Cosopt Pf

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

COSOPT PF, 20 mg/ml + 5 mg/ml, eye drops, solution in a single-dose container

Dorzolamide + Timolol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is COSOPT PF and what is it used for
• 2. Important information before using COSOPT PF
• 3. How to use COSOPT PF
• 4. Possible side effects
• 5. How to store COSOPT PF
• 6. Contents of the pack and other information

1. What is COSOPT PF and what is it used for

COSOPT PF 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-adrenergic receptor blockers" (beta-adrenolytics). These medicines lower intraocular pressure through two different mechanisms.

COSOPT PF is indicated for the treatment of glaucoma to lower elevated intraocular pressure, when beta-adrenergic receptor blocker eye drops alone are not enough.

2. Important information before using COSOPT PF

When not to use COSOPT PF

• if the patient is allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has a history of respiratory problems, such as asthma or severe chronic obstructive pulmonary disease (a serious lung disease that may cause wheezing, breathing difficulties, and/or a long-lasting cough);
• if the patient has a slow heart rate, heart failure, or irregular heart rhythm;
• if the patient has severe kidney disease or severe kidney function disorders, or a history of kidney stones;
• if the patient has excessive acidification of the blood due to the accumulation of chloride ions in the body (hyperchloremic acidosis).

In case of doubt about whether to use this medicine, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use COSOPT PF, discuss it with your doctor.
Tell your doctor about all current or past eye disorders and diseases:

• ischemic heart disease (symptoms include chest pain or feeling of pressure in the chest, shortness of breath, or feeling of suffocation), heart failure, low blood pressure;
• heart rhythm disorders, such as slow heart rate;
• breathing difficulties, asthma, or chronic obstructive pulmonary disease;
• diseases related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as timolol may mask the subjective and objective symptoms of hypoglycemia (low blood sugar);
• hyperthyroidism, as timolol may mask its subjective and objective symptoms.

Before surgery, inform the anesthesiologist about the use of COSOPT PF, as timolol may affect the action of certain anesthetics.
Also, tell your doctor about any allergies to medications or anaphylactic reactions.
Tell your doctor if you have experienced muscle weakness or been diagnosed with myasthenia gravis (Myasthenia gravis).
If you experience eye irritation or any new eye problems, such as redness of the eye or swelling of the eyelids, see a doctor immediately.
If you suspect that COSOPT PF is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or redness and itching of the eye), stop using this medicine and contact your doctor immediately.
Tell your doctor if you have an eye infection, eye injury, or have had eye surgery, or if you experience a reaction with new or worsening symptoms.
After administering the medicine to the eye, COSOPT PF may cause systemic effects.
No studies have been conducted on the use of this medicine in patients using contact lenses.
Before using COSOPT PF, individuals using soft contact lenses should consult a doctor.

Use in children

Experience with the use of COSOPT (preservative-containing form) in infants and children is limited.

Use in the elderly

In studies conducted with COSOPT (preservative-containing form), COSOPT caused similar effects in elderly and younger patients.

Use in patients with liver function disorders

Tell your doctor about any current or past liver diseases.

COSOPT PF and other medicines

COSOPT PF may affect the action of other medicines or other medicines used by the patient may affect the action of COSOPT PF. This includes other ophthalmic glaucoma medicines. Tell your doctor about taking or planning to take blood pressure-lowering medicines, heart medicines, or anti-diabetic medicines. Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is especially important in the case of:

• taking blood pressure-lowering medicines or heart medicines (such as calcium channel blockers, beta-adrenergic receptor blockers, or digoxin);
• taking medicines for heart rhythm disorders or restoring a regular heart rhythm (such as calcium channel blockers, beta-adrenergic receptor blockers, or digoxin);
• using other eye drops containing beta-adrenergic receptor blockers;
• taking other carbonic anhydrase inhibitors, such as acetazolamide;
• taking monoamine oxidase inhibitors (MAOIs);
• taking parasympathomimetic (cholinergic) medicines, which may be used for urinary disorders. Parasympathomimetic medicines are also sometimes used to restore normal bowel motility;
• taking narcotics, such as morphine, used to treat moderate to severe pain;
• taking anti-diabetic medicines;
• taking antidepressants, such as fluoxetine and paroxetine;
• taking sulfonamide chemotherapeutics;
• taking quinidine (a medicine used to treat heart diseases and certain types of malaria).

Pregnancy and breastfeeding

Before taking any medicine, consult a doctor or pharmacist.

Use during pregnancy

This medicine should not be used during pregnancy unless the doctor considers it necessary.

Use during breastfeeding

This medicine should not be used during breastfeeding. Timolol may pass into breast milk. Before taking any medicine during breastfeeding, consult your doctor.

Driving and using machines

No studies have been conducted on the effect on the ability to drive or operate machinery. Some side effects associated with the use of COSOPT PF, such as blurred vision, may affect the ability to drive or operate machinery. Patients who feel unwell or have blurred vision should not drive or operate machinery.

3. How to use COSOPT PF

This medicine should always be used exactly as prescribed by your doctor. In case of doubt, consult a doctor or pharmacist. The doctor will determine the correct dose and duration of treatment.
The recommended dose is one drop into the affected eye(s) in the morning and evening.
If you are using other eye drops in addition to COSOPT PF, wait at least 10 minutes between administering each medicine.
Do not change the dose of the medicine without consulting your doctor.
If you have difficulty applying the drops, ask a family member or caregiver for help.
Do not allow any part of the single-dose container to touch the eye or its surroundings. This may cause eye injury or contamination of the container with bacteria, which can lead to eye infection and serious damage to the eye, even vision loss. To avoid possible contamination of the single-dose container, wash your hands before using the medicine and avoid touching the tip of the single-dose container to any surface. A new single-dose container should be opened just before each use. Each single-dose container contains enough solution for one dose of the medicinal product for both eyes, if the doctor has prescribed it for both eyes. Opened single-dose containers should be discarded immediately after use.

Instructions for use

Open the foil sachet containing the single-dose containers. Note the date of first opening on the sachet.
Using COSOPT PF

• 1. Wash your hands.
• 2. Remove the strip of single-dose containers from the sachet.
• 3. Tear off one single-dose container from the strip.
• 4. Put the strip with the remaining single-dose containers back and fold the edge to close the sachet.
• 5. If the solution is not at the tip of the single-dose container, tap the closed single-dose container a few times with your finger, with the dosing tip facing down, to get the solution to the tip.
• 6. Open the single-dose container by twisting off the top. (Figure A).
• 7. Hold the single-dose container between your thumb and index finger. Remember that the tip of the single-dose container should not protrude more than 5 mm beyond the edge of your index finger. (Figure B).
• 8. Tilt your head back or lie down. Place your hand on your forehead. Your index finger should be along the eyebrow arch or resting on the bridge of your nose. Look up and use your other hand to pull the lower eyelid down. Do not allow any part of the single-dose container to touch the eye or its surroundings. Administer one drop into the space between the eyelid and the eyeball by gently squeezing the single-dose container. (Figure C). Do not blink while administering the drop to the eye. Each single-dose container contains enough solution for one dose of the medicinal product for both eyes.
• 9. Close your eye and press the inner corner of your eye with your finger for about two minutes. This helps prevent the medicine from entering the entire body. (Figure D).
• 10. Wipe off any excess solution from the skin around the eyes.

If your doctor has prescribed the drops for both eyes, repeat the above steps for the second eye.
To avoid contaminating the preservative-free solution, discard the single-dose container immediately after administering the medicinal product to the eye(s), even if some solution remains.
Store the remaining single-dose containers in the foil sachet; they can be used within 15 days of opening the sachet. If there are any single-dose containers left in the sachet after 15 days from the date of opening, discard them in an environmentally safe manner and open a new sachet. It is important to use the eye drops continuously as prescribed by your doctor.
In case of doubts about the use of the medicinal product, consult a doctor, pharmacist, or nurse.

Using a higher dose of COSOPT PF than recommended

In case of administering too many drops or swallowing the contents of the single-dose container, among other symptoms, dizziness, breathing difficulties, or a feeling of slow heart rate may occur. Contact a doctor immediately.

Missing a dose of COSOPT PF

COSOPT PF should be used as directed by your doctor.
If you miss a dose, use it as soon as possible. However, if it is almost time for your next dose, do not use the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a missed dose.

Stopping the use of COSOPT PF

Before stopping the medicine, consult your doctor.
In case of further doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects:
If you experience any of the following side effects, stop using this medicine and seek medical help 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, causing respiratory tract obstruction and swallowing difficulties, shortness of breath, hives, itching rash, local and generalized rash, itching, and severe, life-threatening allergic reactions.
Eye drop treatment can usually be continued, unless the side effects are severe. In case of concerns, consult a doctor or pharmacist. Do not stop using COSOPT PF without consulting your doctor
During clinical trials or after the medicine was marketed, the following side effects were reported in relation to COSOPT PF or one of its active substances:
Very common (may affect more than 1 in 10 people)
Burning and stinging in the eye, change in taste
Common (may affect up to 1 in 10 people)
Redness of the eyeball and skin around the eye, tearing or itching of the eye, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation of the eyeball 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 (may affect up to 1 in 100 people)
Dizziness, depression, uveitis, visual disturbances, including changes in refraction (in some cases due to the withdrawal of miotic drugs), slow heart rate, fainting, shortness of breath, indigestion, and kidney stones.
Rare (may affect up to 1 in 1,000 people)
Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs) ,tingling or numbness in the hands or feet, insomnia, nightmares, memory loss, worsening of myasthenia gravis symptoms (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, ptosis (drooping eyelids), double vision, formation of crusts on the eyelids, corneal edema (with subjective symptoms of vision disturbances), low intraocular pressure, tinnitus, low blood pressure, arrhythmia, changes in heart rate or rhythm, 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, severe palpitations (rapid or irregular heartbeat), 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 when walking (claudication), shortness of breath, respiratory failure, rhinitis (runny nose), nosebleeds, bronchospasm, cough, throat irritation, dry mouth, contact dermatitis, hair loss, white-silver rash (psoriasiform rash), Peyronie's disease (which can cause penis curvature), allergic reactions, such as rash, hives, itching, and in rare cases, swelling of the lips, eyelids, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Like other eye medicines, 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 using eye drops locally than after taking these medicines orally or by injection.
Among the additional side effects listed, reactions typical of the therapeutic group of beta-adrenolytic medicines used in ophthalmic disorders are included:
Unknown (frequency cannot be estimated from available data)
Low blood sugar, heart failure, arrhythmia, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual function disorders, hallucinations, foreign body sensation in the eye, rapid heart rate, and increased blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store COSOPT PF

Keep this medicine out of the sight and reach of children.
Do not use unopened COSOPT PF sachets after the expiry date (six digits after the abbreviation EX or EXP) stated on the packaging. The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store in the original foil sachet to protect from light.
COSOPT PF can be used for 15 days after first opening the sachet.
After this time, discard any unused single-dose containers.
Opened single-dose containers should be discarded immediately after use, even if they contain any remaining medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What COSOPT PF contains

• The active substances are dorzolamide and timolol.

Each milliliter of solution contains 20 mg of dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (6.83 mg of timolol maleate).

• The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections.

What COSOPT PF looks like and contents of the pack

COSOPT PF is a clear, colorless or almost colorless, slightly viscous solution.
Each foil sachet contains 15 or 10 single-dose containers made of low-density polyethylene, each containing 0.2 ml of solution.
Pack sizes:
30 x 0.2 ml (2 sachets with 15 single-dose containers or 3 sachets with 10 single-dose containers)
60 x 0.2 ml (4 sachets with 15 single-dose containers or 6 sachets with 10 single-dose containers)
120 x 0.2 ml (8 sachets with 15 single-dose containers or 12 sachets with 10 single-dose containers)
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
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Cosopt
Finland, France, Lithuania, Portugal, Sweden
Cosopt brez konzervansa
Slovenia
Cosopt Conserveermiddelvrij
Netherlands
Cosopt fără conservant
Romania
Cosopt Free
Slovakia
Cosopt Free bez konzervačních přísad
Czech Republic
Cosopt monodose
Italy
Cosopt PF
Bulgaria, Latvia, Poland
Cosopt PF “Χωρίς συντηρητικό”
Greece
Cosopt Preservative-free
Ireland, United Kingdom (Northern Ireland)
Cosopt-S
Germany
Cosopt sine
Austria
Cosopt Ukonserveret
Denmark
Cosopt Unit Dose
Belgium, Luxembourg
Cosopt Uno
Hungary

Date of last revision of the leaflet: 09/2023