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DORZOLAMIDE 20MG/ML EYE DROPS SOLUTION

Active substance: DORZOLAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dorzolamide 20mg/ml Eye drops, solution
dorzolamide

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 Dorzolamide eye drops are and what they are
used for
2. Before you use Dorzolamide eye drops
3. How to use Dorzolamide eye drops
4. Possible side effects
5. How to store Dorzolamide eye drops
6. Further information

1. WHAT DORZOLAMIDE EYE DROPS ARE AND
WHAT THEY ARE USED FOR

The full name of your medicine is ‘Dorzolamide 20mg/ml Eye
drops, solution’ (referred to as Dorzolamide eye drops in the
rest of this leaflet).
Dorzolamide eye drops are a sterile eye drop solution.
Dorzolamide eye drops contain dorzolamide, a
sulphonamide-related compound, as the active ingredient.
Dorzolamide is an ophthalmic carbonic anhydrase inhibitor
which reduces high pressure in the eye.
It is prescribed to lower raised pressure in the eye in
conditions such as ocular hypertension and glaucoma
(open-angle glaucoma, pseudo-exfoliative glaucoma).
Dorzolamide eye drops can be used alone or in addition to
other medicines which lower the pressure in the eye
(so-called beta-blockers).
2. BEFORE YOU USE DORZOLAMIDE EYE DROPS

Do not use Dorzolamide eye drops
- if you are allergic (hypersensitive) to dorzolamide or any of
the other ingredients of this solution.
- if you have severe kidney problems.
Take special care with Dorzolamide eye drops

Before treatment with Dorzolamide eye drops, tell your doctor
- if you have or have had liver problems in the past
- if you have been told you have a problem in the surface
layer of the eye
- if you have had any allergies to any medicines
- if you have had, or are about to have eye surgery
- if you have suffered an eye injury or have an eye infection
- if you have a prior history of kidney stones
- if you are taking orally another carbonic anhydrase inhibitor
such as acetazolamide
- if you wear contact lenses (see the section ‘Important
information about some of the ingredients of Dorzolamide
eye drops).
You should contact your doctor immediately if you develop any
eye irritation or any new eye problems such as redness of the
eye or swelling of the surface layer of the eye or eyelids.
Stop using Dorzolamide eye drops and contact your doctor
immediately if you suspect that Dorzolamide eye drops are
causing an allergic reaction (for example, skin rash or itching,
inflammation of the eye).
Use in children
Dorzolamide eye drops have 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.

Using other medicines

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

In particular you should tell your doctor if you are taking
another carbonic anhydrase inhibitor such as acetazolamide.
You may be taking this type of medicine by mouth, as eye
drops, or by some other method.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any
medicine. Tell your doctor if you are pregnant or planning to
become pregnant. Dorzolamide eye drops should not be used
during pregnancy unless your doctor still recommends it.
Dorzolamide eye drops should not be used while
breast-feeding.
Driving and using machines

Dorzolamide eye drops may cause dizziness and visual
disturbances in some patients. Do not drive or use any tools
or machines until the symptoms have cleared.

Important information about some of the
ingredients of Dorzolamide eye drops

Dorzolamide eye drops contain the preservative
benzalkonium chloride.
• Benzalkonium chloride may cause eye irritation.
• Benzalkonium chloride is known to discolour soft
contact lenses.
• Avoid contact with soft contact lenses.
• Remove contact lenses prior to application and wait until
15 minutes before reinsertion.
3. HOW TO USE DORZOLAMIDE EYE DROPS

Always use Dorzolamide eye drops 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 Dorzolamide eye drops are used alone, the usual dose
is one drop in the affected eye(s) three times a day, for
example in the morning, in the afternoon and in the evening.
If your doctor has recommended you use Dorzolamide eye
drops with a beta-blocker eye drop (medicines which lower the
pressure of the eye), then the usual dose is one drop of
Dorzolamide eye drops in the affected eye(s) two times a day,
for example in the morning and in the evening.
If you use Dorzolamide eye drops with another eye drop,
leave at least 10 minutes between putting in Dorzolamide eye
drops and the other medicine. Alternatively if you are going to
use Dorzolamide eye drops to replace another eye drop
medicine, used to lower eye pressure, you should stop using
the other medicine after taking the proper dosing on one day,
and start Dorzolamide eye drops on the next day.
Do not change the dosage of the drug without consulting your
doctor. If you must stop treatment, contact your doctor
immediately.
Do not allow the tip of the container to touch your eye or areas
around your 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
of the container, keep the tip of the container away from
contact with any surface.
Instructions for proper 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.
1. Before using the medication
for the first time, be sure that
the tamper-proof seal on the
bottle neck is unbroken. A gap
between the bottle and the cap
is normal for an unopened
bottle.
2. Take off the cap of the bottle.
3. Tilt your head back and gently pull your lower eyelid down
to form a small pocket between your eyelid and your eye.

4. Turn the bottle upside down, and squeeze it until a single
drop is dispensed into the eye as directed by your doctor.
DO NOT TOUCH YOUR EYE OR EYELID WITH THE
DROPPER TIP.
5. Repeat steps 3 & 4 with the other eye if instructed to do so
by your doctor.
6. Put the cap back on and close the bottle straight after you
have used it.
If you use more Dorzolamide eye drops than
you should

If you put too many drops in your eye or swallow any of the
contents, you should contact your doctor immediately.
If you forget to use Dorzolamide eye drops

It is important to use Dorzolamide eye drops as prescribed by
your doctor.
If you miss a dose, use it as soon as possible. However, if it is
almost time for the next dose, skip the missed dose and go
back to your regular dosing schedule.
Do not use a double dose to make up for forgotten individual
doses.
If you stop using Dorzolamide eye drops

Dorzolamide eye drops should be used every day to work
properly. If you must stop treatment, contact your doctor
immediately.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

Like all medicines, Dorzolamide eye drops can cause side
effects, although not everybody gets them.
If you develop allergic reactions including hives, swelling of
the face, lips, tongue, and/or throat which may cause difficulty
in breathing or swallowing, you should stop using this
medicine and seek immediate medical advice.
The following side effects may be seen with Dorzolamide
eye drops:
Very common (affects more than 1 in 10 people)
• burning and stinging of the eyes
Common (affects in between 1 and 10 out of every
100 people)
• disease of the surface layer of the eye with sore eye and
blurred vision, inflammation or swelling of the surface layer
of the eye(s) and possible inflammation of the eyelid(s)
and/or skin around the eye(s), watering or itching of the
eye(s), blurred vision, effects on the surface of the eye
• nausea, bitter taste
• weakness/fatigue
• headache
Uncommon (affects in between 1 and 10 out of every
1,000 people)
• inflammation of the middle layer of the eye
Rare (affects in between 1 and 10 out of every
10,000 people)
• swelling of the surface layer of the eye(s), separation of
part of the lining of the eye due to a build up of fluid which
may be accompanied by visual changes/disturbances
(following eye surgery), low pressure in the eye, redness of
the eye(s), eye pain, crusting of the eyelid(s), temporary
shortsightedness (which stops when the medicine is
discontinued)
• throat irritation, dry mouth
• Hypersensitivity: signs and symptoms of local reaction
(affecting the eye lids) and general allergic reactions such
as rash, hives, itching, in rare cases possible swelling of
the lips, eyes and mouth, shortness of breath and more
rarely wheezing
• dizziness, numbness/tingling sensation
• formation of kidney stones in the urinary system
• bleeding from the nose
• skin inflammation
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.

5. HOW TO STORE DORZOLAMIDE EYE DROPS

Keep out of the reach and sight of children.
Do not use Dorzolamide eye drops after the expiry date which
is stated on the bottle label and the carton after EXP: The
expiry date refers to the last day of that month.
Keep the bottle in the outer carton in order to protect from
light. Store below 30°C.
Dorzolamide eye drops should be used within 28 days after
the bottle is first opened. Therefore, you must throw away the
bottle 4 weeks after you first opened it, even if some solution
is left. To help you remember, write down the date that you
opened it in the space on the carton.
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 Dorzolamide eye drops contain

- The active substance is dorzolamide. Each ml contains
20mg dorzolamide (as dorzolamide hydrochloride).
- The other ingredients are Mannitol, Hydroxyethyl Cellulose,
Benzalkonium Chloride (as a preservative), Sodium Citrate,
Sodium Hydroxide for pH adjustment and Water for
injections.
What Dorzolamide eye drops look like and
contents of the pack

Dorzolamide eye drops are a sterile, isotonic, buffered,
colourless, clear, slightly viscous solution in a white opaque
medium density polyethylene bottle with a sealed dropper tip
and a two-piece cap assembly. Each bottle contains 5mL of
the eye drop solution.
Dorzolamide eye drops are available in packs containing 1
bottle, 3 bottles or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder

Pharmathen S.A.
6 Dervenakion str.,
153 51 Pallini Attiki,
Greece

Manufacturer
Pharmathen S.A.
6 Dervenakion str.,
153 51 Pallini Attiki,
Greece
or
Famar S.A.
63 Agiou Dimitriou Street,
174 56 Alimos
Greece

Distributor:
Aspire Pharma Limited
Antrobus House Business Centre
18 College Street
Petersfield
Hampshire
GU31 4AD
United Kingdom

This leaflet was last approved in
02/2011

1010122/P2

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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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