Uses

This product contains two medications used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. These two medications work together to decrease the amount of fluid within the eye. Brinzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. Timolol belongs to a class of drugs known as beta-blockers.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using brinzolamide/timolol and each time you get a refill. If you have any questions regarding the information, ask your doctor or pharmacist.

This medication is for use in the eye(s), usually one drop in the affected eye(s) 2 times a day or as directed by your doctor. Shake the bottle well before each dose.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using your eye drops. Wait at least 15 minutes after using this medication before putting your contact lenses back in.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Keep using this medication even if you feel well. Most people with glaucoma or high pressure in the eyes do not have symptoms.

Side Effects

Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, dry eyes, feeling as if something is in the eye, bitter/sour/unusual taste in your mouth, or headache may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• dizziness
• new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)
• slow/irregular heartbeat
• eye or eyelid swelling/pain/discharge
• mental/mood changes (such as depression)
• coldness/numbness/pain in the hands or feet

Get medical help right away if you have any very serious side effects, including:

• wheezing/difficulty breathing
• chest/jaw/left arm pain
• fainting
• weakness on one side of the body
• trouble speaking
• confusion
• sudden vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this product, tell your doctor or pharmacist if you are allergic to timolol or other beta-blockers; or to brinzolamide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• lung disease/breathing problems (such as current or past history of asthma, severe chronic obstructive pulmonary disease)
• slow/irregular heartbeat (such as sinus bradycardia, second- or third-degree AV block)
• heart disease (such as chest pain, heart failure)
• kidney disease (such as kidney stones, renal failure)
• liver disease
• diabetes
• low blood flow to the brain (cerebrovascular insufficiency)
• overactive thyroid disease
• certain muscle/nerve disease (myasthenia gravis)
• severe allergic reaction (such as anaphylaxis, atopy)

If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of brinzolamide/timolol. You may be advised to start using a new bottle.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you can do it safely.

This product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). The risk is higher if you have diabetes, or are vomiting, fasting, or not eating regularly. Other symptoms of low blood sugar level, such as dizziness and sweating, are not affected by this drug.

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• high doses of aspirin or related salicylates (such as high doses used for arthritis)
• beta-blockers (such as propranolol)
• clonidine
• digoxin
• epinephrine
• methyldopa

Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day), should be continued. Consult your doctor or pharmacist for more details.

Other medications can affect the removal of brinzolamide/timolol from your body, which may affect how this medication works. Examples include cimetidine, ketoconazole, itraconazole, clotrimazole, quinidine, ritonavir, troleandomycin, certain antidepressants (such as SSRIs like fluoxetine), among others.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: trouble breathing or slow/irregular heartbeat.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as eye exams, heart rate) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store between 36-86 degrees F (2-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. Discard 60 days after opening.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.