Ocuflox

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

OcuFlox 3 mg/g ophthalmic ointment

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, ask 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, it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT OcuFlox IS AND WHAT IT IS USED FOR

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

• to treat infections of the anterior segment of the eye: chronic inflammation of the conjunctiva, cornea, corneal ulcers, and chlamydial infections. OcuFlox is not recommended for use in children under one year of age.

2. WHAT YOU NEED TO KNOW BEFORE USING OcuFlox

Do not use OcuFlox

• if you are allergic to ofloxacin or to other quinolone antibiotics, or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using OcuFlox.
• Use OcuFlox only in the eye.
• If you notice allergic reactions such as eyelid itching, swelling or redness of the eyes, stop treatment with OcuFlox and consult your doctor. Such hypersensitivity may also occur if you use other antibiotics administered topically or systemically.
• Contact your doctor if your symptoms worsen or persist.
• If you use OcuFlox for a prolonged period, you may become more susceptible to other eye infections. Heart problems: Particular caution is required when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, the electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that can cause abnormal changes in the ECG (see section 'Other medicines'). You must not use OcuFlox in case of inflammation of the posterior segment of the eye (e.g. retina or vitreous body). During treatment with OcuFlox, you should avoid excessive exposure to sunlight or artificial ultraviolet light (e.g. sunbathing, sunlamps, solarium) as you may experience an excessive skin reaction similar to a severe sunburn. Your nails may also become discolored or detached. Even after the first dose of fluoroquinolones, hypersensitivity reactions and allergic reactions have been reported. Severe allergic reactions (anaphylactic and anaphylactoid reactions) may lead to potentially life-threatening shock immediately after the first dose. In such cases, treatment with OcuFlox must be stopped and immediate medical assistance must be sought. Tendon swelling and rupture have occurred in people taking oral or intravenous fluoroquinolones, particularly in elderly patients and in those receiving concomitant corticosteroid therapy. Stop taking OcuFlox if you begin to experience tendon pain or swelling (tendinitis). As with other antibiotics, OcuFlox may lead to increased growth of non-susceptible microorganisms. If a new infection develops during treatment, your doctor will take appropriate measures. If you have corneal defects or corneal ulcers, your doctor will administer OcuFlox with caution due to the possible risk of corneal perforation. Your doctor will monitor your response to OcuFlox treatment accordingly and, if necessary, adjust the treatment. Ophthalmic ointments may delay healing of corneal wounds. To prevent contamination, fingers or other objects must not touch the opening of the tube. Do not wear contact lenses during treatment for an eye infection.

When no longer needed, return any remaining medicine to your pharmacist and do not keep it for any future treatment.
Other medicines and OcuFlox
Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might take/use any other medicines, including those obtained without a prescription.
During treatment with OcuFlox, no other preparations containing zinc, lead, or mercury should be used, as they may reduce the effectiveness of OcuFlox.
You must inform your doctor if you are taking other medicines that may alter your heart rhythm: medicines belonging to the class of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide class), and some antipsychotics.
If you are receiving additional treatments with other ophthalmic medicines, at least 15 minutes should elapse between each application. Ophthalmic ointments should always be applied last.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Since harmful effects on the newborn cannot be completely ruled out, it is preferable not to use OcuFlox during pregnancy and breastfeeding.
Children
Experience with the use of OcuFlox in children is limited. Consult your doctor before starting to use OcuFlox in children.
Driving and using machines
No studies on the ability to drive vehicles or use machines have been conducted. As with other ophthalmic ointments, blurred vision or slight visual impairment may occur. During this time, do not operate machinery, do not work without proper protection, or drive vehicles.
OcuFlox 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 to the eyes and mucous membranes.

3. HOW TO USE OcuFlox

For ophthalmic use (i.e. in the eye).
Always use this medicine exactly as instructed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
If not otherwise directed by your doctor, the recommended dose is:
Insert a 1 cm strip of ointment (equivalent to 0.12 mg of ofloxacin) 3 times daily (for chlamydia infections, 5 times daily) into the conjunctival sac of the affected eye.

Use in children and adolescents
The dosage in children is not different from that in adults. In children under one year of age, data are limited and efficacy has not been demonstrated.

OcuFlox is applied as a thin layer of ointment inside the conjunctival sac. Gently pull down the lower eyelid with your finger to form a 'V'-shaped pouch between the eyeball and the lower eyelid. Do not touch the eye, the surrounding area, or any other surface with the tip of the tube, as germs could otherwise enter the ointment. Apply a strip of ointment approximately 1 cm long into the formed conjunctival sac, without letting the tip of the tube touch the eye.

Look downward before closing the eye.

Do not use OcuFlox for more than 14 days.

Note: If other eye drops/ophthalmic ointments are used concomitantly, the application of these medicines should be performed with an interval of at least 15 minutes between administrations, and OcuFlox should always be applied last.

If you use more OcuFlox than you should
If you have used too much ophthalmic ointment, rinse the eye with lukewarm water. Apply the next dose at the scheduled time.

If systemic side effects occur as a result of improper use or accidental overdose, these should be treated systemically. In such a case, consult your doctor.

If you forget to use OcuFlox
Apply the ophthalmic ointment as soon as possible and continue treatment at the regular intervals prescribed by your doctor. Do not use a double dose to make up for the missed dose.

If you stop using OcuFlox
Even if there is an improvement in disease symptoms, treatment with OcuFlox must never be modified or discontinued without medical advice. This is to prevent worsening or recurrence of the infection.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions:
If you experience one or more of the following adverse reactions, you may have had a severe allergic reaction. Stop using OcuFlox immediately and contact your doctor.
Allergic reactions:
Very rare adverse reactions (may affect up to 1 in 10,000 people)

• Allergic reactions in the eye (including itching of the eye and/or eyelid)
• Skin inflammation due to allergy (including: irritation, itching, or hives)
• Allergic reaction (anaphylactic) potentially fatal, manifesting as swelling under the skin which may appear in areas such as the face, lips or other parts of the body, swelling of the mouth, tongue or throat that can block the airways causing wheezing, difficulty swallowing, breathing difficulties or labored breathing.
• Potentially fatal skin irritations (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of OcuFlox, which initially appear as reddish spots resembling targets or circular patches often with central blisters on the trunk. The following adverse reactions are also known to occur: Consult your doctor if any of the following adverse reactions are bothersome or persist over time. Common adverse reactions (may affect up to 1 in 10 people)
• Eye irritation
• Eye discomfort Frequency not known (frequency cannot be estimated from the available data) Ocular adverse reactions:
• Visual disturbance
• Tearing
• Inflammation
• Redness
• Light sensitivity
• Sensation of foreign body in the eye
• Swelling of the eyes
• Swelling around the eyes (including swelling of the eyelid)
• Eye pain
• Dryness (mild stinging or burning) Systemic adverse reactions:
• Dizziness
• Nausea Cardiac adverse reactions:
• Abnormally fast heart rate
• Life-threatening irregular heart rhythm
• Changes in heart rhythm (known as 'QT interval prolongation', seen on the heart's electrical activity in an ECG).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OcuFlox

Do not store above 30°C.
After opening: Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container.
The expiry date refers to the last day of that month.
After opening the tube, OcuFlox must be used within 6 weeks.
Do not dispose of any medicine via 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 PACKAGE AND OTHER INFORMATION

What OcuFlox contains

• The active substance is: ofloxacin
• 1 g of ophthalmic ointment contains 3 mg of ofloxacin. A single dose (a 1 cm layer of ointment) contains 0.12 mg of ofloxacin.
• The other components are: liquid paraffin, lanolin, white vaseline

Description of the appearance of OcuFlox and contents of the package
1 plastic tube containing 3 g of ophthalmic ointment

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy

Manufacturer
TUBILUX PHARMA S.p.A
Via Costarica, 20/22
00071 Pomezia (Rome)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria VisioFlox 3 mg/g eye ointment
Italy OcuFlox 3 mg/g ophthalmic ointment
Luxembourg VisioFlox 3 mg/g eye ointment
Poland VisioFlox