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VIVIDRIN EYE DROPS

Active substance(s): SODIUM CROMOGLYCATE / SODIUM CROMOGLYCATE / SODIUM CROMOGLYCATE

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Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

Nazwa produktu
Product Name

medicines.

ULOTKA PIL

Package Leaflet:
Information for the user

Vividrin antiallergic
DRP 10 ml

Kolor nadruku Colours

United Kingdom (UK);

Nr wykrojnika
Spec No

12036

Kod Wytwórcy
Manufacturer code

49136PB255/1-UK

Kod farmaceutyczny
Pharmacode

804

Black
Kraj
Country (ISO)
Opracowane przez
Designed by
Nr korekty
Proof No

10

Kod wersji
Valeant version code

P1UK01

Inny kod
Other code

-

Rozmiar czcionki
Font size

minimum 9,5 pt

Wymiar ulotki
PIL size

120 x 360 mm

Krój czcionki
Font used

Data
Date

12.09.2017

Futura LT Pro Book
Futura LT Pro Heavy
Futura Md BT Bold

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
Change from POM to GSL product
PMR_ICN-14-1120-A
Packing site: DMP Berlin
Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

- g/m2

Vividrin Hayfever
2 % w/v Eye Drops,
solution
Sodium cromoglicate
Read all of this leaflet
carefully before you start
using this medicine because
it contains important
information for you.
Always use this medicine exactly
as described in this leaflet or as
your pharmacist has told you.
-- Keep this leaflet. You may
need to read it again.
-- Ask your pharmacist if you
need more information or
advice.
-- If you get any side effects,
talk to your pharmacist. This
includes any possible side
effects not listed in this leaflet.
See section 4.
-- You must talk to your doctor if
your eyes do not feel better or
if they feel worse after 2 days.
What is in this leaflet
1. What Vividrin is and what it is
used for
2. What you need to know
before you use Vividrin
3. How to use Vividrin
4. Possible side effects
5. How to store Vividrin
6. Contents of the pack and
other information
1. What Vividrin is and
what it is used for
Vividrin contains the active
substance sodium cromoglicate.
This belongs to a group of
medicines called anti-allergics.
Vividrin is used for the relief and
treatment of the eye symptoms
of hayfever (which is an allergic
condition) such as red, sore, itchy
and watery eyes.
You must talk to a doctor if you
do not feel better or if you feel
worse.
2. What you need to know
before you use Vividrin
Do not use these drops
-- If you are allergic
(hypersensitive) to sodium
cromoglicate or any of
the other ingredients of
this medicine including
benzalkonium chloride (listed
in section 6).
Warnings and precautions
-- Vividrin contains
benzalkonium chloride which
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.
-- Do not use if the bottle has
been opened before you are
given it.
-- Throw the bottle away
1 month after first opening it
or if the solution stops looking
clear.
Other medicines and
Vividrin
-- Tell your pharmacist if you
are using, have recently
used or might use any other

Pregnancy and breastfeeding
-- If you are pregnant or breastfeeding, think you may be
pregnant or are planning to
have a baby, ask your doctor
or pharmacist for advice
before taking this medicine.
Driving and using
machines
-- Vividrin can cause stinging
and blurring of vision when
first used. Do not drive or
operate machinery until proper
vision is restored.
3. How to use Vividrin
Always use this medicine exactly
as described in this leaflet or as
your pharmacist has told you.
Check with your pharmacist if
you are not sure.
If your eyes are no better after
2 days of using the eye drops,
see your doctor or pharmacist.
If you find you need to use the
drops continuously for more than
14 days, then check with your
pharmacist or doctor before
continuing.
Dosage
Unless otherwise prescribed, the
dose for adults and children over
6 years is 1 or 2 drops into each
eye 4 times daily.
Apply your eye drops in
the following way:
1. Before using your Vividrin
Hayfever Eye Drops you
should wash your hands.
2. You may find it helps to sit in
front of a mirror, so that you
can see what you are doing.
Tilt your head backwards,
gently pull down your lower
eyelid and carefully place
one or two Vividrin Hayfever
Eye Drops in the space
between the eyelid and the
eye. Take care not to touch
the dropper with your eye or
fingers.
3. Release the eyelid and blink
a few times to make sure
the liquid covers the whole
surface of the eye.
4. Repeat the procedure with
the other eye and then
replace the cap on the bottle.

If you use more Vividrin
than you should
If you use more Vividrin than
you should contact you doctor or
pharmacist.
If you forget to use
Vividrin
Use your drops as soon as you
remember and then carry on in
the usual way. Do not take a
double dose to make up for a
forgotten dose.
If you have any further questions
on the use of this medicine, ask
your pharmacist.

P1UK01_49136PB255-1-UK_Vividrin_antiallergic_DRP10ml_UK_v2.indd 1

2017-09-12 13:40:36

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

Nazwa produktu
Product Name

ULOTKA PIL

Vividrin antiallergic
DRP 10 ml

Kolor nadruku Colours

United Kingdom (UK);

Nr wykrojnika
Spec No

12036

Kod Wytwórcy
Manufacturer code

49136PB255/1-UK

Kod farmaceutyczny
Pharmacode

804

Black
Kraj
Country (ISO)
Opracowane przez
Designed by
Nr korekty
Proof No

10

Kod wersji
Valeant version code

P1UK01

Inny kod
Other code

-

minimum 9,5 pt

Wymiar ulotki
PIL size

120 x 360 mm

Rozmiar czcionki
Font size
Krój czcionki
Font used

Data
Date

12.09.2017

Futura LT Pro Book
Futura LT Pro Heavy
Futura Md BT Bold

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
Change from POM to GSL product
PMR_ICN-14-1120-A
Packing site: DMP Berlin
Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

- g/m2

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although
not everybody gets them. If you
experience any difficulty stop
using your drops and talk to
your doctor or pharmacist.
Like all eye drops you may
briefly have blurred vision or a
slight stinging feeling after using
your drops.
There is also a slight possibility
that irritation or itching of the
eye may occur in a very small
number of people.

The Manufacturer is:
Dr. Gerhard Mann Chem-pharm
Fabrik GmbH
13581 Berlin
Germany
This leaflet was last revised:
September 2017.
®/™ are trademarks of
Bausch & Lomb Incorporated or
its affiliates.
© Bausch & Lomb Incorporated.

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:
United Kingdom
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.
5. How to store Vividrin
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 carton and label. The
expiry date refers to the last
day of that month.
-- Do not use the eye drops more
than four weeks after first
opening the bottle. Discard
any unused medicine after this
time.
-- Do not use this medicine if you
notice the solution is cloudy.
Store below 25ºC.
Keep bottle in outer carton to
protect from light.
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 Vividrin contains
-- The active substance is Sodium
Cromoglicate.
-- The other ingredients are
Benzalkonium Chloride,
Edetic Acid Disodium Salt,
Polysorbate, Sorbitol, Sodium
Hydroxide and Purified Water.
What Vividrin looks like
and contents of the pack
Your eye drops are sterile
preserved multidose eye drops
and are supplied in plastic
bottles. Each bottle has a volume
of 10.0 ml. The eye drops are a
clear solution.
Marketing Authorisation
Holder and Manufacturer
The Marketing Authorisation
Holder is:
Bausch & Lomb UK Limited
106 London Road
Kingston-Upon-Thames
Surrey, United Kingdom
KT2 6TN

P1UK01 / 49136PB255/1-UK

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2017-09-12 13:40:36

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.

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