Timolol Maleate Ophthalmic Solution: Uses, Side Effects and Dosage

What is TIMOLOL MALEATE OPHTHALMIC SOLUTION used for?

TIMOLOL MALEATE OPHTHALMIC SOLUTION lowers the pressure in the eye for conditions such as open-angle glaucoma and ocular hypertension.

How does TIMOLOL MALEATE OPHTHALMIC SOLUTION work?

The active ingredient, timolol maleate, is a beta-blocking drug. It helps lower the pressure in the eye.

What are the ingredients in TIMOLOL MALEATE OPHTHALMIC SOLUTION?

Medicinal ingredients: Timolol maleate

Non-medicinal ingredients: Benzalkonium chloride (preservative), monobasic and dibasic sodium phosphate, sodium hydroxide and water for injection.

TIMOLOL MALEATE OPHTHALMIC SOLUTION comes in the following dosage forms:

Ophthalmic solution: 5 mg (0.5%) timolol (timolol maleate) per mL.

Do not use timolol maleate ophthalmic solution if:

• You are allergic to any of its components (see What are the ingredients in TIMOLOL MALEATE OPHTHALMIC SOLUTION section).
• You have now or have had certain serious breathing problems such as asthma or chronic obstructive lung disease.
• You have certain heart diseases or conditions (such as slow or irregular heartbeats).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TIMOLOL MALEATE OPHTHALMIC SOLUTION. Talk about any health conditions or problems you may have, including if you:

• Have any medical problems now or have had any in the past, especially asthma and other lung problems, heart problems or poor blood circulation.
• Have any allergies.
• Have now or have had in the past, thyroid problems.
• Have or have had in the past, diabetes or other blood sugar problems.
• Are planning major surgery, including eye surgery, as using TIMOLOL MALEATE OPHTHALMIC SOLUTION may change the effects of some medicines during anesthesia.
• Had past eye problems such as choroidal detachment.
• Had problems or develop problems with blood flow to the brain.

• Are pregnant or intend to become pregnant.

• Are breastfeeding or intend to breastfeed. Timolol has been detected in human breast milk.

Other warnings you should know about:

TIMOLOL MALEATE OPHTHALMIC SOLUTION is not recommended for children.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TIMOLOL MALEATE OPHTHALMIC SOLUTION:

• Beta-blockers such as atenolol, epinephrine, quinidine.
• Calcium channel blockers or catecholamine depleting drugs such as reserpine.
• Clonidine.
• Epinephrine.

How to take TIMOLOL MALEATE OPHTHALMIC SOLUTION:

Read the following information carefully. If you need any explanations, or further information, ask your physician or pharmacist.

1. 1. Do not start taking any other medicines unless you have discussed the matter with your physician or pharmacist.
2. 2. If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your physician immediately.
3. 3. If you are using TIMOLOL MALEATE OPHTHALMIC SOLUTION with another eye drop, the drops should be instilled at least 10 minutes apart.
4. 4. Do not change the dosage of the drug without consulting your physician. If you must stop treatment, contact your physician immediately.
5. 5. Do not allow the tip of the container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.
6. 6. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use. TIMOLOL MALEATE OPHTHALMIC SOLUTION contains benzalkonium chloride as a preservative. This preservative may be absorbed by soft contact lenses.

Instructions for Use:

Step 1 - Before using the medication for the first time, be sure the tamper evident ring between the bottle and cap is unbroken (see Figure A).

Step 2 - Wash your hands.

Step 3 - To open the bottle, tear off the tamper evident ring to break the seal (see Figure B).

Step 4 - Remove the cap by turning it in the counter-clockwise direction (see Figure C).

Step 5 - Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye (see Figure D).

Step 6 - Invert the bottle, grasping it with the thumb or index finger, and press gently on the middle of the bottle until a single drop is dispensed into the eye as directed by your physician (see Figure E).

Step 7 - After using TIMOLOL MALEATE OPHTHALMIC SOLUTION, press a finger into the corner of your eye, by the nose (see Figure F) for 2 minutes. This helps keep TIMOLOL MALEATE OPHTHALMIC SOLUTION in your eye.

Step 8 - If drop dispensing is difficult after opening for the first time, replace the cap on the bottle and tighten (DO NOT OVERTIGHTEN) and then remove by turning the cap in the opposite direction.

Step 9 - Repeat steps 5 to 7 with the other eye if instructed to do so by your physician.

Step 10 - Replace the cap by turning until it is firmly touching the bottle. Do not overtighten or you may damage the bottle and cap.

Step 11 - The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.

Step 12 - After you have used all doses, there will be some TIMOLOL MALEATE OPHTHALMIC SOLUTION left in the bottle. You should not be concerned since an extra amount of TIMOLOL MALEATE OPHTHALMIC SOLUTION has been added and you will get the full amount of TIMOLOL MALEATE OPHTHALMIC SOLUTION that your physician prescribed. Do not attempt to remove excess medicine from the bottle.

Usual dose:

One drop in the affected eye(s) in the morning and in the evening. Your doctor may change your dose based on your condition.

Overdose:

If you put too many drops in your eye or swallow the contents of the bottle, you should contact your physician immediately.

Missed Dose:

It is important to apply TIMOLOL MALEATE OPHTHALMIC SOLUTION as prescribed by your physician. If you miss a dose, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose.

What are possible side effects from using TIMOLOL MALEATE OPHTHALMIC SOLUTION?

These are not all the possible side effects you may have when taking TIMOLOL MALEATE OPHTHALMIC SOLUTION. If you experience any side effects not listed here, tell your healthcare professional.

You may experience:

1. 1. muscle pain
2. 2. abdominal pain
3. 3. nausea
4. 4. vomiting
5. 5. eye symptoms such as burning and stinging, dry eyes, redness of the eye, foreign body sensation or visual changes, such as double vision.

Other side effects may also occur rarely, and some of these may be serious. These may include shortness of breath.

TIMOLOL MALEATE OPHTHALMIC SOLUTION has been reported rarely to increase muscle weakness in some patients with myasthenia gravis.

There are side effects of TIMOLOL MALEATE OPHTHALMIC SOLUTION that may affect some patients’ ability to drive and use machines.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature 15°C - 25°C.

Protect from light. Discard 28 days after opening the bottle.

Keep out of reach and sight of children.

If you want more information about TIMOLOL MALEATE OPHTHALMIC SOLUTION:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1 (800) 715-6915.

Last Revised: NOV 22, 2024