Package leaflet: Information for the user

Multifloxofta 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Multifloxofta is and what it is used for
What you need to know before using Multifloxofta
How to use Multifloxofta
Possible side effects
How to store Multifloxofta
Contents of the pack and other information

1. What Multifloxofta is and what it is used for

Multifloxofta eye drops, solution is a medicinal product for ophthalmic use.
The active substance is ofloxacin, a fluoroquinolone antibiotic. Ofloxacin works by killing certain types
of bacteria that can cause infections.
Multifloxofta is indicated in adults and children aged 1 year and older.
Multifloxofta is used to treat external ocular infections caused by microorganisms sensitive to ofloxacin, such as:

Conjunctivitis (inflammation of the conjunctiva);
Blepharitis (inflammation of the eyelids);
Blepharoconjunctivitis (inflammation of the conjunctiva and eyelids);
Dacryocystitis (infection of the tear ducts);
Keratitis (corneal ulcers).

Multifloxofta is also indicated for the prophylaxis of pre- and post-operative infections and for ocular trauma in general.

2. What you need to know before using Multifloxofta

Do not use Multifloxofta

if you are allergic to ofloxacin, to other quinolones (ciprofloxacin, levofloxacin, and norfloxacin), 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 Multifloxofta.

The use of Multifloxofta is not recommended in children under 1 year of age unless the potential benefit outweighs the potential risk. The efficacy and safety of ofloxacin in children under one year of age have not yet been established.
Stop using Multifloxofta and contact your doctor if you develop red spots (rash) or other signs of hypersensitivity, or if you notice the development of corneal deposits (precipitates).
Avoid excessive exposure to sunlight during treatment with Multifloxofta due to the possibility of photosensitization.
The use of ofloxacin may cause false positive results in urine tests for opiates.
If the infection does not improve after one week of treatment, or if ocular symptoms worsen during treatment, consult your doctor for a better assessment of the clinical situation.
If you wear contact lenses – stop wearing them if you experience any sign or symptom of eye infection. Use glasses instead. Do not use contact lenses until signs and symptoms of infection have disappeared or until completion of treatment. You should also be examined by an ophthalmologist before resuming contact lens use.
Although rarely, as with other antibiotics, prolonged use of ofloxacin may promote the development of opportunistic infections, such as fungal infections. In such cases, Multifloxofta should be discontinued and appropriate therapy initiated.
Tendon swelling and rupture have been reported in people taking oral or intravenous fluorquinolones, particularly in elderly patients and in those receiving concomitant corticosteroid therapy. Discontinue use of Multifloxofta if you begin to experience tendon pain or swelling (tendinitis).

Other medicines and Multifloxofta
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Specific interaction studies between ofloxacin ophthalmic solution and other medicines have not been conducted. However, since systemic absorption may occur following topical application of ofloxacin, the possibility of drug interactions should be considered, as reported with systemic administration of certain quinolones (e.g., interactions with theophylline, caffeine, oral anticoagulants, cyclosporine, corticosteroids, etc.).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
The use of this medicine during pregnancy is not recommended. There is insufficient information on the use of Multifloxofta in pregnant women. This medicine should be used during pregnancy only if the therapeutic benefits outweigh the potential risks to the fetus.

Breastfeeding
The use of this medicine during breastfeeding is not recommended. Ofloxacin may be excreted in breast milk and therefore should not be used during breastfeeding. Interruption of breastfeeding should be clinically considered if treatment is necessary.

Driving and using machines
The use of Multifloxofta does not affect the ability to drive or operate machinery. However, if you experience blurred vision for a short time after using Multifloxofta, do not drive or operate machinery until normal vision is restored.

Multifloxofta contains benzalkonium chloride
This medicine contains 0.1 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. 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, burning, or pain in the eye after using this medicine, speak with your doctor.

Multifloxofta contains phosphate buffer
This medicine contains 4.0 mg of phosphate buffer per ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Multifloxofta

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dosage and duration of treatment must be determined by the doctor, according to the individual
needs of the patient.
Recommended dose in adults:

Days 1 and 2	Apply 1-2 drops every 2 hours or every 4 hours
From day 3	4 times a day (every 6 hours)
In more severe cases (e.g. keratitis)	The dosage may be increased to 1-2 drops applied every hour or every two hours.

Use in children
The recommended dose in children aged one year and older is the same as in adults.
Apply the eye drops into the conjunctival sac (between the eye and the eyelid).
Avoid touching the dropper tip to the eye, fingers, or other surfaces to prevent contamination of the solution.
Close the bottle immediately after use.
Treatment should be continued for 48 hours after symptoms have resolved and for a minimum of 5 days.
In elderly patients and in patients with renal or hepatic impairment, dose adjustment is not required.

If you use more Multifloxofta than you should
Cases of overdose with this medicinal product have not been reported.
In case of accidental ingestion of the contents of the bottle, consult your doctor or pharmacist.

If you forget to use Multifloxofta
Apply the next dose as soon as you remember, then continue as before. Do not use a double dose to make up for the missed dose.

If you stop using Multifloxofta
Do not stop treatment with Multifloxofta before the end of the treatment period recommended by your doctor, even if you feel better.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, ofloxacin ophthalmic solution is well tolerated after topical application.
The adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

System Organ Class	Frequency	Adverse Reactions
Eye disorders	Common	Transient ocular irritation Ocular discomfort
	Rare	Hemorrhagic conjunctivitis with eyelid swelling (edema) Corneal deposits (precipitates)
	Very rare	In very rare cases, some patients with severe damage to the outermost transparent layer of the eye (cornea) developed opaque corneal spots due to calcium accumulation during treatment.
	Not known (cannot be estimated from available data)	Increased blood flow in the conjunctiva (conjunctival hyperemia) Superficial inflammation of the cornea (keratitis) Inflammation of the conjunctiva (conjunctivitis) Foreign body sensation in the eye Blurred vision Eye pain Light sensitivity (photophobia) Itching of the eyes Stinging sensation Increased lacrimation Dryness Swelling around the eye (including eyelid swelling) – non-serious adverse reaction
Gastrointestinal disorders	Rare	Nausea
Systemic disorders and administration site conditions	Not known (cannot be estimated from available data)	Facial swelling (facial edema)
Nervous system disorders	Rare	Dizziness
Skin and subcutaneous tissue disorders	Not known (cannot be estimated from available data)	Serious adverse reactions: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Multifloxofta, which initially appear as reddish or circular spots, often with central blisters, on the trunk.

Due to the possibility of systemic absorption of ofloxacin following topical use, the adverse effects are those reported with systemic use, such as irregular heartbeat (cardiac arrhythmia), QT interval prolongation, central nervous system stimulation, tremors, mental confusion, hallucinations, etc.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Multifloxofta

Do not store above 25°C.
Use Multifloxofta within 28 days after first opening the bottle.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month.
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. Package contents and other information

What Multifloxofta contains

The active substance is ofloxacin;
The other components are: monohydrate sodium dihydrogen phosphate, dodecahydrate disodium hydrogen phosphate, sodium chloride, benzalkonium chloride (50% solution), and water for injections. It may contain hydrochloric acid or sodium hydroxide for pH adjustment.

Description of the appearance of Multifloxofta and contents of the pack
Multifloxofta is a clear, colourless or slightly yellow solution.
Multifloxofta is supplied in a white opaque low-density polyethylene bottle with a dropper, containing 3 ml, 5 ml or 10 ml of solution. The bottle is sealed with a white opaque high-density polyethylene screw cap, with a tamper-evident closure (safety closure).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Italy

Manufacturer
Laboratório Edol - Produtos Farmacêuticos, S.A.
Rua Quinta do Salrego 22-22A, Portela de Carnaxide, 2790-144 Carnaxide - Portugal
Rua Casal do Canas 6-6A, 2790-204 Carnaxide - Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy – Multifloxofta 3 mg/ml eye drops, solution
Portugal – Audret 3 mg/ml eye drops, solution