URSAB 3 mg /Ml Krople Do Oczu, Roztwór
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Treść ulotki
UrsAB 3 mg/ml eye drops, solution
Ofloxacin
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 their symptoms are the same as yours, as it could 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 UrsAB is and what it is used for
- 2. What you need to know before you use UrsAB
- 3. How to use UrsAB
- 4. Possible side effects
- 5. How to store UrsAB
- 6. Contents of the pack and other information
1. What is UrsAB and what is it used for
UrsAB is an eye drop used for the treatment, in adults and children, of infections of the
external part of the eye such as bacterial conjunctivitis (inflammation of the conjunctiva) and keratitis
(inflammation of the cornea) caused by organisms sensitive to Ofloxacin.
Ofloxacin belongs to a group of medicines called 4th generation quinolone antibiotics.
2. What you need to know before you use UrsAB
Do not use UrsAB
If you are allergic to Ofloxacin or to any of the other ingredients of this medicine
(listed in section 6), or to any other quinolone.
Warnings and precautions
Talk to your doctor before using UrsAB
- If you are hypersensitive to quinolone antibiotics
- If you have defects or lesions of the ocular surface. Prolonged use of the product may cause new bacterial infections that do not respond to treatment with UrsAB Long.
During treatment with eye drops containing ofloxacin, you should avoid exposure to sunlight or to
ultraviolet light (e.g. tanning lamps, solariums) due to potential
photosensitivity.
The use of contact lenses in patients undergoing treatment for an eye infection is not
recommended.
Swelling and rupture of tendons have been reported in people taking fluoroquinolones by
mouth or intravenously, particularly in elderly patients and those treated in
conjunction with corticosteroids. Stop taking UrsAB if you start to experience pain or
swelling of the tendons (tendonitis).
Caution should be exercised when using this type of medicine if you have been born with or have a family
history of prolonged QT interval (seen on ECG, electrical recording of the heart), if you
have an imbalance of salts in the blood (especially low levels of potassium or magnesium in
the blood), if you have a very slow heart rate (called 'bradycardia'), if you have a weak heart
(heart failure), if you have a history of heart attack (myocardial infarction), if you are female or
elderly or are taking other medicines that cause abnormal changes in the ECG (see
section Other medicines and UrsAB).
Children and adolescents
The product can be used in children. Safety and efficacy in children under one
year of age have not been established.
Other medicines and UrsAB
Tell your doctor or pharmacist if you are taking, have recently taken or are currently taking any other medicines.
If, in addition to UrsAB, you are using other eye drops or ointments, an interval of about 15 minutes should be maintained between applications of the medicines. Ocular ointments should
always be applied last.
Tell your doctor if you are taking other medicines that may alter your heart rate:
medicines belonging to the group of antiarrhythmics (e.g. Quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which
belong to the group of macrolides), some antipsychotics.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine. The
doctor can then decide whether you can use UrsAB. The use of UrsAB is not recommended in
pregnant women.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and operating machinery
Immediately after applying this product to the eye, some minutes of blurred vision may occur.
During this time, do not drive vehicles, use machinery or perform
work without a stable support.
UrsAB contains Benzalkonium chloride
This medicine contains 0.125 mg of benzalkonium chloride per 5 ml equivalent to 0.025 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
changing their color. Remove contact lenses before using this medicine and wait 15
minutes before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an
abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.
3. How to use UrsAB
Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Instill one drop of UrsAB into the infected eye(s) every 2/4 hours for the first two days and
subsequently 4 times a day. To be effective, UrsAB must be taken regularly.
Method of administration
- 1. Wash your hands.
- 2. Take a clean cloth and gently dab the area around the eye to remove moisture (Figure 1).
- 3. Unscrew the bottle and check that the applicator is clean.
- 4. Tilt your head back and gently lower the lower eyelid (Figure 2)
- 5. Instill 1 or 2 drops into the center of the lower eyelid (Figure 3). Be careful that the applicator does not touch the eye.
- 6. Release the lower eyelid and gently press the inner corner of the eye towards the nose (Figure 4). Keep your finger pressed against the nose, closing your eye slowly for a few seconds so that the drop spreads over the surface of the eye.
- 7. Remove excess medicine.
- 8. Repeat the operation for the other eye as well.
Figure 1 Figure 2 Figure 3 Figure 4
If you cannot get the drop into your eye, try again.
To avoid contamination, make sure that the tip of the applicator does not touch the eye or
anything else.
Replace the cap correctly and close the package tightly after use.
It is very important that you apply the eye drops correctly; if you have any doubts, consult your doctor or pharmacist.
Duration of treatment
The duration of treatment should not exceed 14 days. If symptoms persist after this
period, contact your doctor.
Use in children
The product can be used in children. Safety and efficacy in children under one
year of age have not been established.
If you use more UrsAB than you should
If you have applied too many drops, wash your eye(s) with clean water. Apply the next dose when
due.
If you accidentally ingest the product, contact your doctor immediately.
If you forget to use UrsAB
If you forget to apply a dose, apply it as soon as you remember, unless it is almost
time to apply the next dose. In this case, skip the forgotten dose.
Apply the next dose as normal and continue to take the product as prescribed.
Do not use a double dose to make up for a missed dose.
If you stop using UrsAB
UrsAB must be used as prescribed by your doctor.
If you have any doubts about using 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.
If you experience an allergic reaction (including swelling of the skin, mucous membranes, throat and/or
tongue, shortness of breath), stop using the eye drops and contact your doctor immediately.
Serious side effects, frequency not known (cannot be estimated from the available data): with the use
of eye drops based on ofloxacin, potentially life-threatening skin rashes have been reported
(Stevens-Johnson syndrome, toxic epidermal necrolysis) which initially appear as reddish spots
similar to a target or circular patches often with central blisters on the trunk.
Eye irritation and discomfort are common side effects (may affect up to 1 in 10 people).
The following side effects are known, although their frequency is not known.
If any of the following side effects cause you problems or if they do not resolve on their own, see your
doctor:
Side effects affecting the eyes:
Eye redness/Eye allergy
Itching
Blurred vision
Increased tearing
Dry eyes
Eye pain
Sensitivity to light
Swelling around the eyes (including eyelid swelling)
Side effects affecting the whole body:
Allergic reactions
Dizziness
numbness
nausea
headache
swelling of the face or skin around the eye
Heart disorders:
Not known: abnormally fast heart rate, potentially life-threatening irregular heartbeat,
alteration of the heart rhythm (called 'prolongation of the QT interval', seen with ECG, heart
electrical activity).
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
5. How to store UrsAB
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging,
after Exp. The expiry date refers to the last day of that month.
Once the container is opened, the product should not be used for more than 4 weeks, even
if the bottle is not empty.
Do not store at temperatures above 25°C.
Store the product in the original packaging to protect the medicine from light.
If the solution becomes yellowish-green in colour, the product must be discarded.
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 UrsAB contains
The active ingredient is Ofloxacin 3 mg/ml.
The other ingredients are benzalkonium chloride, sodium chloride, hydrochloric acid solution and
sodium hydroxide (for pH adjustment), water for injections.
Description of UrsAB and contents of the pack
UrsAB is a clear, pale yellow/green coloured solution contained in a plastic bottle
with a dropper and screw cap.
Each pack contains 1 bottle of 5 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
URSAPHARM S.r.l., Via Vittor Pisani 16, 20124 Milano
Manufacturer
URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrücken, Germany
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
CZ Ofloxacin-POS 3mg/ml eye drops, solution
DE Ofloxacin-POS 3 mg/ml eye drops, solution
ES OFLOXACINO POS 3 MG/ML EYE DROPS IN SOLUTION
IT UrsAB, 3 mg/ml eye drops, solution
NL Ofloxacine-POS 3 mg/ml, eye drops, solution
PL Ofloxacin-POS
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 3 MG/ML
- Kod ATCS01AE01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki URSABPostać farmaceutyczna: Eye drops, solution, 3 MG/MLSubstancja czynna: ofloxacinProducent: BIONATIVA S.P.A.Wymaga receptyPostać farmaceutyczna: Ointment, 0.3%Substancja czynna: ofloxacinProducent: ABBVIE S.R.L.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 3 MG/MLSubstancja czynna: ofloxacinProducent: FARMIGEA S.P.A.Wymaga recepty
Odpowiedniki URSAB w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik URSAB w Polska
Odpowiednik URSAB w Ukraina
Odpowiednik URSAB w Hiszpania
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URSAB wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w URSAB jest ofloxacin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
URSAB jest produkowany przez URSAPHARM SRL. 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 URSAB 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 URSAB 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 (ofloxacin) to m.in. DUNAFLOT, EXOKIN, FLOXIJEN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
