Visufl ox

Package Leaflet: Information for the User

Visuflox 5 mg/ml eye drops, solution

Levofloxacin (as hemihydrate)
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 Visuflox eye drops, solution is and what it is used for

A bottle of Visuflox 5 mg/ml eye drops solution contains 5 ml of solution with the active substance
levofloxacin.
Based on a theoretical drop volume of 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 belonging to a class known as fluoroquinolones (sometimes called quinolones). It works
by killing certain types of bacteria that can cause infections.
When administered as eye drops, levofloxacin 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 in this area is called bacterial conjunctivitis, which is an infection of the tissue covering the front of the eye (conjunctiva).
Visuflox eye drops are not indicated for the treatment of eye infections that have spread into deeper layers of the eye tissue or into the fluid surrounding the eyeball. Antibiotics in tablet form or by injection are required to treat these deeper and more serious infections.
Visuflox eye drops are not recommended for use in children below 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 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, consult your doctor or pharmacist first.

Warnings and precautions
Talk to your doctor or pharmacist before using Visuflox eye drops

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

As with all products containing benzalkonium chloride as a preservative, you must not wear soft contact lenses while using this medicine, as it may cause irritation of the area covering the eye.

Children and adolescents
The precautions and warnings for the use of this medicine in adolescents and children aged ≥ 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 not requiring a prescription.

In particular, inform your doctor or pharmacist if you are applying any other type of eye drops or 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 drops.

Fertility, pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or 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 baby.

Although a very small amount of ofloxacin may reach the bloodstream and breast milk, respectively, after instillation of the eye drops, it is very unlikely that this could harm the baby.

Your doctor will be aware of the potential risk and will advise you whether or not to use Visuflox eye drops in this case.

Your fertility (ability to become pregnant or conceive a child) will not be affected by using Visuflox as directed.

Driving and using machines
Levofloxacin may slightly affect the ability to drive or use 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 eye drops, solution

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

• 1 or 2 drops in the affected eye(s) every 2 hours
• Use up to a maximum of 8 times per day
  Days 3 - 5
• 1 or 2 drops in the affected eye(s)
• 1 or 2 drops in the affected eye(s)
• Use up to a maximum of 4 times per day

No dose adjustment is required in elderly patients.
The usual treatment duration is five days. Your doctor will tell you how long to use the eye drops.
If you are using any other eye medication, wait 15 minutes between applications of different types of eye drops.

Use in children and adolescents
No dosage adjustment is required in children aged ≥ 1 year and adolescents. Levofloxacin is not recommended in children under 1 year of age.

Before applying the eye drops:
If possible, ask someone else to apply the eye drops for you. Ask someone to read the instructions with you before applying the drops.

1. Wash your hands
2. Open the bottle. Be careful not to let the tip of the dispenser touch the eye, the skin around the eye, or your fingers. If this happens accidentally, inform your doctor or pharmacist so you can obtain a clean bottle. Tilt your head backwards while sitting or lying on your back.

3. Position the tip of the bottle over the eye.

4. Pull down the lower eyelid and look upwards.

5. Gently press the bottle and release one drop 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 one minute. This helps prevent the drop from draining into the tear duct.

7. Remove any excess solution from the skin around the eye.
   If another application is needed or when both eyes are being treated, repeat steps 3 to 6.
   Close the container tightly after use.
   Visuflox eye drops must not be injected into the inside of the eyeball.

If you use more Visuflox eye drops, solution than you should
If you use more Visuflox eye drops solution than prescribed, rinse your eyes with water and contact your doctor or pharmacist.

If you forget to use Visuflox eye drops, 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 ingest Visuflox eye drops, 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 steps to take.

If you stop treatment with Visuflox eye drops before the recommended time, it may delay the healing process.
If you have any doubts about using this medicine or if you wish to discontinue 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.
About 1 in 10 people experiences a side effect when using levofloxacine eye drops. Most of these effects affect only the eye and do not last long. If you experience any severe or persistent side effect, you must stop using levofloxacine eye drops and contact your doctor immediately.
The frequency of possible side effects is defined as follows:

Very rarely, this medicine may cause serious allergic reactions.
The following symptoms may occur even after a single dose of levofloxacin eye drops:

• Swelling and tightness in the throat
• Difficulty breathing. In rare cases, other allergic reactions may develop. Symptoms of such reactions include:
• Worsening of eye redness and itching
• Increased swelling or immediate puffiness of the eyelids

If you experience any of these symptoms, stop using Visuflox immediately and contact your doctor without delay.

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

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

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

• Burning or irritation in the eyes
• Eye pain
• Dry and painful eyes
• Swelling and redness (bloodshot eyes) of the conjunctiva (the front covering of the eye) or eyelid
• Unusual sensitivity to light
• Itching of the eyes
• Sticky eyelids
• Headache
• Skin rash around the eye
• Stuffy or runny nose

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

• Allergic reactions such as skin rash

Very rare side effects (may affect fewer than 1 user in 10,000):

• Swelling and narrowing of 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.
If you experience any side effect, contact your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 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.
Visuflox eye drops must be used within 28 days of first opening the bottle. Any remaining solution should be
returned to the pharmacist for safe disposal.
To prevent infections, you must discard the bottle 28 days after first opening and use a new one.
Do not dispose of medicines 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 Visuflox eye drops, solution contains

• The active substance 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 pH), water for injections.

Description of the appearance of Visuflox eye drops, solution and package contents
Yellowish-green clear aqueous solution.
5 ml of solution are contained in a low-density polypropylene (LDPE) bottle with a low-density polypropylene (LDPE) dropper and a high-density polypropylene cap (HDPE or HDPE/LDPE).
Marketing Authorization 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.Box 37, Greece
Tel + 30 210 6643835
This medicinal product is authorized in the Member States of the European Community under the following names:
PL: Levofloxacin Adamed
PT: Levofloxacina Velka Hellas
UK: Levofloxacin 5mg/ml Eye Drops, Solution
This Patient Information Leaflet was last approved on (MM/YYYY).