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Trusopt® 2% Ophthalmic Solution
(dorzolamide hydrochloride)
Your medicine is available as the above name, but will be referred to as
Trusopt throughout this:
Patient Information Leaflet
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 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
What is in this leaflet:
1) What Trusopt is and what it is used for
2) What you need to know before you use Trusopt
3) How to use Trusopt
4) Possible side effects
5) How to store Trusopt
6) Contents of the pack and other information

1) What Trusopt is and what it is used for
TRUSOPT 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 use Trusopt
Do not use Trusopt:

if you are allergic to dorzolamide hydrochloride or any of the other
ingredients of this medicine (listed in section 6).
if you have severe kidney impairment or problems, or a prior history of
kidney stones.

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

3) How to use Trusopt
Always use this medicine exactly as your doctor has told you. 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 recommended 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 recommended dose is one drop of
Trusopt in the affected eye(s) in the morning and in the evening.
If you are using Trusopt 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:
1. Before using the medication for the first time, be sure the Safety Strip on
the front of the bottle is unbroken. A gap between the bottle and the cap is
normal for an unopened bottle.
Opening Arrows ►

Safety Strip ►

Warnings and precautions
Talk to your doctor or pharmacist before using Trusopt.
Tell your doctor or pharmacist about any medical problems you have now or
have had in the past, including eye problems and eye surgeries, and about
any allergies to any medications.
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.

2. First wash your hands, then tear off the Safety Strip to break the seal.

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

Gap ►
Finger Push Area ►

Use in elderly
In studies with Trusopt, the effects of this medicine were similar in both
elderly and younger patients.
Use in patients with liver impairment
Tell your doctor about any liver problems you now have or have suffered
from in the past.

3. To open the bottle, unscrew the cap by turning as indicated by the arrows
on the top of the cap. Do not pull the cap directly up and away from the
bottle. Pulling the cap directly up will prevent your dispenser from operating

Other medicines and Trusopt
Tell your doctor or pharmacist if you are using, have recently used or might
use any other medicines (including eye drops). This is particularly important
if you are taking another carbonic anhydrase inhibitor such as
acetazolamide, or a sulpha 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 breastfeed.
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 trusopt, 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.
Trusopt contains benzalkonium chloride
Trusopt contains the preservative benzalkonium chloride. This preservative
may be deposited in soft contact lenses and may possibly discolour the

4. Tilt your head back and pull your lower eyelid down slightly to form a
pocket between your eyelid and your eye

Not known: (frequency cannot be estimated from the available data)
Shortness of breath, foreign body sensation in eye (feeling that there is
something in your eye).

5. Invert the bottle, and press lightly with the thumb or index finger over the
“Finger Push Area” (as shown) until a single drop is dispensed into the eye
as directed by your doctor.

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: or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the
safety of this medicine.

5) How to store Trusopt.

Finger Push Area

Keep all medicines out of the sight and reach of children.
Do not use Trusopt after the expiry date which is stated by the six
numbers following EX (or EXP) on the container. The first two numbers
indicate the month; the last four numbers indicate the year. The expiry
date refers to the last day of the month.
Trusopt should be used within 28 days after the bottle is opened.
Store the bottle in the outer carton as this product is sensitive to light.
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.
If your doctor tells you to stop using this solution, please take it back to
your pharmacist for safe disposal. Only keep the solution if your doctor
tells you to. If the solution becomes discoloured or shows signs of any
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.


6) Contents of the pack and other information
6. If drop dispensing is difficult after opening for the first time, replace the
cap on the bottle and tighten (Do not overtighten) and then remove by
turning the cap in the opposite directions as indicated by the arrows on the
top of the cap.
7. Repeat steps 4 & 5 with the other eye if instructed to do so by your
8. Replace the cap by turning until it is firmly touching the bottle. The arrow
on the left side of the cap must be aligned with the arrow on the left side of
the bottle label for proper closure. Do not overtighten or you may damage
the bottle and cap.
9. The dispenser tip is designed to provide a single drop; therefore, do NOT
enlarge the hole of the dispenser tip.

What Trusopt contains
The active substance in Trusopt is dorzolamide.
Trusopt contains 2% dorzolamide, a sulphonamide-related compound, as
the active ingredient. Each ml contains 22.3mg of dorzolamide
hydrochloride equivalent to 20.0mg of dorzolamide.
In addition Trusopt contains the following inactive ingredients:
hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide,
benzalkonium chloride (a preservative) and water for injections.
What Trusopt looks like and the contents of the pack
Trusopt is a clear, colourless, isotonic, buffered, slightly viscous, sterile
aqueous solution.
Trusopt is available as plastic dropper bottles containing 5 ml of solution.

10. After you have used all doses, there will be some medicine left in the
bottle. You should not be concerned since an extra amount of medicine has
been added and you will get the full amount of medicine that your doctor
prescribed. Do not attempt to remove the excess medicine from the bottle.
If you use more Trusopt than you should
If you put too many drops in your eye or swallow any of the contents of the
container, you should contact your doctor immediately.
If you forget to use Trusopt
It is important to take this medicine as prescribed by your doctor. If you miss
a dose, take 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 take a double dose to make up for the forgotten dose.
If you stop using Trusopt
If you want to stop using this medicine talk to your doctor first. If you have
any further questions on the use of this product, ask your doctor or

4) Possible side effects
Like all medicines, this medicine 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 have been reported with Trusopt either during
clinical trials or during post-marketing experience:
Very Common side effects: (affects more than 1 user in 10)
Burning and stinging of the eyes.

PL 10383/0577


Who makes and repackages your medicine:
Your medicine is manufactured by Laboratoires Merck Sharp & DohmeChibret, Mirabel Plant, Route de Marsat, Riom 63963 Clermont Ferrand
Cedex 9, France. Procured from within the EU and repackaged by the
Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 21.12.2017
How can I learn more about Trusopt, increased eye pressure or
This leaflet gives you the most important information about Trusopt. If you
have any questions after you have read it, ask your doctor or pharmacist,
who can give you more information about Trusopt and your eye condition.
Further information about glaucoma is available from:
International Glaucoma Association (IGA)
Woodcote House
15 Highpoint Business Village
Kent, TN24 8DH
Tel: 01233 648170
Registered Charity number 274681.
Alternatively, if you or someone you know has problems with their vision,
and you require further advice or information, please phone the Royal
National Institute for the Blind (RNIB) Helpline on 0303 123 9999, Monday
to Friday 8.45am to 6pm and Saturday 9am to 4pm, calls charged at local

Common side effects: (affects 1 to 10 users in 100)
Disease of the cornea with sore eye and blurred vision (superficial
punctuate keratitis), discharge with itching of the eyes (conjunctivitis),
irritation/inflammation of the eyelid, blurred vision, headache, nausea, bitter
taste, and fatigue.

(The IGA and RNIB are independent UK charities and are not associated
with Merck Sharp & Dohme Limited or Primecrown Ltd.)

Uncommon side effects: (affects 1 to 10 users in 1,000)
Inflammation of the iris.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

Rare side effects: (affects 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.

Trusopt® is a registered trade mark of Merck & Co., Inc., Whitehouse
Station, NJ, USA.

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