OFTAQUIX 0.5% Eye drops, solution

Зміст інструкції

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

Oftaquix 5 mg/ml eye drops, solution

Levofloxacin

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 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Oftaquix and what is it used for

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 that
affect the anterior surface of the eye in children aged one 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 Oftaquix is not recommended in children under 1 year of age.
Contact your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using Oftaquix

Do not use Oftaquix

• 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 Oftaquix

• if you experience an allergic reaction even after a single dose, do not use this medicine anymore
• if you experience a worsening of eye symptoms during treatment, contact your doctor as soon as possible
• if you do not experience 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
• Oftaquix contains the preservative benzalkonium chloride, which can cause eye irritation.

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

Other medicines and Oftaquix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are using any other type of eye drops or eye ointment before starting to use Oftaquix.
If you are using other eye drops, wait at least 15 minutes between applying Oftaquix and any other type of eye drops.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Oftaquix eye drops should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus.
Although very small amounts of levofloxacin pass into the blood and breast milk, respectively, after application of the eye drops, it is very unlikely that the eye drops can cause harm to the baby.
Your doctor is aware of the potential risks and will tell you if you can take Oftaquix eye drops.
Your fertility (the ability to become pregnant or to have a child) is not impaired if you apply Oftaquix following the instructions for use.

Driving and using machines
Oftaquix slightly alters the ability to drive and use machines.
If the use of the eye drops causes blurred vision, wait for this effect to pass before driving or using machines.

Oftaquix contains benzalkonium chloride
It can cause irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before re-applying them. It is known to cause discoloration of soft contact lenses.

3. How to use Oftaquix

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Oftaquix eye drops are a product 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 a maximum of 8 times a day.

DAYS 3 - 5

• Apply one or two drops to the affected eye(s).
• Apply a maximum of 4 times a day.

No dose adjustment is necessary in elderly patients.
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 your eyes, 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 and adolescents. The use of
Oftaquix is not recommended in children under 1 year of age.

Before applying the eye drops
If possible, ask someone to apply the eye drops to your eyes. 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. Take particular care to avoid touching the tip of the dropper bottleto the eye, the skin around the eyes, or your fingers.

3) Tilt your head back and turn the bottle upside down over your eye.	a d e l
4) Pull down your lower eyelid and look upwards. Gently press on the a bottle and let one drop fall into the space between your lower eyelid and i your eye. l a	n
t 5) Close your eye and press with your finger I on the inner corner of your eye for about one minute. This will prevent the a eye drops from being eliminated into the tear duct. i

• 6) Remove any excess solution from the skin around your eye.
• 7) Reapply the cap and close the bottle tightly.

If you need to apply another drop or if you need to treat both eyes, repeat steps 3 to 7.
Do not inject Oftaquix eye drops inside the eyeball.

If you use more Oftaquix than you should
If you use more Oftaquix than you should, rinse your eye(s) with water and consult your doctor or
pharmacist.

If you forget to use Oftaquix
If you forget to use the eye drops, apply the next dose as soon as you remember. Do not take a
double dose to make up for a forgotten dose.

If you accidentally swallow Oftaquix
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 necessary measures.

If you stop using Oftaquix before completing the course, it may delay the healing process.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Approximately one in ten people who use Oftaquix experiences a side effect. Most side effects only affect the eye and do not last long. If you experience any serious or persistent side effect, stop using the eye drops and consult your doctor urgently.
Very rarely, this medicine can cause serious allergic reactions.
The following symptoms may appear even after application of a single dose of Oftaquix:

• 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 Oftaquix and consult a doctor immediately.

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 irritation of the eye
• painful eyes
• dry or inflamed eyes
• swelling or redness (bloodshot eyes) of the conjunctiva (front lining of the eye) or eyelids
• sensitivity to light
• itching of the eyes
• sticky eyelids
• headache
• rash around the eyes
• nasal congestion or runny nose.

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

• allergic reactions, e.g. rash.

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

• 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 are expected to be the same as in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Oftaquix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the
pack after “EXP.”. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the plastic coating around the cap and neck of the
bottle is not present or is damaged before starting a new bottle.
Store the bottle tightly closed.

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 Oftaquix contains

• The active substance is levofloxacin. 1 ml contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin.
• The other ingredients are benzalkonium chloride (0.05 mg in 1 ml of eye drops, solution, preservative), sodium chloride, sodium hydroxide or hydrochloric acid and water for injections.

Description of the appearance of Oftaquix and contents of the pack

• Oftaquix is a transparent solution, with a colour between light yellow and light yellowish-green, free from visible precipitate.
• It is supplied in a pack containing 1 white plastic bottle with 5 ml of solution. The plastic bottle is closed with a screw cap.

Marketing authorisation holder and manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Legal Representative:
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10
20124 Milano
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
This medicinal product is authorised with the trade name Oftaquix in the following Member
States of the European Economic Area:
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy,
Latvia, Lithuania, Luxembourg, Portugal, Romania, Slovakia, Sweden, United Kingdom.

Oftaquix 5 mg/ml eye drops, solution, single-dose container

Levofloxacin

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. 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Oftaquix and what is it used for

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 that
affect the anterior surface of the eye in children aged one 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 Oftaquix is not recommended in children under one year of age.
Contact your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using Oftaquix

Do not use Oftaquix

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

Warnings and precautions
Consult your doctor, pharmacist or nurse before using Oftaquix

• if you experience an allergic reaction even after a single dose, do not use this medicine again.
• if you experience a worsening of eye symptoms during treatment, contact your doctor as soon as possible
• if you do not experience any improvement within a specified 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.

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

Other medicines and Oftaquix
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine.
In particular, tell your doctor or pharmacist if you are using any other type of eye drops or ointment before starting to use Oftaquix.
If you are using other eye drops, wait at least 15 minutes before applying Oftaquix and any other type of eye drops.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Oftaquix 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 application of the eye drops, it is very unlikely that the eye drops can harm the baby.
Your doctor is aware of the potential risks and will tell you if you can take Oftaquix eye drops.
Your fertility (the ability to become pregnant or have a child) is not impaired if you apply Oftaquix following the instructions for use.

Driving and using machines
Oftaquix slightly alters the ability to drive vehicles or use machines.
If the use of the eye drops causes blurred vision, wait for this effect to pass before driving vehicles or using machines.

3. How to use Oftaquix

Use this medicine following the instructions of your doctor or pharmacist exactly as given. If you have
any doubts, consult your doctor or pharmacist.
Oftaquix eye drops are a product 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 most 8 times a day.

DAYS 3 - 5

• Apply one or two drops to the affected eye(s).
• Apply the drops at most 4 times a day. In elderly patients, no dose adjustment is necessary.

Generally, the total duration of treatment is five days. Your doctor will be able to tell you how long
you should apply the eye drops.
If you are using any other medicine for your eyes, wait at least 15 minutes between applications of the various eye drops.

Use in children and adolescents
In children aged ≥ 1 year and adolescents, no dosage adjustment is necessary. The use
of Oftaquix is not recommended in children under 1 year of age.

Before applying the eye drops
If possible, ask someone to apply the eye drops to your eyes. Before applying the eye drops, ask
the person helping you to read these instructions together with you.

• 1) Wash your hands.
• 2) Open the sachet along the dotted line.
• 3) Detach a single-dose container from the strip.
• 4) Replace the strip in the sachet and fold the edge of the sachet to close it.

5) Check that the solution is in the bottom part of the single-dose container. n	a d e l
a 6) To open the container, detach the tab i by rotating it. l a t I
a 7) Sit with your head tilted back, or lie down on your back. i 8) Bring the tip of the container close z to the eye. n e
g 9) Pull down the lower eyelid and look up. A 10) Gently press on the container and let a drop fall into the space between the lower eyelid and the eye.

11) Close your eye for a moment. With your index finger, press on the inner corner of the eye for about one minute. This will prevent the drop from being eliminated into the tear duct.	m a c o

If you need to apply another drop, or if you need to treat both eyes, repeat steps 8 to 11.
Do not inject Oftaquix eye drops inside the eyeball.
For single use only. Use the eye drops immediately after first opening the single-dose container.
A single-dose container contains a sufficient dose for both eyes.
After use, discard the container with any remaining solution.

If you use more Oftaquix than you should
If you use more Oftaquix than you should, rinse the eye(s) with water and consult your doctor or
pharmacist.

If you forget to use Oftaquix
If you forget to use the eye drops, apply the next dose as soon as you remember. Do not take a
double dose to make up for a forgotten dose.

If you accidentally swallow Oftaquix
The amount of levofloxacin contained in the single-dose containers provided is too small to cause
adverse effects. However, if you are concerned, consult your doctor or pharmacist, who will inform
you about any necessary measures.

If you stop using Oftaquix before the indicated time, it may delay the healing process.
If you have any doubts about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Approximately one in ten people who use Oftaquix experiences a side effect. Most side effects only affect the eye and do not last long. If you experience any serious or persistent side effect, stop using the eye drops and consult your doctor urgently.
Rarely, it is possible to develop an allergic reaction to Oftaquix even after applying a single
dose. You may recognise this reaction by redness or itching of the eyes or swelling of the
eyelids. In this case, stop using Oftaquix and consult your doctor immediately.

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 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)
• sensitivity to light
• itchy eyes
• sticky eyelids
• headache
• skin rash around the eyes
• nasal congestion or runny nose Rare side effects (may affect up to 1 in 1,000 users)
• allergic reactions such as, for example, skin rash

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

• swelling and tightness in the throat
• difficulty breathing Additional side effects in children and adolescentsThe 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 get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Oftaquix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the single-dose container, on the
sachet, and on the carton behind ‘Exp’. The expiry date refers to the last day of that month.
The containers of Oftaquix must be stored in the original sachet to protect them from light.
You can use Oftaquix within 3 months after the first opening of the sachet.
After this time, discard any unused single-dose containers.
After first use, immediately discard the opened single-dose container with any
remaining solution.
Do not use this medicine if you notice insoluble particles in the solution.
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 Oftaquix contains

• The active substance is levofloxacin. 1 ml contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin. One single-dose container (0.3 ml) contains 1.5 mg of levofloxacin.
• The excipients are sodium chloride, diluted sodium hydroxide solution or diluted hydrochloric acid and water for injections.

Description of the appearance of Oftaquix and contents of the pack

• Oftaquix is a transparent solution, with a colour ranging from light yellow to light yellowish-green, free from visible precipitate.
• The single-dose containers in strips of ten are packaged in a foil-polyethylene pouch coated with paper.
• One single-dose container contains 0.3 ml of solution.
• Pack sizes: 10 x 0.3 ml, 20 x 0.3 ml, 30 x 0.3 ml and 60 x 0.3 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Legal Representative:
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10
20124 Milano
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Oftaquix: Denmark, Finland, Iceland, Italy and Sweden
Oftaquix sine: Germany
Oftaquix Unit Dose: United Kingdom