LEVODROP 5 mg /Ml Eye Drops, Solution

Зміст інструкції

1. Levodrop 5 mg/ml eye drops, solution
   1. What Levodrop eye drops, solution is and what it is used for
   2. What you need to know before using Levodrop eye drops, solution
   3. How to use Levodrop eye drops, solution
   4. Possible side effects
   5. How to store Levodrop eye drops, solution
   6. Contents of the pack and other information

Levodrop 5 mg/ml eye drops, solution

Levofloxacin (as hemihydrate)
Generic medicine

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 solution based on 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 briefly called 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 or older and in adults. One type of
infection of this part of the eye is bacterial conjunctivitis, an infection of the anterior lining
of the eye (conjunctiva).
The use of Levodrop eye drops is not recommended in children under 1 year of age.
See 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, ask 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, do not use this medicine again
• if, during treatment, you feel a worsening of your eye symptoms, contact your doctor as soon as possible
• if you do not feel any improvement within a specific treatment period agreed with your doctor, contact your doctor as soon as possible
• generally the use of any type of contact lenses is not recommended while an infection is present in the eye
• Levodrop eye drops contains 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 because this may cause irritation to the
ocular surface.

Children and adolescents
The special warnings and precautions for the use of this medicine are the same for adults, adolescents and
children aged 1 year and over.

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 available without a prescription.
In particular, tell your doctor or pharmacist if you are using any other type of eye drops or ophthalmic ointment
before starting to use Levodrop eye drops.
If you are using other eye drops, you should 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 are pregnant or are planning to become pregnant, ask your doctor
or pharmacist for advice before using this medicine.
Levodrop eye drops should only be used during pregnancy if the potential benefit justifies the potential
risk to the fetus.
Although very small amounts of levofloxacin pass into the blood and breast milk, respectively, after
instillation of the eye drops it is very unlikely that this could harm the baby.
Your doctor is aware of the potential risks and will tell you if you can take Levodrop eye drops.
Fertility (ability to become pregnant or conceive a child) is not impaired when you apply
Levodrop following the instructions for use.

Driving and operating machinery
Levodrop slightly alters the ability to drive vehicles or operate machinery.
If the use of the eye drops causes blurred vision, you should wait for this effect to pass before
driving or operating machinery.

3. How to use Levodrop eye drops, solution

Use this medicine following exactly the instructions of 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 to the affected eye(s) every two hours.
• Apply the drops at a maximum of 8 times a day. DAYS 3 - 5
• Apply one or two drops to the affected eye(s).
• Apply the drops at a maximum of 4 times a day.

No dosage adjustment is necessary in elderly patients.
Generally, the total duration of treatment is five days. Your doctor will tell you how long you should
apply the eye drops.
If you are using any other medicine for the eyes, you should wait at least 15 minutes between applications of the various eye drops.

Use in children and adolescents
No dosage adjustments are necessary in children aged 1 year or 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 apply the eye drops for you. Before applying the eye drops, ask the person
helping you to read these instructions together with you.

• 1) Wash your hands
• 2) Open the bottle. Pay particular attention to avoid touching the tip of the dropper bottle to the eye, the skin around the eye or your fingers. If this happens accidentally, you should promptly inform your doctor or pharmacist so that you can purchase a clean bottle. Tilt your head back in a sitting position or lie on your back.

• 3) Position the tip of the bottle near the eye.

• 4) Pull down the lower eyelid and look upwards.

• 5) Gently press the bottle and let one drop fall into the space between the lower eyelid and the eye.

• 6) Close your eye and press with your finger on the inner corner of the eye for about one minute. This will prevent the eye drops from being eliminated into the tear duct.
• 7) Remove any residual solution present on the skin around the eye.

If you need to apply another drop or if you need to treat both eyes, repeat steps 3 to 6.
Reapply the cap and close the bottle tightly after use.
You should not inject Levodrop eye drops inside the eyeball.

If you use more Levodrop eye drops, solution than you should
If you use more Levodrop eye drops than you should, 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 inform you about any measures
that may be necessary.

If you stop the treatment with Levodrop eye drops before than indicated, it may delay the healing process.
If you have any doubts about the use of this medicine or wish to stop the treatment, consult your
doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In about one in ten people who use Levodrop eye drops, a side effect occurs. Most of these side effects only affect the eye and do not last long. If you experience any serious or persistent side effect, do not use Levodrop eye drops anymore and consult your doctor urgently.
The frequency of possible side effects is defined as follows:
Very rarely, this medicine can cause serious allergic reactions.
The following symptoms may appear even after applying a single dose of Levodrop eye drops:

• swelling and a feeling of tightness in the throat
• difficulty breathing. In rare cases, other allergic reactions may develop. The symptoms of these reactions are:
• worsening of redness and itching of the eyes
• sudden increase or appearance of swelling of the eyelids. If any of these symptoms occur, stop using Levodrop eye drops and consult a doctor immediately. Common side effects (affect 1 to 10 people in 100):
• burning sensation in the eye,

• reduced vision or mucus in the eye.

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

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

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

• allergic reactions, e.g. skin rash.

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

• swelling and a feeling 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 should be
the same as those observed in adults.
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is 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 of first opening the bottle. For safe disposal of any remaining solution, ask your pharmacist.

To prevent infections, you must discard the bottle 28 days after first opening and use a new one.
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 Levodrop eye drops, solution contains

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

Description of the appearance of Levodrop eye drops, solution and contents of the pack
Clear solution, with a yellowish-green color.
5 ml of solution is provided 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 Authorisation 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 authorised in the Member States of the European Economic Area with the following
names:
Portugal: Levofloxacina Optacare
Italy: Levodrop