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DORZOLAMIDE WARREN 20 MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dorzolamide Warren 20 mg/ml eye drops, solution
(dorzolamide)

Read all of this leaflet carefully before you start taking 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 signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dorzolamide Warren is and what it is used for
2. What you need to know before you take Dorzolamide Warren
3. How to use Dorzolamide Warren
4. Possible side effects
5. How to store Dorzolamide Warren
6. Contents of the pack and other information

1.

What Dorzolamide Warren is and what it is used for

Dorzolamide Warren contains dorzolamide which belongs to a group of medicines called "carbonic
anhydrase inhibitors".
This medicine is prescribed to lower raised pressure in the eye and to treat glaucoma. This medicine
can be used alone or in addition to other medicines which lower the pressure in the eye (so-called
beta-blockers).

2.

What you need to know before you take Dorzolamide Warren

Do not take Dorzolamide Warren if
 you are allergic (hypersensitive) to dorzolamide hydrochloride or any of the other ingredients of
this medicine (listed in Section 6).
 you have severe kidney impairment or problems, or a prior history of kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before taking your medicine if:






you have now or have had in the past, including eye problems and eye surgeries, and about any
allergies to any medications.
you develop any eye irritation or any new eye problems such as redness of the eye or swelling of
the eyelids.
you suspect that this medicine is causing an allergic reaction (for example, skin rash, severe skin
reaction or itching) and stop its use.
any liver problems you now have or have suffered from in the past.
if you wear contact lenses (see the section Dorzolamide Warren contains the preservative
benzalkonium chloride).

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Children
Dorzolamide Warren has been studied in infants and children less than 6 years of age who have raised
pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your
doctor.
Other medicines and Dorzolamide Warren
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines including those obtained without a prescription, particularly another carbonic anhydrase
inhibitor such as acetazolamide, or a sulfa drug.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice befor taking this medicine.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed. There are side
effects associated with this medicine, such as dizziness and blurred vision, which may affect your
ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or
your vision is clear.
Dorzolamide Warren contains Benzalkonium Chloride
Dorzolamide Warren contains the preservative 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 Dorzolamide Warren

Always use Dorzolamide Warren exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure. The appropriate dosage and duration of treatment will be
established by your doctor.
When this medicine is used alone, the dose is one drop in the affected eye(s) in the morning, in the
afternoon and in the evening.
If your doctor has recommended you use this medicine with a beta-blocker eye drop to lower eye
pressure, then the dose is one drop of Dorzolamide Warren in the affected eye(s) in the morning and
in the evening.
If you are using this medicine with another eye drop, the drops should be instilled at least 10 minutes
apart.
Do not allow the tip of the container to touch the eye or areas around the eye. It may become
contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even
loss of vision.
To avoid possible contamination, wash your hands before using this medicine and keep the tip of the
container away from contact with any surface. If you think your medication may be contaminated, or
if you develop an eye infection, contact your doctor immediately concerning continued use of this
bottle.
Instructions for use
It is recommended that you wash your hands before putting in your eye drops.
It may be easier to apply your eye drops in front of a mirror.

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1.
2.
3.

4.
5.
6.

Before using the medicatiion for the first
fi time, be sure that the tamper-pro
oof seal on tthe bottle
b
the bottle
b
and thhe cap is norm
mal for an un
nopened botttle. Then
neeck is unbrokken. A gap between
brreak the seal.
Take off the cap
c of the botttle.
g
pull your
y
lower eyelid
e
down to form a small pocket between
Tiilt your headd back and gently
yoour eyelid an
nd your eye.

Innvert the botttle, and squeeeze it until a single dropp is dispensedd into the eyye as directedd by your
dooctor. DO NO
OT TOUCH
H YOUR EYE
E OR EYELID WITH TH
HE DROPPE
ER TIP.
R
Repeat steps 3 and 4 with the other eyee if instructed to do so byy your doctorr.
Puut the cap baack on and cllose the bottlle straight aftter you have used it.

use more Dorzolamide Warren
W
than
n you should
d
If you u
If you pput too manyy drops in your
y
eye or the
t contents of the contaainer are sw
wallowed, yoou should
contact yyour doctor immediately
i
.
de Warren
If you foorget to use Dorzolamid
It is impportant to takke this medicine as prescrribed by your doctor. If you
y miss a doose, take it as soon as
possiblee. However, if it is almost time for the
t next dosee, skip the missed
m
dose and go backk to your
regular dosing
d
scheddule.
t
a doublee dose to makke up for a forgotten
fo
dose.
Do not take
If you sttop using Doorzolamide Warren
If you w
want to stop using
u
this medicine
m
talk to your docttor first. If you
y have any
y further questions on
the use oof this mediccine, ask youur doctor or pharmacist.
p

4.

Possible side effects

D
e Warren can
n cause side effects,
e
altho
ough not everrybody gets them.
t
Like all medicines, Dorzolamide
t
and//or throat
If you ddevelop allerrgic reactionns includingg hives, swellling of the face, lips, tongue,
which m
may cause diffficulty in brreathing or swallowing,
s
yyou should stop
s
using thhis medicine and seek
immediaate medical advice.
a
e
have been
b
reported with Dorzoolamide Warrren either duuring clinicaal trials or
The following side effects
during ppost-marketinng experiencce:
e
(moree than 1 userr in 10)
Very Coommon side effects:
Burningg and stingingg of the eyes.
Commonn side effectss: (1 to 10 ussers in 100)
Disease of the corneea with sore eye
e and blurrred vision (ssuperficial pu
unctuate keraatitis), dischaarge with
e
blurrred vision, headache,
h
itching of the eyes (conjunctiviitis), irritatioon/inflammattion of the eyelid,
a fatigue.
nausea, bbitter taste, and

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Uncommon side effects: (1 to 10 users in 1,000)
Inflammation of the iris.
Rare side effects: (1 to 10 user in 10,000)
Tingling or numbness of the hands or feet, temporary shortsightedness which may resolve when
treatment is stopped, development of fluid under the retina (choroidal detachment, following filtration
surgery), eye pain, eyelid crusting, low pressure in the eye, swelling of the cornea (with symptoms of
visual disturbances), eye irritation including redness, kidney stones, dizziness, nose bleed, throat
irritation, dry mouth, localized skin rash (contact dermatitis), severe skin reactions, allergic type
reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth,
shortness of breath, and more rarely wheezing.
If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell
your doctor or pharmacist.
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 Dorzolamide Warren

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 after ‘EXP’. The
expiry date refers to the last day of that month.
Shelf-life after first opening: 28 days.
This medicinal product does not require any special storage conditions. Keep the bottle in the outer
carton in order 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 to protect the environment.

6.

Contents of the pack and other information

What Dorzolamide Warren contains
- The active substance is dorzolamide.
Each ml contains 22.3 mg of dorzolamide hydrochloride corresponding to 20 mg of dorzolamide
- The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide and
water for injections. Benzalkonium chloride is added as a preservative
What Dorzolamide Warren looks like and contents of the pack
Dorzolamide Warren 20 mg/ml eye drops, solution is a slightly opalescent, colourless to nearly
colourless, slightly viscous solution filled in gamma sterilized low density polyethylene (LDPE) bottle
with translucent LDPE nozzle and white high density polyethylene (HDPE) cap with a tamper evident
ring, that has to be broken upon first time use.
Pack sizes:
1 x 5.0 ml (single 5 ml container)

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3 x 5.0 ml (three 5 ml containers)
6 x 5.0 ml (six 5 ml containers)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
WARREN GENERICS s.r.o.
U Staré tvrze 285/21,
196 00 Praha 9,
Czech Republic
Manufacturer:
IMUNA PHARM, a.s.
Jarková 269/17
Šarišské Michaľany 082 22
Slovak Republic
Wessling Hungary Kft.
1047 Budapest, Fóti út 56.
Hungary
This medicinal product is authorised in the Member States of the EEA under the following
names:
Cyprus
Germany
Greece
Hungary
The Netherland
The United Kingdom

UNIDROPS® 20 mg/ml οφθαλμικές σταγόνες, διάλυμα
Dorzolamid Warren 20 mg/ml Augentropfen, Lösung
UNIDROPS® 20 mg/ml οφθαλμικές σταγόνες, διάλυμα
Dorzolamide Warren 20 mg/ml oldatos szemcsepp
Dorzolamide Warren 20 mg/ml oogdruppels, oplossing
Dorzolamide Warren 20 mg/ml eye drops, solution

This leaflet was last revised in April 2016.

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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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