Dunafolt

Package leaflet: Information for the user

DUNAFLOT 3 mg/ml eye drops, solution

Ofloxacin
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DUNAFLOT is and what it is used for

DUNAFLOT contains the active substance: ofloxacin.
Ofloxacin is an antibiotic belonging to the "quinolone" family.
Contact your doctor if you do not feel better or if you feel worse after 10 days.
DUNAFLOT 3 mg/ml eye drops is used to treat external ocular infections caused by microorganisms sensitive to ofloxacin, leading to inflammation of the front covering of the eye (conjunctivitis), inflammation of the eyelid (blepharitis), simultaneous inflammation of the front covering of the eye and the eyelid (blepharoconjunctivitis), simultaneous inflammation of the cornea and the front covering of the eye (keratoconjunctivitis), inflammation of the tear sac (dacryocystitis), inflammation of the group of sebaceous glands located in the eyelid (meibomitis), or inflammation of the cornea (keratitis). DUNAFLOT is also indicated for the treatment of corneal ulcers caused by infections and for the prevention of infections following surgical procedures.

2. What you need to know before using DUNAFLOT

Do not use DUNAFLOT

• if you are allergic to the active substance (or to other quinolone antibacterial agents) 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 DUNAFLOT:
  • if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
  • if you wear contact lenses;
  • if you are a woman or an elderly patient;
  • if you are allergic to other antibiotics belonging to the "quinolone" family;
  • if the medicine is for a child under one year of age;
• if you have a defect in the tissue covering the cornea (corneal epithelial defect) or corneal lesions (corneal ulcer), or if you notice any irregularities on the surface of the eye, as use of the medicine may increase the risk of corneal perforation;
• if you are taking other medicines that may cause abnormal changes in the ECG (see section "Other medicines and DUNAFLOT");
• if you have previously had an injury/wound or an ulcer on the surface of the eye.

If you have heart problems (cardiac), before using this medicine, inform your doctor, who will pay particular attention if you:

• were born with or have a family history of heart rhythm disorders (prolonged QT interval), as seen on ECG (an electrical recording of the heart);
• have an imbalance of certain salts in the blood (especially low levels of potassium or magnesium);
• have a very slow heart rate (bradycardia);
• have a weak heart (heart failure);
• have a history of heart attack (myocardial infarction);
• are taking other medicines for the heart (see "Other medicines and DUNAFLOT").

During treatment with DUNAFLOT, avoid exposure to sunlight or UV rays, as you may develop light sensitivity (photosensitivity).
DUNAFLOT is for ophthalmic use only; do not use this medicine for intraocular injections.
Avoid wearing contact lenses during treatment with DUNAFLOT.
Swelling and rupture of tendons have occurred in people taking fluorquinolones orally or intravenously, particularly in elderly patients and those receiving concomitant corticosteroid therapy.
Discontinue use of DUNAFLOT if you develop tendon pain or swelling (tendinitis).
Patients who have taken quinolones, including ofloxacin, systemically (in the body) or orally have experienced severe allergic reactions (anaphylactic/anaphylactoid), occasionally fatal, even after the first dose. Some reactions were accompanied by severe drop in blood pressure with weak and rapid heartbeat (cardiovascular collapse), loss of consciousness, swelling of the legs, arms, face, mucous membranes or tongue (angioedema), including swelling of the larynx and pharynx, airway obstruction, difficulty breathing (dyspnea), hives and itching.
Therefore, if an allergic reaction occurs during treatment with this medicine, stop treatment immediately and contact your doctor.
Prolonged use of ofloxacin may lead to a new bacterial infection that cannot be adequately treated with DUNAFLOT.
When using DUNAFLOT eye drops, there is a risk that the medicine may drain into the nose and back of the throat, promoting the emergence and spread of antibiotic resistance in bacteria (bacterial resistance). As with any other antibiotic, prolonged use may lead to overgrowth of antibiotic-resistant bacteria; therefore, if you do not notice improvement after 10 days, stop treatment and consult your ophthalmologist.
Corneal precipitates (inflammatory deposits on the eye surface) have been reported in patients receiving ofloxacin eye drops, but it is unclear whether the eye drops were the cause.
Anterior segment eye damage has been reported in patients with pre-existing corneal injuries/wounds or ulcers when treated with fluorquinolone antibiotic eye drops.
However, significant confounding factors have been observed in many of these reports, such as advanced age, presence of large ulcers, concomitant ocular conditions (e.g. severe dry eye), systemic inflammatory diseases (e.g. rheumatoid arthritis), and concomitant use of ocular steroids or non-steroidal anti-inflammatory drugs (NSAIDs). Nevertheless, caution is required regarding the risk of corneal perforation when using DUNAFLOT to treat patients with pre-existing corneal injuries/wounds or ulcers.

Children
The safety and efficacy of ofloxacin use in children under one year of age have not been established; therefore, use is not recommended.
Neonates (children up to 28 days of age)
Information on the use of ofloxacin in neonates for the treatment of conjunctivitis is very limited.
Use of ofloxacin is not recommended in neonates with neonatal ophthalmia caused by Neisseria gonorrhoeae or Chlamydia trachomatis, as the product has not been evaluated in such patients.
Your doctor will decide the best treatment for the neonate.

Other medicines and DUNAFLOT
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
No interaction studies with other medicines have been conducted.
Inform your doctor if you are taking medicines that may alter heart rhythm such as:

• antiarrhythmic medicines used to regulate heart rhythm (quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• tricyclic antidepressants used for depression;
• certain antimicrobial medicines (belonging to the macrolide class) used to treat bacterial infections;
• certain antipsychotic medicines used to treat mental and behavioral disorders.

With systemic administration (in the body) of some quinolones, cases of altered metabolism of caffeine and theophylline (used to treat asthma) have been reported. However, it has been demonstrated that systemic ofloxacin does not significantly affect their metabolism. Additionally, when quinolones are administered concomitantly with non-steroidal anti-inflammatory drugs (NSAIDs), increased toxicity in the central nervous system has been reported. However, this toxicity has not occurred with concomitant systemic use of ofloxacin and non-steroidal anti-inflammatory drugs (NSAIDs).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Use of DUNAFLOT during pregnancy is not recommended.
Breastfeeding
Since quinolone antibiotics administered systemically (in the body) pass into breast milk, there may be a risk to the nursing infant.
Consult your doctor to evaluate whether to discontinue breastfeeding or the treatment, taking into account the importance of the medicine for the mother.

Driving and using machines
No studies have been conducted on the ability to drive vehicles or use machinery.
Immediately after using the medicine, you may experience temporary blurred vision; if this occurs, do not drive or operate machinery until your vision clears.

DUNAFLOT "multi-dose" contains benzalkonium chloride
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

DUNAFLOT contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use DUNAFLOT

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:

• 1-2 drops 4-6 times daily, or as prescribed by the physician.

For the treatment of corneal inflammations (keratitis) due to infections and corneal lesions caused by bacteria (infectious corneal ulcers), the recommended dose is:

• for the first two days, 1-2 drops every 30 minutes during daytime. For the following 7 days, 1-2 drops every hour initially, then gradually reduce the dose (1-2 drops 4 times daily) until completion of treatment. Treatment with DUNAFLOT should be limited to the period necessary to achieve clinical healing. DUNAFLOT may only be used as an ophthalmic solution for topical ocular use: do not use for injections or intraocular use. Instructions for use 10 ml bottle
  1. Unscrew the cap, and the bottle is ready for use.
  2. Close the bottle immediately after use. To avoid any contamination, do not let the dropper tip touch any surface, nor make direct contact with the eye. Single-dose container 0.5 ml
  3. Open the container by removing the cap.
  4. Gently squeeze the body of the container to apply one drop of solution onto the affected ocular surface. If you use more DUNAFLOT than you should If you have used an excessive dose of DUNAFLOT, rinse the eye with water. In case of accidental ingestion of an excessive dose of DUNAFLOT, contact your doctor immediately or go to the nearest hospital. If you forget to use DUNAFLOT Do not use a double dose to make up for the missed dose. If you stop using DUNAFLOT

Continue treatment with the medicine as directed by your doctor in order to achieve
complete healing.
If you have any doubts 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 everyone gets them.

Serious side effects:

If you experience one or more of the following side effects, you may be having a severe allergic reaction. Stop using DUNAFLOT immediately and contact your doctor.

Allergic reactions:

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

• allergic reactions in the eye (including eye and/or eyelid itching)
• skin inflammation due to allergy (including rash, itching or hives)
• sudden severe allergic reaction (anaphylactic) that may be life-threatening, presenting as swelling under the skin which may occur in areas such as the face, lips or other body parts; swelling of the mouth, tongue or throat that may block the airways, causing wheezing, difficulty swallowing, breathing difficulties or shortness of breath
• potentially life-threatening skin rashes have been reported with the use of DUNAFLOT (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.

The following side effects may also occur:
You should contact your doctor if any of the following side effects bother you or persist.

Common side effects (may affect up to 1 in 10 people)
Eye-related side effects:

• eye irritation
• eye discomfort.

Side effects with frequency not known (cannot be estimated from the available data)
Eye-related side effects:

• inflammation of the clear front part of the eye
• redness and inflammation of the thin layer covering the white part of the eye
• blurred vision
• sensitivity to light
• eye swelling
• sensation of a foreign body in the eye
• increased tearing
• swelling around the eyes (including eyelid swelling)
• dry eyes
• eye pain
• eye redness.

Body-related side effects:

• dizziness
• nausea.

Heart-related side effects:

• abnormally fast heart rate
• life-threatening irregular heart rhythm
• changes in heart rhythm (called 'QT interval prolongation', seen on ECG, the heart's electrical activity).

To reduce the risk of side effects, use DUNAFLOT exactly as prescribed by your doctor.

Reporting of side effects
If you experience any side effect, 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 DUNAFLOT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store the product in its original packaging.

DUNAFLOT 10 ml vial:
After first opening of the vial, use the medicine within 28 days; after this period, discard any remaining medicine.

DUNAFLOT single-dose container:
After opening the single-dose container, use the medicine immediately. If only partially used, discard any remaining medicine, as it does not contain preservatives.
After first opening the aluminium pouch, use the medicine within 3 months.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DUNAFLOT contains
Multidose vial of 10 ml
The active substance is: ofloxacin. Each 1 ml of eye drops contains 3.00 mg of ofloxacin.
The other components are: benzalkonium chloride, sodium chloride, hydrochloric acid, water for injections.
Single-dose containers of 0.5 ml
The active substance is: ofloxacin. Each 1 ml of eye drops contains 3.00 mg of ofloxacin.
The other components are: sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of DUNAFLOT and package contents
Eye drops, solution.
Carton pack containing one 10 ml dropper bottle.
Carton pack containing 20 single-dose containers of 0.5 ml each, divided into strips enclosed in an aluminum pouch.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bionativa S.p.A.
Via Raffaello 15
Loc. Sambuca V.P. - 50028 Florence
Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora – 84084 Fisciano (SA)