Timoptic XE Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Glaucoma, Open Angle, Intraocular Hypertension|
|Class:||Ophthalmic glaucoma agents|
|Form:||Liquid solution, Eye drops (ophthalmic)|
|Ingredients:||timolol maleate, monobasic and dibasic sodium phosphate, sodium hydroxide, and water for injection|
timolol maleate ophthalmic solution, USP
About this Medication
What the Medication is used For
TIMOPTIC is the brandname for the medication timolol maleate ophthalmic solution available only on prescription through your physician. TIMOPTIC is an ophthalmic solution of a beta-blocking drug which lowers the pressure in the eye for conditions such as glaucoma and ocular hypertension and is only available through a prescription by your physician.
Remember - This medicine is prescribed for the particular condition that you have. Do not give this medicine to other persons, nor use it for any other condition.
What it Does
The active ingredient timolol maleate is a beta-blocking drug. It helps lower the pressure in the eye.
When it Should not Be Used
Do not use TIMOPTIC if you:
- are allergic to any of its components (see What the nonmedicinal ingredients are section below);
- have now or have had in the past certain serious breathing problems such as asthma;
- have chronic obstructive lung disease;
- have certain heart diseases or conditions (such as slow or irregular heartbeats);
- are breast feeding or intend to breast feed.
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Monobasic and dibasic sodium phosphate, sodium hydroxide, and water for injection. Benzalkonium chloride is added as a preservative.
What Dosage Forms it Comes In
TIMOPTIC (timolol maleate) ophthalmic solution is a sterile eye drop.
Ophthalmic Solution TIMOPTIC, equivalent to 5 mg (0.5%) timolol per mL; in 5 mL, 10 mL and 15 mL dispensers, colour-coded with a dark pink label on the cap.
Warnings and Precautions
This medicine may not be suitable for some patients. So, tell your physician if you think any of the following applies to you:
- If you have any medical problems now or have had any in the past, especially asthma and other lung problems or heart problems.
- If you have any allergies to any medications.
- TIMOPTIC contains benzalkonium chloride as a preservative. This preservative may be absorbed by soft contact lenses. If you wear soft contact lenses, consult your physician before using TIMOPTIC. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.
- If you have now or have had in the past, thyroid problems.
- If you have now or have had in the past, heart problems (such as coronary heart disease, heart failure or low blood pressure).
- If you have now or have had in the past, heart rate disturbances (such as slow or irregular heartbeats).
- If you have or have had in the past, poor blood circulation problems (such as Raynaud’s syndrome).
- If you have or have had in the past, lung or breathing problems (such as asthma or chronic obstructive lung disease).
- If you have or have had in the past, diabetes or other blood sugar problems.
- If you are planning major surgery, including eye surgery, as using TIMOPTIC may change the effects of some medicines during anesthesia.
- If you had past eye problems such as choroidal detachment.
- If you had problems or develop problems with blood flow to the brain.
- If you are pregnant or intend to become pregnant.
- If you are breast feeding or intend to breast feed. Timolol has been detected in human breast milk. Discuss with your physician.
TIMOPTIC IS NOT RECOMMENDED FOR CHILDREN.
Interactions with this Medication
Your physician also needs to know about drugs (including eye drops) that you are using or plan to use, including drugs obtained without a prescription. This is particularly important if you are taking medicine to lower blood pressure or to treat heart disease, diabetes or depression including beta-blockers such as atenolol, epinephrine, quinidine, calcium channel blockers or catecholamine depleting drugs such as reserpine.
No specific drug interaction studies have been done for TIMOPTIC.
Proper Use of this Medication
Read the following information carefully. If you need any explanations, or further information, ask your physician or pharmacist.
- Do not start taking any other medicines unless you have discussed the matter with your physician or pharmacist.
- If you suspect that TIMOPTIC is causing an allergic reaction (for example, skin rash or redness and itching of the eye), stop its use and contact your physician as soon as possible.
- 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.
- If you are using TIMOPTIC with another eye drop, the drops should be instilled at least 10 minutes apart.
- Do not change the dosage of the drug without consulting your physician. If you must stop treatment, contact your physician immediately.
- 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.
- Contact your physician without delay if you have ocular surgery or develop a condition that was not present at the time this medication was prescribed (eg. trauma, an infection, etc.).
Usual Adult Dose
The appropriate dosage and duration of treatment will be established by your physician.
The usual dose is one drop in the affected eye(s) in the morning and in the evening.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you put too many drops in your eye or swallow the contents of the bottle, you should contact your physician immediately.
It is important to apply TIMOPTIC 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.
Instructions for Use
- Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
- Tear off the Safety Strip to break the seal.
- To open the bottle, unscrew the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
- Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
- Invert the bottle, grasping it with the thumb or index finger over the Finger Push Area as shown. Press lightly until a single drop is dispensed into the eye as directed by your physician.
DO NOT TOUCH YOUR EYE OR EYELID WITH THEDROPPER TIP.
Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result form using contaminated ophthalmic medications. If you think your medication may be contaminated, or if you develop an eye infection, contact your physician immediately concerning continued use of this bottle.
- After using TIMOPTIC, press a finger into the corner of your eye, by the nose (as shown) for 2 minutes. This helps keep TIMOPTIC in your eye.
- 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 as indicated by the arrows on top of the cap.
- Repeat steps 4 & 5 with the other eye if instructed to do so by your physician.
- Replace the cap by turning until it is firmly touching the bottle. The arrow on the left side of the cap must be aligned with the arrow on the left side of the bottle label for proper closure. Do not overtighten or you may damage the bottle and cap.
- The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
- After you have used all doses, there will be some TIMOPTIC left in the bottle. You should not beconcerned since an extra amount of TIMOPTIC has been added and you will get the full amount of TIMOPTIC that your physician prescribed. Do not attempt to remove excess medicine from the bottle.
- Tell your physician if you wear contact lenses. Depending on the type of lense, your physician may advise that you re-insert your contact lenses not earlier than 15 minutes after application of TIMOPTIC.
Side Effects and what to Do About Them
- Any medicine may have unintended or undesirable effects, so-called side effects. Although not all of these side effects may occur, if they do occur, you may need medical attention.
- You may experience muscle pain; abdominal pain; nausea; vomiting; 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.
- TIMOPTIC has been reported rarely to increase muscle weakness in some patients with myasthenia gravis.
- Your physician or pharmacist has a complete list of the possible side effects from this medication. Please tell your physician or pharmacist promptly about any unusual symptom.
- There are side effects of TIMOPTIC that may affect some patients’ ability to drive and use machines.
Serious Side Effects how often they Happen and what to Do About Them
|Symptom / effect||Talk with your|
swelling of the
This is not a complete list of side effects. For any unexpected effects while takingTIMOPTIC, contact your physician or pharmacist.
How to Store It
Store at room temperature 15°-25°C. Protect from light.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect
or at Merck Canada Inc. by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-800-369-3090, or
- Mail to: Merck Canada Inc.
P.O. Box 1005
Pointe-Claire–Dorval, QC H9R 4P8
NOTE:Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program or Merck do not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.merck.ca or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594.