OCUFLOX 3 mg /G Ointment

Зміст інструкції

1. OcuFlox 3 mg/g ophthalmic ointment
   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

OcuFlox 3 mg/g ophthalmic ointment

Ofloxacin

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 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 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 and inhibits a specific bacterial enzyme (gyrase). Consequently, the
bacterial metabolism cannot be maintained 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 chlamydia 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 allergicto ofloxacin or other gyrase inhibitors, or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk 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 can also occur if you use other antibiotics administered at a
topical or systemic level.

• Talk to your doctor if your symptoms worsen or persist.
• If you use OcuFlox for a prolonged period of time, you may be more prone to other eye infections. Heart problems:Particular care should be taken when using this type of medicine if you were born with or have a family history of prolonged QT interval (displayed on an ECG, electrical recording of the heart), have an electrolyte imbalance in the blood (especially a low level 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 a woman or elderly or if you are taking other medicines that can cause abnormal changes in the ECG (see section ‘Other medicines’). Do not use OcuFlox in case of inflammation of the posterior segment of the eye (e.g. retina or vitreous body). During treatment with OcuFlox, excessive exposure tosunlight or artificial ultraviolet light(e.g. sunbathing, sunlamps, solariums) should be avoided as you may experience an exaggerated skin reaction, similar to a severe sunburn. Your nails may also become discolored or detached. Reactions of hypersensitivity and allergic reactions have been reported even after the first administration of fluoroquinolones. Severe allergic reactions (anaphylactic and anaphylactoid reactions) can lead to shock potentially fatal immediately after the first administration. In these cases, treatment with OcuFlox must be discontinued and immediate medical assistance must be requested. Swelling and rupture of tendons have occurred in people taking fluoroquinolones orally or intravenously, particularly in elderly patients and those treated concurrently with corticosteroids. Stop taking OcuFlox if you start to experience pain or swelling of the tendons (tendonitis). As with other antibiotics, OcuFlox can cause an increased development of microorganisms that are not susceptible. If an infection occurs during treatment, your doctor will take appropriate measures. If you have corneal defects or corneal ulcers, your doctor will administer the treatment with OcuFlox with caution, given the possible risk of corneal perforation. Your doctor will monitor your response to treatment with OcuFlox accordingly and, if necessary, modify the treatment. Ophthalmic ointments may delay the healing of corneal wounds. To prevent contamination, your fingers or other objects should not come into contact with the opening of the tube. Do not use contact lenses during treatment for an eye infection.

When you no longer need it, hand over any remaining medicine to your
pharmacist and do not keep it for any other treatment.

Other medicines and OcuFlox
Tell your doctor or pharmacist if you are taking, have recently taken or could take any other medicine, including over-the-counter medicines.
During treatment with OcuFlox, no otherpreparationcontaining zinc, lead or mercuryshould be used, as they may attenuate
the effect of OcuFlox.
You should inform your doctor if you are taking other medicines that can alter your
heart rhythm: medicines that belong to the class of antiarrhythmics (for example
quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
tricyclic antidepressants, some antimicrobials (that belong to the class of macrolides),
some antipsychotics.
If you are receiving additional treatments with other ophthalmic medicines, at least 15 minutes must elapse between individual applications. Ophthalmic ointments should
always be applied last.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.
Since harmful effects on the newborn cannot be completely excluded, it is preferable not to use OcuFlox during pregnancy and breastfeeding.

Children
There is limited experience in the use of OcuFlox in children. Talk to your doctor before
starting to use OcuFlox in children.

Driving and operating machinery
No studies have been performed on the ability to drive and operate machinery.
As with other ophthalmic ointments, blurring or slight
reduction of vision may occur. During this period, do not use machinery, work without
adequate protection or drive vehicles.

OcuFlox contains lanolin and butylated hydroxytoluene (BHT)
Lanolin can cause local skin reactions (e.g. contact dermatitis).
Butylated hydroxytoluene can 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. on the eye).
Use this medicine following the doctor's instructions exactly. If you have
any doubts, consult your doctor or pharmacist.
Unless otherwise indicated by your doctor, the recommended dose is:
Insert a 1 cm layer of ointment (equivalent to 0.12 mg of ofloxacin) 3
times a day (for chlamydia infections, 5 times a day) into the conjunctival sac
of the affected eye.

Use in children and adolescents
The dosage in children is no different from that of adults. In children under one
year of age, data are limited and efficacy has not been demonstrated.
OcuFlox is inserted as a thin layer of ointment inside the conjunctival sac. Gently pull down the lower eyelid with your finger, until
a 'V' shaped pocket is formed between the eyeball and the lower eyelid. Do not touch the eye or
the area around the eyes or other surfaces with the tip of the tube, as germs
could otherwise enter the ointment. Apply a layer of ointment, approximately
1 cm long, inside the sac thus formed, but without letting the tip of the
tube touch the eye.
Look downwards before closing your eye.
Do not use OcuFlox for more than 14 days.
Note: In the case of concomitant use of other eye drops/ ophthalmic ointments, the application of
medicines must be carried out with an interval of at least 15 minutes between instillations
and OcuFlox must always be applied last.

If you use more OcuFlox than you should
If you have used too much ophthalmic ointment, rinse your eye with lukewarm water. Apply the
next dose at the scheduled time.
If systemic side effects occur as a result of misuse or accidental overdose, these must be treated at a systemic level.
In this case, consult your doctor.

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

If you stop using OcuFlox
Even if there is an improvement in the symptoms of the disease, treatment with OcuFlox
should never be changed or interrupted without medical advice. This is to
prevent a worsening or return of the disease.
If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Serious side effects:
If you have one or more of the following side effects, you may have had a serious
allergic reaction.Stop using OcuFlox immediately and contact your doctor.

Allergic reactions:

Very rare side effects(may affect up to 1 in 10,000 people)

• Allergic reactions in the eye (including eye and/or eyelid itching)
• Skin inflammation due to allergy (including: irritation, itching or hives)
• Life-threatening allergic (Anaphylactic) reaction that manifests as swelling under the skin that may appear in areas such as the face, lips or other parts of the body, swelling of the mouth, tongue or throat that can obstruct the airways causing wheezing, difficulty swallowing, breathing or shortness of breath.
• 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 a target or circular patches often with central blisters on the trunk. It is also known that the following side effects may occur:Consult your doctor if any of the following side effects become bothersome or persist over time. Common side effects(may affect up to 1 in 10 people)
• Eye irritation
• Eye discomfort Frequency not known(the frequency cannot be estimated based on available data) Ocular side effects:
• Visual disturbance
• Tearing
• Inflammation
• Redness
• Light sensitivity
• Feeling of a foreign body in the eye
• Eye swelling
• Swelling around the eyes (including eyelid swelling)
• Eye pain
• Dryness (mild stinging or burning) Systemic side effects
• Dizziness
• Nausea Cardiac side effects:
• Abnormally fast heart rate
• Life-threatening irregular heart rhythm
• Alteration of the heart rhythm (called ‘prolongation of the QT interval’, seen on the heart's electrical activity in an ECG).

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 OcuFlox

Do not store at a temperature above 30°C.
After opening: Do not store at a temperature above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and
on the 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 in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What OcuFlox contains

• The active ingredient is: ofloxacin
• 1 g of ophthalmic ointment contains 3 mg of ofloxacin. A single dose (one 1 cm layer of ointment) contains 0.12 mg of ofloxacin.
• The other ingredients are: liquid paraffin, lanolin, white petrolatum Description of the appearance of OcuFlox and contents of the pack1 plastic tube with 3 g of ophthalmic ointment Marketing Authorisation Holder and Manufacturer

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

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 denominations:
Austria VisioFlox 3 mg/g eye ointment
Italy OcuFlox 3 mg/g ophthalmic ointment
Luxembourg VisioFlox 3 mg/g eye ointment
Poland VisioFlox