Skip to Content

TRUSOPT 2% OPHTHALMIC SOLUTION

Active substance(s): DORZOLAMIDE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

27/02/14

DATE:

DATE:

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Trusopt ophthalmic solution

ARTWORKER:

CODE:

6464/2123 E

DATE OF PROOF:

PROOF HISTORY:
v.1 - waymade - 27/02/14

Vusż‹
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JULY 2010
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

POM

PL No: 6464/2123

This product is manufactured by Laboratoires Merck Sharp & Dohme –Chibret, Riom, 63963
Clermont-Ferrand Cedex 9, France and is procured from within the EU and repackaged by the Product
Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 27.02.2014
Trusopt® is a registered trademark of Merck & Co. Inc.
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 Waymade Plc.)

TRUSOPT® 2% OPHTHALMIC SOLUTION
(dorzolamide hydrochloride)
Patient Information Leaflet

This medicine is known as the above name 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.
In this leaflet:
1. What Trusopt is and what it is used for
2. Before you use Trusopt
3. How to use Trusopt
4. Possible side effects
5. How to store Trusopt
6. Further 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. 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 breastfeeding 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.

Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

¥uhuGK
,}6sZ²

¦h6Zƒ

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Trusopt ophthalmic solution

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/2123 E

DATE OF PROOF:

27/02/14

DATE:

CUSTOMER
APPROVED:
DATE:

PROOF HISTORY:
v.1 - waymade - 27/02/14

Vusż‹
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JULY 2010
REPORTING OF SIDE EFFECTS

Pg 2

3. How to use Trusopt

Pg 3

9.

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.
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.
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.
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.
Opening Arrows

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.

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

Safety Strip

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
post-marketing experience:

Fig. 1

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

Fig. 2
Gap

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.

2. Tear off the Safety Strip to break the seal.
Finger - Push
Area

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

Fig. 3

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.

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

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.

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

Fig. 4

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

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Trusopt

Fig. 5
w Finger Push Area

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.

Trusopt 2% ophthalmic solution should not be stored above 30°C. Keep in it’s original packaging and
protect from light. Discard 28 days after opening.
Do not use after the expiry date printed on the carton or bottle label. The expiry date refers to the last
day of the month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the eye drops, please take them back to the pharmacist for safe
disposal. Only keep the eye drops if your doctor tells you to.
If the eye drops become discoloured or show any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.
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
Your medicine is called Trusopt 2% ophthalmic solution. Trusopt 2% ophthalmic solution is a sterile eye
drop solution. Each millilitre of solution contains 20mg of the active ingredient, dorzolamide present as
the hydrochloride in a clear, colourless solution.

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.

Trusopt 2% ophthalmic solution also contains the following inactive ingredients:
hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and purified water.
Benzalkonium chloride is added as a preservative.
Trusopt 2% ophthalmic solution is available as bottles containing 5ml of solution.

Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

¥uhuGK
,}6sZ²

¦h6Zƒ

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Expand view ⇕

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.

Hide