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Preservative Free Dorzolamide hydrochloride/Timolol maleate

Consumer Medicine Information

This leaflet answers some common questions about COSOPT-Preservative Free.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-Preservative Free against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

COSOPT-Preservative Free is used to lower raised pressure in the eye and to treat glaucoma for patients who might be sensitive to preservative-containing formulations or for whom the use of a preservative free formulation is otherwise advisable.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, how toxic is methotrexate 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-Preservative Free helps control your glaucoma it does not cure it.

For more information about glaucoma, contact Glaucoma Australia (PO Box 420, Crows Nest 1585, telephone 1800 500 880).

COSOPT-Preservative Free 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-Preservative Free is not addictive.

Do not use COSOPT-Preservative Free if you have an allergy to COSOPT-Preservative Free or any of the ingredients listed at the end of this leaflet.

Do not use COSOPT-Preservative Free if:

you have now or have had in the past certain serious breathing problem such as asthma, chronic obstructive lung disease (emphysema), or other breathing problems.

you have certain heart conditions, such as a slow heart rate, an irregular heart beat, or heart failure.

Do not use COSOPT-Preservative Free if you are breast-feeding or intend to breast-feed.

Your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

COSOPT-Preservative Free has not been studied in people wearing contact lenses.

Do not use COSOPT-Preservative Free if:

the unit seal is broken

the packaging 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-Preservative Free, talk to your doctor.

There is limited experience with COSOPT-Preservative Free in children.

Tell your doctor if you are pregnant or intend to become pregnant

Your doctor will discuss the possible risks and benefits of using COSOPT-Preservative Free during pregnancy and a decision can be made if you should or should not use it.

Tell your doctor if you have any medical conditions, especially the following:

heart problems (such as coronary heart disease, heart failure or low blood pressure) heart rate disturbances (such as slow or irregular heartbeats)

poor blood circulation problems (such as Raynaud’s syndrome)

lung or breathing problems (such as asthma or chronic obstructive lung disease)

diabetes or other blood sugar problems

thyroid disease

kidney disease

liver disease

Tell your doctor if you have an allergy to sulfonamide medicines

One of the active ingredients of COSOPT-Preservative Free, dorzolamide hydrochloride, is a sulfonamide-related compound. Therefore, if you are allergic to sulfonamide medicines you may be allergic to COSOPT-Preservative Free. Check with your doctor or pharmacist if you are not sure whether you are allergic to sulfonamides.

Tell your doctor if you are already using another beta-blocker eye drop

It is not recommended to use two beta-blocker eye drops at the same time.

Tell your doctor if you have a history of allergic problems, including eczema, hives or hay fever.

Tell your doctor if 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 them before you use COSOPT-Preservative Free.

Tell your doctor before you have an operation that you are using COSOPT-Preservative Free, as it may change the effects of some medicines during anaesthesia.

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and COSOPT-Preservative Free 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

medicine to treat depression

These medicines may be affected by COSOPT-Preservative Free, 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-Preservative Free.

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

Use COSOPT-Preservative Free only when prescribed by your doctor.

The usual dose for adults is one drop of COSOPT-Preservative Free 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-Preservative Free 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-Preservative Free, wait at least 10 minutes before putting any other eye drops in your eye(s).

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

The solution from one individual unit dose pipette of COSOPT-Preservative Free is to be used immediately after opening.Since sterility cannot be maintained after the individual unit dose pipette is opened, any remaining contents must be discarded immediately after administration.

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

Wash your hands well with soap and water.

Open the foil pouch which contains 15 individual unit dose pipettes.There are three strips of 5 pipettes each in the pouch.

Break off one pipette from the strip and twist open the top of the pipette.

Hold the pipette upside down in one hand, with your thumb or index finger over the “finger push” area.

Using your other hand, gently pull down your lower eyelid to form a pouch.

Tilt your head back and look up.

Put the tip of the pipette 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 squeezing the pipette.

Close your eye and keep it closed.Do not blink or rub your eye.

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.

If you are using COSOPT-Preservative Free in both eyes, repeat this procedure for your other eye.

Discard the pipette, even if there is some solution remaining.

Store the remaining unopened pipettes in the foil pouch; the remaining pipettes must be used within 15 days.

Wash your hands again with soap and water to remove any residue.

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.

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

If it is almost time for your next dose, skip the dose you missed and have 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 think that you or anyone else may have swallowed any or all of the contents of a pipette of COSOPT-Preservative Free, or used too many drops, immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to accident or emergency at your nearest hospital.Do this even if there are no signs of discomfort or poisoning.

If COSOPT-Preservative Free 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.

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

If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor.

Your doctor may advise you to stop your treatment with COSOPT-Preservative Free.

If you become pregnant while using COSOPT-Preservative Free, tell your doctor.

After opening a unit of COSOPT-Preservative Free, immediately use it in one or both eyes then discard the pipette, even if there is some solution remaining.

COSOPT-Preservative Free does not contain any preservatives.Therefore, if you keep the remaining solution for your next dose, there is a risk that it may be contaminated with germs and cause an eye infection.

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

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

Do not stop using COSOPT-Preservative Free 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.

Be careful driving or operating machinery until you know how COSOPT-Preservative Free affects you.

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

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

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

watering of the eyes or discharge

conjunctivitis

irritation or feeling of having something in the eye, dry eyes

swelling of the eyelids, drooping of eyelids

difficulty thinking or working because of:

headache

tiredness, weakness

ringing or buzzing in the ears

difficulty sleeping, nightmares

changes in mood such as depression, memory loss

mouth or stomach problems

feeling sick (nausea), upset stomach, stomach pain

diarrhoea

bitter or abnormal taste, dry mouth

respiratory problems

cough

sore throat and discomfort when swallowing

cold or flu-like symptoms such as sneezing, runny nose, cough, red or infected throat

feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes with a throbbing ache, also called sinusitis

changes in the way your hands and feet feel such as:

cold hands or feet

numbness, tingling and colour change (white, blue then red) in fingers when exposed to the cold (Raynaud’s Phenomenon)

numbness or tingling in the fingers or toes

symptoms of a urinary tract infection including an urge to urinate frequently and in small amounts, or painful burning when passing urine

back pain

nose bleeds

hair loss or thinning

less desire for sex

These are usually mild side effects.

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

fast or irregular heart beats, also called palpitations

slow or irregular heart beats

dizziness and light-headedness, which may be due to low blood pressure

skin rash, itching

swelling of the hands feet or ankles

These may be serious side effects.You may need urgent medical attention.

Serious side effects are rare.

If any of the following happen, stop using COSOPT-Preservative Free 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 side effects.You may need urgent medical attention.These side effects are rare.

Other side 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 side effects.You may not experience any of them.

Keep your eye drops in a cool place where the temperature stays below 25C.Do not freeze.

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 – store unopened pipettes in protective foil pouch.

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.

Write the date on the pouch when you open it and throw out any remaining pipettes after 15 days.

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 pipettes.

COSOPT-Preservative Free comes as eye drops in a 0.2mL individual pipette.

A pack contains 15 or 60 individual pipettes.

Active ingredients:

dorzolamide hydrochloride, equivalent to dorzolamide 2% w/v

timolol maleate, equivalent to timolol 0.5% w/v

Inactive ingredients:

sodium citrate

hydroxyethylcellulose

sodium hydroxide

mannitol

water for injections

COSOPT-Preservative Free is supplied in Australia by:

Mundipharma Pty Limited

88 Phillip Street

Sydney NSW 2000

This leaflet was prepared in May 2016.

Australian Register Number:

AUST R 165915.