Visioflox

Leaflet included in the packaging: information for the user

VisioFlox 3 mg/g, eye ointment
Ofloxacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not give it to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is VisioFlox and what is it 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 packaging and other information

1. What is VisioFlox and what is it used for

VisioFlox contains the active substance ofloxacin. Ofloxacin is an antibiotic that inhibits a certain bacterial enzyme (gyrase). As a result, the metabolism of bacteria 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 ulcers, chlamydial infections.

VisioFlox is indicated for use in adults, adolescents, and children over one year of age.

2. Important information before using VisioFlox

When not to use VisioFlox

if the patient is allergic to ofloxacin or other gyrase inhibitors, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with VisioFlox, you should discuss it with your doctor or pharmacist.

• VisioFlox should only be used for the eye.
• If allergic reactions occur, such as eyelid itching, swelling, or eye redness, treatment with VisioFlox should be discontinued and a doctor consulted. Such hypersensitivity may also occur with the use of other topical or systemic antibiotics.

if symptoms worsen or the disease recurs, you should contact your doctor.

• If VisioFlox is used for a long time, the susceptibility to other eye infections may be increased.

Heart disorders:

Cautions should be exercised when using this medicine in patients with congenital or known QT interval prolongation (observed in ECG, a record of the heart's electrical activity), patients with electrolyte imbalance in the blood (especially low potassium or magnesium levels in the blood), with very slow heart rate (called "bradycardia"), with impaired heart function (heart failure), with a history of myocardial infarction (heart attack), in women, the elderly, or patients taking other medicines that cause abnormal changes in the ECG (see section VisioFlox and other medicines). VisioFlox should not be used in case of posterior segment eye inflammation (e.g., retinitis or vitreitis). During treatment with VisioFlox, you should avoid excessive exposure to sunlight or ultraviolet radiation (e.g., sunbathing, sunlamps, solarium), as this may cause an excessive skin reaction, similar to severe sunburn. Discoloration or nail detachment may also occur. Even after the first administration of fluoroquinolones, hypersensitivity reactions and allergic reactions have been reported. Severe allergic reactions (anaphylactic and anaphylactoid reactions) can lead to life-threatening conditions immediately after the first administration. In such cases, the use of VisioFlox should be discontinued and a doctor consulted immediately. Tendinitis and tendon rupture have occurred in people taking fluoroquinolones orally or intravenously, especially in older patients and those treated with corticosteroids at the same time. Treatment with VisioFlox should be discontinued if pain or tendinitis occurs. Like other antibiotics, VisioFlox may lead to the proliferation of pathogenic microorganisms that are insensitive to this medicine. If such a situation occurs, the doctor will apply appropriate treatment. In case of corneal damage or corneal ulcers, the doctor will recommend the use of VisioFlox with caution due to the risk of corneal perforation. The doctor will monitor the reaction to VisioFlox and adjust the treatment if necessary. Eye ointments may delay the healing of the cornea. To avoid contamination, fingers and other objects must not come into contact with the tube opening. Contact lenses should not be used during eye infection treatment. After completing the treatment, any remaining medicine should be handed over to the pharmacist and not left for another treatment.

VisioFlox and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as medicines you plan to take, including those available without a prescription. During treatment with VisioFlox, you should not use other eye preparations containing zinc, lead, or mercury, as they may reduce the effectiveness of VisioFlox. You should inform your doctor about taking other medicines that may affect heart rhythm: medicines belonging to the group of antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobial medicines (belonging to the group of macrolides), some antipsychotic medicines. If VisioFlox is used at the same time as other eye medicines, you should maintain an interval of at least 15 minutes between the administration of the individual medicines. Eye ointment should always be used as the last one.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Since it cannot be entirely ruled out that the medicine may have a harmful effect on the child, VisioFlox should not be used during pregnancy and lactation.

Children

The experience in 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, you should discuss it with a doctor.

Driving and using machines

No studies have been conducted on the impact on the ability to drive and use machines. Like other eye ointments, blurred vision or minor vision disturbances may occur. During this time, you should not operate machines, work without proper protection, 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 eye and mucous membrane irritation.

3. How to use VisioFlox

Administration to the eye. This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist. Unless the doctor recommends otherwise, the recommended dose is: 1 cm of this ointment (which corresponds to 0.12 mg of ofloxacin) 3 times a day (in the case of chlamydial infections, 5 times a day) to the conjunctival sac of the affected eye.

Use in children and adolescents

Dosing in children does not differ from dosing in adults. In children under one year of age, data are limited, and efficacy has not been demonstrated. VisioFlox is introduced as a thin layer of ointment into the conjunctival sac. Gently pull down the lower eyelid with your finger to form a "V"-shaped pocket between the eyelid and the eyeball. Do not touch the eye or the area around the eye with the tube tip, as this may cause microorganisms to enter the ointment. Introduce about 1 cm of this ointment into the formed conjunctival sac without touching the eye with the tube tip. Look down before closing your eye. Do not use VisioFlox for more than 14 days. Note: if other eye drops/eye ointments are used at the same time, you should maintain an interval of at least 15 minutes between the administration of the individual medicines, and VisioFlox should always be used as the last one.

Use of a higher than recommended dose of VisioFlox

In case of using a higher dose of the medicine than recommended, the eye should be rinsed with warm water. The next dose should be used at the normal time. If systemic side effects occur due to improper use or accidental overdose, general treatment should be applied. In such a case, you should consult a doctor.

Missing a dose of VisioFlox

The medicine should be used as soon as possible and the treatment continued at the normal intervals recommended by the doctor. A double dose should not be used to make up for a missed dose.

Discontinuation of VisioFlox

Even if there is an improvement in the symptoms of the disease, the dosage should not be changed or the treatment discontinued without consulting a doctor. This is to prevent the patient's condition from worsening or the disease from recurring. In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

If any of the following side effects occur, it may be a serious allergic reaction. You should stop using VisioFlox and consult a doctor immediately.
Allergic reactions:
Very rare side effects(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 an allergy (including rash, itching, or hives).
• Severe life-threatening allergic reaction (anaphylactic reaction) with swelling localized to 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, or shortness of breath.
• During the use of VisioFlox, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as red spots or oval patches on the torso, often with blisters in the center.

In addition, the following side effects may occur:

You should consult a doctor if any of the following side effects are troublesome or persistent.
Common side effects(may occur in fewer than 1 in 10 people):

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

Frequency not known(cannot be estimated from the available data):
Eye disorders:

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

General disorders:

• dizziness;
• nausea.

Heart disorders:

• abnormal rapid heart rhythm;
• life-threatening irregular heart rhythm;
• change in heart rhythm (called "QT interval prolongation", observed in the ECG record of the heart's electrical activity).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store VisioFlox

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

6. Contents of the packaging and other information

What VisioFlox contains

• The active substance of VisioFlox is ofloxacin.
• 1 g of eye ointment contains 3 mg of ofloxacin. A single dose (1 cm of this ointment) contains 0.12 mg of ofloxacin.
• The other ingredients are liquid paraffin, lanolin, white petrolatum.

What VisioFlox looks like and contents of the pack

1 plastic tube containing 3 g of eye ointment

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized 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

Date of last revision of the leaflet: