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COSOPT 20MG/ML + 5MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE / TIMOLOL

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Rare:
Systemic lupus erythematosus (an immune
disease which may cause an inflammation of
internal organs), tingling or numbness of the
hands or feet, trouble sleeping, nightmares,
memory loss, an increase in signs and symptoms
of myasthenia gravis (muscle disorder), decreased
sex drive, stroke, temporary short sightedness
which may resolve when treatment is stopped,
detachment of the layer below the retina that
contains blood vessels following from filtration
surgery which may cause visual disturbances,
drooping of the eyelids (making the eye stay half
closed), double vision, eyelid crusting, swelling of
the cornea (with symptoms of visual disturbances),
low pressure in the eye, ringing noises in your ear,
low blood pressure, changes in the rhythm or
speed of the heartbeat, congestive heart failure
(heart disease with shortness of breath and
swelling of feet and legs due to fluid build up),
oedema (fluid build up), cerebral ischaemia
(reduced blood supply to the brain), chest pain,
palpitations (a quicker and/or irregular heartbeat),
heart attack, Raynaud’s phenomenon, swelling or
coldness of your hands and feet and reduced
circulation in your arms and legs, leg cramps
and/or leg pain when walking (claudication),
shortness of breath, feeling out of breath, runny or
stuffed nose, nose bleed, constriction of the
airways in the lungs causing difficulty in breathing,
cough, throat irritation, dry mouth, diarrhoea,
contact dermatitis, hair loss, skin rash with white
silvery coloured appearance (psoriasiform rash),
Peyronie’s disease (which may cause a curvature
of the penis), allergic type reactions such as rash,
hives, itching, in rare cases possible swelling of
the lips, eyes and mouth, wheezing, or severe skin
reactions (Stevens Johnson syndrome,
toxic epidermal necrolysis).
Like other medicines applied into your eyes,
timolol is absorbed into the blood. This may cause
similar side effects as seen with oral beta-blocking
agents. Incidence of side effects after topical
ophthalmic administration is lower than when
medicines are, for example, taken by mouth or
injected. Listed additional side effects include
reactions seen within the class of beta-blockers
when used for treating eye conditions:
Not known:
Low blood glucose levels, heart failure, a type of
heart rhythm disorder, abdominal pain, vomiting,
muscle pain not caused by exercise, sexual
dysfunction.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE COSOPT
• Keep out of the sight and reach of children.
• Do not use Cosopt after the expiry date which
is stated on the bottle and carton.
• You can use Cosopt for 28 days after first
opening the container.
• 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.
• If your medicine becomes discoloured or show
any other signs of deterioration, ask your
pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Cosopt contains
• The active substances are dorzolamide
hydrochloride and timolol maleate.
• Each ml contains 20 mg of dorzolamide (as
22.26 mg dorzolamide hydrochloride) and 5 mg
of timolol (as 6.83 mg timolol maleate).
• The other ingredients are hydroxyethyl cellulose,
mannitol, sodium citrate, sodium hydroxide, and
water for injections. Benzalkonium chloride is
added as a preservative.
What Cosopt looks like and contents of the
pack
Cosopt is a clear, colourless to nearly colourless
slightly viscous solution.
Each bottle contains 5ml of solution. Tamper
evidence is provided by a safety strip on the
container label.
Manufacturer and Licence Holder
This medicine is manufactured by Laboratories
Merck Sharp & Dohme-Chibret, Route de Marsat,
63200 Riom, France and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM
PL 15184/1443 Cosopt 20mg/ml + 5mg/ml
eye drops solution
Cosopt is a registered trademark of Merck Sharp
& Dohme Corp.
Leaflet revision date: 22/09/2014

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Ref: 1443/220914/1/F

®

Cosopt 20mg/ml + 5mg/ml eye drops solution
(dorzolamide hydrochloride / timolol maleate)
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 side effects not
listed in this leaflet. See section 4.
Your medicine is called Cospot 20mg/ml + 5mg/ml
eye drops solution and will be referred to as
Cospot throughout the rest of this leaflet.
What is in this leaflet:
1. What Cosopt is and what it is used for
2. What you need to know before you use Cosopt
3. How to use Cosopt
4. Possible side effects
5. How to store Cosopt
6. Contents of the pack and other information
1. WHAT COSOPT IS AND WHAT IT IS USED
FOR
Cosopt contains two medicines: dorzolamide and
timolol.
• Dorzolamide belongs to a group of medicines
called “carbonic anhydrase inhibitors”.
• Timolol belongs to a group of medicines called
“beta blockers”.
These medicines lower the pressure in the eye in
different ways.
Cosopt is prescribed to lower raised pressure in
the eye in the treatment of glaucoma when
beta-blocker eyedrop medicine used alone is not
adequate.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE COSOPT
Do not use Cosopt
• if you are allergic to dorzolamide hydrochloride,
timolol maleate or any of the other ingredients
of this medicine (listed in section 6).
• if you have now or had in the past respiratory
problems, such as asthma or severe chronic
obstructive bronchitis (severe lung disease
which may cause wheeziness, difficulty in
breathing and/or long-standing cough).
• if you have a slow heart beat, heart failure or
disorders of heart rhythm (irregular heart beats).
• if you have severe kidney disease or problems,
or a prior history of kidney stones.
• if you have excess acidity of the blood caused
by a build up of chloride in the blood
(hyperchloraemic acidosis).
If you are not sure whether you should use this
medicine, contact your doctor or pharmacist.

Warnings and precautions
Talk to your doctor before using Cosopt.
Tell your doctor about any medical or eye
problems you have now or have had in the past:
• coronary heart disease (symptoms can include
chest pain or tightness, breathlessness, or
choking), heart failure, low blood pressure.
• disturbances of heart rate such as slow heart
beat.
• breathing problems, asthma or chronic
obstructive pulmonary disease.
• poor blood circulation disease (such as
Raynaud’s disease or Raynaud’s syndrome).
• diabetes as timolol may mask signs and
symptoms of low blood sugar.
• overactivity of the thyroid gland as timolol may
mask signs and symptoms.
Tell your doctor before you have an operation that
you are using Cosopt as timolol may change
effects of some medicines used during
anaesthesia.
Also tell your doctor about any allergies or allergic
reactions including hives, swelling of the face, lips,
tongue, and/or throat which may cause difficulty in
breathing or swallowing.
Tell your doctor if you have muscle weakness or
have been diagnosed as having myasthenia
gravis.
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 Cosopt is causing an allergic
reaction or hypersensitivity (for example, skin rash,
severe skin reaction, or redness and itching of the
eye), stop using this medicine and contact your
doctor immediately.
Tell your doctor if you develop an eye infection,
receive an eye injury, have eye surgery, or
develop a reaction including new or worsening
symptoms.
When Cosopt is instilled into the eye it may affect
the entire body.
If you wear soft contact lenses, you should consult
your doctor before using this medicine.
Use in children
There is limited experience with Cosopt in infants
and children.
Use in elderly
In studies with Cosopt, 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 Cosopt
Cosopt can affect or be affected by other
medicines you are using, including other eye
drops for the treatment of glaucoma.

Tell your doctor if you are using or intend to use
medicines to lower blood pressure, heart medicine
or medicines to treat diabetes. Please tell your
doctor or pharmacist if you are using, have
recently used or might use any other medicines.
This is particularly important if you are:
• taking medicine to lower blood pressure or to
treat heart disease (such as calcium channel
blockers, beta-blockers or digoxin).
• taking medicines to treat a disturbed or irregular
heartbeat such as calcium channel blockers,
beta-blockers or digoxin.
• using another eyedrop that contains a betablocker.
• taking another carbonic anhydrase inhibitor
such as acetazolamide.
• taking monoamine oxidase inhibitors (MAOIs)
which are used to treat depression.
• taking a parasympathomimetic medicine which
may have been prescribed to help you pass
urine. Parasympathomimetics are also a
particular type of medicine which is sometimes
used to help restore normal movements through
the bowel.
• taking narcotics such as morphine used to treat
moderate to severe pain.
• taking medicines to treat diabetes.
• taking antidepressants known as fluoxetine and
paroxetine.
• taking a sulfa medicine.
• taking quinidine (used to treat heart conditions
and some types of malaria).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.

If you are using this medicine with another eye
drop, the drops should be instilled at least 10
minutes apart.
Do not change the dose of the medicine without
consulting your doctor.
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 of the container, 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.

Use in breast-feeding
Do not use Cosopt if you are breast-feeding.
Timolol may get into your milk. Ask your doctor for
advice before taking any medicine during
breast-feeding.

Cosopt contains benzalkonium chloride
If you wear soft contact lenses, you should consult
your doctor before using Cosopt (the preservative
benzalkonium chloride may possibly discolour the
lenses).
3. HOW TO USE COSOPT
Always use Cosopt 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.
The recommended dose is one drop in the
affected eye(s) in the morning and in the evening.

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.

If you forget to use Cosopt
It is important to use this medicine as prescribed
by your doctor. If you miss a dose, use 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 use a double
dose to make up for the forgotten dose.
If you stop using Cosopt
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, Cosopt can cause side effects,
although not everybody gets them.

DO NOT TOUCH YOUR EYE OR EYELID WITH
THE DROPPER TIP.
6. After using Cosopt press a finger into the
corner of your eye, by the nose, or close your
eyelids for 2 minutes.
This helps to stop the medicine from getting
into the rest of the body.

2. Tear off the Safety Strip to break the seal.

Use in pregnancy
Do not use Cosopt if you are pregnant unless your
doctor considers it necessary

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 Cosopt, such as
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.

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.

7. 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.
8. Repeat steps 4 & 5 with the other eye if
instructed to do so by your doctor.
9. 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.
10. The dispenser tip is designed to provide a
single drop; therefore, do NOT enlarge the hole
of the dispenser tip.
11. After you have used all doses, there will be
some Cosopt left in the bottle. You should not
be concerned since an extra amount of this
medicine has been added and you will get the
full amount of Cosopt that your doctor
prescribed. Do not attempt to remove the
excess medicine from the bottle.
If you use more Cosopt than you should
If you put too many drops in your eye or swallow
any of the contents of the container, among other
effects, you may become light-headed, have
difficulty breathing, or feel that your heart rate has
slowed. Contact your doctor immediately.

You can usually carry on taking the drops, unless
the effects are serious. If you’re worried, talk to a
doctor or pharmacist.Do not stop using Cosopt
without speaking to your doctor.
Generalised allergic reactions including swelling
beneath the skin that can occur in areas such as
the face and limbs, and can obstruct the airway
which may cause difficulty swallowing or
breathing, hives or itchy rash, localised and
generalised rash, itchiness, severe sudden
life-threatening allergic reaction.
The frequency of possible side effects listed below
is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from
the available data)
The following side effects have been reported with
Cosopt or one of its components either during
clinical trials or during post-marketing experience:
Very Common:
Burning and stinging of the eyes, unusual taste.
Common:
Redness in and around the eye(s), watering or
itching of the eye(s), corneal erosion (damage to
the front layer of the eyeball), swelling and/or
irritation in and around the eye(s), feeling of
having something in the eye, decreased corneal
sensitivity (not realising of getting something in the
eye and not feeling pain), eye pain, dry eyes,
blurred vision, headache, sinusitis (feeling of
tension or fullness in the nose), feeling sick, also
called nausea, weakness/tiredness, and fatigue.
Uncommon:
Dizziness, depression, inflammation of the iris,
visual disturbances including refractive changes
(in some cases due to withdrawal of medication to
treat excessive contraction of the pupil of the eye),
slow heartbeat, fainting, difficulty breathing
(dyspnoea), indigestion, and kidney stones (often
marked by a sudden onset of excruciating,
cramping pain in their low back and/or side, groin,
or abdomen).

Ref: 1443/220914/1/B

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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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