Visioflox

Package leaflet: Information for the user

VisioFlox, 3 mg/g, ointment for eyes
Ofloxacinum
It is important to read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What VisioFlox is and what it is used for
2. Important information before using VisioFlox
3. How to use VisioFlox
4. Possible side effects
5. How to store VisioFlox
6. Contents of the pack and other information

1. What VisioFlox is and what it is used for

VisioFlox contains the active substance ofloxacin. Ofloxacin is a so-called antibiotic
that inhibits a bacterial enzyme (DNA gyrase). As a result, bacterial metabolism cannot be
maintained and the bacteria die.
VisioFlox is used for:

• treatment of infections of the anterior segment of the eye: chronic conjunctivitis, keratitis, corneal ulceration, chlamydial infection.

VisioFlox is indicated for use in adults, adolescents, and children after completion of the first year of life.

2. Important information before using VisioFlox

When not to use VisioFlox
Do not use VisioFlox if the patient is allergic to ofloxacin or other quinolone inhibitors, or to any
of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with VisioFlox, discuss this with your doctor or pharmacist.

• VisioFlox should be used only in the eye.
• If allergic reactions occur, such as eyelid itching, swelling or redness of the eye, discontinue treatment with VisioFlox and consult your doctor.
  Such hypersensitivity may also occur with the use of other antibiotics applied locally or systemically.
• If symptoms worsen or the disease recurs, contact your doctor.
• Prolonged use of VisioFlox may increase susceptibility to other eye infections.

Heart disorders:
Exercise caution when using this medicine in patients with congenital or family history of prolonged QT interval (observed on ECG, the recording of the heart's electrical activity), in patients with electrolyte imbalance in the blood (particularly low potassium or magnesium levels), with very slow heart rate (called "bradycardia"), with impaired heart function (heart failure), with a history of heart attack (myocardial infarction), in women, elderly individuals, or in patients taking other medicines that cause abnormal changes in the ECG (see section "VisioFlox and other medicines").

Do not use VisioFlox in cases of posterior eye inflammation (e.g. retina or vitreous body).

During treatment with VisioFlox, avoid excessive exposure to sunlight or ultraviolet radiation (e.g. sunbathing, sunlamps, solarium), due to the possibility of an exaggerated skin reaction similar to severe sunburn. Discoloration or loosening of nails may also occur.

Severe hypersensitivity reactions and allergic reactions have been reported even after the first dose of fluoroquinolones. Severe allergic reactions (anaphylactic and anaphylactoid reactions) may lead to life-threatening shock immediately after the first dose. In such cases, discontinue use of VisioFlox and contact your doctor immediately.

Swelling and tendon rupture have occurred in patients taking fluoroquinolones orally or intravenously, particularly in elderly patients and in patients receiving corticosteroids concurrently. Discontinue treatment with VisioFlox if tendon pain or swelling occurs (tendonitis).

As with other antibiotics, VisioFlox may lead to overgrowth of pathogenic microorganisms resistant to this medicine. If such a situation occurs, the doctor will initiate appropriate treatment.

If corneal damage or corneal ulcers are present, the doctor will advise caution when using VisioFlox due to the risk of corneal perforation.

The doctor will monitor the response to VisioFlox and adjust treatment if necessary.

Ocular ointments may delay corneal healing.

To avoid contamination, fingers and other objects must not come into contact with the tube opening.

Do not wear contact lenses during treatment of eye infections.

After completing treatment, return any remaining medicine to the pharmacist and do not keep it for future use.

VisioFlox and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used, including those obtained without a prescription.

During treatment with VisioFlox, do not use other eye preparations containing zinc, lead, or mercury, as they may reduce the effectiveness of VisioFlox.

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 antimicrobial agents (belonging to the macrolide group), certain antipsychotic medicines.

If VisioFlox is used simultaneously with other eye medicines, maintain at least a 15-minute interval between administration of each medicine. The ointment should always be applied last.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Since harmful effects on the child cannot be completely ruled out, VisioFlox should not be used during pregnancy and lactation.

Children
Experience with the use of VisioFlox in children is limited. VisioFlox is not recommended for use in children under one year of age. Before starting treatment with VisioFlox in children, discuss this with your doctor.

Driving and operating machinery
No studies on the effect on the ability to drive vehicles or operate machinery have been conducted. As with other eye ointments, blurred vision or minor visual disturbances may occur. During this time, do not operate machinery, work without proper safety precautions, or drive vehicles.

VisioFlox contains lanolin and butylated hydroxytoluene (BHT)
Lanolin may cause local skin reactions (e.g. contact dermatitis).
Butylated hydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use VisioFlox

Ophthalmic administration.
This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Unless otherwise prescribed by the physician, the recommended dose is:
1 cm of extruded ointment (corresponding to 0.12 mg of ofloxacin) 3 times daily (in cases of chlamydial infections, 5 times daily) into the conjunctival sac of the affected eye.

Use in children and adolescents
Dosing in children does not differ from that in adults. Data in children under one year of age are limited, and efficacy has not been established.

VisioFlox ointment is administered as a thin strip into the conjunctival sac.
Gently pull down the lower eyelid with a finger to form a "V"-shaped pouch between the eyelid and the eyeball. Do not touch the eye, the area around the eye, or any other surface with the tip of the tube, as microorganisms may otherwise contaminate the ointment. Apply approximately 1 cm of extruded ointment into this formed conjunctival sac, taking care not to touch the eye with the tip of the tube. Look downward before closing the eye.

Do not use VisioFlox for longer than 14 days.

Note: If other eye drops or eye ointments are used simultaneously, an interval of approximately 15 minutes should be maintained between the administration of the different products, and VisioFlox should always be administered last.

Use of more than the recommended dose of VisioFlox
If more than the recommended dose is used, rinse the eye with warm water.
The next dose should be administered at the usual time.
If systemic adverse effects occur due to improper use or accidental overdose, general supportive treatment should be initiated. In such cases, contact your doctor.

Missed dose of VisioFlox
Apply the medicine as soon as possible and continue treatment at the regular intervals prescribed by the physician. Do not use a double dose to make up for a missed dose.

Discontinuation of VisioFlox
Even if symptoms improve, do not alter the dosage or discontinue treatment without consulting your doctor. This is to prevent worsening of the patient's condition or recurrence of the disease.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although they do not occur in everyone.
Serious adverse reactions:
If any of the following occur, a severe allergic reaction may have occurred. You should immediately stop using VisioFlox and contact your doctor.
Allergic reactions:
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):

• Allergic reactions affecting the eye (including eye and/or eyelid swelling).
• Skin inflammation caused by allergy (including rash, itching or hives).
• Severe, sudden, life-threatening allergic reaction (anaphylactic reaction) with swelling of the face, lips or other parts of the body, swelling of the mouth, tongue or throat, which may block the airways. This may cause wheezing, difficulty swallowing, breathing difficulties or shortness of breath.
• During treatment with VisioFlox, potentially life-threatening skin rashes have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis), initially appearing as reddish spots or oval patches on the trunk, often with blisters in the center.

In addition, the following adverse reactions may occur:
Contact your doctor if any of the following eye-related adverse reactions become troublesome or are prolonged.
Common adverse reactions (may occur in fewer than 1 in 10 people):

• eye irritation;
• sensation of discomfort in the eye.

Frequency unknown (cannot be estimated from available data):
Eye disorders:

• disturbances in vision;
• tearing;
• inflammation;
• redness;
• sensitivity to light;
• sensation of a foreign body in the eye;
• eye swelling;
• swelling around the eyes (including eyelid swelling);
• eye pain;
• dryness (mild pricking or burning).

General disorders:

• dizziness;
• nausea.

Cardiac disorders:

• irregular fast heartbeat;
• life-threatening irregular heartbeat;
• change in heart rhythm (called "QT interval prolongation", observed on electrocardiogram ECG).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to collect more information on the safety of the medicine.
Adverse reactions may also be reported to the responsible entity.

5. How to store VisioFlox

Do not store above 30°C.
After first opening of the tube: do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated (after EXP) on the carton and container.
The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the tube: 6 weeks.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Such action will help protect the environment.

6. Contents of the package and other information

What VisioFlox contains

• The active substance is ofloxacin.
• 1 g of ophthalmic ointment contains 3 mg of ofloxacin. A single dose (1 cm of ointment squeezed out) contains 0.12 mg of ofloxacin.
• The other ingredients are: liquid paraffin, lanolin, white soft paraffin.

What VisioFlox looks like and contents of the pack
1 plastic tube containing 3 g of ophthalmic ointment

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharm Supply Sp. z o.o.
Marconich 2/9,
02-954 Warsaw
Poland

Manufacturer
Tubilux Pharma S.p.A
Via Costarica, 20/22
00071 Pomezia (Roma)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: VisioFlox 3 mg/g Augensalbe
Italy: OcuFlox 3 mg/g unguento oftalmico
Luxembourg: VisioFlox 3 mg/g Augensalbe
Poland: VisioFlox