Levodrop

Package leaflet: Information for the user

Levodrop 5 mg/ml eye drops, solution

Levofloxacin (as hemihydrate)
Generic medicine
Please read all of 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, pharmacist, or nurse.
• 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

Contents of this leaflet:

1. What Levodrop eye drops are and what they are used for
2. What you need to know before using Levodrop eye drops
3. How to use Levodrop eye drops
4. Possible side effects
5. How to store Levodrop eye drops
6. Contents of the pack and other information

1. What Levodrop eye drops, solution is and what it is used for

A bottle of Levodrop 5 mg/ml eye drops contains 5 ml of a solution containing the active substance levofloxacin.
For the theoretical volume of one drop, equivalent to 0.05 ml, the amount of active substance is 0.256 mg of
levofloxacin hemihydrate, equivalent to 0.250 mg of levofloxacin.
Levofloxacin is an antibiotic of the fluoroquinolone type (also commonly referred to simply as quinolones).
The antibiotic works by killing certain types of bacteria that can cause infections.
Levofloxacin in the form of eye drops is indicated for the treatment of bacterial infections affecting the
anterior surface of the eye in children aged 1 year and older and in adults. One type of
infection affecting this part of the eye is bacterial conjunctivitis, an infection of the front lining of the eye (conjunctiva).
The use of Levodrop eye drops is not recommended in children under 1 year of age.
Consult your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using Levodrop eye drops, solution

Do not use Levodrop eye drops, solution

• if you are allergic to levofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6). If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Levodrop eye drops

• if you experience an allergic reaction, even after a single dose, stop using this medicine
• if your eye symptoms worsen during treatment, contact your doctor as soon as possible
• if you do not notice any improvement within the treatment period agreed with your doctor, contact your doctor as soon as possible
• in general, wearing any type of contact lenses is not recommended while an eye infection is present
• Levodrop eye drops contain benzalkonium chloride as a preservative, which may cause eye irritation.

As with all products containing the preservative benzalkonium chloride, soft contact lenses
should not be worn during the use of this medicine, as this may cause irritation of the
ocular surface.
Children and adolescents
The special warnings and precautions for use of this medicine are the same for adults, adolescents, and
children aged 1 year and older.
Other medicines and Levodrop eye drops, solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines – including those not requiring a prescription.
In particular, inform your doctor or pharmacist if you are using any other type of eye drops or ophthalmic ointment before starting Levodrop eye drops.
If you use other eye drops, you must wait at least 15 minutes between the application of Levodrop and any other type of eye drops.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Levodrop eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Although very small amounts of levofloxacin may pass into the bloodstream and breast milk, respectively, after instillation of the eye drops, it is very unlikely that this could cause harm to the infant.
Your doctor is aware of the potential risks and will advise you whether you can use Levodrop eye drops.
Fertility (ability to become pregnant or conceive a child) is not impaired when Levodrop is used according to the instructions for use.
Driving and using machines
Levodrop may slightly affect the ability to drive or use machinery.
If the use of the eye drops causes blurred vision, you should wait until this effect has passed before driving or using machinery.

3. How to use Levodrop eye drops, solution

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Levodrop eye drops are for ophthalmic use and must be applied to the external surface of the eye.
For patients over 1 year of age, the recommended dose is as follows:
DAYS 1 - 2

• Apply one or two drops into the affected eye(s) every two hours.
• Apply the drops a maximum of 8 times per day. DAYS 3 - 5
• Apply one or two drops into the affected eye(s).
• Apply the drops a maximum of 4 times per day.

No dosage adjustment is required in elderly patients.
The total duration of treatment is generally five days. Your doctor will advise you on how long you should
continue using the eye drops.
If you are using any other eye medication, you must wait at least 15 minutes between applications of the different eye drops.
Use in children and adolescents
Dosage adjustments are not required in children aged 1 year and older and in adolescents. The use of Levodrop is not recommended in children under 1 year of age.
Before applying the eye drops:
If possible, ask someone to help you apply the eye drops. Before application, ask the person assisting you to read these instructions together with you.

1. Wash your hands
2. Open the bottle. Take particular care to avoid the dropper tip touching the eye, the skin around the eye, or your fingers. If this happens accidentally, you must promptly inform your doctor or pharmacist so that a new, clean bottle can be obtained.
   Tilt your head backwards while sitting or lie down on your back.

3. Position the dropper tip close to the eye.

4. Pull down the lower eyelid and look upwards.

5. Gently squeeze the bottle and allow one drop to fall into the space between the lower eyelid and the eye.

6. Close the eye and press with your finger on the inner corner of the eye for about one minute. This helps prevent the eye drops from draining into the tear duct.

7. Remove any excess solution remaining on the skin around the eye.
   If you need to apply another drop or treat both eyes, repeat steps 3 to 6.
   Replace the cap and close the bottle tightly after use.
   Do not inject Levodrop eye drops into the eyeball.
   If you use more Levodrop eye drops, solution than you should
   If you use more Levodrop eye drops than recommended, you should rinse the eye(s) with water and consult your doctor or pharmacist.
   If you forget to use Levodrop eye drops, solution
   If you forget to use the eye drops, apply the next dose as soon as you remember. Do not use a double dose to make up for the missed dose.
   If you accidentally swallow Levodrop eye drops, solution
   The amount of levofloxacin contained in the supplied bottle is too small to cause adverse effects.
   However, if you are concerned, consult your doctor or pharmacist, who will advise you on any necessary measures.
   If you stop treatment with Levodrop eye drops before the recommended time, it may delay the healing process.
   If you have any doubts about using this medicine or wish to stop treatment, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
An adverse reaction occurs in approximately one in ten people using Levodrop eye drops.
Most of these side effects affect only the eye and are not long-lasting.
If you experience any severe or persistent side effect, you must stop using Levodrop eye drops and consult your doctor urgently.
The frequency of possible side effects is defined as follows:

Very rarely, this medicine may cause severe allergic reactions.
The following symptoms may occur even after the first dose of Levodrop eye drops:

• swelling and sensation of tightness in the throat
• difficulty breathing. In rare cases, other allergic reactions may occur. Symptoms of these reactions include:
• worsening of eye redness and itching
• increase or sudden onset of swelling of the eyelids. If you experience any of these symptoms, stop using Levodrop eye drops and consult a doctor immediately.

Common side effects (may affect from 1 to 10 people in 100):

• burning sensation in the eye
• reduced vision or mucus in the eye

Uncommon side effects (may affect from 1 to 10 people in 1,000):

• stinging or irritation of the eye
• painful eyes
• dry or inflamed eyes
• swelling or redness (bloodshot eyes) of the conjunctiva (the front covering of the eye) or eyelids
• unusual sensitivity to light
• itching of the eyes
• sticky eyelids
• headache
• skin rash around the eyes
• blocked nose or runny nose

Rare side effects (may affect from 1 to 10 people in 10,000):

• allergic reactions, e.g. skin rash

Very rare side effects (may affect less than 1 in 10,000 people):

• swelling and sensation of tightness in the throat
• difficulty breathing

Additional side effects in children and adolescents
The frequency, type, and severity of side effects in children and adolescents are expected to be the same as those observed in adults.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levodrop eye drops, solution

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
Do not use this medicine if, before starting a new bottle, you notice that the plastic seal around the cap and neck is missing or broken.
Levodrop eye drops must be used within 28 days after first opening the bottle. For safe disposal of any remaining solution, please ask your pharmacist.
To prevent infections, discard the bottle 28 days after first opening and use a new one.
Do not dispose of any medicine 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 Levodrop eye drops, solution contains

• The active substance is levofloxacin (as hemihydrate) 5 mg/ml.
• The other components of Levodrop eye drops are: benzalkonium chloride, sodium chloride, sodium hydroxide solution or hydrochloric acid, and water for injections.

Description of the appearance of Levodrop eye drops, solution and package contents
Clear solution, yellowish-green in colour.
5 ml of solution are supplied in a 5 ml LDPE (low-density polyethylene) bottle with a dropper in LDPE and a cap in HDPE (high-density polyethylene) or in HDPE/LDPE.
Marketing Authorization Holder
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera, 26 - 80026 Casoria (NA)
Manufacturer
Rafarm S.A., Thesi Pousi-Xatzi Agiou Louka, 19002 Paiania, Attiki, Greece
This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Levofloxacina Optacare
Italy: Levodrop