Doclevo

Package leaflet: Information for the user

DOCLEVO 5 mg/ml eye drops, solution

Levofloxacin
Equivalent 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What DOCLEVO is and what it is used for

Levofloxacin is an antibiotic belonging to the fluoroquinolone class (also known simply as quinolones).
It 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 front 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
clear membrane covering the front of the eye (conjunctiva).
The use of DOCLEVO is not recommended in children under 1 year of age. Consult your doctor if you
do not feel better or feel worse after 5 days.

2. What you need to know before using DOCLEVO

Do not use DOCLEVO

• 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 before using this medicine.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using DOCLEVO

• if you experience an allergic reaction, even after a single dose, do not use this medicine anymore;
• if during treatment you notice worsening of eye symptoms, 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, the use of any type of contact lenses is not recommended while an eye infection is present;
• swelling and rupture of the tendon have occurred in patients taking oral or intravenous fluoroquinolones, particularly in elderly patients and in those receiving concomitant corticosteroid therapy. Discontinue use of DOCLEVO if you develop pain or swelling in the tendons (tendinitis).

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

Other medicines and DOCLEVO
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
In particular, inform your doctor or pharmacist if you are using any other type of eye drops or ophthalmic ointment before starting to use DOCLEVO.
If you use other eye drops, wait at least 15 minutes between the application of DOCLEVO and any other type of eye drops.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
DOCLEVO 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 application of the eye drops, it is very unlikely that the eye drops could cause harm to the infant.
Your doctor is aware of the potential risks and will advise you whether you can use DOCLEVO eye drops.
Your fertility (the ability to conceive or father a child) is not affected when applying DOCLEVO as directed.

Driving and using machines
DOCLEVO may slightly affect the ability to drive or use machines.
If use of the eye drops causes blurred vision, wait until this effect has passed before driving or using machines.

3. How to use DOCLEVO

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

• Instill one or two drops into the affected eye(s) every two hours.
• Apply a maximum of 8 times per day. DAYS 3 – 5
• Instill one or two drops into the affected eye(s).
• Apply a maximum of 4 times per day. In elderly patients, no dose adjustment is required.

The total duration of treatment is usually five days. Your doctor will advise you on how long
you should use the eye drops.
If you are using any other eye medication, wait at least 15 minutes between applications
of different eye drops.
Use in children and adolescents
No dosage adjustments are necessary in children aged ≥ 1 year and adolescents.
The use of DOCLEVO is not recommended in children under 1 year of age.
Before applying the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the tamper-evident seal on the neck of the bottle is broken before first use.
• When using it for the first time, practice using the dropper bottle by gently squeezing it to release a drop away from the eye.
• Once you feel confident in releasing one drop at a time, choose the position you find most comfortable for instilling the drops (you may sit, lie on your back, or stand in front of a mirror).

Instillation

1. Hold the bottle directly under the cap and twist the cap to open the bottle. To avoid contaminating the solution, take particular care that the tip of the bottle does not touch anything (e.g. the skin around your eyes or your fingers).

2. Tilt your head backward and hold the bottle above your eye.
3. Pull down the lower eyelid and look upward. Gently squeeze the middle of the bottle and let one drop fall into the eye. Note that there may be a delay of a few seconds between squeezing and the drop coming out. Do not squeeze too hard. Ask your doctor, pharmacist, or nurse for help if you are unsure how to use these eye drops.

4. Blink several times so that the drop spreads across the eye.

Press with your finger at the corner of the eye near the nose for a few minutes. This helps prevent the eye drops from entering the rest of your body.

Repeat steps 2 – 5 to instill a drop into the other eye, if your doctor has instructed you to do so. Your doctor will tell you whether only one eye needs to be treated and, if so, which eye is affected.
After each use and before replacing the cap, shake the bottle while holding it upside down, without touching the dropper tip, to remove any residual liquid from the tip. This is necessary to ensure proper drop delivery for subsequent use.

8. After completing the treatment as directed by your doctor, there may still be some DOCLEVO left in the bottle. Do not attempt to use any excess medicine remaining in the bottle after treatment is completed. Do not use the eye drops more than 28 days after first opening the bottle.

If you use more DOCLEVO than you should
If you use more DOCLEVO than prescribed, rinse the eye(s) with water and consult your doctor or pharmacist.
If you forget to use DOCLEVO
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 DOCLEVO
The amount of levofloxacin contained in the provided 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 using DOCLEVO before the recommended time, it may delay the healing process.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
An adverse reaction occurs in about 1 in 10 people using DOCLEVO.
Most side effects affect only the eye and are not long-lasting. If you experience any severe or persistent side effect, stop using the eye drops and consult your doctor urgently.
It is possible, although rare, to develop an allergic reaction to DOCLEVO even after a single dose.
You may notice this because your eyes may become red or itchy, or your eyelids may swell.
If this happens, stop using DOCLEVO immediately and contact your doctor without delay.

Common side effects (may affect up to 1 in 10 users):

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

Uncommon side effects (may affect up to 1 in 100 users):

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

Rare side effects (may affect up to 1 in 1,000 users):

• allergic reactions, e.g. skin rash

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

• swelling and tightness sensation 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 in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
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 DOCLEVO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and on the carton after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store the DOCLEVO bottle inside the carton to protect the medicine from light.
After first opening: you may use DOCLEVO within 28 days of first opening the bottle. Discard any unused liquid after this period.
Do not use this medicine if you notice any insoluble particles in the solution.
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 DOCLEVO contains
The active substance is levofloxacin. 1 ml contains 5.12 mg of levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin.
The other components are: sodium chloride, sodium hydroxide (E524), hydrochloric acid (E507), water for injections.

Description of the appearance of DOCLEVO and contents of the pack
DOCLEVO is a clear, pale yellow solution free from visible particles.
It is supplied in one white vial (LDPE), equipped with a Novelia® nozzle (HDPE and silicone), and sealed with a white cap (HDPE).
Pack: 1 vial of 5 ml.

Marketing Authorization Holder:
DOC Generici S.r.l.
Via Turati, 40
20121 Milan, Italy

Manufacturer:
RAFARM S.A.
Thesi Pousi – Xatzi
Agiou Louka
19002, Paiania Attiki
Greece