Инструкция по применению OPATANOL
Содержание инструкции
Opatanol 1 mg/mL eye drops, solution
olopatadine
Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell 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 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
1. What is Opatanol and what is it used for
Opatanol is indicated for the treatment of signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis.Some materials (allergens) such as pollen, house dust or animal hair can cause allergic reactions, causing itching, redness and even swelling of the
surface of the eye.
Opatanol is a medicinefor 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 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 should 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 because there is no data to confirm that it is safe and effective in children under 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 eye ointments, leave at least 5 minutes between using one medicine and the next. Ointments should be used last.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding,ask your doctor or pharmacist for advice before using this medicine.
You should not use Opatanol if you are breastfeeding: ask your doctor for advice before using this medicine.
Driving and using machines
You may experience blurred vision for a certain period after using Opatanol. Do not drive and do not use machines until this sensation has stopped.
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, can be absorbed by soft contact lenses and may lead to discoloration. Remove contact lenses before using this medicine and wait 15 minutes before re-applying them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to 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 layer of the eye (the cornea), phosphates may, in very rare cases, cause opaque spots on the cornea due to calcium deposits during treatment.
3. How to use Opatanol
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one drop in the eye/eyes, twice a day - morning and evening.
Use this dose unless your doctor tells you otherwise. Instill Opatanol in
both eyes only if prescribed by your doctor. Use the product for the period of time
specified by your doctor.
Opatanol must be used only as an eye drop.
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 is loose, remove it before using the product.
- Hold the bottle upside down between your thumb and middle finger.
- Tilt your head back. Lower your eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled in this area (figure 1).
- Bring the tip of the bottle close to the eye. Use the mirror if it can be helpful.
- Do not touch the eye, eyelid, surrounding areas or other surfaces with the dropper tip to avoid infecting the drops remaining in the bottle.
- Gently press the base of the bottle, releasing one drop of Opatanol at a time.
- Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is sufficient (figure 2).
- If you instill drops in both eyes, repeat the same operation for the other eye.
- Immediately replace the cap after use, screwing it on properly.
If a drop does not enter the eye, try again.
If you use more Opatanol than you should
Wash it away with lukewarm water. Do not instill the eye drops again until the time of the next dose.
If you forget to use Opatanol
Instill a drop as soon as possible and then return to your normal instillation times. However, if
it is almost time to instill the next dose, do not instill the forgotten dose and return to your normal
instillation times. 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 the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with Opatanol:
Common (may affect up to 1 in 10 people)
Effects on the eye
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)
Effects on the eye
Blurred, reduced or abnormal vision, corneal disorder, inflammation, with or without damage, of the
surface of the eye, inflammation or infection of the conjunctiva, eye secretion, sensitivity
to light, increased tear production, eye itching, eye redness, eyelid abnormality, itching, redness, swelling, or
crusting of the eyelid.
General side effects
Abnormal or reduced sensation, dizziness, runny nose, dry skin, skin inflammation.
Not known (frequency cannot be estimated from available data)
Effects on the eye
Eye swelling, corneal swelling, change in pupil size.
General side effects
Shortness of breath, increased allergy symptoms, facial swelling, drowsiness, generalised weakness,
nausea, vomiting, sinusitis, skin redness and itching.
In very rare cases, some patients with severe damage to the transparent layer in front of the eye (cornea)
have developed opaque spots 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 side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the packaging after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The bottle must be discarded 4 weeks after first opening ,to prevent possible infections and a
new bottle must be used. Note the date of opening in the appropriate space (i) on the bottle and the
packaging label.
Do not dispose of any medicine in drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Opatanol contains
- The active ingredient 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 and colorless liquid (a solution) supplied in a pack containing a
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 Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50
България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28
Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Česká republika
Novartis s.r.o.
Tel: +420 225 775 111
Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00
Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0
Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810
Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12
Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00
Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00
Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220
România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55
Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Ísland
Vistor hf.
Sími: +354 535 7000
Slovenská republika
Novartis Slovakia s.r.o.
Tel: + 421 2 5542 5439
Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1
Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690
Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070
United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/

- Страна регистрации
- Форма выпускаEye drops, solution, 1 MG/ML
- Код АТХS01GX09
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги OPATANOLФорма выпуска: Eye drops, solution, 1 MG/MLДействующее вещество: олопатадинПроизводитель: DOC GENERICI SRLОтпускается без рецептаФорма выпуска: Eye drops, solution, 2%Действующее вещество: cromoglicic acidПроизводитель: BRUSCHETTINI S.R.L.Отпускается без рецептаФорма выпуска: Eye drops, solution, 250 MICROGRAMMI/MLДействующее вещество: ketotifenПроизводитель: BRUSCHETTINI S.R.L.Отпускается без рецепта
Аналоги OPATANOL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог OPATANOL в Испания
Аналог OPATANOL в Польша
Аналог OPATANOL в Украина
Врачи онлайн по OPATANOL
Обсудите применение OPATANOL и возможные следующие шаги — по оценке врача.
Получите рецепт на OPATANOL онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
OPATANOL не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество OPATANOL — олопатадин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
OPATANOL производится компанией NOVARTIS EUROPHARM LIMITED. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения OPATANOL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить OPATANOL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (олопатадин) включают KALMIRA, BRUNIKROM, BRUNISTILL. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















