Patient information: uses, side effects, how to take - Zolymbus

What is ZOLYMBUS?

ZOLYMBUS is a prescription eye gel 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. ZOLYMBUS belongs to a group of medicines called prostaglandin analogs.

ZOLYMBUS is not recommended in children younger than 16 years of age because of the potential for eye and eyelid color changes.

Do not use ZOLYMBUS ifyou are allergic to bimatoprost or any of the ingredients in ZOLYMBUS. See the end of this Patient Information leaflet for a complete list of ingredients in ZOLYMBUS.

Before using ZOLYMBUS, tell your healthcare provider about all your medical conditions, including if you:

have or have had eye problems including any surgery on your eye or eyes
are using any other eye medicines
are pregnant or plan to become pregnant. It is not known if ZOLYMBUS will harm your unborn baby. If you become pregnant while using ZOLYMBUS talk to your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if ZOLYMBUS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZOLYMBUS.

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

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 ZOLYMBUS?

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

Use 1 drop of ZOLYMBUS in your affected eye or eyes each evening.Talk to your healthcare provider or pharmacist if you are not sure how to use ZOLYMBUS.
Your ZOLYMBUS may not work as well if you use it more than 1 time each evening.
If you miss a dose of ZOLYMBUS, skip the missed dose and use the next dose at your regular time.
If you use other medicines in your eye, wait at least 5 minutes between using ZOLYMBUS and your other eye medicines.
Contact lenses should be taken out before using ZOLYMBUS and you should wait at least 15 minutes after giving the dose of ZOLYMBUS before putting the contact lenses back into your eyes.
Use your ZOLYMBUS right away after opening for use in 1 or both eyes. Each ZOLYMBUS single-dose container is sterile and is to be used 1 time then thrown away. Do not save any ZOLYMBUS that may be left over after you use your medicine. Using ZOLYMBUS that is not sterile may cause other eye problems.

What are the possible side effects of ZOLYMBUS?

ZOLYMBUS may cause serious side effects including:

changes in the color of your eye (iris).Your iris may become more brown in color while using ZOLYMBUS. This color change may not go away when you stop using ZOLYMBUS. If ZOLYMBUS is used in 1 eye only, the color of that eye may always be a different color from the color of your other eye.
darkening of the color of the skin around your eye (eyelid).These skin changes usually go away when you stop using ZOLYMBUS.
increasing the length, thickness, color, and number of your eyelashes.These eyelash changes usually go away when you stop using ZOLYMBUS.
hair growth on skin around the treated eye.This hair growth usually goes away when you stop using ZOLYMBUS.
inner eye swelling(inflammation). Swelling or thickening may occur in the center of your eye (macular edema) and swelling in the middle layer of your eye (uvea, intraocular inflammation). Tell your healthcare provider if you experience eye inflammation or have a known risk of macular edema.

The most common side effects of ZOLYMBUS include:

redness of and around the eye (conjunctival hyperemia)
eye irritation
itchy eyes (eye pruritus)
dry eye

foreign body sensation in the eyes
increase of tears in the eye (increased lacrimation)
eye pain
blurry vision

Tell your healthcare provider right away if you have any new eye problems while using ZOLYMBUS, including:

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

Additionally, the following side effects have been reported in other bimatoprost medicines like ZOLYMBUS, when used in the eye (topical use):

asthma-like symptoms
dizziness
shortness of breath (dyspnea)
eye discharge (eye mucus)
inflammation of the eye (eye edema)
headache
signs and symptoms of eye allergy and allergic inflammation of the skin (allergic dermatitis)
hypertension
periorbital and lid changes associated with loss of fat leading to skin tightness
deepening of the eyelid crease (eyelid sulcus)
drooping eyelid (eyelid ptosis)
sunken eye (enophtalmos)
eyelid retraction
sensitivity to light (photophobia)

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

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

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

How should I store ZOLYMBUS?

Before opening the foil pouches:

Keep the ZOLYMBUS single-dose containers in their original foil pouch. Protect from light.
Store the unopened foil pouches between 68°F to 86°F (20°C to 30°C).
Do not open the foil pouch containing ZOLYMBUS until you are ready to use the eye drops.

After opening the foil pouch:

Store the single-dose containers in the opened foil pouch between 68°F to 86°F (20°C to 30°C), for up to 14 days.
Write down the date of first opening the foil pouch in the space provided on the pouch.
Throw away all unused ZOLYMBUS single-dose containers in the opened foil pouch after 14 days.

Keep ZOLYMBUS and all medicines out of the reach of children.

General information about the safe and effective use of ZOLYMBUS.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZOLYMBUS for a condition for which it was not prescribed. Do not give ZOLYMBUS to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about ZOLYMBUS that is written for health professionals.

What are the ingredients in ZOLYMBUS?

Active ingredients:bimatoprost

Inactive ingredients:carbomer, polyethylene glycol, sodium acetate trihydrate, sorbitol, sodium hydroxide and water.

ZOLYMBUS does not contain a preservative.

Manufactured for: Thea Pharma Inc.Waltham, MA 02451.

Instructions for Use ZOLYMBUS™ (zoh LIM bus) (bimatoprost ophthalmic gel) 0.01% for topical ophthalmic use
Read this Instructions for Use before using your ZOLYMBUS™ 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 Information You Need to Know Before Using ZOLYMBUS: ZOLYMBUS is for use in the eye. Do not swallow ZOLYMBUS. ZOLYMBUS single-dose containers are packaged in a foil pouch. Do notuse the ZOLYMBUS single-dose containers if the foil pouch is already opened when you receive it. Write down the date you open the foil pouch in the space provided on the pouch. Use 1 drop of ZOLYMBUS in your affected eye or eyes each evening. If you use other eye medicines dropped into the eye (topically applied ophthalmic medicines), use the medicines at least 5 minutes before or 5 minutes after the use of ZOLYMBUS. Do notopen the ZOLYMBUS single-dose container until you are ready to use the eye drops.
Please follow these instructions to use ZOLYMBUS:
Step 1.	Wash your hands and sit or stand comfortably.
Step 2.	Open the foil pouch containing a strip of 10 single-dose containers. Write down the date of first opening on the foil pouch.
Step 3.	Take the strip of single-dose containers from the foil pouch. Break off 1 single-dose container from the strip. Place the remaining strip of unopened single-dose containers back in the foil pouch and fold the edge to close the pouch.
Step 4.	Hold the single-dose container upright. Make sure that your ZOLYMBUS medicine is in the bottom part of the single-dose container. Twist open the top of the single-dose container as shown. Do not touch the tip after opening the container.
Step 5.	Tilt your head backwards. If you are unable to tilt your head, lie down. Use your finger to gently pull down the lower eyelid of your affected eye.
Step 6.	Place the tip of the single-dose container close to, but not touching your eye.
Step 7.	Squeeze the single-dose container gently so that only 1 drop goes into your eye, then release the lower eyelid. If the drop misses your eye completely, try again.
If your healthcare provider has told you to use ZOLYMBUS drops in both eyes, repeat Step 5 to Step 7 for your other eye. Each single-dose container contains enough drops for both eyes. Throw away the single-dose container after use. Do not keep it to use it again even if there is product left in the container.To lessen the chance of infection, a new single-dose container must be opened each time you are ready to use ZOLYMBUS. Place the folded foil pouch back in the carton. The unopened single-dose containers must be used within 14 days after opening the foil pouch. Protect from light.
Manufactured for: Thea Pharma Inc.Waltham, MA 02451. U.S. Patent N°. 10,314,780. ©2025, Laboratoires Théa. All rights reserved. ZOLYMBUS™ is a trademark of Laboratoires Théa.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.		Approved: 09/2025

Zolymbus (Bimatoprost): Uses, Side Effects and Dosage