DUNAFLOT 3 mg /Ml Krople Do Oczu, Roztwór

Treść ulotki

1. DUNAFLOT 3 mg/ml eye drops, solution
   1. What is DUNAFLOT and what is it 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

DUNAFLOT 3 mg/ml eye drops, solution

Ofloxacin

Read this leaflet carefully before you start using this medicine as 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 they have the same symptoms as you, as it may 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 DUNAFLOT is and what it is used for
• 2. What you need to know before you use 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 is DUNAFLOT and what is it used for

DUNAFLOT contains the active ingredient: ofloxacin.
Ofloxacin is an antibiotic that belongs to the “quinolone” family.
Consult your doctor if you do not feel better or if you feel worse after 10 days.
DUNAFLOT 3 mg/ml eye drops are used for the treatment of external eye infections caused by germs
sensitive to ofloxacin, which lead to inflammation of the anterior lining of the eye (conjunctivitis),
or inflammation of the eyelid (blepharitis), simultaneous inflammation of the anterior lining
of the eye and the eyelid (blepharoconjunctivitis), simultaneous inflammation of the cornea and the
anterior lining of the eye (keratoconjunctivitis), inflammation of the tear sac
(dacryocystitis), inflammation of the group of sebaceous glands present in the eyelid (meibomianitis) and
inflammation of the cornea (keratitis). DUNAFLOT is also indicated for the treatment of ulcers on the
surface of the eye caused by infections and to prevent infections following surgical procedures.

2. What you need to know before using DUNAFLOT

Do not use DUNAFLOT

• if you are allergic to the active ingredient (or to other antibacterial quinolone agents) or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk 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 of the tissue covering the cornea (corneal epithelial defect) or have corneal lesions (corneal ulcer), or if you notice any imperfections 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 can cause abnormal changes in the ECG (see section “Other medicines and DUNAFLOT”);
• if you have had a lesion/wound or an ulcer on the surface of the eye in the past.

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

• were born with or have a family history of heart rhythm disturbance (prolonged QT interval), shown on the 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 the use of DUNAFLOT avoid exposure to the sun or UV rays as you may develop sensitivity to
light (photosensitivity).
DUNAFLOT is for ophthalmic use only, do not use this medicine for injections inside the eye.
Avoid the use of contact lenses during therapy with DUNAFLOT.
Swelling and rupture of the tendon have occurred in people who take fluoroquinolones orally or
intravenously, particularly in elderly patients and those treated concurrently with corticosteroids.
Stop taking Dunaflot if you develop pain or swelling of the tendons (tendinitis).
Patients who have taken quinolones, including ofloxacin, systemically (in the body) or orally have experienced severe (anaphylactic/anaphylactoid) and occasionally life-threatening allergic reactions,
even after the first dose. Some reactions were accompanied by severe
decrease in blood pressure with a 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, closure of the airways, difficulty
breathing (dyspnea), hives and itching.
Therefore, if you experience an allergic reaction during therapy with the medicine, stop the
treatment and consult your doctor immediately.
Prolonged use of ofloxacin can cause a new bacterial infection that cannot be
sufficiently treated with DUNAFLOT.
With the use of DUNAFLOT eye drops there is a risk that the medicine passes into the nose and the back
of the throat, favoring the emergence and spread of bacterial resistance to antibiotics (bacterial resistance). As with any other antibiotic, prolonged use can cause excessive development of
bacteria resistant to antibiotics, so if you do not notice an improvement after 10 days, stop the
treatment and consult your eye doctor.
Corneal precipitates (inflammatory deposits on the surface of the eye) have been reported in patients who
have received ofloxacin eye drops, but it is not clear whether the eye drops were the cause.
Damage to the front of the eye has been reported in patients with pre-existing lesions/wounds or ulcers on the surface of the eye when treated with fluoroquinolone antibiotic eye drops.
However, significant elements of confusion have been found in many of these reports, such as advanced age, presence of extensive ulcers, concomitant eye 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. However, caution is needed regarding the risk of
corneal perforation when using DUNAFLOT for the treatment of patients with pre-existing lesions/wounds or ulcers
on the surface of the eye.

Children
The safety and efficacy of ofloxacin use in children under one year of age have not been
established, therefore use in the product is not recommended.

Newborns (Children up to 28 days of age)
Information on the use of ofloxacin in newborns in the treatment of conjunctivitis is very limited.
The use of ofloxacin in newborns with ophthalmia neonatorum caused by Neisseria

gonorrhoeaeor Chlamydia trachomatisis not recommended as the use of the product in these patients has not been evaluated.
Your doctor will decide the best treatment for the newborn.

Other medicines and DUNAFLOT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interaction studies with other medicines have been conducted.
Tell your doctor if you are taking medicines that can alter the heart rate such as:

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

Cases of
alteration of the metabolism of caffeine and theophylline (used to treat asthma) have been reported with the administration of some quinolones in the body (systemically). However, it has been
shown that ofloxacin systemically (in the body) does not significantly influence its metabolism. In addition, an increase in toxicity at the level of the central nervous system has been reported with the concomitant administration of quinolones and non-steroidal anti-inflammatory drugs (NSAIDs).
However, this toxicity has not occurred with the concomitant systemic use of ofloxacin and non-steroidal anti-inflammatory drugs (NSAIDs).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of DUNAFLOT during pregnancy is not recommended.
Breastfeeding
As quinolone antibiotics administered in the body (systemically) pass into breast
milk, there may be a risk to the infant.
Consult your doctor to assess whether to discontinue breastfeeding or therapy, taking into account the importance
of the drug for the mother.

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

DUNAFLOT “multidose” contains benzalkonium chloride
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in
their color. Remove contact lenses before using this medicine and wait 15 minutes before
reapplying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in your eye,
burning or pain after using this medicine, talk to 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 following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:

• 1-2 drops 4-6 times a day, or as prescribed by your doctor.

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 the day. For the next 7 days, 1-2 drops every hour initially, then gradually decrease the dose (1-2 drops 4 times a day) until the treatment is completed. Treatment with DUNAFLOT should be limited to the period necessary to achieve clinical healing. DUNAFLOT can only be used as an ophthalmic eye drop: do not use for injections or intraocular use. Instructions for use10 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 bring the dropper into contact with any surface, or into direct contact with the eye. 0.5 ml single-dose container
• 1. Open the container by detaching the cap.
• 2. Apply gentle pressure to the body of the container to apply one drop of solution to the affected ocular surface. If you use more DUNAFLOT than you shouldIf you have used an excessive dose of DUNAFLOT, rinse your eye with water. In case of accidental ingestion of an excessive dose of DUNAFLOT, immediately inform your doctor or go to the nearest hospital. If you forget to use DUNAFLOTDo not use a double dose to make up for a missed dose. If you stop treatment with DUNAFLOT

Continue treatment with the medicine as indicated by your doctor in order to achieve
complete healing.
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 everybody gets them.
manifest.

Serious side effects:
If you experience one or more of the following side effects, you may have had a serious allergic
reaction. Stop using DUNAFLOT immediately and contact your doctor.
Allergic reactions:
Frequency not known (cannot be estimated from available data):

• allergic reactions in the eye (including itchy eyes and/or eyelids)
• skin inflammation due to allergy (including: rash, itching or hives)
• sudden, severe allergic reaction (anaphylactic) that is life-threatening, which presents with swelling under the skin that can occur 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, which can cause wheezing, difficulty swallowing, breathing or shortness of breath
• life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of DUNAFLOT, which initially appear as reddish spots resembling a target or circular patches often with central blisters on the trunk.

The following side effects may also occur:
You should contact your doctor if any of these side effects cause you problems or if they persist.

Common side effects(may affect up to 1 in 10 people)
Side effects affecting the eye:

• eye irritation
• eye discomfort.

Side effects with frequency not known(cannot be estimated from available data)
Side effects affecting the eye:

• 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
• swelling of the eyes
• feeling that something is in the eye
• increased tearing
• swelling around the eyes (including eyelid swelling)
• dry eye
• eye pain
• eye redness.

Side effects affecting the body:

• dizziness
• nausea.

Side effects affecting the heart:

• abnormally fast heart rate
• life-threatening irregular heart rhythm
• alteration of the heart rhythm (called ‘prolongation of the QT interval’, seen on ECG, heart electrical activity).

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

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-avvers e.
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 which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Keep the product in its original packaging.

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

DUNAFLOT single-dose:
after opening the single-dose container, use the medicine immediately, if partially used, discard the
remaining medicine as it does not contain preservatives.
After the first opening of the aluminum sachet, use the medicine within 3 months.
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 protect the environment.

6. Contents of the pack and other information

What DUNAFLOT contains

Multidose bottle of 10 ml
The active ingredient is: ofloxacin. 1 ml of eye drops contains 3.00 mg of ofloxacin.
The other ingredients are: benzalkonium chloride, sodium chloride, hydrochloric acid, water for injections.

Single-dose containers of 0.5 ml
The active ingredient is: ofloxacin. 1 ml of eye drops contains 3.00 mg of ofloxacin.
The other ingredients are: sodium chloride, hydrochloric acid, water for injections.

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

Marketing authorisation holder and manufacturer

Marketing authorisation 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)