patient information leaflet cosopt

PATIENT INFORMATION LEAFLET

COSOPT® Eyedrops solution

(2% dorzolamide hydrochloride and 0.5% timolol maleate)

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE, EVEN IF YOU HAVE JUST HAD A REPEAT PRESCRIPTION. SOME OF THE INFORMATION IN YOUR PREVIOUS LEAFLET MAY HAVE CHANGED.

Keep this leaflet. You may want to read it again.

WHAT IS IN YOUR EYE DROPS?

‘Cosopt’ (2% dorzolamide hydrochloride and 0.5% timolol maleate) is a clear colourless sterile eye drop solution. Each ml of solution contains 20 mg dorzolamide and 5 mg of timolol as the active ingredients.

In addition, ‘Cosopt’ contains the following inactive ingredients: hyetellose, mannitol E421, sodium citrate, sodium hydroxide and water for injection. Benzalkonium chloride (0.075 mg/ml) is added as preservative.

‘Cosopt’ is available in bottles containing 5 ml of solution.

‘Cosopt’ is a combination of dorzolamide hydrochloride, an ophthalmic carbonic anhydrase inhibiting drug and timolol maleate, an ophthalmic beta-blocking drug, both of which lower raised pressure in the eye in different ways.

WHAT IS ‘COSOPT’ AND HOW DOES IT WORK?

‘Cosopt’ is prescribed to lower raised pressure within the eye in the treatment of glaucoma when beta-blocker eye drops used alone are not adequate.

If left untreated this raised pressure in the eye may damage the optic nerve resulting in deterioration of vision and possible blindness. There are generally few symptoms that you can feel that tell you whether you have raised pressure in your eye. If your doctor has diagnosed raised pressure in your eye, regular eye examinations and measurements of the pressure within your eyes will be necessary.

ARE THERE PATIENTS WHO SHOULD NOT TAKE ‘COSOPT’?

Yes, do not use ‘Cosopt’ if you:

have a respiratory disease such as asthma, have a history of asthma or have chronic obstructive lung disease
have certain heart problems
have severe kidney problems, or have a disturbance in the pH (acid/alkali balance) of your blood.
are allergic to any of its ingredients.

If you think any of these apply to you, do not use ‘Cosopt’ until you have consulted your doctor.

WHAT ELSE SHOULD YOU KNOW ABOUT TAKING ‘COSOPT’?

If you have a history of heart disease your doctor may wish to monitor your pulse rate and other signs of this disease while you are using ‘Cosopt’.

Tell your doctor if you now have or have had liver problems, if you have muscle weakness or have been diagnosed as having myasthenia gravis.

You should also tell your doctor if you now have, or have had in the past, asthma or other lung problems, Prinzmetal’s angina (chest pains while resting), other heart problems, circulatory problems, low blood pressure, diabetes or hypoglycaemia (low blood sugar), thyroid problems and about any allergies to a medicine you have taken.

If you develop conjunctivitis (redness and irritation of the eye[s]), swelling of the eye or eyelids, skin rash, or itching in and around the eye contact your doctor immediately. Such symptoms may be due to an allergic reaction or may be a side-effect of ‘Cosopt’ (See ‘What unwanted effects may ‘Cosopt’ have’).

Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, develop other reactions or worsening of symptoms.

If you wear soft contact lenses, you should consult your doctor before using ‘Cosopt’ (the preservative benzalkonium chloride may possibly discolour the contact lenses). It is important that your lenses are removed before using your eye drops and not put back into your eyes until 15 minutes after using your eye drops. Your doctor can explain this to you.

Before surgery and anaesthesia (even at the dentist), tell your doctor or dentist that you are taking ‘Cosopt’, as there may be a sudden fall in blood-pressure associated with the anaesthetic.

Use in children.

There is limited experience with ‘Cosopt’ in infants and children.

Use in pregnancy and breast feeding

Tell your doctor if you are pregnant, think you could be pregnant, or are planning to become pregnant. You should not use ‘Cosopt’ during pregnancy.

Tell your doctor if you are breast-feeding or intend to breast-feed. You should not use ‘Cosopt’ during breast-feeding.

CAN YOU USE ‘COSOPT’ WITH OTHER MEDICINES?

Tell your doctor about all drugs, including other eye drops, that you are using or plan to use, including those obtained without a prescription. This is particularly important if any of the following apply to you:

You are taking antihypertensive medicines which are used to lower high blood pressure or medicines to treat heart disease such as calcium channel blockers and ß-blockers or digoxin
You are taking medicines to treat a disturbed or uneven heartbeat such as quinidine or digoxin
You are using another eyedrop that contains a ß-blocker
You are taking another carbonic anhydrase inhibitor such as acetazolamide. You may be taking this type of medicine by mouth, as eye drops, or by some other method
You are taking monoamine oxidase inhibitors (MAOIs) to treat depression or another illness
You are taking a parasympathomimetic medicine which may have been prescribed to help you pass urine. Parasympathomimetics are also a particular type of medicine which are sometimes used to help restore normal movements through the bowel
You are taking narcotics such as morphine used to treat moderate to severe pain or if you are taking large doses of aspirin. Although there is no evidence that dorzolamide hydrochloride interacts with aspirin, some other medicines which are related to dorzolamide hydrochloride and which are taken by mouth, have been known to interact with aspirin
You are taking medicines to treat diabetes or high blood sugar
You are taking epinephrine (adrenaline).

WHAT ABOUT DRIVING AND OPERATING MACHINERY?

Potential side effects such as blurred vision may affect some patients’ ability to drive and/or operate machinery. If you experience any problems talk to your doctor, he will advise you.

HOW SHOULD YOU USE ‘COSOPT’?

It is important to use ‘Cosopt’ as prescribed by your doctor.

The usual dose is one drop in the affected eye(s) two times a day, for example in the morning and in the evening.

If you are using ‘Cosopt’ with another eye drop, the drops should be instilled at least ten minutes apart.

Do not change the dose of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately.

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, keep the tip of the container away from contact with any surface.

Instructions for use

It is recommended that you wash your hands before putting in your eye drops.

1. Before opening a new bottle of ‘Cosopt’ eye drops solution for the first time, please check that the safety strip on the front of the bottle is unbroken. The safety strip helps guarantee an intact package. It is quite normal for unopened bottles to have a small gap between the bottle and cap (Fig. 1).

2. Tear off the safety strip to break the seal (Fig 2).

3. To open the bottle, unscrew the cap by turning it in the direction indicated by the arrows (counterclockwise) (Fig 3).

4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye (Fig. 4).

5. Invert the bottle, and press lightly with your thumb or first finger over the ‘Finger-Push Area’ as shown (Fig. 5) until a single drop, as directed by your doctor, is dispensed into your eye. DO NOT TOUCH YOUR EYE OR EYELID WITH THE TIP OF THE BOTTLE.

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

7. Replace the cap by turning until it is firmly touching the bottle. DO NOT over-tighten the cap. Return the bottle to the original outer carton.

8. The dispenser tip is designed to provide a pre-measured drop; therefore, do not enlarge the hole of the dispenser tip.

9. 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.

WHAT SHOULD YOU DO IF YOU TAKE TOO MUCH ‘COSOPT’, OR MISS A DOSE?

It is important to keep to the dose your doctor has prescribed. If you put too many drops in your eye or swallow any of the contents of the bottle, you may feel unwell, for example you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. If you feel any of the above effects you should seek medical attention immediately.

If you miss a dose, take 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.

WHAT UNWANTED EFFECTS MAY ‘COSOPT’ HAVE?

Like all medicines ‘Cosopt’ can have unintended or undesirable effects (side effects), in some patients.

The following have been seen with 'Cosopt':

Nervous system: headache, dizziness, numbness/tingling sensation, stroke, depression, insomnia, nightmares, decreased sex drive.

Effects on the eye: burning, stinging and 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), eyelid crusting, eye pain, dry eyes, visual disturbances such as blurred vision, choroidal detachment which may be accompanied by visual changes/disturbances (following eye surgery).

Ear: ringing noises in your ear.

Heart and circulation: slowing of your heart rate, an irregular heartbeat, low blood-pressure, fainting, palpitations, chest pain, heart attack, swelling or coldness of your hands and feet and reduced circulation in your arms and legs.

Respiratory: coughing and nose bleed, sinusitis, rhinitis and breathing difficulties such as shortness of breath/breathlessness and more rarely wheezing.

Gastro-intestinal: nausea, upset stomach, dry mouth, some patients have reported a bitter taste after putting in their eye drops.

Skin: rash, psoriasis or worsening of psoriasis, hair loss.

Kidneys: there have been rare reports of the development of kidney stones.

Reproductive: Peyronie’s disease (which may cause a curvature of the penis).

General: weakness/tiredness, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth rarely wheezing.

There are possible side-effects of the components of ‘Cosopt’, which may also be potential side-effects of ‘Cosopt’ in some patients. These include:

Blood: systemic lupus erythematosus.

Nervous system: memory loss, muscle weakness/worsening of myasthenia gravis.

Effects on the eye: drooping eyelid, double vision, temporary short sightedness which may resolve when treatment is stopped.

Heart and circulation: leg cramps and/or leg pain when walking (claudication).

Gastro-intestinal: diarrhoea, throat irritation,

If any of these happen to you, or you have any other unusual symptoms or feelings, contact your doctor immediately, particularly if you experience any changes/visual disturbance when using 'Cosopt' after eye surgery.

HOW SHOULD YOUR MEDICINE BE KEPT?

Do not use this medicine after the expiry date which is clearly marked on the container.

‘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.

REMEMBER, this medicine is for you. Do not share it with anyone else.

HOW SHOULD I STORE ‘COSOPT’?

Store ‘Cosopt’ at room temperature. Store the bottle in the outer carton as this product is sensitive to light.

Keep all medicines safely away from children.

Medicine: cosopt