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EXOCIN 3 MG/ML EYE DROPS SOLUTION.

Active substance(s): OFLOXACIN

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Insert - EXOCIN® - UK - MoH Submission

5. How to store EXOCIN

Keep out of the reach and sight of children.
Once you have opened the bottle do not use it longer than 28 days,
even if there is solution remaining.

Do not use EXOCIN after the expiry date which is stated on the bottle label
and the bottom of the carton after EXP. The expiry date refers to the last
day of that month.
Do not store above 25°C.
Do not use EXOCIN if you notice the tamper-proof seal on the bottle is broken.
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 to protect the environment.
6. Further Information

What EXOCIN contains
• The active substance is Ofloxacin 0.3% w/v.
• The other ingredients are benzalkonium chloride, sodium chloride,
sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH) and
purified water
What EXOCIN looks like and contents of the pack
EXOCIN is an eye drop solution in a plastic bottle. Each carton contains
1 plastic bottle with a screw cap.
Marketing Authorisation Holder
Allergan Limited
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL
United Kingdom

Package leaflet:
Information for the user

EXOCIN® 0.3% w/v

Eye drops, solution
Ofloxacin

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

EXOCIN is an eye-drop used to treat external eye infections such as some
types of conjunctivitis.
EXOCIN belongs to a group of medicines called 4-quinolone antibacterial
agents.
EXOCIN is not recommended for use in infants below the age of one year.

Tel: 01628 494026
Manufacturer
Allergan Pharmaceuticals Ireland
Westport
Co. Mayo
Ireland

2. Before you use EXOCIN

Do not use EXOCIN
• If you are allergic (hypersensitive) to ofloxacin, benzalkonium chloride,
any of the other ingredients, or any other quinolones.

This leaflet was last revised in March 2016.

To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information:
Ofloxacin 0.3% reference number PL 00426/0070.
This is a service provided by the Royal National
Institute of Blind People.

Take special care with EXOCIN
This product should be used with caution in patients sensitive to other
quinolone antibacterial agents.
Long term use may result in a new bacterial infection which does not
respond to EXOCIN.
This product should be used with caution in patients with a defect or
ulceration of the surface of the eye.
EXOCIN potentially increases sensitivity to sunlight. You should avoid
exposure to direct sunlight or sun during use of EXOCIN.
Heart problems:
Caution should be taken when using this kind of medicine, if you were
born with or have family history of prolonged QT interval (seen on ECG,
electrical recording of the heart), have salt imbalance in the blood
(especially low level of potassium or magnesium in the blood), have a very
slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure),
have a history of heart attack (myocardial infarction), you are female or
elderly or you are taking other medicines that result in abnormal ECG
changes (see section Taking other medicines).
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used
any other medicine, including medicines obtained without a prescription.

© 2016 Allergan, Inc., Irvine CA 92612
® marks owned by Allergan, Inc.

Artwork created at 100%
Drop all keylines and notes before printing
Part Number: 71965MD012H
Drawing Number: 0106901

71965MD012H

You must tell your doctor if you are taking other medicines that can alter
your heart rhythm: medicines that belong to the group of anti-arrhythmics
(e.g. quindine, hydroquindine, disopyramide, amiodarone, sotalol,
dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that
belong to the group of macrolides), some antipsychotics.

If you forget to use EXOCIN
If you forget a dose apply it as soon as you remember, unless it is almost time
for your next dose, in which case you should miss out the forgotten dose.
Then apply your next dose as usual and continue with your normal routine.
Do not use a double dose to make up for a forgotten dose.
If you stop using EXOCIN
EXOCIN should be used as advised by your doctor. If you have any further
questions on the use of this product, ask your doctor or pharmacist.
Pregnancy and breast-feeding
Tell your doctor before you start using EXOCIN if you are pregnant or if you
are breast-feeding. Your doctor can then decide whether you can use EXOCIN.
Ask your doctor or pharmacist for advice before using any medicine.
Children
There is limited experience of the use of EXOCIN in children. Talk to your
doctor before you start using EXOCIN in children.
Driving and using machines
Your sight may become blurred for a short time just after using EXOCIN.
You should not drive or use machines until your sight is clear again
Important information about some of the ingredients of EXOCIN
Contact lenses
• Normally you should not wear contact lenses whilst being treated with
this product. However, there may be situations where use of contact
lenses is unavoidable. In these situations remove the lenses before
using EXOCIN. Wait at least 15 minutes after using the eye drops before
putting your lenses back in your eyes.
• A preservative in EXOCIN (benzalkonium chloride) may cause eye
irritation and is also known to discolour soft contact lenses.
3. How to use EXOCIN

Always use EXOCIN exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure. The usual dose is
1 or 2 drops into the affected eye(s) every 2 to 4 hours for the first 2 days
and then 4 times a day from then on.
To be effective EXOCIN must be taken regularly.

The length of treatment should not exceed ten days.

Instructions for use
You must not use the bottle if the tamper-proof seal on the bottle neck is
broken before you first use it.
Apply your eye drops in the following way:
1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket
3. Turn the bottle upside down and squeeze it to release one or two drops
into each eye that needs treatment.
4. Let go of the lower lid, and close your eye for 30 seconds
1.

2.

3.

4.

4. Possible side effects
Like all medicines, EXOCIN can cause side effects, but not everyone gets them.
Serious side effects:
If you have one or more of the following side effects, you may have
had a serious allergic reaction. Stop taking EXOCIN immediately and
contact your physician.
Allergic reactions:
Frequency not known (cannot be estimated from available data)
• Allergic reactions in the eye (including itchiness of the eye and/or eyelid)
• Inflammation of the skin due to allergy (including: rash, itching or hives)
• Severe sudden life-threatening allergic reaction (Anaphylactic)
presenting as swelling beneath the skin that can occur in areas such
as the face, lips or other parts of the body, swelling of the mouth,
tongue or throat that can obstruct the airways which may cause
wheezing, difficulty swallowing, breathing or shortness of breath
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome,
toxic epidermal necrolysis) have been reported with the use of
EXOCIN, appearing initially as reddish target-like spots or circular
patches often with central blisters on the trunk.
The following side effects are also known to occur:
You should see your doctor if any of the following side effects prove
troublesome or if they are long-lasting.
Common side effects (may affect up to 1 in 10 people)
• Eye irritation
• Ocular discomfort
Frequency not known (cannot be estimated from available data)
Side effects affecting the eye:











Visual disturbance
Tearing
Inflammation
Redness
Sensitivity to light
A feeling that something is in your eye
Eye swelling
Swelling around the eyes (including eyelid swelling)
Eye pain
Dryness (mild stinging or burning)

Side effects affecting the body:
• Dizziness
• Nausea
Side effects affecting the heart:

If a drop misses your eye, try again.
To avoid contamination, do not let the tip of the dropper touch your eye
or anything else.
Replace and tighten the cap straight after use.
The proper application of your eye drops is very important. If you have any
questions ask your doctor or pharmacist.
If you use more EXOCIN than you should
If you have placed too many drops in your eye(s), wash the eye(s) with
clean water. Apply your next dose at the normal time.
If, by accident, anyone drinks this medicine, contact your doctor
straight away.

• Abnormal fast heart rhythm
• Life-threatening irregular heart rhythm
• Alteration of the heart rhythm (called ‘prolongation of QT interval’,
seen on ECG electrical activity of the heart)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via:
Yellow Card Scheme
Website: 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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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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