COSOPT EYEDROPS SOLUTION

Active substance: TIMOLOL MALEATE

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COSOPT® EYEDROPS SOLUTION
(dorzolamide / timolol)







PATIENT INFORMATION LEAFLET
Your medicine is available using the name Cosopt Eyedrops Solution but will be referred to as Cosopt
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
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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.

this leaflet:
What Cosopt is and what it is used for
Before you use Cosopt
How to use Cosopt
Possible side effects
How to store Cosopt
Further information

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.

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).

WHAT COSOPT IS AND WHAT IT IS USED FOR

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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”.

The usual dose is one drop in the affected eye(s) in the morning and in the evening.

Cosopt is prescribed to lower raised pressure in the eye in the treatment of glaucoma when betablocker eyedrop medicine used alone is not adequate.

If you are using this medicine with another eye drop, the drops should be instilled at least 10 minutes
apart.

BEFORE YOU USE COSOPT

Do not change the dose of the medicine without consulting your doctor.

Do not use Cosopt






HOW TO USE COSOPT

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.

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

2.

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).

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).

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.

2.

Tear off the Safety Strip to break the seal.

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 are not sure whether you should use this medicine, contact your doctor or pharmacist.

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.
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.

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.
Page 1 of 2

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.

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).

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.

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.
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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.

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.

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.

Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.

5.




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 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.



6.

If you use more Cosopt than you should

FURTHER INFORMATION

What Cosopt contains

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.

Each ml of solution contains 20mg dorzolamide and 5mg of timolol as the active ingredients
(2% dorzolamide hydrochloride and 0.5% timolol maleate).
In addition, Cosopt contains the following inactive ingredients: hyetellose, mannitol, sodium
citrate, sodium hydroxide and water for injection. Benzalkonium chloride (0.075mg/ml) is added as
preservative.

What Cosopt looks like and contents of the pack
Cosopt is a clear colourless sterile eye drop solution.

Cosopt is available in bottles containing 5ml of solution.

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.

HOW TO STORE COSOPT

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use this medicine after the expiry date which is clearly marked on the container. The expiry
date refers to the last day of that month.
Store Cosopt at room temperature. Store the bottle in the outer carton as this product is sensitive
to light.
Cosopt should be used within four weeks after the bottle is first opened.
Do not transfer Cosopt eye drops into another container, they might get mixed up or
contaminated.
If your eye drops appear to be discoloured or show any other signs of deterioration, please return
your medicine to your pharmacist who will advise you further.
If your doctor tells you to stop using the eye drops, please take them back to the pharmacist for
safe disposal. Only keep the medicine if your doctor tells you to.
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.

Manufacturer

Your medicine is manufactured by: Laboratoires Merck Sharp and Dohme Chibret (Mirabel Plant),
Route de Marsat, Riom, 63963 Clermont-Ferrand, Cedex 9, France.

POSSIBLE SIDE EFFECTS

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Like all medicines, Cosopt 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.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

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 No: 21828/0093

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)

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.

POM

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT COSOPT, INCREASED EYE
PRESSURE OR GLAUCOMA?

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.

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.

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 Landmark Pharma Ltd.)

Uncommon:

COSOPT® is a registered trademark of Merck Sharp & Dohme Corp.

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).

Leaflet revision date: 18.01.13

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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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