COSOPT EYE DROPS

Active substance: TIMOLOL MALEATE

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Cosopt® Eye Drops
(dorzolamide / timolol)
Your medicine is known by the above name, but will be referred to as
Cosopt throughout this:

Patient Information 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 Cosopt is and what it is used for
2) Before you use Cosopt
3) How to use Cosopt
4) Possible side effects
5) How to store Cosopt
6) Further 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.

 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 breastfeeding.
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 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.

Important information about some of the ingredients of Cosopt
If you wear soft contact lenses, you should consult your doctor before
using Cosopt (the preservative benzalkonium chloride may possibly
discolour the lenses).

2) Before you use Cosopt

3) How to use Cosopt

Do not use Cosopt
 if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol
maleate or any of the other ingredients of Cosopt.
 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 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).

Always use Cosopt 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 not sure whether you should use Cosopt, contact your doctor or
pharmacist.

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.

Take special care with 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.

The usual dose is one drop in the affected eye(s) in the morning and in the
evening.
If you are using Cosopt 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.

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.

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.

2. Tear off the safety strip to break the seal

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.

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.

Use in children
There is limited experience with Cosopt in infants and children.
Use in elderly
In studies with Cosopt, the effects of Cosopt 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
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 taking or have recently taken any other medicines,
including medicines obtained without a prescription. 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 beta-blocker
 taking another carbonic anhydrase inhibitor such as acetazolamide.
 taking monoamine oxidase inhibitors (MAOIs) which are used to treat
depression.

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.

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.

7. Close your eye for a moment and press the inner corner of the eye with
your finger for about one minute. This helps to prevent the eye drop from
draining down the tear duct.
8. 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.
9. Repeat steps 4 & 5 with the other eye if instructed to do so by your
doctor.
10. 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.
11. The dispenser tip is designed to provide a single drop; therefore, do
NOT enlarge the hole of the dispenser tip.
12. 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 Cosopt
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 Cosopt 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.

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.

5) How to store Cosopt
 Keep all medicines 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 day; the
second two digits indicate the month and the last 2 digits indicate the
year. The expiry date refers to the last day of that month.
 Discard any unused solution 28 days after opening.
 Do not transfer ‘Cosopt Eye Drops’ into another container, they might get
mixed up or contaminated.
 Store ‘Cosopt Eye Drops’ at room temperature below 25°C. Protect from
light.
 If the solution becomes discoloured or shows signs of any deterioration,
you should seek the advice of your pharmacist who will advise you what
to do.
 Medicines should not be thrown in your bin or put down the drain. If they
are out of date, or no longer suitable for you, return them to your
pharmacist for safe disposal. These measures will help protect the
environment.

6) Further information
What Cosopt contains:
 The active substances are dorzolamide and timolol.
 ‘Cosopt Eye Drops’ is a sterile eye drop solution. Each ml of solution
contains Dorzolamide hydrochloride equivalent to 20mg Dorzolamide
and Timolol maleate equivalent to 5mg Timolol.

Like all medicines, Cosopt can cause side effects, although not everybody
gets them.

In addition, ‘Cosopt Eye Drops’ contains the following inactive ingredients:
hydroxyethylcellulose, mannitol E421, sodium citrate, sodium hydroxide
and water for injection. Benzalkonium chloride (0.075 mg/mI) is added as
preservative.

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.

What Cosopt looks like and contents of the pack
‘Cosopt Eye Drops’ is a clear liquid and is available in dropper applicator
plastic bottles containing 5ml of solution.

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.

PL 10383/1023

4) Possible side effects

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).

Cosopt Eye Drops POM

Who makes and repackages your medicine?
Your medicine is manufactured Merck Sharp & Dohme Chibret
Laboratories, 200 Boulevard Etienne Clementel 63018 Clermen-Ferrand
Cedex France Procured from within the EU and repackaged by Product
Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue
Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 25.09.2012
Cosopt® is a registered trademark of Merck Sharp & Dhome Corp.
Whitehouse Station, NJ, USA.

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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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