Cosopt
(Dorzolamide Hydrochloride/Timolol Maleate)

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.

How to take Cosopt

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 this medicine 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. 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. Opening Arrows Safety Strip 2. First wash your hands, then tear off the Safety Strip to break the seal. Gap Finger Push Area 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. Finger Push Area 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. Finger Push Area DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP. Profile: PB00-2_SP11031 Profile Revision: C Profile Revision Date: 140111 Dimensions (mm): 160 x 315 Black Technical Info Profile Item No.: Revision Date & No.: Pharma Code: MBS Job No.: 517315Z 010915-1 159 375238 ITEM# and REVISION# in OCRB font Horizontal Scale 71% Size 5 points 6. After using COSOPT press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stop the medicine from getting into the rest of the body. 7. 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. 8. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor. 9. 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. 10. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip. 11. 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 this medicine 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 this medicine 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, 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 without speaking to your doctor. Generalised allergic reactions including swelling beneath the skin that 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 frequency of possible side effects listed below is defined using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Not known (frequency cannot be estimated from the available data)

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: Burning and stinging of the eyes, unusual taste.

Common: 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 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, weakness/ tiredness, and fatigue.

Uncommon: Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (in some cases due to withdrawal of medication to treat excessive contraction of the pupil of the eye), slow heartbeat, fainting, difficulty breathing (dyspnoea), 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: 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, 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, feeling out of breath, runny or stuffed nose, nose bleed, constriction of the airways in the lungs causing difficulty in breathing, 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 Johnson 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. Profile: PB00-2_SP11031 Profile Revision: C Profile Revision Date: 140111 Dimensions (mm): 160 x 315 ITEM# and REVISION# in OCRB font Horizontal Scale 71% Size 5 points Black Technical Info Profile Item No.: Revision Date & No.: Pharma Code: MBS Job No.: 517315Z 010915-1 159 375238

Not known: 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme at: mhra.gov.uk/yellowcard Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: [email protected]

How to Store Cosopt

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