Skip to Content

OFTAQUIX 5 MG/ML EYE DROPS

Active substance(s): LEVOFLOXACIN / LEVOFLOXACIN / LEVOFLOXACIN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

20306-3
Package leaflet: Information for the user
Oftaquix® 5 mg/ml eye drops, solution
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.
- Oftaquix contains the preservative benzalkonium chloride,
which may cause eye irritation.
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, 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.
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
advise 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.
Oftaquix contains benzalkonium chloride
May cause eye irritation. Avoid contact with soft contact
lenses. Remove contact lenses prior to application and wait
at least 15 minutes before reinsertion. Known to discolour
soft contact lenses.
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 bottle. Take special care that the tip of the
dropper bottle does not touch your eye, the skin
around your eye or your fingers.

5) Close the eye and
3) Tilt your head 4) Pull the lower
backwards
eyelid downwards
press the inner
and hold the
and look up.
corner of the eye
bottle upside
Gently squeeze
with your finger for
down over
the bottle and
about one minute.
the eye.
let one drop fall
Thus you can
into the space
prevent the eye
between the lower
drop from draining
eyelid and the eye.
down the tear
duct.
322100 20306-3 Oftaquix.indd 1

27.7.2017 7:14:57

6) Wipe off any excess solution from the skin around the eye.
7) Put the cap back on and close the bottle tightly.
If another drop is needed, and when both eyes are to be
treated, repeat steps 3 to 7.
Oftaquix eye drops should not be injected into the interior
part of the eyeball.
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 bottle 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.
Very rarely this medicine can cause severe allergic reactions.
The following symptoms can occur even after just one dose
of Oftaquix:
- swelling and tightness in the throat
- breathing difficulties.
In rare cases other allergic reactions can develop. Symptoms
of such reactions are:
- worsening of redness and itching of the eyes
- increased or sudden swelling of eyelids.
Stop using Oftaquix and contact a doctor immediately if any
of these symptoms occurs.
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) or eyelid
- 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
10,000 users)
- swelling and tightness in the throat
- breathing difficulty
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.
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 bottle label and carton after “EXP”. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice that the plastic film
around the cap and neck is missing or broken before you
start a new bottle.
Keep the bottle tightly closed.
To prevent infections, you must throw away the bottle 28
days after you first opened it, and use a new bottle.
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.
- The other ingredients are benzalkonium chloride (0.05 mg
in 1 ml eye drops, solution; preservative), sodium chloride,
sodium hydroxide or 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.
- It is supplied in a pack containing 1 white plastic bottle
with 5 ml solution. The plastic bottle is closed with a
screw cap.
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:
This medicinal product is authorised under the trade name
Oftaquix in the following Member States of the EEA:
Austria, Czech Republic, Denmark, Estonia, Finland,
Germany, Hungary, Iceland, Italy, Latvia, Lithuania,
Luxembourg, Portugal, Romania, Slovakia, Sweden, United
Kingdom.
This leaflet was last revised in 07/2017

322100 20306-3 Oftaquix.indd 2

27.7.2017 7:14:57

Expand Transcript

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.

Hide