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TRUSOPT OPHTHALMIC SOLUTION 2%

Active substance(s): DORZOLAMIDE HYDROCHLORIDE

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Trusopt® Ophthalmic Solution, 2%
(dorzolamide hydrochloride)
This medicine is known by the above name but will be referred to as
Trusopt throughout this leaflet.
Package leaflet: information for the user
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 4.
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.

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 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 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 betablocker 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.

Warnings and precautions
Talk to your doctor or pharmacist before using Trusopt.

Instructions for use:

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.

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.

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.
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.
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.
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.

Opening Arrows
Safety Strip

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

Gap
Finger Push Area
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 properly.

Finger Push Area

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

Finger Push Area

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 (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at : www.mhra.gov.uk/yellowcard

5. HOW TO STORE TRUSOPT

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
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
doctor.
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.
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
pharmacist.

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

Do not store above 30°C. Protect from light.
Keep out of the sight and reach of children.
Discard any unused solution 28 days after first opening.
Do not use this medicine after the expiry date which is stated on the bottle
and outer carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop using the eye drops, take them back to your
pharmacist for safe disposal.
Only keep them if your doctor tells you to.
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.
If your eye drops become discoloured or show any other signs of
deterioration, seek the advice of your pharmacist who will tell you what to
do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
The name of your medicine is Trusopt.
Dorzolamide (as the hydrochloride).

Each ml contains 2%w/v

Your eye drops also contain the following ingredients: mannitol (E421),
hydroxyethylcellulose, sodium citrate, sodium hydroxide, water for
injections and benzalkonium chloride.
Trusopt is available as a 5ml sterile ophthalmic solution contained in a
translucent polyethylene container with a dropper tip and a flexible fluted
side area which is depressed to dispense drops. Fitted with a two piece
cap assembly with tamper-evident seal provided by the label.
Dorzolamide hydrochloride is an ophthalmic carbonic anhydrase inhibitor
which lowers pressure in the eye.
Trusopt is manufactured by Laboratoires Merck, Sharp and DohmeChibret, Mirabel Plant, Route de Marsat, Riom 63963 Clermont-Ferrand
Cedex 9, France and is procured from within the EU by the Product
Licence holder: Caseview (PL) Ltd, 20 Alliance Court, Alliance Road,
London W3 0RB and repackaged by OPD Laboratories Ltd, Unit 6
Colonial Way, Watford, Herts WD24 4PR.
PL 13826/0914

POM
Trusopt® Ophthalmic Solution, 2%
Leaflet revision and issue date (Ref) 07/08/2015

Trusopt is a registered trademark of Merck Sharp & Dohme Corp., USA.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.
How can I learn more about Trusopt, increased eye pressure or
glaucoma?
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
Henwood,
Ashford
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 5.30pm, calls charged at local rate.

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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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