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TRUSOPT 20MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE / DORZOLAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRUSOPT® 20 MG/ML EYE DROPS, SOLUTION
(dorzolamide hydrochloride)
This product is available in the above name but will be referred
to as Trusopt throughout the remainder of this 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 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.

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 ►

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.

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

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.
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.

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.

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.
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.

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

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 the contents of the
container are swallowed, 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 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.
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 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 TRUSOPT

Keep 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 bottle and outer carton.
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.
This medicinal product does not require any special temperature
storage conditions.
Store in the original package. Protect from 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
6.

Contents of the pack and other information

What TRUSOPT contains
 The active substance is dorzolamide.
Each ml contains 20mg of dorzolamide (as hydrochloride).
 The other ingredients are hydroxyethyl cellulose, mannitol,
sodium citrate, sodium hydroxide for pH adjustment, and water
for injections. Benzalkonium chloride is added as a preservative.
What TRUSOPT looks like and contents of the pack
TRUSOPT is a clear, colourless to nearly colourless slightly viscous
solution. The OCUMETER Plus Ophthalmic Dispenser consists of a
translucent high-density polyethylene container containing 5.0 ml of
solution. Tamper evidence is provided by a safety strip on the
container label.
Pack sizes: 1 x 5.0ml (single 5ml container)
Manufacturer
Manufactured by Laboratories Merck Sharp & Dohme-Chibret,
Mirabel Plant, Route de Marsat, RIOM, 63963 Clermont-Ferrand
Cedex 9, France. Procured within the EU. Repackaged by the
Product Licence holder: G-Pharma Ltd, Salford M50 2PU.
PL 16369/1509

POM

Leaflet revision: 9th December 2015
‘Trusopt’ is a registered trademark of Merck Sharp & Dohme.

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 6pm and Saturday 9am to
4pm, calls charged at local rate.
(The IGA and RNIB are independent UK charities and are not
associated with Merck Sharp & Dohme Limited.)

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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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