ACULAR 0.5% Krople do oczu, roztwór
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Treść ulotki
ACULAR 0.5% p/v eye drops, solution
(Ketorolac trometamol)
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor has
told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your 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 could be harmful.
- If any side effects occur, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- 1. What ACULAR is and what it is used for
- 2. What you need to know before using ACULAR
- 3. How to use ACULAR
- 4. Possible side effects
- 5. How to store ACULAR
- 6. Contents of the pack and other information
1. What is ACULAR and what is it used for
ACULAR is used for the prophylaxis and reduction of ocular inflammation following cataract surgery in adults.
ACULAR belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
2. What you need to know before you use ACULAR
Do not use ACULAR
- If you are allergic to ketorolac trometamol or any of the excipients of this medicine (listed in section 6).
- If you are allergic to aspirin or any other similar medicine, such as other non-steroidal anti-inflammatory drugs.
Warnings and precautions
Talk to your doctor or pharmacist before using ACULAR.
If you suffer from or have suffered in the past from:
- viral or bacterial infections of the eye
- a tendency to bleeding (e.g., anemia) or stomach ulcers
- diabetes
- rheumatoid arthritis
- dry eye syndrome
- asthma after the use of non-steroidal anti-inflammatory drugs
- if you have recently undergone eye surgery
- if you have lost sensitivity in the cornea (the clear surface that covers the pupil and iris) or if the normally smooth surface of the cornea is damaged.
Children
ACULAR should not be prescribed for use in children.
ACULAR and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If you use ACULAR with other eye medicines, leave at least 5 minutes between the
administration of ACULAR and that of another medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
ACULAR should not be used if you are pregnant or breastfeeding, unless your doctor
recommends it.
Driving and using machines
In some patients ACULAR may cause blurred vision. Do not drive vehicles or use
machinery until the symptoms manifest.
ACULAR contains Benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride in each millilitre, equivalent to 0.1 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may lead to a change
in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before
reapplying 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
eye sensation, burning or pain after using this medicine, talk to your doctor.
3. How to use ACULAR
Always use ACULAR exactly as your doctor or pharmacist has told you. If you have any doubts
ask your doctor or pharmacist. The recommended dose is one drop in the affected eye 3 times a day for 3-4 weeks, starting 24 hours before cataract surgery.
Instructions for use
Apply the eye drops as follows:
- 1. Wash your hands. Tilt your head back and look up.
- 2. Gently pull down your lower eyelid to form a small pocket.
- 1. Turn the bottle upside down and apply gentle pressure to release one drop of eye drops into each eye to be treated.
- 2. Release your lower eyelid and keep your eye closed for 30 seconds. If a drop comes out of your eye, repeat. To avoid contamination or injury, do not let the tip of the dropper touch your eye or anything else. After use, close the bottle tightly and screw the cap back on. Wipe away any excess liquid on your cheek with a clean tissue. It is very important that the application is done correctly. If you have any questions or need clarification, ask your doctor or pharmacist. If you use more ACULAR than you shouldApplying a number of drops higher than expected should not cause any undesirable effects. Apply the next prescribed dose at the usual administration times. If, accidentally, the product is ingested, drink liquids to dilute it and contact your doctor.
If you forget to use ACULAR
If you forget to apply a dose, apply it as soon as you remember, unless it is already time for
your next dose, in which case you should skip the missed dose. Then take the next dose
and follow the usual administration times.
Do not take a double dose to make up for a forgotten dose.
If you stop using ACULAR
If you have any doubts about the use of ACULAR, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people):
Eye irritation, stinging and/or burning sensation in the eye, eye pain.
Common(may affect up to 1 in 10 people):
Allergic reaction, swelling/tumefaction of the eye and/or eyelid, itchy eyes, red eyes,
eye infection, eye inflammation (on the surface or inside), retinal bleeding,
swelling of the central retina (the light-sensitive layer of the eye), headache, accidental injury caused
by contact with the eye of the dropper tip, increased eye pressure,
blurred and/or decreased vision.
Uncommon(may affect up to 1 in 100 people):
Inflammation or damage to the transparent front layer of the eye, dry eye
and/or tearing.
Not known(frequency cannot be estimated from available data):
Damage to the surface of the eye such as thinning, erosion, perforation, deterioration
of the cell(s), difficulty breathing or wheezing, worsening of asthma, facial swelling,
ulceration/damage to the surface of the eye.
Side effects related to the cornea(the surface of the eye) may occur more
likely if ACULAR is used for more than two weeks or if topical steroid eye drops are
used at the same time or if you have a related eye disease. Consult
your doctor immediately if you experience pain, increased eye irritation or changes
in vision.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
3. How to store ACULAR
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 label and on the
pack after EXP. The expiry date refers to the last day of the month.
Discard the bottle 28 days after first opening, even if some solution remains.
Store at a temperature below 25°C.
Do not use this medicine if you notice the security seal is broken.
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.
4. Contents of the pack and other information
What ACULAR contains
- The active ingredient is Ketorolac trometamol 0.5% w/v.
- The excipients are: benzalkonium chloride, disodium edetate, octoxinol 40, sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment) and purified water.
Description of the appearance of ACULAR and contents of the pack
ACULAR is an eye drop, a transparent solution from colorless to pale yellow contained in a bottle of
plastic.
Each pack contains a plastic bottle of 10ml with a screw cap.
Each bottle contains 5 ml or 10 ml of eye drops. It is possible that not all
packs are marketed.
Marketing Authorisation Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer
Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
| g Austria | ACULAR 0.5% Eye Drops |
| Belgium | ACULARE eye drops |
| Denmark, Ireland, Italy, United Kingdom | ACULAR |
| A Finland | ACULAR 5 mg/ml eye drops |
| France | ACULAR 0.5% |
| Germany | ACULAR 5 mg/ml Eye Drops |
| Greece | ACULAR 0.5% |
| Luxembourg | ACULARE eye drops |
| Netherlands | ACULAR eye drops 0.5% |
| Portugal | ACULAR 0.5% w/v eye drop solution |
| Spain | ACULAR 0.5% w/v eye drop solution |
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 0.5%
- Kod ATCS01BC05
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki AKULARPostać farmaceutyczna: Eye drops, solution, 5 MG/MLSubstancja czynna: ketorolacProducent: FIDIA FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.5%Substancja czynna: bendazacProducent: OMNIVISION ITALIA SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.9 MG/MLSubstancja czynna: bromfenacProducent: BIONATIVA S.P.A.Wymaga recepty
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AKULAR nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w AKULAR jest ketorolac. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
AKULAR jest produkowany przez ABBVIE S.R.L.. 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 AKULAR 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 AKULAR 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 (ketorolac) to m.in. KOMOREBI, BENDALINA, BROMOFTIL. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
