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COSOPT PRESERVATIVE FREE 20 MG/ML + 5 MG/ML EYE DROPS SOLUTION SINGLE-DOSE CONTAINER

Active substance(s): DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE / DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE

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Package leaflet: information for the user
COSOPT® Preservative-Free 20 mg/ml + 5 mg/ml
eye drops, solution,single dose container
(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.
What is in this leaflet
1. What COSOPT Preservative-Free is and what it is used for
2. What you need to know before you use COSOPT Preservative-Free
3. How to use COSOPT Preservative-Free
4. Possible side effects
5. How to store COSOPT Preservative-Free
6. Contents of the pack and other information
1. What COSOPT Preservative-Free is and what it is used for
COSOPT Preservative-Free 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 pressure in the eye in different ways.
COSOPT Preservative-Free 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 Preservative-Free
Do not use COSOPT Preservative-Free
• 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 Preservative-Free
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 Preservative-Free as
timolol may change effects of some medicines used during anaesthesia.
Also tell your doctor about any allergies or anaphylactic reactions.
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 Preservative-Free 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 Preservative-Free is instilled into the eye it may affect the entire body.
COSOPT Preservative-Free has not been studied in patients wearing contact lenses. If you wear
soft contact lenses, you should consult your doctor before using this medicine.
Use in children
There is limited experience with COSOPT (preserved formulation) in infants and children.
Use in elderly
In studies with COSOPT (preserved formulation), the effects of COSOPT (preserved formulation)
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 Preservative Free
COSOPT Preservative-Free 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).
• 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 Preservative-Free if you are pregnant unless your doctor considers it
necessary.
Use in breast-feeding
Do not use COSOPT Preservative-Free if you are breast-feeding. Timolol may get into your milk. Ask
your doctor for advice before taking any medicine during breast-feeding.
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 Preservative-Free, 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.
3. How to use COSOPT 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.
The recommended dose is one drop in the affected eye(s) in the morning and in the evening.
If you are using COSOPT Preservative-Free 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.
If you have difficulty administering your eye drops, seek the assistance of a family member or carer.
Do not allow the single dose container to touch the eye or areas around the eye. It could cause
injury to your eye. It may also 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. A new single dose container should be
opened immediately prior to each use; there is enough solution in each container for both eyes if
your doctor has told you to use the drops in both eyes
Discard the opened container with any remaining contents immediately after use.
Instructions for use
Open the foil sachet which contains 15 individual single dose containers. There are three strips of 5
single dose containers each in the sachet. Write the date of first opening on the sachet.
Every time you use COSOPT Preservative-Free
Max. 5 mm {

A.

B.

C.

D.

1.
2.
3.
4.
5.
6.

Wash your hands.
Take the strip of containers from the sachet.
Detach one single dose container from the strip.
Put the remaining strip back in the pouch and fold the edge to close the pouch.
To open the container, twist off the tab. (Picture A)
Hold the container between your thumb and index finger. Note that the tip of the container
must not show more than 5 mm above the edge of your index finger. (Picture B)
7. Tilt your head backwards or lie down. Place your hand on your forehead. Your index finger
should be aligned with your eyebrow or resting on the bridge of the nose. Look up. Pull the
lower eyelid downwards with the other hand. Do not allow any part of the container to touch
your eye or any area around your eye. Gently squeeze the container to let one drop fall into the
space between the lid and the eye (Picture C). Do not blink while applying the drop to your eye.
Each single dose container contains enough solution for both eyes.
8. Close your eye and press the inner corner of the eye with your finger for about two minutes.
This helps to stop the medicine from getting into the rest of the body (Picture D).
9. Wipe off any excess solution from the skin around the eye.
If your doctor has told you to use drops in both eyes, repeat steps 7 to 9 for your other eye.
After putting the drop into the eye(s), throw away the used single dose container even if there is

solution remaining to avoid contamination of the preservative free solution.
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 are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.
Santen would like to find out what you think about the dropper and how you were able to put the
drops into your eyes. If you would like to provide us with any feedback please use the following
free phone line to call and you will be asked some short questions.
Tel: 08450754863
If you use more COSOPT Preservative-Free 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 Preservative-Free
It is important to take COSOPT Preservative-Free 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 take a double dose to make up for the forgotten dose.
If you stop using COSOPT 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.
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 Preservative-Free without speaking to your
doctor.
Generalised allergic reactions including swelling beneath the skin 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 following adverse reactions have been reported with COSOPT Preservative-Free or one of its
components either during clinical trials or during post-marketing experience:
Very common (may affect more than 1 in 10 people):
Burning and stinging of the eyes, taste perversion.
Common (may affect up to 1 in 10 people):
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 realizing of getting something in the eye
and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or
fullness to the nose), nausea, weakness/tiredness and fatigue.
Uncommon (may affect up to 1 in 100 people):
Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes
(due to withdrawal of miotic therapy in some cases), slow heartbeat, fainting, difficulty breathing
(dyspnoea), indigestion, and kidney stones.
Rare (may affect up to 1 in 1,000 people):
Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal
organs), tingling or numbness of the hands or feet, insomnia, 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, respiratory
failure, rhinitis, nose bleed, constriction of the airways in the lungs, 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 Johnsons 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 (side effects have been reported. However, it is not known how often these occur):
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 Preservative-Free
Keep this medicine out of the sight and reach of children.
Do not use the unopened sachets of COSOPT Preservative-Free after the expiry date shown by the
six digits following EX (or EXP) on the foil package. 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 foil sachet in order to protect from light.
You can use COSOPT Preservative-Free 15 days after first opening the sachet.
Discard any unused single dose containers after this time.
Discard the opened single dose container with any remaining solution immediately after first use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What COSOPT Preservative-Free contains

-- The active substances are 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).
-- The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for
injections.

What COSOPT Preservative-Free looks like and contents of the pack
COSOPT Preservative-Free is a clear, colourless to nearly colourless slightly viscous solution. Each
aluminium sachet contains 15 low density polyethylene single dose containers containing 0.2 ml
of solution.
Pack sizes:
30 x 0.2 ml (2 sachets with 15 single dose containers)
60 x 0.2 ml (4 sachets with 15 single dose containers)
120 x 0.2 ml (8 sachets with 15 single dose containers)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder UK:
Santen Oy
Niittyhaankatu 20, 33720 Tampere, Finland
Manufacturer
Merck Sharp & Dohme-Chibret
Route de Marsat, Riom
63963 Clermont-Ferrand Cedex 9
France
This medicinal product is authorised in the Member States of the EEA under the following
names
Cosopt
Finland, France, Lithuania, Portugal, Sweden
Cosopt brez konzervansa
Slovenia
Cosopt Conserveermiddelvrij
Netherlands
Cosopt fără conservant
Romania
Cosopt Free Slovakia
Cosopt Free bez konzervačních přísad
Czech Republic
Cosopt monodose Italy
Cosopt PF
Bulgaria, Latvia, Poland, Spain
Cosopt PF “Χωρίς συντηρητικό”
Greece
Cosopt Preservative-free
Ireland, United Kingdom
Cosopt-S Germany
Cosopt sine Austria
Cosopt Ukonserveret
Denmark
Cosopt Unit Dose
Belgium, Luxemburg
Cosopt Uno Hungary
This leaflet was last revised in February 2017.
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT COSOPT PRESERVATIVE-FREE,
INCREASED EYE PRESSURE OR GLAUCOMA?
This leaflet gives the most important information about COSOPT Preservative-Free. If you have
any questions after you have read it, ask your doctor or pharmacist, who can give you more
information
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.)

Santen Oy,
Niittyhaankatu 20, 33720 Tampere, Finland

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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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