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OFTAQUIX UNIT DOSE 5 MG/ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINER

Active substance(s): LEVOFLOXACIN HEMIHYDRATE / LEVOFLOXACIN HEMIHYDRATE

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20193/4

Package leaflet: Information for the user
Oftaquix® Unit Dose 5 mg/ml eye drops in
single dose container
Levofloxacin
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 further questions, ask your doctor, pharmacist
or nurse.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in 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 Oftaquix is and what it is used for
Levofloxacin is an antibiotic of the type called fluoroquinolones
(sometimes shortened to quinolones). It works by killing some
types of bacteria that can cause infections.
When levofloxacin is given in eye drops, it is used in children aged
1 year or over and in adults to treat bacterial infections that affect
the front surfaces of the eye.
One type of infection in this area is called bacterial conjunctivitis,
which is an infection of the covering of the front of the eye
(conjunctiva).
Oftaquix is not recommended to be used in children aged below 1
year.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.

2. What you need to know before you use Oftaquix
Do not use Oftaquix
- if you are allergic to levofloxacin or other quinolones or any of
the other ingredients of this medicine (listed in section 6).
If you are not sure, ask your doctor or pharmacist first.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Oftaquix
- if an allergic reaction occurs even after a single dose stop
using the medicine
- if you observe worsening of your eye symptoms during
treatment, please contact your doctor as soon as possible
- if you do not see any sign of recovery within a certain treatment
period agreed with your doctor, please contact your doctor as
soon as possible
- generally, no types of contact lenses should be worn when the
eye is infected.
Children and adolescents
The special warnings and precautions for using 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 using or have recently
used or might use any other medicines.
In particular, tell your doctor or pharmacist if you are applying any
other type of eye drop or eye ointment before you start to use
Oftaquix.
If you are using other eye drops, you should wait at least 15
minutes between applying Oftaquix and any other type of eye drop.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.

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Oftaquix eye drops should be used during pregnancy only if the
potential benefit justifies the potential risk to the growing baby.
Although very small amounts of levofloxacin reach the blood and
the breast milk, respectively, after instilling eye drops it is very
unlikely that the eye drops would harm the growing baby.
Your doctor is informed about the potential risk and will advice you
whether to take Oftaquix eye drops in this case.
Your fertility (ability to become pregnant or to father a child) is not
impaired when you apply Oftaquix following its instructions for use.
Driving and using machines
Oftaquix has minor influence on the ability to drive and use
machines.
If the eye drops cause blurring of your sight when you use them,
you should wait until this clears before driving or operating
machinery.

3. How to use Oftaquix
Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Oftaquix eye drops are for ocular use and have to be applied to the
outer surface of the eye.
For patients above 1 year of age, the recommended dose is as
follows:
DAYS 1 - 2
- Use one to two drops in the affected eye(s) every two hours.
- Use a maximum of 8 times per day.
DAYS 3 - 5
- Use one to two drops in the affected eye(s).
- Use a maximum of 4 times per day.
In elderly patients no adjustment of the recommended dose is
required.
The usual total treatment course is five days. Your doctor will
advise you how long to apply the drops.
If you are putting any other medicine in your eye, you should wait at
least 15 minutes between applying the different types of drops.
Use in children and adolescents
No dosage modification is required in children ≥1 year old and in
adolescents. Oftaquix is not recommended to be used in children
aged below 1 year.
Before applying the drops:
If possible, ask someone else to apply the drops for you. Ask them
to read these instructions with you before applying the drops.
1) Wash your hands.
2) Open the pouch along the dashed line.
3) Remove one single-dose container from the strip.
4) Put the remaining strip back in the pouch and fold the edge to
close the pouch.
5) Make sure that the solution is in the bottom
part of the single dose-container.

6) To open the container, twist off the tab

7) Tilt your head backwards while seated,
or lie down on your back.
8) Place the tip of the container close to your eye.

9) Pull the lower eyelid downwards and look up.
10) Press the container slightly and let one
drop fall into the space between the lower
eyelid and the eye.
11) Close your eye for a moment. Press the inner
corner of the eye with your index finger for
about one minute. Thus you can prevent the
eye drop from draining down the tear duct.

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If another drop is needed, and when both eyes are to be treated,
repeat steps 8 to 11.
Oftaquix eye drops should not be injected into the interior part of
the eyeball.
For single use only. The eye drops should be used immediately
after first opening the single dose container.
The contents of one single-dose container are sufficient for both
eyes.
Discard container with any remaining solution after single use.
If you use more Oftaquix than you should
If you use more Oftaquix than you should, flush the eye(s) with
water and tell your doctor or pharmacist.
If you forget to use Oftaquix
If you forget to use the eye drops, put in the next dose as soon
as you remember. Do not take a double dose to make up for a
forgotten dose.
If you swallow Oftaquix by accident
The amount of levofloxacin in the provided amount of single-dose
containers is too small to cause side effects. However, if you are
concerned, tell your doctor or pharmacist, who will advise you on
any necessary measures.
If you stop using Oftaquix earlier than instructed, 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.
About one in ten people have a side effect when using Oftaquix.
Most of these affect only the eye and may not last very long. If you
have any severe or persistent side effect you should stop using
these eye drops and seek urgent advice from your doctor.
It is possible, even though rare, to develop an allergic reaction to
Oftaquix even after just one dose. You notice this because your
eyes may become red or itchy, or the lids may be swollen. If
this should happen, stop using Oftaquix and contact your doctor
immediately.
Common side effects (may affect up to 1 in 10 users)
- burning feeling in the eye
- decreased vision or mucus in the eye.
Uncommon side effects (may affect up to 1 in 100 users)
- stinging or irritation of the eyes
- painful eyes
- dry or sore eyes
- swelling or redness (bloodshot eyes) of the conjunctivae (front
covering of the eye)
- sensitivity to light
- itchy eyes
- sticky eyelids
- headache
- rash around the eye
- stuffed or runny nose.
Rare side effects (may affect up to 1 in 1,000 users)
- allergic reactions such as skin rash.
Very rare side effects (may affect less than 1 in
10,000 users)
• swelling and tightness in the throat
• breathing difficulty.

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, pouch and carton after “EXP”. The expiry
date refers to the last day of that month.
Oftaquix containers must be stored in the original pouch in order to
protect from light.
You can use Oftaquix 3 months after first opening the pouch.
Discard any unused single dose container after that time.
Discard the opened single dose container with any remaining
solution after first use immediately.
Do not use this medicine if you notice insoluble parts in the
solution.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures 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 other ingredients are sodium chloride, diluted sodium
hydroxide solution or diluted hydrochloric acid and water for
injections.
What Oftaquix looks like and contents of the pack
- Oftaquix is a clear, light yellow to light greenish-yellow solution,
free of visible particulate matter.
- Single-dose containers of strip of ten are packed in papercoated, aluminium-polyethylene foil pouch.
- 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
For any information about this medicinal product, please contact
the local representative of the Marketing Authorisation Holder:
Kestrel Ophthalmics Ltd
7 Moor Road
Broadstone
Dorset
BH18 8AZ
United Kingdom
This medicinal product is authorised in the Member States
of the EEA under the following names:
Oftaquix: Denmark, Finland, Iceland, Italy and Sweden
Oftaquix sine: Germany
Oftaquix Unit Dose: United Kingdom
This leaflet was last revised in 03/2017

Additional side effects in children and adolescents
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. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of this
medicine.

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4.5.2017 10:27:22

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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