PMS-Timolol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

pms-TIMOLOL is the brandname for the medication timolol maleate ophthalmic solution available only on prescription through your physician. pms-TIMOLOL (timolol maleate ophthalmic solution) is an ophthalmic solution of a beta-blocking drug which lowers the pressure in the eye for conditions such a 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 conditions.

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 take pms-TIMOLOL ophthalmic solution if you:

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

• are breast feeding or intend to breast feed.

What the medicinal ingredient is:

Timolol maleate.

What the important non-medicinal 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:

pms-TIMOLOL (timolol maletate ophthalmic solution) is a sterile eye drop.

pms-TIMOLOL (timolol maleate ophthalmic solution) equivalent to 2.5 mg (0.25%) or 5 mg (0.5%) timolol per mL, is a clear to lightly yellow solution supplied in a 5 mL or 10mL fill size in a 11 mL white, opaque, plastic ophthalmic dispenser bottle, closed with a white opaque, plastic dropper and yellow, opaque, plastic cap with sealing tape.

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;

• pms-TIMOLOL (timolol maleate ophthalmic solution) 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 pms-TIMOLOL ophthalmic solution. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.

• If you have 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.

pms-TIMOLOL OPHTHALMIC SOLUTION 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, 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

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 pms-TIMOLOL (timolol maleate

  ophthalmic solution) 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 pms-TIMOLOL ophthalmic

  solution with another eyedrop, the drops should be instilled at least 10 minutes apart.

• Do not allow the tip of the container to touch the

  eye or area 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, ect.)

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, you should contact your physician immediately.

Missed Dose:

It is important to apply pms-TIMOLOL 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.

INSTRUCTIONS FOR USE

1. 1.

   Before using the medications for the first time, be sure the yellow plastic sealing tape between the bottle and the cap is unbroken (Fig.1).

   1. 2. To break the seal and open the bottle, unscrew the cap by turning as indicated by the arrow (Fig. 2).
   2. 3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye (Fig. 3).
   3. 4. Invert the bottle, and press lightly (as shown in Fig.4) until a single drop is dispensed into the eye as directed by your doctor.

DO NOT TOUCH YOUR EYE EYELID WITH THE DROPPER TIP.

Ophthalmic medications, if handled improperly, can became 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.

1. 5. Repeat steps 3 & 4 with the other eye if instructed to do Cap

Sealing

tape

Bottle

so by your physician.

1. 6. Replace the cap by turning until it is firmly touching the bottle. Do not overtighten the cap.
2. 7.

   After you have used all doses there will be some pms-

   TIMOLOL ophthalmic solution left in the bottle. You should not be concerned since an extra amount of pms-TIMOLOL ophthalmic solution has been added and you will get a full amount of pms-TIMOLOL ophthalmic solution that your physician prescribed. Do not attempt to remove excess medicine from the bottle.

3. 8.

   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 pms-TIMOLOL ophthalmic solution.

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 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 ophthalmic

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

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This is not a complete list of side effects. For any unexpected effects while taking pms-TIMOLOL ophthalmic solution contact your physician or pharmacist.

HOW TO STORE IT

Store at room temperature (15^oC -30^oC). 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

  Health Canada

  Postal Locator 0701C

  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.

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

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Pharmascience Inc. at, 1-888-550-6060.

This leaflet can also be found at: http://www/pharmascience.ca

Montreal Quebec

H4P 2T4

Last Revised: June 18, 2012