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MOXIVIG 0.5%W/V EYE DROPS SOLUTION

Active substance(s): MOXIFLOXACIN HYDROCHLORIDE

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PACKAGE LEAFLET : INFORMATION FOR THE USER

MOXIVIG*

0.5 % w / v eye drops, solution

Moxifloxacin hydrochloride
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 or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If you get any of the side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

1

2. What you need to know before you use
MOXIVIG
3. How to use MOXIVIG
4. Possible side effects
5. How to store MOXIVIG
6. Contents of the pack and other information

by bacteria. The active ingredient is moxifloxacin
an ophthalmological anti-infective.

WHAT YOU NEED TO KNOW BEFORE
YOU USE MOXIVIG

Do not use MOXIVIG
• If you are allergic ( hypersensitive ) to
moxifloxacin, to other quinolones, or any of the
other ingredients of this medicine.

Warnings and Precautions
• If you experience an allergic reaction
to MOXIVIG. Allergic reactions occur
uncommonly and serious reactions occur
rarely. If you experience any allergic
( hypersensitivity ) reaction or any side effect
please refer to section 4.
• If you wear contact lenses – stop wearing
your lenses if you have any signs or symptoms
of an eye infection. Wear your glasses instead.
Do not start wearing your lenses again until
the signs and symptoms of the infection have
cleared and until you have stopped using the
medicine.
• Tendon swelling and rupture have happened
in people taking oral or intravenous
fluoroquinolones, particularly in older

3

1. What MOXIVIG is and what it is used for

WHAT MOXIVIG* IS AND WHAT IT IS USED FOR

MOXIVIG eye drops are used for the treatment of
infections of the eye ( conjunctivitis ) when caused

2

What’s in this leaflet :

patients and in those treated concurrently
with corticosteroids. Stop taking MOXIVIG if
you develop pain or swelling of the tendons
( tendinitis ).
As with any antibiotic, use of MOXIVIG for a long
time may lead to other infections.

Other medicines and MOXIVIG
Please tell your doctor or pharmacist if
you are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.

Pregnancy, breast feeding and
fertility
Ask your doctor before using MOXIVIG eye
drops.

Driving and using machines
You may find that your vision is blurred for a short
time just after you use MOXIVIG. Do not drive or
use machines until this has worn off.

HOW TO USE MOXIVIG

Always use this medicine exactly as your doctor
has told you.

Check with your doctor or pharmacist if you are
not sure.

The usual dose is…

on the use of this medicine in the newborn and
its use is not recommended in the newborn.

Adults, including the older, and
children :
1 drop in the affected eye or eyes, 3 times
a day ( in the morning, in the afternoon and at
night ).

Only use the medicine in both eyes if your doctor
told you to. Only use MOXIVIG for dropping in
your eyes.

MOXIVIG can be used in children, in patients over
65 years of age and patients with kidney or liver
problems. There is only very limited information

The infection normally improves within 5 days.
If no improvement is seen, contact your doctor.
You should continue to use the drops for a
further 2 - 3 days or as long as your doctor told
you to.

• Get the MOXIVIG bottle and stand in front of a
mirror
• Wash your hands
• Twist off the cap
• After cap is removed, if tamper evident snap
collar is loose, remove before using the product
• Hold the bottle, pointing down, between your
thumb and fingers
1
• Tilt your head back. Pull
down your eyelid with a
clean finger, until there is a
‘pocket’ between the eyelid
and your eye. The drop will
go in here ( picture 1 )
• Bring the bottle tip close to the eye. Use the
mirror if it helps
• Don’t touch your eye or eyelid,
surrounding areas or other surfaces with
the dropper. It could infect the drops

• Gently press the bottom of
2
the bottle to release one
drop of medicine at a time
( picture 2 )
• After using MOXIVIG,
press a finger into the
corner of your eye, by
the nose for 2 - 3 minutes
3
( picture 3 ). This helps to
stop the medicine getting
into the rest of the body
and is important in young
children
• If you are using the drops
in both eyes, wash your hands before you
repeat the steps for your other eye. This
will help prevent spreading the infection from
one eye to the other
• Close the bottle cap firmly immediately after
use

Now turn over

3

HOW TO USE MOXIVIG* ( continued )

How to use : see also side 1
If a drop misses your eye, try again.

If you forget to use the medicine, continue
with the next dose as planned. Do not use a
double dose to make up for a forgotten dose.

If you use more medicine than you should,
rinse it all out with warm water. Don’t put in any
more drops until it’s time for your next regular
dose.

If you are using other eye drops, leave at
least 5 minutes between putting in MOXIVIG
and the other drops.

If you accidentally swallow MOXIVIG contact
your doctor or pharmacist for advice.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines MOXIVIG can cause side
effects although not everybody gets them.
You can usually carry on taking the drops,
unless the effects are serious or if you suffer a
severe allergic reaction.
If you experience a severe allergic reaction
and any of the following happen, stop
taking MOXIVIG immediately and tell your
doctor immediately : swelling of the hands,
feet, ankles, face, lips, mouth or throat which
may cause difficulty in swallowing or breathing,
rash or hives, large fluid - filled blisters, sores
and ulceration.

Not known
( Frequency cannot be estimated from the
available data )
Effects in the eye : infection in the eye, eye
surface becomes cloudy, corneal swelling,
deposits on the eye surface, increased pressure
in eye, scratch on surface of eye, eye allergy,
eye discharge, increased tear production,
sensitivity to light
General side effects : shortness of breath,
irregular heart rhythm, dizziness, increased
allergic symptoms, itching, rash, skin redness,
nausea and urticaria

Common side effects

Reporting of side effects

( May affect up to 1 in 10 people )

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 the national
reporting system ( see details below ). By
reporting side effects you can help provide more
information on the safety of this medicine.

Effects in the eye : eye pain, eye irritation

Uncommon side effects
( May affect up to 1 in 100 people )
Effects in the eye : dry eye, itchy eye, redness
of the eye, eye surface inflammation or scarring,
broken blood vessel in eye, abnormal eye
sensation, eyelid abnormality, itching, redness or
swelling
General side effects : headache and bad taste

Rare side effects
( May affect up to 1 in 1000 people )
Effects in the eye : corneal disorder, blurred or
reduced vision, inflammation or infection of the
conjunctiva, eye strain, eye swelling

United Kingdom
Yellow Card Scheme
Website : www.mhra.gov.uk / yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel : + 353 1 6764971
Fax : + 353 1 6762517
Website : www.hpra.ie
E-mail : medsafety@hpra.ie

General side effects : vomiting, nose
discomfort, feeling of a lump in the throat,
decreased iron in blood, abnormal liver blood
tests, abnormal skin sensation, pain, throat
irritation

5

HOW TO STORE MOXIVIG

Keep out of the sight and reach of children.
Don’t use the drops after the expiry date which
is stated on the bottle and the carton after ‘Exp’.
The expiry date refers to the last day of that
month.
This medicine does not need any special
storage conditions.

6

Stop using the bottle 4 weeks after first
opening. This is to prevent infections.
Do not dispose of medicines into the water
supply or in household waste. Ask your
pharmacist how to dispose of medicines you
no longer need. This will help protect the
environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

What MOXIVIG contains
The active substance is moxifloxacin.
One ml of eye drops contains 5 mg of
moxifloxacin ( as moxifloxacin hydrochloride,
5.45 mg ).
One eye drop contains 190 micrograms of
moxifloxacin.
The other ingredients are : sodium chloride,
boric acid, purified water.
Tiny amounts of sodium hydroxide and
hydrochloric acid may be added to keep acidity
levels ( pH levels ) normal.

What MOXIVIG looks like and the
contents of the pack
The medicine is a liquid ( a clear, greenish - yellow
solution ) supplied in a pack containing one 5 ml
plastic bottle with a screw cap.

Marketing Authorisation Holder
Alcon Laboratories ( UK ) Ltd
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK
Manufacturer
S.A. Alcon - Couvreur N.V.
Rijksweg 14, B - 2870 Puurs, Belgium
This medicinal product is authorized in the
Member States of the EEA under the following
names :
MOXIFLOXACIN ALCON : Germany
KANAVIG : Belgium, Luxembourg
VIGAMOX : Bulgaria, Cyprus, Czech Republic,
Denmark, Estonia, Finland, Greece, Hungary,
Iceland, Italy, Latvia, Lithuania, Malta,
Netherlands, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden
MOXIVIG : UK, Ireland
®

This leaflet was last revised in August 2014.
08- 2014

* A trademark of Novartis
© 2010, 2013, 2014 Novartis
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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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