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Details for: TIMOLOL MALEATE-EX

Company: SANDOZ CANADA INCORPORATED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02242275TIMOLOL MALEATE-EXTIMOLOL (TIMOLOL MALEATE)0.25 %SOLUTION (EXTENDED RELEASE)OPHTHALMIC
02242276TIMOLOL MALEATE-EXTIMOLOL (TIMOLOL MALEATE)0.5 %SOLUTION (EXTENDED RELEASE)OPHTHALMIC
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

T-LO and TIMOLOL MALEATE-EX are prescription eyes medications. They are used to lower high eye pressure in adults with glaucoma or other eyes diseases (e.g., ocular hypertension).

What it does

T-LO and TIMOLOL MALEATE-EX are brand names. Both T-LO and TIMOLOL MALEATE-EX contains the active ingredient timolol maleate. Timolol maleate belong to a class of medication called beta-blockers. It lowers eye pressure by causing the eye to make less fluid.

When it should not be used
  • if you are allergic to:
    • timolol or any ingredient in T-LO or TIMOLOL MALEATE-EX (see What are the ingredients in T-LO or TIMOLOL MALEATE-EX?).
    • if you are allergic to any other beta-blockers such as atenolol, betaxolol, labetalol, levobunolol, metoprolol, nadolol, propranolol, sotalol.
  • if you have or have had lung diseases or breathing problems such as asthma, chronic obstructive pulmonary disease (COPD).
  • if you suffer from certain heart disease, such as a slow heart rate, an irregular heartbeat, or heart failure.
What the medicinal ingredient is

T-LO

T-LO contains the active ingredient timolol maleate. It is available in the following two strengths:

  • T-LO 0.25% - each mL contains 2.5 mg of timolol (as timolol maleate).
  • T-LO 0.5% - each mL contains 5.0 mg of timolol (as timolol maleate).

TIMOLOL MALEATE-EX

TIMOLOL MALEATE-EX contains the active ingredient timolol maleate. It is available in the following two strengths:

  • TIMOLOL MALEATE-EX 0.25% - each mL contains 2.5 mg of timolol (as timolol maleate).
  • TIMOLOL MALEATE-EX 0.5% - each mL contains 5.0 mg of timolol (as timolol maleate).
What the non-medicinal ingredients are

T-LO

Benzalkonium chloride 0.01% (preservative), monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid to adjust pH, and purified water.

TIMOLOL MALEATE-EX

Benzododecinium bromide 0.012% (preservative), xanthan gum, mannitol, boric acid, tromethamine, polysorbate 80, purified water.

What dosage form it comes in

T-LO, 0.5% or 0.25% comes as a solution (liquid) to use as eye drops.

T-LO, 0.5% is supplied in 5 mL and 10 mL bottle designed to deliver a precise quantity of the medication. T-LO, 0.25% is supplied in a similar 10mL bottle.

TIMOLOL MALEATE-EX, 0.25% or 0.5% comes as a gel-forming solution (a liquid that thickens to a gel when instilled in the eye) to use as eye drops. It is supplied in 5 mL bottle designed to deliver a precise quantity of the medication.

Warnings and precautions

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

  • have or have had diabetes or other blood sugar problems. Timolol may mask signs of low blood sugar;
  • have or have had thyroid problems;
  • have or have had diseases that causes weakness in your muscles. Beta-blockers have been reported to increase muscle weakness in some patients;
  • have or have had heart diseases such as:
    • coronary heart disease (narrowing of the small blood vessels that supply blood and oxygen to the heart causing chest pain or discomfort when you do certain activities);
    • heart failure (weak heart);
    • low blood pressure, heartbeat that is not normal, or a very slow heartbeat.
  • have or have had lung or breathing problems (e.g., asthma, chronic obstructive lung disease);
  • have or have had blood circulation problems such as Raynaud’s syndrome;
  • have allergic problems such as eczema, hives or hay fever;
  • have allergies to any other medications, foods or any other substances such as preservatives or dyes;
  • wear contact lenses. TIMOLOL MALEATE-EX has not been studied in people wearing contact lenses (see “Other warnings you should know about section” below);
  • are already using another beta-blocker eye drop. It is not recommended to use two beta-blocker eye drops at the same time;
  • have or have had eye problems;
  • are pregnant or planning to become pregnant;
  • are breast feeding or planning to breast feed.

Other warnings you should know about:

While you are using T-LO and TIMOLOL MALEATE-EX

  • Driving and using machines: T-LO and TIMOLOL MALEATE-EX may cause temporary blurred vision after using the drops. Make sure that your vision is clear before driving a car or operating machinery.
  • If you wear contact lenses:
    • T-LO contains a preservative (benzalkonium chloride) which may cause eye irritation and discolour soft contact lenses. If you wear contact lenses, remove them before using T-LO. Wait at least 15 minutes after using T-LO to put your lenses back in.
    • TIMOLOL MALEATE-EX contains a preservative (benzododecinium chloride) that may be absorbed by contact lenses.
  • If you are planning a surgery. Timolol may change effects of some medicines used during anaesthesia. Anaesthesia is a treatment with certain medicines so that you do not feel pain during surgery.
  • If you have an eye injury, or develop an eye infection while using T-LO eye drops, tell your healthcare professional.

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

Interactions with this medication
  • Adrenaline (epinephrine) (used to treat life-threatening allergic reactions).
  • A group of medicines called oral calcium channel blockers such as diltiazem,verapamil.
  • A group of medicines called Catecholamine-depleting drugs (e.g. reserpine).
  • Beta-adrenergic blocking agents commonly referred to as beta-blockers such as atenolol, labetalol, metoprolol, nadolol, propranolol, sotalol.
  • Medications used to treat certain type of abnormal heart rhythm such as amiodarone, digoxin, quinidine.
  • Clonidine (a medication used to treat high blood pressure). Do not stop taking clonidine without talking to your healthcare professional.
  • Cimetidine (a medication used to treat stomach problem), Fluoxetine and paroxetine [both medications are used to treat depression (low blood mood)]. Ask your healthcare professional if you are not sure if any of your medicines are listed above.

This is not a list of all drugs that interact with T-LO or TIMOLOL MALEATE-EX.

Always keep a list of your medicines and show it to your healthcare professional when you get a new medicine. It is important that your healthcare professional reviews all medications and supplements you are taking before prescribing T-LO or TIMOLOL MALEATE-EX.

Proper use of this medication
  1. Wash your hands before use. Remove contact lenses before using eye drops.

  2. Twist the cap off, being careful not to touch the dropper tip.

  3. Hold the bottle between the thumb and middle finger.
  4. Tilt head back.
  5. Pull the lower eyelid down to form a pocket below the eye.
  6. Gently press on the base of the bottle to release one drop. Do not squeeze the bottle.
  7. Close the eye for 2 or 3 minutes. If a drop misses the eye, try again.
  8. Repeat steps 3 to 7 for the other eye if required.

  9. After use, immediately put the cap back on the bottle and keep tightly closed when not in use.
  • Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.
  • If you are using another eye medication, use it at least 10 minutes before or after you use T-LO or TIMOLOL MALEATE-EX.

Usual dose

  • For T-LO: Instill one drop in the affected eye(s) twice a day.
  • For TIMOLOL MALEATE-EX: Instill one drop in the affected eye(s) once a day.

Follow the directions on your prescription label carefully, and ask your healthcare professional to explain any part you do not understand.

Use T-LO or TIMOLOL MALEATE-EX exactly as directed. Do not start, stop, or change the dose of any drug without checking with your healthcare professional

Overdose

If you use too many drops, you may feel light-headed or dizzy, you may faint, have a very slow pulse rate, or have wheezing or difficulty breathing.

If you or someone accidently swallow T-LO or TIMOLOL MALEATE-EX or if you use too much drops, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Use T-LO or TIMOLOL MALEATE-EX at the same time of day. 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.

Side effects and what to do about them
  • Stomach or bowel problems:
    • Nausea and vomiting
    • Dry mouth
    • Discomfort in the upper belly or abdomen
    • Change in taste
  • Problems with your eye/s such as:
    • Blurred vision
    • Burning and stinging
    • Dry eyes
    • Pain in the eye
    • Conjunctivitis (pink eye)
    • Itching and redness of the eye
    • Feeling of having something in the eye,
    • Bleparitis (eyelids problem with signs such as irritated, itchy, reddened and swollen eyelids with dandruff-like debris builds up at the base of the eyelashes)
    • Visual changes (e.g. double visions)
    • Watery eyes
  • Changes in the way your hands and feet feel such as:
    • Raynaud’s phenomenon
      • cold fingers or toes
      • colour change in (white, blue then red) in fingers when exposed to the cold or stress
      • numbness or tingling in the fingers or toes
  • Paresthesia : abnormal sensation such as burning or prickling sensation that is usually felt in the hands or feet, but can also occur in other parts of the body
  • Difficulty thinking or working because of:
    • Headache
    • Tiredness, weakness
    • Difficulty sleeping, nightmares
  • Hair loss or thinning
  • Less desire for sex
  • Skin rash

Call your healthcare professional or get medical help if any of the side effects listed above bother you or do not go away.

These are not all the possible side effects you may feel when taking T-LO or TIMOLOL MALEATE-EX. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
dizziness and light-headedness, which may be due to low blood pressure   ✔  
swelling of the hands, feet, ankles or legs   ✔  
Breathing problems:
  • wheezing, difficulty in breathing
  • shortness of breath
     ✔
Heart problems:
  • feelings that your heart is skipping a beat or beating too hard or too fast Raynaud’s phenomenon palpitations)
  • feeling dizzy or confused,
  • have trouble breathing,
  • think you may faint,
  • have pain or tightness in your chest
     ✔
Allergic reactions:
  • swelling of the face, lips, mouth, tongue or and throat which may cause difficulty in breathing or swallowing
  • wheezing, difficulty in breathing,shortness of breath
  • hives, severe itching and rash
     ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
  • Keep T-LO and TIMOLOL MALEATE-EX:
    • away from direct light.
    • out of the reach and sight of children.
  • T-LO: Store at room temperature (15°C - 30°C).
  • TIMOLOL MALEATE-EX: Store at 4 °C - 30°C.
  • Write the date on the bottle when you open the eye drops and throw out any remaining solution one month after opening the bottle. The best way to dispose of your medication is through a medicine take-back program. Check with your pharmacist about how to throw out unused medicines.
  • Do not use T-LO and TIMOLOL MALEATE-EX after the expiry date on the bottle.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information
  • 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; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.

This leaflet was prepared by Sandoz Canada Inc.

Last Revised: September 26, 2017

Date modified: