Consumer Medicine Information

COSOPT^®

dorzolamide hydrochloride/timolol maleate

5 mL Eye Solution Bottle

What is in this leaflet

This leaflet answers some common questions about COSOPT. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using COSOPT against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What COSOPT is used for

COSOPT is used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Also, some people with raised eye pressure may not have glaucoma.

Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye.

There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems. You may have no symptoms but eventually glaucoma can lead to total blindness. In fact, untreated glaucoma is one of the most common causes of blindness.

Although COSOPT helps control your glaucoma it does not cure it.

For more information about glaucoma, contact Glaucoma New Zealand, Department of Ophthalmology, Private Bag 92019, Auckland, telephone 09 373 8779, email: info@glaucoma.org.nz

COSOPT contains two active ingredients, dorzolamide hydrochloride and timolol maleate. Both of these active ingredients lower pressure in the eye by reducing the production of fluid, but they do this in different ways.

Dorzolamide hydrochloride belongs to a family of medicines called carbonic anhydrase inhibitors. Timolol maleate belongs to a family of medicines called beta-blockers.

COSOPT is not addictive.

Before you use COSOPT

When you must not use it

Do not use COSOPT if:

you have an allergy to COSOPT or any of the ingredients listed at the end of this leaflet.
you have asthma, or a history of asthma, chronic obstructive lung disease (emphysema), or other breathing problems
you have certain heart conditions, such as a very slow heart rate, an irregular heart beat, or heart failure.
if you are breastfeeding or intend to breastfeed.
Your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in COSOPT (benzalkonium chloride) may be deposited in soft contact lenses. Wait at least 15 minutes after you have used COSOPT to put your soft contact lenses back into your eyes.

Do not use COSOPT if:

the seal around the cap is broken
the bottle shows signs of tampering
the expiry date on the pack has passed.
If you use this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start using COSOPT, talk to your doctor.

There is limited experience with COSOPT in infants and children.

Before you start to use it

Tell your doctor if:

you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of using COSOPT during pregnancy and a decision can be made if you should or should not use it.
you have any medical conditions, especially the following:
- heart disease
- lung disease
- kidney disease
- liver disease
you have an allergy to sulphonamide medicines.
One of the active ingredients of COSOPT, dorzolamide hydrochloride, is a sulphonamide-related compound. Therefore, if you are allergic to sulphonamide medicines you may be allergic to COSOPT. Check with your doctor or pharmacist if you are not sure whether you are allergic to sulphonamides.
you are already using another beta-blocker eye drop.
It is not recommended to use two beta-blocker eye drops at the same time.
you have a history of allergic problems, including eczema, hives or hay fever
you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell him/her before you use COSOPT.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and COSOPT may interfere with each other. These include:

medicines for high blood pressure or heart conditions, including a group of medicines called beta-blockers
quinidine, a medicine used to treat irregular heart beats
tablets used to treat glaucoma
large amounts of aspirin or salicylates
medicines to treat depression

These medicines may be affected by COSOPT, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using COSOPT.

How to use COSOPT

How much to use

Your doctor will tell you how many drops you need to use each day.

Use COSOPT only when prescribed by your doctor.

The usual dose for adults is one drop of COSOPT twice a day, in either one or both eyes.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Use COSOPT every day, at about the same time each day, unless your doctor tells you otherwise. Using your eye drops at the same time each day will have the best effect on your eye pressure. It will also help you remember when to use the eye drops.

After using COSOPT, wait at least 10 minutes before putting any other eye drops in your eye(s).

How to use it

Before opening the bottle for the first time, make sure the two safety seals joining the cap to the bottle are not broken. If they are, do not use the bottle and return it to your pharmacist.

You will notice a small space between the cap and the bottle - this is normal.

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing contact lenses, remove them before putting the drops in your eye.

Wash your hands well with soap and water.
To open the bottle for the first time, hold the bottle upright, and turn the cap in the direction of the arrows until you can lift it off. This will break the two safety seals.
Locate the "finger press" area on the side of the bottle between the vertical lines.
Hold the bottle upside down in one hand, with your thumb or index finger over the "finger press" area and place the other finger on the other side of the bottle. Do not insert fingers into base of bottle.
Using your other hand, gently pull down your lower eyelid to form a pouch.
Tilt your head back and look up.
Hold the bottle vertically and put the tip close to your lower eyelid. Do not let it touch your eye.
Release one drop into the pouch formed between your eye and eyelid by gently pressing on the "finger press" area.
Close your eye and keep it closed. While your eye is still closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique. Do not blink or rub your eye.
Replace the cap. Turn it clockwise until firm resistance is felt (approximately one full turn). Do not over tighten the cap.
Wash your hands again with soap and water to remove any residue.

Wait at least 15 minutes before replacing your contact lenses.

These eye drops should be used at least 10 minutes before or after using any other eye preparation. Store the bottle away from direct sunlight, preferably in a cool place where the temperature stays below 30°C.

At the end of use, you will notice a small quantity of solution remaining in the bottle. This retained solution cannot be removed and is normal.

Discard any remaining solution 4 weeks after opening the bottle.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

Contaminated eye drops may give you an eye infection.

You may feel a slight burning sensation in the eye after using the eye drops. If this persists, or is very uncomfortable, contact your doctor or pharmacist.

How long to use it

COSOPT helps control your condition but does not cure it. Therefore COSOPT must be used every day. Continue using COSOPT for as long as your doctor prescribes.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using them as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the amount to make up for the dose that you missed.

If you have trouble remembering to use your eye drops, ask your pharmacist for some hints.

If you use too much (overdose)

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of COSOPT, or used too many drops, immediately telephone your doctor or National Poisons Centre (telephone 0800 POISON or 0800 764 766), or go to accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. If COSOPT is accidentally swallowed, or if you use too many drops, you may feel light-headed or dizzy, you may faint, have a very slow pulse rate, or have wheezing or difficulty breathing.

While you are using COSOPT

Things you must do

Have your eye pressure checked when your eye specialist says, to make sure COSOPT is working.

If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor. Your doctor may tell you to use a new container of COSOPT because of possible contamination of the old one, or may advise you to stop your treatment with COSOPT.

If you become pregnant while using COSOPT tell your doctor.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are using COSOPT.

Things you must not do

Do not give COSOPT to anyone else, even if they have the same condition as you.

Do not stop using COSOPT without first talking to your doctor. If you stop using your eye drops, your eye pressures may rise again and damage to your eye may occur.

Things to be careful of

Be careful driving or operating machinery until you know how COSOPT affects you. COSOPT generally does not cause any problems with your ability to drive a car or operate machinery. However, COSOPT may cause blurred vision or dizziness in some people. Make sure you know how you react to COSOPT or that your vision is clear before driving a car or operating machinery.

Adverse Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using COSOPT.

COSOPT helps most people with high eye pressure and glaucoma, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

problems with your eye/s such as:
- blurred vision
- double vision
- or other visual problems
allergic reactions including redness, swelling and/or itching of the eye
burning and stinging of the eyes
watering of the eyes
conjunctivitis
irritation or feeling of having something in the eye
swelling of the eyelids, drooping of eyelids
difficulty thinking or working because of:
- headache
- tiredness, weakness
- changes in mood such as depression
mouth or stomach problems:
- bitter taste
- feeling sick (nausea)
numbness or tingling in the fingers or toes
hair loss or thinning

These are usually mild adverse effects.

Tell your doctor immediately if you notice any of the following:

fast or irregular heart beats, also called palpitations
dizziness and light-headedness, which may be due to low blood pressure
skin rash, itching.

These may be serious adverse effects. You may need urgent medical attention. Serious adverse effects are rare.

If any of the following happen, stop using COSOPT and tell your doctor immediately or go to accident and emergency at your nearest hospital:

wheezing, difficulty in breathing, shortness of breath
very slow pulse, chest pain
fainting
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing
severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettlerash

These are serious adverse effects. You may need urgent medical attention. These adverse effects are rare.

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

After using COSOPT

Storage

Keep your eye drops in a cool place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Do not carry the eye drops in pockets of your clothes. Heat and dampness can destroy some medicines.

Keep the eye drops away from light.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave the cap off the bottle for any length of time to avoid contaminating the eye drops.

Disposal

Write the date on the bottle when you open the eye drops and throw out any remaining solution after four weeks.

Eye drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should be opened.

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining solution.

Product description

What it looks like

COSOPT comes as eye drops in a 5 mL dropper pack.

Ingredients

Active ingredients:

dorzolamide hydrochloride, equivalent to dorzolamide 2%
timolol maleate, equivalent to timolol 0.5%

Inactive ingredients:

sodium citrate
hydroxyethylcellulose
sodium hydroxide
mannitol
water for injection
benzalkonium chloride as preservative

Supplier

COSOPT is supplied in New Zealand by:

Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673

This leaflet was reviewed in August 2008

CP-CST-0808(290808)

^®Registered Trademark of Merck & Co Inc., Whitehouse Station, NJ, USA

INFORMATION FOR CONSUMERS