1 mg/ml eye drops, solution
olopatadine
What Opatanol is and what it is used for
Opatanol is used to treat the signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Some substances ( allergens ) such as pollen, dust, or animal hair can cause allergic reactions in the eye, which causes itching, redness, and swelling on the surface of the eye.
Opatanol is a drug for the treatment of allergic conditions in the eyes. It works by reducing the rate of allergic reactions.
What you need to know before using Opatanol
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 cautions
Talk to your doctor or pharmacist before using Opatanol.
If you wear contact lenses, remove them before using Opatanol.
Children
- Do not use Opatanol for children under 3 years. Do not give this medicine to children under 3 years as there is no data showing that it is safe and works on 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 use other eye drops or ointments, take the medicine at least 5 minutes apart. Eye ointments should be used last.
Pregnancy, breastfeeding 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 taking this medicine.
You should not use Opatanol if you are breast-feeding, talk to your doctor or pharmacist before using this medicine.
Driving and using machines
You may notice that your vision becomes a little foggy after you use Opatanol. Do not drive or use any tools or machines until your vision is clear.
Opatanol contains benzalkonium chloride and disodium phosphate dodecahydrate
Opatanol contains benzalkonium chloride
This medicine contains 0.5 mg benzalkonium chloride per 5 ml corresponding to 0.1 mg/ml.
The preservative in Opatanol, benzalkonium chloride, can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, contact
Doctor.
Opatanol contains disodium phosphate dodecahydrate
This medicine contains 16.72 mg of phosphate (in 63.05 mg of disodium phosphate dodecahydrate) per 5 ml bottle equivalent to 3.34 mg/ml.
If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How to use Opatanol
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 drop in one or both eyes twice daily (morning and evening).
Use this dosage unless your doctor prescribes otherwise. Opatanol should only be used in both eyes if your doctor prescribes it. Use the medicine for as long as your doctor prescribes it.
Opatanol should only be used as eye drops.
How to use Opatanol
How much to use
- Get the bottle of Opatanol and a mirror.
- Wash your hands.
- Take the bottle and unscrew the screw cap.
- If the warranty seal is loose, it must be removed after removing the bottle cap and before using the product.
- Hold the bottle with the tip facing down between your thumb and forefinger.
- Tilt your head back. Pull down the lower eyelid with a clean finger, so that a pocket is formed between the eye and the eyelid. The drop should end up here (see picture 1).
- Place the bottle tip close to the eye. Use the mirror if it facilitates.
- Do not touch the eye, eyelid, surrounding tissue or other surfaces with the drip tip – it may contaminate the contents of the bottle.
- Press lightly on the bottom of the bottle to release one drop of Opatanol.
- Do not squeeze the bottle – it is made so that a light pressure at the bottom is all that is needed (see picture 2).
- If both eyes are to be treated, now repeat the steps above for the other eye.
- Replace the screw cap on the bottle immediately after use.
If a drop misses the eye – try again.
If you use more Opatanol than you should
Rinse everything out of the eye with lukewarm water. Do not take more drops until it is time for the next dose.
If you forget to take Opatanol
Take a drop as soon as you remember and then go back to your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop using Opatanol
Do not stop using Opatanol without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Opatanol
Common (may affect more than 1 user in 10)
The eye
Eye pain, eye irritation, dry eyes, abnormal sensation in the eye, eye discomfort
General side effects ar
Headache, fatigue, dry nose, taste disturbance.
Uncommon (may affect up to 1 in 100 people)
The eye
Blurred vision, decreased visual acuity, abnormal vision, diseases of the cornea, inflammation of the surface of the eye with or without damage to the surface inflammation or infection of the conjunctiva, eye secretions, photosensitivity, increased tear production, itchy eyes, red eyes, eyelid diseases, itching, reddened or swollen eyelids, crust formation on the eyelids.
General side effects ar
Abnormal or decreased sensation, dizziness, runny nose, dry skin, dermatitis.
Has been reported (occurs in an unknown number of users)
The eye
Eye swelling, corneal swelling, altered pupil size.
General side effects ar
Shortness of breath, increased allergic symptoms, swelling of the face, drowsiness, general weakness, nausea, vomiting, sinus infection, reddening of the skin, and itching.
In very rare cases, some patients with severe damage to the transparent membrane in front of the eye (cornea) have had milky spots on the cornea caused by a calcium deposit during treatment.
How to store Opatanol
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 carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage conditions.
You should discard the bottle 4 weeks after you first opened it to prevent infection. Then use a new bottle. Write down the date you first opened the bottle on each bottle label and carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures are to protect the environment.
Contents of the pack and other information
Content declaration
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 the medicine looks like and contents of the pack
Opatanol is a clear and colorless liquid (a solution) that is supplied in a pack of either one 5 ml bottle or three 5 ml plastic bottles with screw caps. Not all pack sizes need to be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharmacéutica, SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
SA Alcon-Couvreur NV
Rijksweg 14
B-2870 Puurs
Belgium
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Siegfried El Masnou, SA
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: + 421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| .ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370 |