VISUFLOX 5 mg /Ml Eye Drops, Solution

Зміст інструкції

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

Visuflox 5 mg/ml eye drops, solution

Levofloxacin (as hemihydrate)

Read this leaflet carefully before 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.

Contents of this leaflet

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

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

A bottle of Visuflox 5 mg/ml eye drops, solution contains 5 ml of solution with 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 equal to 0.250 mg of levofloxacin.
Levofloxacin is an antibiotic of the type known as fluoroquinolones (sometimes called quinolones). It works
by killing some types of bacteria that can cause infections.
When levofloxacin is administered as eye drops, it is used in children from 1 year of age and in adults
for the treatment of bacterial infections affecting the front surface of the eye. One type of
infection of this area is called bacterial conjunctivitis, which is an infection of the area covering the
front part of the eye (conjunctiva).
Visuflox eye drops are not indicated for the treatment of eye infections that have spread into the deeper
layers of the area covering the eye or into the fluid around the eyeball. Antibiotics in
tablets or by injection are needed to treat these deeper and more serious infections.
Visuflox eye drops are not recommended for use in children under one 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 Visuflox eye drops solution

Do not use Visuflox 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 or pharmacist before using Visuflox eye drops

• If you experience an allergic reaction even after a single dose, stop using the medicine
• If you notice a worsening of your eye symptoms during treatment, contact your doctor as soon as possible
• If you do not notice any improvement within a certain period of treatment agreed with your doctor, contact them as soon as possible
• Generally, no type of contact lens should be worn when the eye is infected
• Visuflox eye drops contains the preservative benzalkonium chloride, which can cause eye irritation.

As with all products containing benzalkonium chloride as a preservative, you should not wear
soft contact lenses while using this medicine as this may cause irritation of the area
covering the eye.
Children and adolescents
The precautions and warnings to be used for the use of this medicine in adolescents and children of
age ≥ 1 year are the same as for adults.

Other medicines and Visuflox eye drops solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those without a prescription.
In particular, tell your doctor or pharmacist if you are applying any other type of eye drops or eye ointment
before starting to use Visuflox eye drops.
If you are using another eye drop, wait 15 minutes before applying Visuflox or any other type of eye drop.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Visuflox eye drops should be used during pregnancy only if the potential benefits outweigh the risks to the
child.
Although a very small amount of ofloxacin reaches the bloodstream and breast milk, respectively, after
instilling the eye drops, it is very unlikely that this could harm the
child.
Your doctor is informed of the potential risk and will advise you whether or not to take Visuflox eye drops in this
case.
Your fertility (ability to become pregnant or to conceive a child) will not be affected
by applying Visuflox following the instructions for use.

Driving and operating machinery
Levofloxacin slightly alters the ability to drive and operate machinery.
If the eye drops cause blurred vision when you use them, wait until your vision clears before
driving or operating machinery.

3. How to use Visuflox collirio, solution

Always use this medicine exactly as your doctor or pharmacist has told you. If you have doubts
consult your doctor or pharmacist.
Visuflox collirio is for ophthalmic use and must be applied to the external surface of the eye.
For patients aged 1 year and over, the recommended dose is as follows:
Days 1 - 2

• 1 or 2 drops in the affected eyes every 2 hours
• Use for a maximum of 8 times a day Days 3 - 5
• 1 or 2 drops in the affected eyes
• 1 or 2 drops in the affected eyes.
• Use for a maximum of 4 times a day

No dose adjustment is required in elderly patients.
The usual duration of treatment is five days. Your doctor will tell you how long to apply the eye drops.
If you are putting any other medicine in your eyes, wait 15 minutes between applications of the various types of
eye drops

Use in children and adolescents
No dosage modification is required in children aged ≥ 1 year and adolescents. Levofloxacin
is not recommended in children under one year of age.
Before applying the eye drops:
If possible, ask someone else to apply the eye drops. Ask someone to read the instructions with you
before applying the eye drops

• 1) Wash your hands
• 2) Open the bottle. Be careful that the applicator tip does not touch the eye, the skin around the eye, or your fingers. If this happens accidentally, inform your doctor or pharmacist so that you have a clean bottle. Recline your head backwards while sitting or lying on your back.

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

• 4) Lower 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 eyes for a moment and press the inner corner of the eye with your finger for about a minute. This will prevent the drop from being eliminated into the tear duct.

• 7) Remove any excess solution from the skin around the eye.

If another application is necessary and when both eyes are being treated, repeat steps
3 to 6.
Close the bottle tightly after use.
Visuflox collirio should not be injected into the inner part of the eyeball.

If you use more Visuflox collirio, solution than you should
If you use more Visuflox collirio solution than you should, wash your eyes with water and contact your doctor or
pharmacist.

If you forget to use Visuflox collirio, solution
If you forget to use the eye drops, take 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 Visuflox collirio, solution
The amount of levofloxacin contained in the bottle is too small to cause adverse effects.
However, if you are concerned, inform your doctor or pharmacist who will advise you on the necessary measures to
take.

If you stop using Visuflox collirio before completing the treatment as indicated,it may delay the healing
process.
If you have any doubts about using this medicine or if you want to stop treatment, consult your
doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Approximately 1 in 10 people experiences a side effect when using levofloxacina collirio. Most of these effects only affect the eye and do not last long. If you experience any serious or persistent side effects, you should stop using levofloxacina collirio and contact your doctor immediately.
The frequency of possible side effects is defined as follows:

Very rarely, this medicine can cause serious allergic reactions.
The following symptoms may occur even after a single administration of levofloxacina collirio:

• Swelling and 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
• Increased swelling or immediate swelling of the eyelids If any of these symptoms occur, stop using Visuflox and contact your doctor immediately.

Common side effects (affect 1 to 10 users in 100):

• Burning sensation in the eyes,
• Decreased vision or mucus in the eyes.

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

• Burning or irritation of the eyes,
• Eye pain,
• Dry and painful eyes,
• Swelling and redness (bloodshot eyes) of the conjunctiva (front covering of the eye) or eyelid,
• Unusual light sensitivity,
• Itchy eyes
• Crusty eyelids
• Headache
• Skin rash around the eye
• Nasal congestion or runny nose

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

• Allergic reactions such as skin rash

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

• Swelling and constriction of the throat
• Difficulty breathing

Further 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.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: http://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 Visuflox collirio soluzione

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 which is stated on the bottle. The expiry date refers to the last day of that month.
Visuflox collirio must be used within 28 days of first opening the bottle. Any remaining solution must be returned to the pharmacist for safe disposal.

To prevent infections, you must dispose of the bottle after 28 days of 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 Visuflox eye drops, solution contains

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

Description of the appearance of Visuflox eye drops, solution and contents of the pack
Clear, greenish-yellow aqueous solution.
5 ml of solution are contained in a low-density polypropylene (LDPE) bottle with a dispenser made of
low-density polypropylene (LDPE) and a cap in high-density polypropylene (HDPE or HDPE/LDPE).

Marketing authorisation holder
Visufarma S.p.A.
Via Canino, 21

• 00191 - Rome Tel.: +39 (06) 3630-6818 Fax: +39 (06) 3630-6842 e-mail: [email protected]

Manufacturer
RAFARM S.A.,
Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki 19002, P.O.Box37, Greece
Tel + 30 210 6643835

This medicinal product is authorised in the Member States of the European Community with the following names:
PL: Levofloxacin Adamed
PT: Levofloxacina Velka Hellas
UK: Levofloxacin 5mg/ml Eye Drops, Solution