - opatanol

Attesters

What is in this leaflet

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

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.

TURN THE PAGE FOR MORE ADVICE.

Now turn over.

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.
• 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 Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

S.A. Alcon-Couvreur N.V. Rijksweg B-2870 Puurs Belgium

Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

Siegfried El Masnou, S.A. Camil Fabra El Masnou 08320 Barcelona Spain

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: + 421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: