Mylan-Timolol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ABOUT THIS MEDICATION

What the medication is used for:

Mylan-Timolol is the brand name for the medication timolol maleate available only on prescription through your physician. Mylan-Timolol 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 Mylan-Timolol if you:

• are allergic to any of its components
• have asthma or have ever had asthma
• have chronic obstructive lung disease
• have certain heart diseases or conditions

• are breast feeding or intend to breast feed.

What the medicinal ingredient is:

Timolol maleate

What the important nonmedicinal ingredients are: The inactive ingredients include: monobasic and dibasic sodium phosphate, and water for injection. A preservative, benzalkonium chloride 0.01% is also added.

What dosage forms it comes in:

MYLAN-TIMOLOL (timolol maleate USP) is supplied as a sterile isotonic, buffered aqueous solution of timolol maleate equivalent to 2.5 mg (0.25%) or 5 mg (0.5%) timolol per milliliter.

MYLAN-TIMOLOL (timolol maleate USP) 0.25%: clear, colourless liquid supplied in white opaque plastic ophthalmic dispensers of 10 ml, with controlled drop tip.

MYLAN-TIMOLOL 0.5%: clear, colourless liquid supplied in white opaque plastic ophthalmic dispensers of 10 ml, with controlled drop tip.

WARNINGS AND PRECAUTIONS

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;
• Mylan-Timolol 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 Mylan-Timolol. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.
• If you had past thyroid problems.
• 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.

Mylan-Timolol IS NOT RECOMMENDED FOR CHILDREN.

INTERACTIONS WITH THIS MEDICATION NTERACTIONS 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, or depression including beta-blockers such as atenolol, epinephrine, quinidine, calcium channel blockers or catecholamine depleting drugs such as reserpine.

PROPER USE OF THIS MEDICATION

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 Mylan-Timolol 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 Mylan-Timolol with another eyedrop, 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.

Overdose:

If you put too many drops in your eye or swallow the contents of the bottle, immediately contact your doctor, hospital emergency department or regional Poison Control Centre.

Missed Dose:

It is important to apply Mylan-Timolol 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

1. 1. After receiving your prescription for Mylan-Timolol, carefully read the dosage instructions on the outer box.
2. 2. After removing the cap from the product, turn the bottle upside down. Position bottle over the affected eye.
3. 3. Use your index finger to lightly apply pressure to the bottom of the bottle until your metered dose drop is dispensed. Repeat as necessary.
4. 4.

   Once dosage is completed, re-apply cap. Protect from freezing, ensure storage temperature is between 15°C and 30°C.

   If you have any adverse reactions please contact your local pharmacist or your family physician.

   DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER 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 from 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.

   • 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

     Mylan-Timolol left in the bottle. You should not be concerned since an extra amount of Mylan-Timolol has been added and you will get the full amount of Mylan-Timolol 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 Mylan-Timolol.

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 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 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 timolol maleate that may affect some patients’ ability to drive and use machines.

DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking Mylan-Timolol, contact your physician or pharmacist.

Store between 15 and 30°C (59 and 86°F) in a tight, light resistant container. Protect from freezing.

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 the Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701C

    Ottawa, ON K1A 0K9

Postal paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at

www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of the side effect contact your health professional. The Canada Vigilance Program does not provide medical advice.

This document plus the full product monograph, prepared for health professionals can be found by:

contacting the sponsor, Mylan Pharmaceuticals ULC, at: 1-800-575-1379, or

downloading from Mylan’s Website at: www.mylan.ca

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

Issued: July 20, 2010

HOW TO STORE IT