Apo-Timop Gel (Apotex, 0.5 %): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-TIMOP GEL (timolol maleate ophthalmic gel forming solution) 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 APO-TIMOP GEL 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 breathin 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:

Timolol maleate

What the important nonmedicinal ingredients are:

Benzododecinium bromide (as preservative), gellan gum, mannitol, tromethamine and water for injection.

What dosage forms it comes in:

APO-TIMOP GEL 0.25% is an eye drop provided in a white plastic dropper bottle with a light blue cap. APO-TIMOP GEL 0.5% is provided in a white plastic dropper bottle with a light yellow cap. Each bottle

contains 5 mL of solution in an 11 mL bottle.

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
• APO-TIMOP GEL (timolol maleate ophthalmic gel forming solution) contains the preservative benzodo-decinium bromide. If you wear contact lenses, you should consult your physician or pharmacist before using APO-TIMOP GEL. 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 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 APO-TIMOP GEL 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.

APO-TIMOP GEL IS NOT RECOMMENDED FOR USE IN 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 APO-TIMOP GEL.

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 APO-TIMOP GEL (timolol

  maleate ophthalmic gel forming solution) is causing an allergic reaction (for example, skin rash or itching), 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 APO-TIMOP GEL with another

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

• Do not change the dosage recommended by 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 (e.g., trauma, an infection, etc.).

• The contents of the container should not be used for

  more than one month after the date on which the container is first opened.

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) once a day.

Overdose:

If you think you have taken too much APO-TIMOP GEL, contact your healthcare professional, 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 any of the contents of the bottle, you should contact your physician immediately.

In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.

Missed Dose:

It is important to apply APO-TIMOP GEL 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 medication

   for the first time, be sure the white

   plastic sealing tape between the

   bottle and cap is unbroken (Fig. 1).

   1. 2.

      Invert the closed bottle and

      shake ONCE before each use. (It

      is not necessary to shake the bottle

      more than once.)

   2. 3.

      To break the seal and open

      the bottle, unscrew the cap by

      turning as indicated by the arrow

      (Fig. 2).

   3. 4.

      Tilt your head back and pull

      your lower eyelid down slightly to

      form a pocket between your eyelid

      and your eye (Fig. 3).

   4. 5.

      Invert the bottle, and press

      the side of the bottle lightly (as

      shown in Fig. 4) until a single

      drop is dispensed into the eye as

      directed by your physician.

DO NOT TOUCH YOUR EYE OR EYE-LID 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 IMPORTANT: PLEASE READ

immediately concerning continued use of this bottle.

1. 6. Repeat steps 4 & 5 with the other eye if instructed to do so by your physician.
2. 7. The dispenser tip is designed to provide a pre-measured drop; therefore, do NOT enlarge the hole of the dispenser tip.
3. 8. After you have used all doses, there will be some APO-TIMOP GEL left in the bottle. You should not be concerned since an extra amount of APO-TIMOP GEL has been added and you will get the full amount of APO-TIMOP GEL that your physician prescribed. Do not attempt to remove excess medicine from the bottle.
4. 9. Tell your physician if you wear contact lenses. Depending on the type of lens, your physician may advise that you re-insert your contact lenses not earlier than 15 minutes after application of APO-TIMOP GEL.

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 muscle pain; abdominal pain; nausea; vomiting symptoms such as itching, 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.

  Your vision may be temporarily blurred for 30 seconds to 5 minutes immediately after putting APO-TIMOP GEL (timolol maleate ophthalmic gel forming solution) in your eye. Make sure that your vision is clear before you drive a motor vehicle or operate machinery.

Serious side effects and what to do about them

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

HOW TO STORE IT

Store at room temperature 15°C to 30°C. Protect from light and freezing. Discard 28 days after opening.

The expiry date for APO-TIMOP GEL (timolol maleate ophthalmic gel forming solution) is printed on the package. Do not use the medicine in the package after this date.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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

If you want more information about APO-TIMOP GEL:

• 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 ( https://www.canada.ca/en/health-

  canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website

  http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: August 2, 2018