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

Active substance: TIMOLOL MALEATE

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Patient Information Leaflet
Cosopt® 20 mg/ml + 5 mg/ml eye drops, solution
(dorzolamide / timolol)
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.
The name of your medicine is Cosopt 20 mg/ml + 5 mg/ml eye
drops, solution, but will be referred to as Cosopt throughout the
remainder of the 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

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.

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”.

Use in children
There is limited experience with Cosopt in infants and children.

These medicines lower the pressure in the eye in different ways.

Use in patients with liver impairment
Tell your doctor about any liver problems you now have or have
suffered from in the past.

Cosopt is prescribed to lower raised pressure in the eye in the
treatment of glaucoma when beta-blocker eye drop 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.

Use in elderly
In studies with Cosopt, the effects of this medicine were similar in
both elderly and younger patients.

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. 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 eye drop that contains a beta-blocker.

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

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.

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.

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.
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 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.

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

The recommended dose is one drop 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 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.

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.

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.

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

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

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.

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.
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, this medicine can cause side effects, although
not everybody gets them.
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 postmarketing 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).
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.
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.
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 this medicine after the date shown by the six digits
following EX (or EXP) on the 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.
This medicinal product does not require any special temperature
storage conditions. Keep the bottle in the outer carton in order to
protect from light.
You can use Cosopt for 28 days after first opening the container.
Medicine 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 Cosopt contains
Eye drops, solution, containing clear, colourless to nearly
colourless, slightly viscous solution
Cosopt contains the active ingredient dorzolamide and timolol.
Each ml contains 20 mg of dorzolamide (as 22.26 mg
dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg
timolol maleate).
Also contains hydroxyethyl cellulose, mannitol, sodium citrate,
sodium hydroxide for pH adjustment and water for injections.
Benzalkonium chloride is added as a preservative.
Manufactured by Laboratories Merck Sharp & Dohme Chibret
(Mirabel Plant) Route de Marsat, Riom 63963 Clermont-Ferrand,
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.
Cosopt 20 mg/ml + 5 mg/ml eye drops, solution
PL 20774/1282
POM
th
Leaflet revision date 24 October 2014

Cosopt is a registered trademark of Merck Sharp & Dohme Corp.
PP3/1282/V3
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT
COSOPT, INCREASED EYE PRESSURE OR GLAUCOMA?
This leaflet gives you the most important information about
COSOPT. If you have any questions after you have read it, ask
your doctor or pharmacist, who can give you more information
about COSOPT 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 Merck Sharp & Dohme Limited or Quadrant
Pharmaceuticals Ltd.)

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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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