Cosopt PF
(Dorzolamide Hydrochloride/Timolol Maleate)

What Cosopt PF is and what it is used for

COSOPT Preservative-Free 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 pressure in the eye in different ways. COSOPT Preservative-Free 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 PF

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 COSOPT Preservative-Free 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. If you have difficulty administering your eye drops, seek the assistance of a family member or carer. Do not allow the single dose container to touch the eye or areas around the eye. It could cause injury to your eye. It may also become contaminated with bacteria that can cause eye UK Cosopt-SD-077_20171207a infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the single dose container, wash your hands before using this medicine and keep the tip of the single dose container away from contact with any surface. A new single dose container should be opened immediately prior to each use; there is enough solution in each container for both eyes if your doctor has told you to use the drops in both eyes Discard the opened container with any remaining contents immediately after use. Instructions for use Open the foil sachet which contains the individual single dose containers. Write the date of first opening on the sachet. Every time you use COSOPT Preservative-Free 1. Wash your hands 2. Take the strip of containers from the sachet 3. Detach one single dose container from the strip . 4. Put the remaining strip back in the pouch and fold the edge to close the pouch. 5. To open the container, twist off the tab. (Picture A) 6. Hold the container between your thumb and index finger. Note that the tip of the container must not show more than 5 mm above the edge of your index finger. (Picture B) 7. Tilt your head backwards or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of the nose. Look up. Pull the lower eyelid downwards with the other hand. Do not allow any part of the container to touch your eye or any area around your eye. Gently squeeze the container UK Cosopt-SD-077_20171207a to let one drop fall into the space between the lid and the eye (Picture C). Do not blink while applying the drop to your eye. Each single dose container contains enough solution for both eyes. 8. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body (Picture D). 9. Wipe off any excess solution from the skin around the eye. If your doctor has told you to use drops in both eyes, repeat steps 7 to 9 for your other eye. After putting the drop into the eye(s), throw away the used single dose container even if there is solution remaining to avoid contamination of the preservative free solution. Store the remaining containers in the foil sachet; the remaining containers must be used within 15 days after opening of the sachet. If there are any containers left 15 days after opening the sachet they should be safely thrown away and a fresh sachet opened. It is important to continue to use the eye drops as prescribed by your doctor. If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse. Santen would like to find out what you think about the dropper and how you were able to put the drops into your eyes. If you would like to provide us with any feedback please use the following free phone line to call and you will be asked some short questions. Tel: 08450754863 If you use more COSOPT Preservative-Free 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 Preservative-Free It is important to take COSOPT Preservative-Free 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 take a double dose to make up for the forgotten dose. If you stop using COSOPT Preservative-Free 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 Preservative-Free without speaking to your doctor. UK Cosopt-SD-077_20171207a Generalised allergic reactions including swelling beneath the skin 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 lifethreatening allergic reaction. The following adverse reactions have been reported with COSOPT Preservative-Free or one of its components either during clinical trials or during post-marketing experience:

Very common (may affect more than 1 in 10 people): Burning and stinging of the eyes, taste perversion.

Common (may affect up to 1 in 10 people): 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 realizing of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness to the nose), nausea, weakness/tiredness and fatigue.

Uncommon (may affect up to 1 in 100 people): Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), slow heartbeat, fainting, difficulty breathing (dyspnoea), indigestion, and kidney stones.

Rare (may affect up to 1 in 1,000 people): Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, 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, respiratory failure, rhinitis, nose bleed, constriction of the airways in the lungs, 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 Johnsons 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: UK Cosopt-SD-077_20171207a

Not known (side effects have been reported. However, it is not known how often these occur): 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Cosopt PF

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