Patient information: uses, side effects, how to take - Cosopt PF

What is COSOPT PF?

COSOPT PF is a prescription sterile eye drop solution that contains 2 medicines, dorzolamide hydrochloride (a sulfonamide carbonic anhydrase inhibitor) and timolol maleate (a beta-adrenergic blocker). COSOPT PF is used to lower the pressure in the

eye (intraocular pressure) in people with open-angle glaucoma or ocular hypertension, when their eye pressure is too high and beta-adrenergic blocker medicines alone have not adequately lowered the pressure.

It is not known if COSOPT PF is safe and effective in children under 2 years of age.

Who should not use COSOPT PF?

Do not use COSOPT PF if you:

have or have had asthma
have or have had severe lung problems (chronic obstructive pulmonary disease)
have heart problems, including slow or irregular heartbeat or heart failure
are allergic to dorzolamide hydrochloride, timolol maleate, or any of the ingredients in COSOPT PF. See the end of this leaflet for a complete list of ingredients in COSOPT PF.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What should I tell my healthcare provider before using COSOPT PF?

Before you use COSOPT PF, tell your healthcare provider if you:

have problems with muscle weakness (myasthenia gravis)
have diabetes or problems with low blood sugar (hypoglycemia)
have thyroid, kidney, or liver problems
are planning to have surgery
are allergic to sulfa drugs
have or have had eye problems, including any surgery on your eye or eyes, or are using any other eye medicines
have any other medical problems
are pregnant or plan to become pregnant. It is not known if COSOPT PF will harm your unborn baby. If you become pregnant while using COSOPT PF talk to your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known whether dorzolamide or timolol passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use COSOPT PF.

Tell your healthcare provider about all the medicines you take, including prescription and non- prescription medicines, vitamins, and herbal supplements.

COSOPT PF and other medicines may affect each other causing side effects. COSOPT PF may affect the way other medicines work, and other medicines may affect how COSOPT PF works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use COSOPT PF?

Read the Instructions for Use at the end of this Patient Information leaflet for additional instructions about the right way to use COSOPT PF.

Use COSOPT PF exactly as your healthcare provider tells you.
Use 1 drop of COSOPT PF in your eye (or eyes) in the morning and 1 drop in the evening.
If you use other medicines in your eye, wait at least 5 minutes between using COSOPT PF and your other eye medicines.
Use your COSOPT PF right away after opening. Each COSOPT PF single-dose container is sterile and is to be used 1 time then thrown away.
Do not save any COSOPT PF that may be left over after you use a single-dose container. Using COSOPT PF that is not sterile may cause other eye problems.

What are the possible side effects of COSOPT PF?

COSOPT PF may cause serious side effects including:

severe breathing problems. These breathing problems can happen in people who have asthma, chronic obstructive pulmonary disease, or heart failure and can cause death. Tell your healthcare provider right away if you have breathing problems while taking COSOPT PF.
heart failure. This can happen in people who already have heart failure and in people who have never had heart failure before. Tell your healthcare provider right away if you get any of these symptoms of heart failure while taking COSOPT PF:
shortness of breath
irregular heartbeat (palpitations)
swelling of your ankles or feet
sudden weight gain
severe allergic reactions. These allergic reactions can happen the first time you use COSOPT PF or after you have been using COSOPT PF for a while and may cause death. Stop taking COSOPT PF and call your healthcare provider right away or get emergency help if you get any of these symptoms of an allergic reaction:
swelling of your face, lips, mouth, or tongue
trouble breathing
wheezing
severe itching
skin rash, redness, or swelling
dizziness or fainting
fast heartbeat or pounding in your chest (tachycardia)
sweating
worsening muscle weakness. COSOPT PF can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis).
kidney problems. Your healthcare provider may do tests to check your kidney function while you use COSOPT PF.
swelling of your eye (cornea)

The most common side effects of COSOPT PF include:

a bitter, sour, or unusual taste in your mouth after using COSOPT PF
burning, stinging, redness, or itching of the eye
blurred vision
painful, red, watery eyes with increased sensitivity (superficial punctate keratitis)

Tell your healthcare provider if you have any new eye problems while using COSOPT PF including:

an eye injury
an eye infection
a sudden loss of vision eye surgery
swelling and redness of and around your eye (conjunctivitis) problems with your eyelids

Tell your healthcare provider if you have any other side effects that bother you.

These are not all the possible side effects of COSOPT PF. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider about medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I do in case of an overdose?

If you swallow the contents of the container, contact your healthcare provider immediately. Among other effects, you may feel light-headed, have difficulty breathing, or feel your heart rate has slowed.

How should I store COSOPT PF?

Store COSOPT PF at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze.
Keep the COSOPT PF single-dose containers in their original foil pouch to protect from light.
Write down the date you open the foil pouch in the space provided on the pouch.
Throw away all unused COSOPT PF single-dose containers 15 days after first opening the pouch.

Keep COSOPT PF and all medicines out of the reach of children.

General information about the safe and effective use of COSOPT PF.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COSOPT PF for a condition for which it was not prescribed. Do not give COSOPT PF to other people, even if they have the same

symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about COSOPT PF. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for

information about COSOPT PF that is written for health professionals.

What are the ingredients in COSOPT PF?

Active ingredients: dorzolamide hydrochloride and timolol maleate

Inactive ingredients: hydroxyethyl cellulose, mannitol, sodium citrate, sodium

hydroxide, and water for injection.

Manufactured for: Thea Pharma Inc.

Waltham, MA 02451

The COSOPT trademark is owned by Merck Sharp & Dohme Corp. and is used under license.

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised: 4/2026

Instructions for Use

COSOPT®PF (CO-sopt PEA EHF)

(dorzolamide hydrochloride and timolol maleate ophthalmic solution) 2%/0.5%

For topical ophthalmic use

Read these Instructions for Use before using your COSOPT PF and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important:

COSOPT PF is for use in the eye. Do not swallow COSOPT PF.
COSOPT PF single-dose containers are packaged in a foil pouch.
Write down the date you open the foil pouch in the space provided on the pouch.

Every time you use COSOPT PF:

Step 1. Wash your hands.

Step 2. Take the strip of single-dose containers from the pouch.

Step 3. Pull off 1 single-dose container from the strip ( see Figure A).

(Figure A)

Step 4. Put the remaining strip of single-dose containers back in the pouch and fold the edge to close the pouch.

Step 5. Hold the single-dose container upright. The container may appear empty if the solution is in the tip of the container. Make sure that the solution is in the bottom part of the single-dose container before opening ( see Figure B).

(Figure B)

Step 6. Open the single-dose container by twisting off the tab (see Figure C and Figure D).

(Figure C)

(Figure D)

Step 7. Tilt your head backwards. If you are unable to tilt your head, lie down.

Step 8. Place the tip of the single-dose container close to your eye. Be careful not to touch your eye with the tip of the single-dose container.

Step 9. Pull the lower eyelid downwards and look up.

Step 10. Gently squeeze the container and let 1 drop of COSOPT PF fall into the space between your lower eyelid and your eye. If a drop misses your eye, try again (see Figure E).

(Figure E)

Step 11. Blot any excess solution from the skin around the eye with a tissue.

If your healthcare provider has told you to use drops in both eyes, repeat steps 7 to 11 for your other eye.
There is enough COSOPT PF in 1 single-dose container for 1 or both of your eyes.
Throw away the opened single-dose container with any remaining COSOPT PF right away.