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TRUSOPT PRESERVATIVE-FREE 20MG/ML EYE DROPS SOLUTION SINGLE DOSE CONTAINER

Active substance(s): DORZOLAMIDE

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Package leaflet: information for the user

Trusopt® Preservative-Free 20mg/ml
eye drops, solution, single dose container
(dorzolamide hydrochloride)
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 Preservative-Free
is and what it is used for
2. What you need to know
before you use Trusopt
Preservative-Free
3. How to use Trusopt
Preservative-Free

4. Possible side effects
5. How to store Trusopt
Preservative-Free
6. Contents of the pack
and other information

1. What Trusopt Preservative-Free is and what it is used for
Trusopt Preservative-Free 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
Preservative-Free
Do not use Trusopt Preservative-Free
− 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.
If you are not sure whether you should use this medicine, contact
your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Trusopt
Preservative-Free.
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 Preservative-Free is causing an
allergic reaction (for example, skin rash, severe skin reaction, or
itching), stop using this medicine and contact your doctor
immediately.
If you wear contact lenses, you should consult your doctor before
using Trusopt Preservative-Free.

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
You should not use this medicine during breast-feeding. 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 Preservative-Free, 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.
3. How to use Trusopt Preservative-Free
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 Preservative-Free in
the affected eye(s) in the morning and in the evening.
If you are using Trusopt Preservative-Free with another eye
drop, the drops should be instilled at least 10 minutes apart.
Do not change the dose of the drug without consulting your
doctor.
Do not allow the tip of the single dose 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
of the single dose container, wash your hands before using this
medicine and keep the tip of the single dose container away from
contact with any surface.
Instructions for use:
The solution from one individual single dose container of Trusopt
Preservative-Free is to be used immediately after opening for
administration to the affected eye(s). Since sterility cannot be
maintained after the individual single dose container is opened, a
new container must be opened prior to each use and must be
discarded immediately after administration. Each single dose
container contains enough solution for both eyes.
1. Open the foil sachet which contains 15 individual single dose
containers. There are three strips of 5 single dose containers
each in the sachet.
2. First wash your hands then break off one single dose
container from the strip and twist open the top of the single dose
container as shown.

Use in children
Trusopt (preserved formulation) 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 (preserved formulation), the effects of this
medicine were similar in both elderly and younger patients.

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

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 Preservative-Free
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.
4. Put one drop in the affected eye(s) as directed by your doctor.
5. After putting the drop into the eye, throw away the used single
dose container even if there is solution remaining to avoid
contamination of the preservative free solution.

6. Store the remaining containers in the foil sachet; the remaining
containers must be used within 15 days after opening of the
sachet. If there are any containers left 15 days after opening the
sachet they should be safely thrown away and a fresh sachet
opened. It is important to continue to use the eye drops as
prescribed by your doctor.
If you use more Trusopt Preservative-Free 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 Preservative-Free
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 Preservative-Free
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.

6. Contents of the pack and other Information
Each ml contains 22.26 mg of dorzolamide hydrochloride
equivalent to 20 mg of dorzolamide.
Also contains: hydroxyethyl cellulose, mannitol (E421), sodium
citrate (E331), sodium hydroxide for pH adjustment and water for
injections.
Trusopt Preservative-Free is a clear, colourless to nearly
colourless, slightly viscous solution.
Each aluminum sachet contains 15 low density polyethylene
single dose containers containing 0.2 ml of solution.
Trusopt Preservative-Free is available in a pack size of 60 x 0.2
ml (4 sachets with 15 single dose containers).
Manufactured by: Laboratoires Merck Sharp & Dohme Chibret
(MIRABEL PLANT) Route de Marsat, RIOM 63963 ClermontFerrand, Cedex 9, France. Procured from within the EU. Product
Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by
Maxearn Ltd, Bolton BL6 4SA.
PL 20774/1436

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,
localised 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 Preservative-Free 20mg/ml eye drops,
solution

Trusopt is a registered trademark of Merck Sharp & Dohme Ltd
th
Date of preparation 28 October 2015

POM

How can I learn more about Trusopt Preservative-Free,
increased eye pressure or glaucoma?
This leaflet gives you the most important information about
Trusopt Preservative-Free. If you have any questions after you
have read it, ask your doctor or pharmacist, who can give you
more information about Trusopt Preservative-Free 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.
(The IGA and RNIB are independent UK charities and are not
associated with Santen Oy or Quadrant Pharmaceuticals Ltd.)

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 Preservative-Free
Keep out of the sight and reach of children.
Do not use the unopened sachets of Trusopt Preservative-Free
after the expiry date which is stated by the six digits following
EXP on the outer carton, foil package and each single dose
container. The first two digits indicate the month; the last four
digits indicate the year. The expiry date refers to the last day of
that month. Do not store above 30°C. Do not freeze. Store in the
foil sachet in order to protect from light.
You can use Trusopt Preservative-Free 15 days after first
opening the sachet.
Discard any unused single dose containers after that time.
Discard the opened single dose container with any remaining
solution immediately after first use.
If the solution shows any signs of discolouration or deterioration
consult your pharmacist for advice.
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.

PP1/1436/V3

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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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