YELLOX 0.9 MG/ML Krople do oczu, roztwór
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Treść ulotki
Yellox 0.9 mg/ml eye drops, solution
Bromfenac
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 Yellox is and what it is used for
- 2. What you need to know before you use Yellox
- 3. How to use Yellox
- 4. Possible side effects
- 5. How to store Yellox
- 6. Contents of the pack and other information
1. What is Yellox and what is it used for
Yellox contains bromfenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Yellox works by blocking certain substances that cause inflammation.
Yellox is used to reduce inflammation in the eye after cataract surgery in adults.
2. What you need to know before you use Yellox X
Do not use Yellox
- if you are allergic to bromfenac or any of the other ingredients of this medicine (listed in section 6).
- if you have had asthma, skin allergy or severe nasal inflammation in the past when using other NSAIDs. Examples of NSAIDs include acetylsalicylic acid, ibuprofen, ketoprofen and diclofenac.
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
- if you are using topical steroids (e.g. cortisone), because it may cause unwanted effects.
- if you have bleeding problems (e.g. hemophilia) or have had them in the past, or if you are taking other medicines that may prolong bleeding time (e.g. warfarin, clopidogrel, acetylsalicylic acid).
- if you have eye problems (e.g. dry eye syndrome, corneal problems).
- if you have diabetes.
- if you have rheumatoid arthritis.
- if you have undergone repeated eye surgeries in a short period of time.
The use of contact lenses is not recommended after cataract surgery. Therefore, do not wear
contact lenses while using Yellox.
Children and adolescents
Yellox should not be used in children and adolescents.
Other medicines and Yellox
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using Yellox.
Yellox should not be used in the last three months of pregnancy. Your doctor may prescribe
this medicine during pregnancy if the expected benefit for the mother outweighs the possible risk
to the baby.
Yellox can be prescribed during breastfeeding and has no significant effect on
fertility.
Driving and using machines
After using this eye drop, your vision may be blurred for a short time. If you experience blurred
vision after use, do not drive or use machinery until your vision returns to normal.
Yellox contains benzalkonium chloride
This medicine contains 0.00185 mg of benzalkonium chloride per single drop, equivalent to
- 0.05 mg/ml. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost transparent layer of the eye). If you experience an abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.
3. How to use Yellox
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose is one drop of Yellox in the eye or eyes that have undergone cataract
extraction, twice a day (morning and evening). Do not use more than one drop in the eye or eyes
2 times a day.
Start using the drops the day after cataract surgery.
Method of administration
Yellox is for ophthalmic use.
- Wash your hands before using the eye drops.
- Assume a comfortable and stable position.
- Unscrew the cap of the bottle.
- Hold the bottle upside down between your thumb and other fingers.
- Tilt your head back.
- Pull down your lower eyelid with a clean finger.
- Bring the tip of the bottle close to the eye.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the dropper.
- Press lightly on the bottle to release one drop of Yellox.
- Close the cap of the bottle tightly immediately after use.
- Keep the bottle tightly closed when not in use.
If you are using any other eye drops, allow at least five minutes to pass between using Yellox and using another
eye drop.
Duration of treatment
Continue to use the eye drops for the first 2 weeks after surgery. Do not use Yellox for more than
2 weeks.
If you use more Yellox than you should
Rinse the eye with warm water. Do not apply any more drops until the time of the next dose. In
case of accidental ingestion of Yellox, a glass of water or other liquid should be drunk to
dilute the medicine.
If you forget to use Yellox
Apply a single dose as soon as you remember. If it is almost time for the next dose, skip the
forgotten dose. Continue normally with the next dose as scheduled. Do not use a double
dose to make up for a missed dose.
If you stop using Yellox
Do not stop using Yellox without consulting your doctor.
Upon discontinuation of Yellox, a flare-up of the inflammatory response, such as retinal
swelling, has been observed in rare cases following cataract surgery.
If you have any doubts about using Yellox, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice a reduction or blurring of vision in the week following the end of
treatment, contact your doctor immediately.
Contact your doctor immediately if you experience any of the following side effects while using the
eye drops.
Uncommon side effects (may affect up to 1 in 100 people)
Foreign body sensation in the eye, redness and inflammation of the eye, damage and
inflammation of the eye surface, eye discharge, itching, irritation or pain in the eye,
swelling or bleeding of the eyelid, visual disturbances due to inflammation, “floating” or moving spots in front of the eyes or reduced vision, which may indicate bleeding or
damage to the back of the eye (retina), eye discomfort, sensitivity to light, reduction or
blurring of vision, facial swelling, cough, nosebleed or runny nose.
Rare side effects (may affect up to 1 in 1,000 people)
Damage to the eye surface, redness of the eye, asthma.
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 through the national reporting system as described in
Appendix V.
By reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store Yellox
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 vial and the carton after
“EXP”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
To avoid infections, discard the vial 4 weeks after first opening, even if it contains residual
solution.
Write the date of opening on the carton label, in the designated space.
Do not dispose of any medicine in wastewater 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 Yellox contains
- The active ingredient is bromfenac. One ml of solution contains 0.9 mg of bromfenac (as sodium sesquidrate). One drop contains approximately 33 micrograms of bromfenac.
- The other excipients are: boric acid, borax, anhydrous sodium sulfite (E221), benzalkonium chloride (see section 2), tiloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide (to maintain normal acidity values).
Description of the appearance of Yellox and contents of the pack
Yellox is a clear yellow liquid (solution) supplied in a pack containing a
5 ml plastic bottle with a screw cap.
Marketing Authorisation Holder
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin
Germany
More detailed information on this medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu .
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 0.9 MG/ML
- Kod ATCS01BC11
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki YELLOXPostać farmaceutyczna: Eye drops, solution, 0.9 MG/MLSubstancja czynna: bromfenacProducent: BIONATIVA S.P.A.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.9 MG/MLSubstancja czynna: bromfenacProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.9 MG/MLSubstancja czynna: bromfenacProducent: FB VISION SPAWymaga recepty
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YELLOX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w YELLOX jest bromfenac. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
YELLOX jest produkowany przez BAUSCH + LOMB IRELAND LIMITED. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie YELLOX jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić YELLOX w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (bromfenac) to m.in. BROMOFTIL, KOXAFEN, IRGASS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
