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OFTAQUIX UNIT DOSE 5MG/ML EYE DROPS

Active substance(s): LEVOFLOXACIN HEMIHYDRATE

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20193/3

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. Oftaquix is not recommended to be
used in children below age 1 year. One type of infection in this area
is called conjunctivitis, which is an infection of the covering of the
front of the eye.

2. BEFORE YOU USE OFTAQUIX®
Do not use Oftaquix®
- if you are allergic (hypersensitive) to levofloxacin or other
quinolones or any of the other ingredients of Oftaquix®

For patients above 1 year old, the usual dose is as following:
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 usual 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
No dosage modification is required in children ≥ 1 year old.
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.

If you are not sure, ask your doctor or pharmacist first.

6) To open the container, twist off the
tab.

Take special care with 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.

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

Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
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 and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
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.
Driving and using machines
Oftaquix® has minor influence on the ability to drive and use
machines.

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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.
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.

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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.

Oftaquix® eye drops are for ocular use and have to be applied to
the outer surface of the eye.

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1. WHAT OFTAQUIX® IS AND WHAT IT IS USED FOR

Always use Oftaquix® exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

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In this leaflet:
1. What Oftaquix® is and what it is used for
2. Before you use Oftaquix®
3. How to use Oftaquix®
4. Possible side effects
5. How to store Oftaquix®
6. Further information

3. HOW TO USE OFTAQUIX®

210 x 320 mm
-

Read all of this leaflet carefully before you start using this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
- If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

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11.2.2015
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PACKAGE LEAFLET: INFORMATION FOR THE USER
OFTAQUIX® UNIT DOSE 5 mg/ml EYE DROPS
Levofloxacin

If the eye drops cause blurring of your sight when you use them,
you should wait until this clears before driving or operating
machinery.

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 use a double dose to make up for a
forgotten dose.

If you have any further questions on the use of this product, ask
your doctor or the other healthcare professionals.

very common:
common:
uncommon:
rare:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from
the available data

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 (affect 1 to 10 users in 100)
• burning feeling in the eye
• decreased vision or mucus in the eye

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:
Denmark

Oftaquix
5 mg/ml øjendråber, opløsning
i enkeltdosisbeholder

Finland

Oftaquix 5 mg/ml silmätipat, liuos kertaannospipetissä

Germany

Oftaquix sine
5 mg/ml Augentropfen
im Einzeldosisbehältnis

Iceland

Oftaquix
5 mg/ml Augndropar,
lausn stakskammtaílá

Rare side effects (affect 1 to 10 users in 10,000)
• allergic reactions such as skin rash

Italy

Very rare side effects (affect less than 1 user in 10,000)
• swelling and tightness in the throat
• breathing difficulty

Oftaquix
5 mg/ml collirio, soluzione,
contenitore monodose

Sweden

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Oftaquix
5 mg/ml ögondroppar, lösning
i endosbehållare

United
Kingdom

Oftaquix Unit Dose
5 mg/ml Eye Drops

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

5. HOW TO STORE OFTAQUIX®

This leaflet was last approved in 12/2014

Keep out of the reach and sight of children.
Do not use Oftaquix® 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 Oftaquix if you notice insoluble parts in the solution.

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The frequency of possible side effects is defined as following:

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Like all medicines, Oftaquix® 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 this
eye drops and seek urgent advice from your doctor.

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 paper-coated,
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.

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4. POSSIBLE SIDE EFFECTS

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.

210 x 320 mm
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If you stop using Oftaquix earlier than instructed, it may delay
the healing process.

6. FURTHER INFORMATION
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Santen Oy

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.

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment.

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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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