Monofloxofta

Patient Information Leaflet: Information for the User

MONOFLOXOFTA 0.3% 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, 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, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MONOFLOXOFTA is and what it is used for

Monofloxofta contains the active substance ofloxacin, which belongs to a class of medicines called
fluoroquinolone antibiotics.
This medicine is indicated for the treatment of external eye infections, in particular:
inflammation of the eyelids (blepharitis)
inflammation of the conjunctiva (conjunctivitis)
inflammation of the eyelid margins and conjunctiva (blepharoconjunctivitis)
inflammation of the cornea and conjunctiva (keratoconjunctivitis)
inflammation of the lacrimal sac (dacryocystitis)
inflammation of the cornea (keratitis)
dysfunction of the glands producing eyelid sebum (meibomitis)
open sores of the cornea (corneal ulcers) caused by bacterial infections
Additionally, the medicine is indicated as preventive treatment following surgical procedures.

2. What you should know before using MONOFLOXOFTA

Do not use Monofloxofta

• if you are allergic to ofloxacin, to other medicines in the same class (quinolones), or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using Monofloxofta.
Monofloxofta is an eye medicine intended for external use only: do not use it by injection or for intraocular administration.
Tendon swelling and rupture have been reported in people taking oral or intravenous fluorochinolones, particularly in elderly patients and in those receiving concomitant corticosteroid therapy.
Discontinue use of Monofloxofta if you develop tendon pain or swelling (tendinitis).
Exercise particular caution with Monofloxofta:

• If you have previously shown sensitivity to medicines similar to Monofloxofta (quinolones), or if you experience allergic reactions during treatment, as severe and rare hypersensitivity reactions (anaphylactic/anaphylactoid), some of which have been fatal and occurring after the first dose, have been reported in patients taking systemic quinolones, including ofloxacin (the active substance in Monofloxofta). Some reactions may be accompanied by circulatory collapse, loss of consciousness, rapid swelling of the skin and mucous membranes (angioedema), including swelling of the larynx, pharynx or facial tissues, airway obstruction, breathing difficulties, urticaria, and pruritus.
  Moreover, a severe, potentially fatal skin allergic reaction (Stevens-Johnson syndrome) has been reported in patients receiving ofloxacin (the active substance in Monofloxofta) via topical ocular administration, although no causal relationship with the medicine has been established.
  If an allergic reaction occurs after using Monofloxofta, stop using the medicine and contact your doctor immediately.

• If you suffer from a heart rhythm disorder known as QT interval prolongation, or if you are at risk for this condition, for example:

• if you are taking medicines known to prolong the QT interval, such as heart medications (Class IA and III antiarrhythmics), antidepressants (tricyclic antidepressants), macrolide antibiotics, or psychiatric medications (antipsychotics) (see "Other medicines and Monofloxofta");

• if you have uncorrected electrolyte imbalances (e.g., low levels of potassium or magnesium in the blood);

• if you have or have had heart problems, such as heart failure, myocardial infarction, or slow heart rate (bradycardia);

• if you are elderly or female, as you may be more sensitive to medicines that prolong the QT interval.

• If you need to use Monofloxofta for a prolonged period, because long-term use may lead to overgrowth of bacteria not sensitive to this medicine; if you do not notice improvement after a reasonable period of time, or if the infection worsens, discontinue use and consult your doctor for alternative therapy.

• If you have a corneal disease, e.g., defects in the surface layer or open lesions (ulcers) of the cornea, due to the risk of corneal perforation. This risk appears to be higher if you are elderly, have large ulcers, or other eye conditions (e.g., severe dry eye), systemic inflammatory diseases (e.g., rheumatoid arthritis), or if you are concurrently using other eye medications (steroids or non-steroidal anti-inflammatory drugs) (see "Other medicines and Monofloxofta"). Cases of corneal opacity (corneal precipitates) have been reported following treatment, but no causal relationship with the medicine has been established.

During use of Monofloxofta:
Avoid exposure to sunlight or UV rays due to potential photosensitivity;
Consider the risk of the drops passing into the upper throat (nasopharynx), which may contribute to the occurrence and spread of bacterial resistance.
Do not wear contact lenses, as their use is not recommended in patients being treated for ocular infections.
Children
Do not use Monofloxofta in children under 1 year of age, as the efficacy and safety of the medicine in this age group have not been established.
Other medicines and Monofloxofta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines that may alter heart rhythm (medicines known to prolong the QT interval), such as heart medications (antiarrhythmics of class IA and III), medicines for depression (tricyclic antidepressants), macrolide antibiotics, or medicines for mental disorders (antipsychotics) (see "Warnings and precautions");
• steroids or non-steroidal anti-inflammatory drugs applied to the eyes, due to the risk of corneal perforation; this may occur if the cornea has an underlying disease or injury, such as defects in the surface layer or open lesions (ulcers) (see "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Monofloxofta during pregnancy (see "Do not use Monofloxofta").
This medicine passes into breast milk; therefore, you and your doctor should consider whether to temporarily discontinue breastfeeding or the treatment with Monofloxofta.
Driving and use of machines
No specific studies have been conducted on the ability to drive or operate machinery. After administration of the medicine, you may experience blurred vision or other temporary visual disturbances.
Do not drive or operate machinery unless your vision has returned to normal.

3. How to use MONOFLOXOFTA

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose is 1-2 drops four to six times a day, or as prescribed by your doctor.

• Treatment of corneal inflammation ( keratitis ) and corneal open lesions ( corneal ulcers ) caused by bacterial infections: during the first two days: 1-2 drops every 30 minutes during daytime; in the following week: 1-2 drops every hour initially, then gradually reduce the dose (1-2 drops four times a day) until completion of treatment. Limit Monofloxofta treatment to the period necessary to achieve healing of your condition.

Instructions for use

• wash your hands thoroughly before administering the eye drops;
• separate a single-dose container from the strip;
• open the single-dose container by twisting the cap;
• instill 1-2 drops into the space between the eyelid and the white part of the eye (conjunctival sac).

Caution: When administering the eye drops, make sure the tip of the single-dose container does not touch
the eye or surrounding areas.
If you are using other eye drops concurrently, administer the medicines at least 15 minutes apart.
If you use more Monofloxofta than you should
In case of accidental ingestion/overdose of Monofloxofta, contact your doctor immediately or go to the nearest hospital.
If you instill an excessive amount of medicine into the eye, rinse the eye with water.
In case of overdose, treat symptoms accordingly and perform ECG monitoring for possible heart rhythm disturbances (QT interval prolongation).
If you forget to use Monofloxofta
If you miss a dose of this medicine, instill it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you stop using Monofloxofta
Do not stop treatment with Monofloxofta without first consulting 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.
Serious reactions after use of Monofloxofta are rare, and most symptoms are reversible.
Since a small amount of Monofloxofta may be absorbed into the body after administration into the eye, other systemic side effects may occur.

Common (may affect up to 1 in 10 people)

• eye irritation
• eye discomfort

Very rare (may affect up to 1 in 10,000 people)
Allergic reactions (hypersensitivity), including:

• rapid swelling of the skin and mucous membranes (angioedema)
• difficulty breathing (dyspnea)
• severe, rapidly occurring allergic reactions (anaphylactic reactions/shock)
• swelling (edema) of the tongue and throat

Frequency not known (frequency cannot be estimated from the available data)

• disturbances in heart rhythm (ventricular arrhythmia, torsade de pointes, QT prolongation on ECG), particularly in patients with known risk factors for QT interval prolongation (see "Warnings and precautions")
• dizziness, nausea
• inflammation of the cornea (keratitis) or conjunctiva (conjunctivitis)
• blurred vision
• increased sensitivity to light (photophobia)
• sensation of a foreign body in the eye
• increased tearing
• dry eye
• eye pain
• hypersensitivity in the eye area (including itching of the eye and/or eyelid)
• eye redness (ocular hyperemia)
• swelling around the eyes (including eyelid swelling)
• swelling of the eye (ocular edema) or around the eye (periorbital edema)
• facial swelling (facial edema)

With the use of Monofloxofta, potentially life-threatening skin rashes have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially appear as red spots resembling targets or circular patches, often with central blisters, typically on the trunk.

Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, 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 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 MONOFLOXOFTA

Keep this medicine out of the sight and reach of children.
Store the medicine at a temperature not exceeding 25°C in the original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, stored correctly.
Use the medicine within 3 months after first opening the pouch; after this period, dispose of any remaining medicine.
Use the eye drops immediately after opening the single-dose container; discard any unused portion.
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 Monofloxofta contains

• The active substance is ofloxacin. 100 ml of solution contain 0.3 g of ofloxacin.
• The other components are: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide (as needed to adjust pH).

Description of the appearance of Monofloxofta and package contents
Monofloxofta is an eye drop solution. It does not contain preservatives.
Box containing 20 single-dose containers of 0.5 ml each.
Marketing Authorization Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD), Italy
Manufacturer
Pharma Stulln GmbH - Werksstraße 3, 92551 Stulln, Germany