Consumer Information for: PMS-TIMOLOL

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


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 betablocking 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 non-medicinal ingredients are

Monobasic and dibasic sodium phosphate, sodium hydroxide, and water for injection. Benzalkonium chloride is added as a preservative.

What dosage form 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 betablockers 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. 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).
  2. To break the seal and open the bottle, unscrew the cap by turning as indicated by the arrow (Fig. 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).
  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.

  5. Repeat steps 3 & 4 with the other eye if instructed to do so by your physician.
  6. Replace the cap by turning until it is firmly touching the bottle. Do not overtighten the cap.
  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.
  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.
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking the drug and call your physician or pharmacist
Uncommon
Slow heartbeat    
Rare
Heart effects such as irregular heartbeat, heart block, low blood pressure    
Allergic reactions with symptoms such as swelling of the mouth and throat, shortness of breath, hives, severe itching and rash.    

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

Store at room temperature (15°C -30°C). Protect from light.

KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.

Reporting 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 three 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 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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

On peut obtenir ce document et la monographie complète du produit, rédigée pour les professionnels de la santé en communicant avec Pharmascience inc., au 1-888-550-6060.

Ce dépliant a été rédigé par
Pharmascience inc.
Montréal, Québec
H4P 2T4

Last Revised: June 18, 2012