DORZOLAMIDE 2% EYE DROPS SOLUTION

Active substance: DORZOLAMIDE HYDROCHLORIDE

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3.

TRUSOPT® 2% EYE DROPS SOLUTION
/ DORZOLAMIDE 2% EYE DROPS SOLUTION
(dorzolamide hydrochloride)

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

PATIENT INFORMATION LEAFLET

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 Trusopt in the affected eye(s) in the morning and in the
evening.

Your medication is available using the names Trusopt 2% Eye Drops Solution / Dorzolamide 2% Eye
Drops Solution, but will be referred to as Trusopt throughout this leaflet.
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.

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HOW TO USE TRUSOPT

Always use Trusopt 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.

If you are using this medicine 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.

this leaflet:
What Trusopt is and what it is used for
Before you use Trusopt
How to use Trusopt
Possible side effects
How to store Trusopt
Further information

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.

2.

Tear off the Safety Strip to break the seal.

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.

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.

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.

BEFORE YOU USE TRUSOPT

Do not use Trusopt



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

Take special care with Trusopt

Tell your doctor 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 this medicine is causing an allergic reaction (for example, skin rash, severe skin
reaction or itching) stop its use 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 Trusopt 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.

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 Trusopt

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.

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

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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.

Manufacturer

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.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

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Your eye drops are made by: Laboratories Merck Sharp & Dohme, Chibret, Route de Marsat, Riom,
63963 Clermont-Ferrand Cedex 9, France.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0158

The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the
dispenser tip.

Leaflet revision and issue date (Ref): 09.01.13

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.

TRUSOPT® is a registered trademark of Merck Sharp & Dohme Corp.

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.

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.

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.

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.

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.

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.

(The IGA and RNIB are independent UK charities and are not associated with BR Lewis Pharmaceuticals
Group Ltd.)

POSSIBLE SIDE EFFECTS

Like all medicines, Trusopt 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 postmarketing experience:

Very Common side effects: (more than 1 user in 10)
Burning and stinging of the eyes.

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

Rare side effects: (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.
If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell
your doctor or pharmacist.

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 on the carton and bottle. The expiry date
refers to the last day of that month.
Do not store above 30°C. Protect from light.
Discard 28 days after first opening.
If the solution becomes discoloured or shows any other sign of deterioration, take it to your pharmacist
who will advise you.
If your doctor tells you to stop using the solution, please take it back to your pharmacist for safe
disposal. Only keep the solution if your doctor tells you to.
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.

POM

FURTHER INFORMATION

What Trusopt contains

Trusopt is a sterile eye drop solution. Trusopt contains 2% dorzolamide, a sulphonamide-related
compound, as the active ingredient.
In addition, Trusopt contains the following inactive ingredients: hydroxyethylcellulose, mannitol E421,
sodium citrate, sodium hydroxide, and water for injection.
Benzalkonium chloride (0.075mg/ml) is added as a preservative.

What Trusopt looks like and contents of the pack
Trusopt is available in bottles containing 5ml of clear solution.

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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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