Cosopt

Package Leaflet: Information for the User

Cosopt, (20 mg + 5 mg)/ml, eye drops, solution

Dorzolamid + Timolol

Read this carefully before using your medicine.

• You should 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Cosopt is and what it is used for
• 2. Before you use Cosopt
• 3. How to use Cosopt
• 4. Possible side effects
• 5. How to store Cosopt
• 6. Contents of the pack and other information

1. What Cosopt is and what it is used for

Cosopt contains two active substances: 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 two substances work together to reduce pressure in the eye by decreasing the amount of fluid produced in the eye.

Cosopt is used to treat glaucoma in adults, where the pressure in the eye is too high.

2. Before you use Cosopt

Do not use Cosopt

• if you are allergic (hypersensitive) to dorzolamide, timolol or any of the other ingredients of Cosopt (see section 6)
• if you have now or have had in the past respiratory problems such as asthma or severe chronic obstructive pulmonary disease (COPD)
• if you have a heart condition (such as a slow heart rate, heart failure or low blood pressure)
• if you have severe kidney problems or kidney failure
• if you have a condition called hyperchloremic acidosis (increased acidity of the blood)

If you are not sure whether you should use Cosopt, consult your doctor or pharmacist.

Take special care with Cosopt

Before using Cosopt, tell your doctor if you have or have had:

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure
• disturbances of heart rhythm (such as slow or irregular heartbeat)
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol may mask signs and symptoms of low blood sugar
• overactive thyroid disease, as timolol may mask signs and symptoms of this condition

Tell your doctor before having an operation that you are using Cosopt.

Tell your doctor if you have any allergies or anaphylactic reactions.

Inform your doctor if you experience any new eye problems, such as eye pain or increased sensitivity to light while using Cosopt.

Inform your doctor if you have eye surgery or develop an eye infection.

Children and adolescents

There is limited experience with the use of Cosopt in children and adolescents.

Elderly

No dosage adjustment is necessary in elderly patients.

Other medicines and Cosopt

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Cosopt can interact with other medicines.

You should not use Cosopt if you are already using another beta-blocker for the treatment of glaucoma.

• taking medicines to lower blood pressure or to treat heart problems (such as beta-blockers, calcium channel blockers or digoxin)
• taking medicines to treat irregular heartbeat or to increase the heart rate (such as quinidine, used to treat certain types of irregular heartbeat, or digoxin)
• taking other eye drops that contain a beta-blocker
• taking other carbonic anhydrase inhibitors (such as acetazolamide)
• taking monoamine oxidase inhibitors (MAOIs) or certain type of antidepressants

Pregnancy and breast-feeding

Do not use Cosopt if you are pregnant or think you may be pregnant.

Do not use Cosopt if you are breast-feeding.

Driving and using machines

Cosopt may cause blurred vision, which may affect your ability to drive or use machines.

Wait until your vision is clear before driving or using machines.

Cosopt contains benzalkonium chloride

This preservative can cause eye irritation and is deposited on contact lenses.

Remove contact lenses before using Cosopt and wait for at least 15 minutes before putting them back.

3. How to use Cosopt

Always use this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

The usual dose is one drop in the affected eye(s) in the morning and in the evening.

Do not touch the dropper tip to the eye or other surfaces.

This may contaminate the dropper.

Instructions for use

• 1. Wash your hands before using the eye drops.

• 2. Open the bottle by twisting the cap.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eye and the eyelid.

• 4. Gently squeeze the bottle to release one drop into the pocket.

• 5. Release the lower eyelid and close your eye for a few minutes.

• 6. Repeat the process for the other eye, if instructed to do so by your doctor.
• 7. Replace the cap on the bottle.

If you use more Cosopt than you should

If you use more eye drops than you should, it is unlikely to cause problems.

If you have accidentally swallowed the entire contents of the bottle, contact your doctor for advice.

If you forget to use Cosopt

Use the drops as soon as you remember.

However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Do not use a double dose to make up for a forgotten dose.

If you stop using Cosopt

Do not stop using Cosopt without consulting your doctor.

4. Possible side effects

Like all medicines, Cosopt can cause side effects, although not everybody gets them.

Stop using Cosopt and contact a doctor immediately if you experience any of the following symptoms:

• severe allergic reactions
• breathing difficulties
• swelling of the face, lips, tongue or throat
• itching, rash or hives

Common side effects include:

• eye irritation, such as burning or stinging
• eye redness
• eye itching
• eye discharge
• foreign body sensation in the eye
• eye pain
• blurred vision
• headache
• sinusitis
• nausea
• fatigue

Uncommon side effects include:

• dizziness
• depression
• uveitis (inflammation of the uvea, the middle layer of the eye)
• visual disturbances, including changes in vision
• slow heart rate
• fainting
• shortness of breath
• indigestion
• kidney stones

Rare side effects include:

• systemic lupus erythematosus (an autoimmune disease that can cause inflammation of the joints, skin, kidneys and other organs)
• numbness or tingling of the hands or feet
• insomnia
• nightmares
• memory loss
• sexual dysfunction
• stroke
• transient myopia (nearsightedness)

Very rare side effects include:

• low blood sugar
• heart failure
• abnormal heart rhythms
• abdominal pain
• vomiting
• muscle weakness
• sexual dysfunction
• hallucinations
• foreign body sensation in the eye

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

5. How to store Cosopt

Keep this medicine out of the sight and reach of children.

Do not use Cosopt after the expiry date which is stated on the carton and bottle.

Store in a cool, dry place, away from direct sunlight.

After first opening, the bottle can be used for 4 weeks.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use.

6. Contents of the pack and other information

What Cosopt contains

• The active substances are dorzolamide and timolol.
• Each milliliter of solution contains 20 mg of dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).

The other ingredients are benzalkonium chloride, hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide and water for injection.

What Cosopt looks like and contents of the pack

Cosopt is a clear, colorless to nearly colorless, slightly viscous solution.

Cosopt is available in a 6 ml or 5 ml bottle, with a screw cap.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects:
If any of the following side effects occur, discontinue use of this medicine and seek medical attention immediately, as they may be symptoms of an allergic reaction to the medicine.
Generalized allergic reactions, including swelling under the skin, may occur in the face and limbs and cause respiratory tract obstruction and swallowing difficulties, shortness of breath, urticaria or itching rash, local and generalized rash, itching, and severe, sudden, and life-threatening allergic reaction.
Eye drop treatment can usually be continued unless the side effects are severe. In case of concerns, consult a doctor or pharmacist. Do not discontinue the use of Cosopt without consulting a doctor.
The frequency of possible side effects listed below is defined according to the following convention:
Very common (occurring in more than 1 person in 10)
Common (occurring in 1 to 10 people in 100)
Uncommon (occurring in 1 to 10 people in 1000)
Rare (occurring in 1 to 10 people in 10,000)
Unknown (frequency cannot be determined based on available data)
During clinical trials or after the marketing of the medicine, the following side effects related to Cosopt or one of its active ingredients have been reported:
Very common:
Burning and stinging sensation in the eye, change in taste perception.
Common:
Redness of the eyeballs and skin around the eye, tearing or itching of the eye, corneal abrasion (damage to the front layer of the eyeball), swelling and/or irritation of the eyeballs and skin around the eye, foreign body sensation in the eye, decreased corneal sensitivity (not feeling a foreign body in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), nausea, weakness, and fatigue.
Uncommon:
Dizziness, depression, uveitis, vision disturbances, including refractive changes (in some cases due to withdrawal of pupil-constricting medications), slowed heart rate, fainting, shortness of breath, gastrointestinal disorders, and kidney stones.
Rare:
Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs), tingling or numbness of hands or feet, insomnia, nightmares, memory loss, exacerbation of objective and subjective symptoms of myasthenia (muscle disorder), decreased libido, stroke, transient myopia, which may resolve after discontinuation of the medicine, detachment of the filtering membrane under the retina, which can cause vision disturbances, drooping eyelids (eyelids are half-closed), double vision, formation of scabs on the eyelids, corneal edema (with subjective vision disturbances), low eye pressure, tinnitus, decreased blood pressure, changes in heart rhythm or rate, congestive heart failure (heart disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, strong heartbeat, which can be rapid or irregular (palpitations), myocardial infarction, Raynaud's disease, swelling of hands and feet or cold hands and feet, and impaired circulation in the upper and lower limbs, muscle cramps in the legs and/or leg pain while walking (claudication), shortness of breath, respiratory failure, rhinitis (runny nose), nosebleeds, bronchospasm, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, white-silver rash (psoriasiform rash), Peyronie's disease (which can lead to penis curvature), allergic reactions, such as rash, urticaria, itching, and in rare cases, lip swelling, eyelid swelling, and oral cavity swelling, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Like other eye medications, timolol is absorbed into the bloodstream, which can cause side effects similar to those observed after oral administration of beta-adrenergic receptor blockers. Side effects occur less frequently after topical application of eye drops than after oral administration or injections of these medications.
Among the additional side effects listed, reactions typical of the therapeutic group of beta-adrenolytic agents used in eye diseases are included:
Unknown:
Low blood sugar, heart failure, arrhythmias, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual dysfunction, hallucinations, foreign body sensation in the eye, accelerated heart rate, and increased blood pressure.

Reporting side effects

If any undesirable symptoms occur, including any side effects not listed in the leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Cosopt

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton (six digits after the abbreviation "EXP"). The first two digits indicate the month, and the last four indicate the year. The expiry date refers to the last day of the specified month.
Store in a temperature below 25°C, in the outer packaging to protect from light.
Shelf life after first opening the bottle: 4 weeks.
Medicines should not be disposed of via wastewater or household waste containers. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Cosopt contains

• The active substances of the medicine are dorzolamide and timolol.
• Each milliliter of solution contains 20 mg of dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).
• The other ingredients are benzalkonium chloride, hydroxyethylcellulose, mannitol, sodium citrate dihydrate, sodium hydroxide, and water for injections.

What Cosopt looks like and what the pack contains

Cosopt is a clear, colorless or almost colorless, slightly viscous solution.
The OCUMETER Plus bottle consists of a semi-transparent high-density polyethylene container containing 5 ml of solution.
The unbroken security strip on the bottle label indicates that the product has not been used.
Pack sizes:
1 x 5 ml (1 bottle of 5 ml)
3 x 5 ml (triple pack containing 3 bottles of 5 ml)
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer

Fareva Mirabel
Route de Marsat – Riom
63963 Clermont-Ferrand, Cedex 9
France

Date of last update of the leaflet: