Ursab

Patient Information Leaflet: Information for the patient

UrsAB 3 mg/ml eye drops, solution

Ofloxacin
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 using 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 UrsAB is and what it is used for

UrsAB is an eye drop used in adults and children for the treatment of external eye infections 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 4-quinolone antibiotics.

2. What you should know before taking 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 taking UrsAB:

• If you are hypersensitive to quinolone antibiotics
• If you have defects or injuries of the ocular surface

Prolonged use of this product may lead to new bacterial infections that are unresponsive to treatment with UrsAB Long.

During treatment with eye drops containing ofloxacin, you must avoid exposure to sunlight or ultraviolet light (e.g. sunlamps, tanning beds) due to potential photosensitivity.
Wearing contact lenses in patients undergoing treatment for an eye infection is not recommended.
Cases of tendon swelling and rupture have occurred in people taking oral or intravenous fluorquinolones, particularly in elderly patients and in those receiving concomitant corticosteroid therapy. Discontinue use of UrsAB if you develop tendon pain or swelling (tendinitis).

Caution should be exercised when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on ECG, the electrical recording of the heart), if you have an electrolyte imbalance (especially low blood potassium or magnesium levels), if you have a very slow heart rate (called 'bradycardia'), if you have heart failure, if you have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal ECG changes (see section Other medicines and UrsAB).

Children and adolescents
This product may be used in children. Safety and efficacy in children under one year of age have not been established.

Other medicines and UrsAB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If, in addition to UrsAB, you are using other eye drops or eye ointments, an interval of approximately 15 minutes should be maintained between applications. Eye ointments should always be applied last.
Inform your doctor if you are taking other medicines that may affect heart rhythm: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (belonging to the macrolide group), or certain antipsychotics.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will 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 using machines
For a few minutes after applying this product to the eye, blurred vision may occur. During this time, you should not drive, operate machinery, or perform tasks requiring 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 may be absorbed by soft contact lenses and may cause a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may 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, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use UrsAB

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Instill one drop of UrsAB into the affected eye(s) every 2 to 4 hours during the first two days, then reduce to four times daily. To be effective, UrsAB must be used regularly.
Method of administration

1. Wash your hands.
2. Take a clean cloth and gently wipe 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 backward and gently pull down the lower eyelid (Figure 2).
5. Instill 1 or 2 drops into the center of the lower eyelid (Figure 3). Be careful not to let the applicator touch the eye.
6. Release the lower eyelid and gently press the inner corner of the eye toward the nose (Figure 4). Keep pressing your finger against the nose while slowly closing the eye for a few seconds, allowing the drop to spread over the eye surface.
7. Remove any excess medicine.
8. Repeat the procedure for the other eye, if necessary.

Figure 1 Figure 2 Figure 3 Figure 4
If you are unable to get the drop into the eye, try again.
To avoid contamination, ensure that the tip of the applicator does not touch the eye or any other surface.
Replace the cap properly and close the package tightly after use.
It is very important to correctly apply the eye drops. If you have any doubts, consult your doctor or pharmacist.
Duration of treatment
The treatment duration should not exceed 14 days. If symptoms persist after this period, contact your doctor.
Use in children
This product may 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 instilled too many drops, rinse the eye(s) with clean water. Apply the next dose as scheduled.
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 for the next dose. In this case, skip the missed dose.
Apply the next dose as usual and continue using the medicine as prescribed.
Do not use a double dose to make up for a forgotten dose.
If you stop using UrsAB
UrsAB must be used as prescribed by your doctor.
If you have any questions about the use of this medicine, consult 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 unknown (cannot be estimated from the available data): with the use of ofloxacin-containing eye drops, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, which initially appear as red, target-like spots 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 bother you or do not go away on their own, consult 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 problems:
Not known: abnormally fast heartbeat, potentially life-threatening irregular heartbeat, changes in heart rhythm (called 'QT interval prolongation', seen on ECG, electrical activity of the heart).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 stated on the label and the carton,
after Exp. The expiry date refers to the last day of that month.
Once the container has been opened, the product must not be used for more than 4 weeks, even
if the bottle is not empty.
Do not store above 25°C.
Keep the product in the original packaging to protect the medicine from light.
If the solution turns yellowish-green, the product must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What UrsAB contains
The active substance is Ofloxacin 3 mg/ml.
The other components are benzalkonium chloride, sodium chloride, hydrochloric acid solution,
and sodium hydroxide (for pH adjustment), water for injections.
Description of the appearance of UrsAB and contents of the pack
UrsAB is a clear, pale yellow/green solution contained in a plastic bottle with a dropper and screw cap.
Each box contains 1 bottle of 5 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
URSAPHARM S.r.l., Via Vittor Pisani 16, 20124 Milano, Italy
Manufacturer
URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrücken, Germany
This medicinal product is authorized in the European Economic Area countries under the
following names:
CZ Ofloxacin-POS 3mg/ml oční kapky, roztok
DE Ofloxacin-POS 3 mg/ml Augentropfen, Lösung
ES OFLOXACINO POS 3 MG/ML COLIRIO EN SOLUCION
IT UrsAB, 3 mg/ml collirio, soluzione
NL Ofloxacine-POS 3 mg/ml, oogdruppels, oplossing
PL Ofloxacin-POS