Cosopt Preservative-Free, Single Dose Eye Drops
 

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Cosopt Preservative-Free, Single Dose Eye Drops



C







COSOPT Preservative-Free 20 mg/ml + 5 mg/ml eye drops, solution, single dose container

(dorzolamide / timolol)

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What COSOPT Preservative-Free is and what it is used for
2. Before you use COSOPT Preservative-Free
3. How to use COSOPT Preservative-Free
4. Possible side effects
5. How to store COSOPT Preservative-Free
6. Further information

What Cosopt Preservative-Free 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.

Before You Use Cosopt Preservative-Free Do not use COSOPT Preservative-Free if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of COSOPT Preservative-Free. if you have respiratory disease, such as asthma, a history of asthma, or chronic obstructive lung disease if you have certain heart diseases, including certain heart rhythm disturbances producing an abnormally slow heart rate or severe heart failure. if you have severe kidney disease or problems, or a prior history of kidney stones. If you have excess acidity of the blood caused by a build up of chloride in the blood (hyperchloremic acidosis)

If you are not sure whether you should use COSOPT Preservative-Free, contact your doctor or pharmacist.

Take special care with COSOPT Preservative-Free

Tell your doctor about any medical or eye problems you have now or have had in the past, especially asthma and other lung problems, heart problems, circulatory problems, low blood pressure, diabetes, low blood sugar (hypoglycaemia), thyroid problems, and about any allergies or anaphylactic reactions.

Tell your doctor if you have muscle weakness or have been diagnosed as having myasthenia gravis.

If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your doctor immediately.

If you suspect that COSOPT Preservative-Free is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the eye), stop using COSOPT Preservative-Free and contact your doctor immediately.

Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, or develop a reaction including new or worsening symptoms.

When COSOPT Preservative-Free is instilled into the eye it may affect the entire body.

COSOPT Preservative-Free has not been studied in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using COSOPT Preservative-Free.

Use in children

There is limited experience with COSOPT (preserved formulation) in infants and children.

Use in elderly

In studies with COSOPT (preserved formulation), the effects of COSOPT (preserved formulation) were similar in both elderly and younger patients.

Use in patients with liver impairment

Tell your doctor about any liver problems you now have or have suffered from in the past.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including other eye drops or medicines obtained without a prescription. This is particularly important if you are:

a. taking medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin)
b. taking medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin
c. using another eye drop that contains a beta-blocker
d. taking another carbonic anhydrase inhibitor such as acetazolamide
e. taking monoamine oxidase inhibitors (MAOIs)
f. taking a parasympathomimetic medicine which may have been prescribed to help you pass urine. Parasympathomimetics are also a particular type of medicine which is sometimes used to help restore normal movements through the bowel.
g. taking narcotics such as morphine used to treat moderate to severe pain.
h. taking medicines to treat diabetes
i. taking medicines to treat depression.
j. taking a sulfa drug

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Use in pregnancy

You should not use COSOPT Preservative-Free during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.

Use in breast-feeding

If treatment with COSOPT Preservative-Free is required breast-feeding is not recommended.

Tell your doctor if you are breast-feeding or intend to breast-feed.

Driving and using machines

No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with COSOPT Preservative-Free, such as blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.

How To Use Cosopt Preservative-Free

Always use COSOPT Preservative-Free exactly as your doctor has told you. You should 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 usual 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 drug without consulting your doctor.

Do not allow the tip of the single dose 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 single dose container, keep the tip of the single dose container away from contact with any surface.

Instructions for use

The solution from one individual single dose container of COSOPT Preservative-Free is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single dose container is opened, a new container must be opened prior to each use and must be discarded immediately after administration.

1. Open the foil sachet which contains 15 individual single dose containers. There are three strips of 5 single dose containers each in the sachet.
2. First wash your hands then break off one single dose container from the strip and twist open the top of the single dose container as shown.

3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and eye as shown.

4. Put one drop in the affected eye(s) as directed by your doctor. Each single dose container contains enough solution for both eyes.
5. After putting the drop into the eye, throw away the used single dose container even if there is solution remaining to avoid contamination of the preservative free solution.
6. 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 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, COSOPT Preservative-Free can cause side effects, although not everybody gets them.

If they do occur, you may need medical attention.

The following adverse reactions have been reported with COSOPT or one of its components either during clinical trials or during post-marketing experience:

Very common: (appearing in more than 1 of 10 treated patients)

Burning and stinging of the eyes, taste perversion.

Common: (occurring in between 1 in 10 and 1 in 100 treated patients)

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, blurred vision, headache, sinusitis, nausea, and fatigue.

Uncommon: (occurring in between 1 in 100 and 1 in 1,000 treated patients)

Dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), slow heartbeat, fainting, indigestion, and kidney stones.

Rare: (occurring in between 1 in 1,000 and 1 in 10,000 treated patients)

Systemic lupus erythematosus, tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, weakening of the muscles, decreased sex drive, stroke, temporary short-sightedness which may resolve when treatment is stopped, choroidal detachment (following filtration surgery), drooping of the eyelids, double vision, ringing noises in your ear, low blood pressure, irregular heartbeat, chest pain, palpitations, heart attack, 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, bronchospasm (predominantly in patients with pre-existing bronchospastic disease), cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis, Peyronie’s disease (which may cause a curvature of the penis), weakness/tiredness, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Cosopt Preservative-Free

Keep out of the reach and sight of children.

Do not use the unopened sachets of COSOPT Preservative-Free after the date shown by the six digits following EX (or EXP) on the foil package. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not freeze.

Store in foil sachet in order to protect from light.

You can use COSOPT Preservative-Free 15 days after first opening the sachet.

Discard any unused single dose containers after this time

Discard the opened single dose container with any remaining solution immediately after first use

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What COSOPT Preservative-Free contains The active substances are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate). The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections. What COSOPT Preservative-Free looks like and contents of the pack

COSOPT Preservative-Free is a clear, colourless to nearly colourless slightly viscous solution.

Each aluminium sachet contains 15 low density polyethylene single dose containers containing 0.2 ml of solution.

Pack sizes:

30 x 0.2 ml (2 sachets with 15 single dose containers)

60 x 0.2 ml (4 sachets with 15 single dose containers)

120 x 0.2 ml (8 sachets with 15 single dose containers)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder UK:

Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

Manufacturer

Merck Sharp & Dohme-Chibret Route de Marsat Riom 63963 Clermont-Ferrand Cedex 9 France

This medicinal product is authorised in the Member States of the EEA under the following names

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxemburg, Netherlands, Portugal, Slovenia, Sweden, United Kingdom

COSOPT

Denmark,:

TIMOSOPT

Greece:

TESOL

This leaflet was last approved in June 2010

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT COSOPT PRESERVATIVE-FREE, INCREASED EYE PRESSURE OR GLAUCOMA?

This leaflet gives the most important information about COSOPT Preservative-Free. If you have any questions after you have read it, ask your doctor or pharmacist, who can give you more information

Further information about glaucoma is available from:

International Glaucoma Association (IGA) 15A Highpoint Business Village Henwood Ashford Kent TN24 8DH Tel:01233 648170

Registered Charity number 274681.

Alternatively, if you or someone you know has problems with their vision, and you require further advice or information, please phone the Royal National Institute for the Blind (RNIB) Helpline on 0303 123 9999, Monday to Friday 8.45am to 6pm and Saturday 9am to 4pm, calls charged at local rate.

(The IGA and RNIB are independent UK charities and are not associated with Merck Sharp & Dohme Limited.)

denotes registered trademark of

Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc. Whitehouse Station NJ USA

© Merck Sharp & Dohme Limited 2010. All rights reserved.

Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

PIL.CST-PF.10.UK.3214 (II-043)







Cosopt Preservative Free Single Dose Eye Drops

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