DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION

Active substance: DORZOLAMIDE HYDROCHLORIDE

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Front of leaflet

Pharma code 296

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before
you start taking 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 Dorzolamide is and what it is
used for
2. Before you use Dorzolamide 20 mg/ml
Eye drops solution
3. How to use Dorzolamide 20 mg/ml
Eye drops
4. Possible side effects
5. How to store Dorzolamide 20 mg/ml
Eye drops
6. Further information

1

WHAT DORZOLAMIDE IS AND
WHAT IT IS USED FOR

Dorzolamide 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).

Use in patients with liver impairment
Tell your doctor about any liver
problems you now have or have
suffered from in the past.
Using other medicines
Tell your doctor about all drugs
(including eye drops) that you are using
or plan to use, including those obtained
without a prescription, particularly
another carbonic anhydrase inhibitor
such as acetazolamide, or a sulfa drug.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for
advice before taking any medicine.
Use in pregnancy
You should not use this medicine
during pregnancy. Tell your doctor if
you are pregnant or intend to become
pregnant.
Use in breast-feeding
If treatment with this medicine is
required, breast-feeding is not
recommended. Tell your doctor if you are
breast-feeding or intend to breast-feed.
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.

Important information about some of
the ingredients of Dorzolamide
This medicinal product contains the
preservative benzalkonium chloride.
This preservative may be deposited in
soft contact lenses and may possibly
2 BEFORE YOU USE DORZOLAMIDE discolour the lenses. If you wear soft
20 MG/ML EYE DROPS SOLUTION contact lenses, you should consult your
doctor before using this medicine. It is
Do NOT use Dorzolamide 20 mg/ml Eye important that your lenses are removed
drops solution
before using your eye drops and not
• If you are allergic (hypersensitive) to put back into your eyes for at least 15
dorzolamide hydrochloride or to any minutes after using your eye drops.
of the other ingredients of this
Your doctor can explain this to you.
medicine
• If you have severe kidney impairment 3 HOW TO USE DORZOLAMIDE
or problems, or a prior history of
20 MG/ML EYE DROPS SOLUTION
kidney stones.
Always use this medicine exactly as
Take special care with Dorzolamide
your doctor has told you. You should
20 mg/ml Eye drops solution
check with your doctor or pharmacist if
Tell your doctor about any medical
you are not sure.
problems you have now or have had in
the past, including eye problems and
The appropriate dosage and duration of
eye surgeries, and about any allergies
treatment will be established by your
to any medications.
doctor.
If you develop any eye irritation or any
new eye problems such as redness of
the eye or swelling of the eyelids,
contact your doctor immediately.

When this medicine is used alone, the
usual dose is one drop in the affected
eye(s) in the morning, in the afternoon
and in the evening.

If you suspect that this medicine is
causing an allergic reaction (for
example, skin rash, severe skin reaction
or itching) stop its use and contact your
doctor immediately.

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
20 mg/ml Eye drops solution in the
affected eye(s) in the morning and in
the evening.

If you wear contact lenses, you should
consult your doctor before using this
medicine.

If you are using this medicine with
another eye drop, the drops should be
Use in children
instilled at least 10 minutes apart.
Dorzolamide has been studied in infants Do not change the dose of your
and children less than six years of age
medicine without consulting your doctor.
who have raised pressure in the eye(s)
or have been diagnosed with glaucoma. Do not allow the tip of the container to
For more information, talk to your doctor. touch your eye or areas around your
eye. It may become contaminated with
bacteria that can cause eye infections
Use in the elderly
In studies with dorzolamide, the effects leading to serious damage of the eye,
even loss of vision. To avoid possible
of dorzolamide were similar in both
contamination of the container, keep
elderly and younger patients.
the tip of the container away from
contact with any surface.

Pharma code 296

DORZOLAMIDE 20 mg/ml
EYE DROPS SOLUTION

Back of leaflet

Instructions for use
Rare side effects (1 to 10 users in
It is recommended that you wash your 10,000)
hands before putting in your eye drops. • Tingling or numbness of the hands or
feet
1. Before using the medication for the
• Temporary shortsightedness which
first time, be sure the tamper seal is
may resolve when treatment is
unbroken.
stopped, development of fluid under
2. To open the bottle, unscrew the cap.
the retina (choroidal detachment,
3. Tilt your head back and pull your
following filtration surgery), eye pain,
lower eyelid down slightly to form a
eyelid crusting, low pressure in the
pocket between your eyelid and your
eye, swelling of the cornea (with
eye.
symptoms of visual disturbances),
4. Invert the bottle, and press lightly on
eye irritation including redness
the sides of the bottle until a single
• Kidney stones
drop is dispensed into the eye as
• Dizziness
directed by your doctor. DO NOT
• Nose bleed
TOUCH YOUR EYE OR EYELID WITH
• Throat irritation, dry mouth
THE DROPPER TIP
.
• Localised skin rash (contact
5. Repeat steps 3 and 4 with the other eye
dermatitis), severe skin reactions
if instructed to do so by your doctor.
• Allergic-type reactions such as rash,
6. Replace the cap by turning until it is
hives, itching, in rare cases possible
firmly touching the bottle.
swelling of the lips, eyes and mouth,
7. The dispenser tip is designed to
shortness of breath and more rarely,
provide a pre-measured drop;
wheezing.
therefore, do not enlarge the hole of
the dispenser tip.
If any of the side effects get serious, or
if you notice any side effects not listed
If you use more Dorzolamide than you in this leaflet, please tell your doctor.
should
If you put too many drops in your eye
5 HOW TO STORE DORZOLAMIDE
or swallow any of the contents of the
20 MG/ML EYE DROPS SOLUTION
container, you should contact your
doctor immediately.
• Keep out of the reach and sight of
children
If you forget to use Dorzolamide
• Do not use this medicine after the
It is important to use your medicine as
expiry date which is stated on the
prescribed by your doctor. If you miss a
bottle and carton. The expiry date
dose, take it as soon as possible.
refers to the last day of that month
However, if it is almost time for the next • Dorzolamide 20 mg/ml Eye drops
dose, skip the missed dose and go back
solution should be used within 28
to your regular dosing schedule. Do not
days after the bottle is first opened
take a double dose to make up for the
• Store below 30°C
forgotten dose.
• Do not refrigerate or freeze
• Do not transfer Dorzolamide 20 mg/ml
If you stop using Dorzolamide
Eye drops solution into another
If you want to stop using this medicine
container, it might get mixed up or
talk to your doctor first.
contaminated
• Medicines should not be disposed of
If you have any further questions on the
via wastewater or household waste.
use of this product, ask your doctor or
Ask your pharmacist how to dispose
pharmacist.
of medicines no longer required.
These measures will help to protect
POSSIBLE SIDE EFFECTS
the environment.
4
Like all medicines, dorzolamide can
cause side effects, although not
everybody gets them.

6

FURTHER INFORMATION

What Dorzolamide contains
• The active substance is dorzolamide.
If you develop allergic reactions
Each ml contains 22.6 mg
including hives, swelling of the face,
dorzolamide hydrochloride,
lips, tongue, and/or throat which may
corresponding to 20 mg of
cause difficulty in breathing or
dorzolomide
swallowing, you should stop using this • The other ingredients are
medicine and seek immediate medical
hydroxyethylcellulose, mannitol
advice.
E421, sodium citrate E331, sodium
hydroxide E524, and water for
The following side effects have been
injection. Benzalkonium chloride
reported with dorzolamide either during
(0.075 mg/ml) is added as a
clinical trials or during post-marketing
preservative.
experience:
What Dorzolamide looks like and
Very common side effects (more than 1 contents of the pack
user in 10)
• Clear, viscous solution, free from
• Burning and stinging of the eyes.
visible particles in white bottles with
white droppers and white, HDPE
Common side effects (1 to 10 users in
tamper proof cap
100)
• Each bottle contains 5 ml of solution.
• Disease of the cornea with sore eye
It is available in pack sizes of 1 x 5 ml,
and blurred vision (superficial
3 x 5 ml and 6 x 5 ml.
punctuate keratitis), discharge with
Not all pack sizes may be marketed.
itching of the eyes (conjunctivitis),
irritation / inflammation of the
Marketing Authorisation Holder and
eyelid, blurred vision
Manufacturer
• Headache
Marketing authorisation holder is
• Nausea, bitter taste
TEVA UK Limited, Eastbourne, BN22 9AG.
• Fatigue.
Manufacturer is TEVA Pharmaceutical
Works Private Limited Company,
Uncommon side effects (1 to 10 users in Táncsics Mihály út 82, H-2100, Gödöllő,
1,000)
Hungary.
• Inflammation of the iris.
This leaflet was last revised in June 2011
PL 00289/1116
3-29119610/A
87166-U

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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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