COSOPT 20 mg/ml + 5 mg/ml eye drops, solution
(dorzolamide / timolol)
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
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.
Before You 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 respiratory disease, such as asthma, a history of asthma, or chronic obstructive lung disease
- if you have certain heart diseases, including some types of heart rhythm disturbances producing an abnormally slow heart rate or
severe heart failure. - 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 (hyperchloremic acidosis).
If you are not sure whether you should use COSOPT, 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, especially asthma and other lung problems,
heart problems, circulatory problems, low blood pressure, diabetes, low blood sugar (hypoglycaemia), thyroid problems, and 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 COSOPT 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 COSOPT.
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
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including other eye drops or 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.
- 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 medicines to treat depression.
- taking a sulfa drug.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Use in pregnancy
You should not use COSOPT during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.
Use in breast-feeding
If treatment with COSOPT is required, breast-feeding is not recommended. Tell your doctor if you are breast-feeding or intend to
breast-feed.
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).
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.
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.
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.
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. 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.
7. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
8. 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.
9. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
10. 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.
Possible Side Effects
Like all medicines, COSOPT can cause side effects, although not everybody gets them.
If they do occur, you may need medical attention.
If you develop allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in
breathing or swallowing, you should stop COSOPT and talk to your doctor immediately:
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: (appearing in more than 1 of 10 treated patients)
Burning and stinging of the eyes, unusual taste
Common: (occurring in between 1 in 10 and 1 in 100 treated patients)
Redness in and around the eye(s), watering or itching of the eye(s), and effects on the surface of the eye(s), swelling and/or
irritation in and around the eye(s), feeling of having something in the eye(corneal erosion), 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, and fatigue
Uncommon: (occurring in between 1 in 100 and 1 in 1,000 treated patients)
Dizziness, depression, inflammation of the iris, blurred vision (in some cases due to withdrawal of medication to treat excessive
contraction of the pupil of the eye) , slow heartbeat, fainting, 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: (occurring in between 1 in 1,000 and 1 in 10,000 treated patients)
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, weakening of the muscles, decreased sex drive, stroke, temporary shortsightedness
which may resolve when treatment is stopped, development of fluid under the retina (choroidal detachment following filtration surgery),
drooping of the eyelids, 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, irregular heartbeat, chest pain, palpitations (a quicker and/or irregular
heartbeat), heart attack, reduced blood flow to the brain, 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, difficulty in breathing, cough, throat irritation, dry mouth,
diarrhoea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis, Peyronie’s disease (which may cause a curvature of the
penis), weakness/tiredness, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and
mouth, wheezing, or severe skin reactions.
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.
How To Store Cosopt
Keep out of the reach and sight 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.
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.
Further Information
What COSOPT 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.
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. The OCUMETER Plus Ophthalmic Dispenser consists of a
translucent, high-density polyethylene container containing 5 ml of solution. Tamper evidence is provided by a safety strip on the
container label.
Pack sizes:
1 x 5 ml (single 5-ml containers)
3 x 5 ml (three 5-ml containers)
6 x 5 ml (six 5-ml containers)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder in UK and Malta:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, Netherlands, Portugal, Spain, Sweden, UK:
COSOPT
Denmark:
TIMOSOPT
This leaflet was last approved in June 2010
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:
Kent
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 6pm and Saturday 9am to 4pm, calls
charged at local rate.
(The IGA and RNIB are independent UK charities and are not associated with Merck Sharp & Dohme Limited.)
denotes registered trademark of
© Merck Sharp & Dohme Limited 2010. All rights reserved.
(Logo) MSD
PIL.CST.10.UK/IRL.3212 (II-043)
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