Odan-Timolol: Uses, Side Effects and Dosage

What the medication is used for:

ODAN-TIMOLOL is the brand name for the medication timolol maleate ophthalmic solution available only on prescription through your physician. ODAN-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 ODAN-TIMOLOL 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

  breathing 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 nonmedicinal 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:

ODAN-TIMOLOL (timolol maleate) ophthalmic solution is a sterile eye drop. Each mL contains 2.5mg or 5mg timolol, available in plastic dropper bottles of 5 ml, 10 mL and 15 mL.

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.

• ODAN-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 ODAN-TIMOLOL. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than

  15 minutes after use.

• If you have now or have had in the 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 ODAN-TIMOLOL 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.

ODAN-TIMOLOL IS NOT RECOMMENDED FOR CHILDREN. ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

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.

If you put too many drops in your eye or swallow the contents of the bottle, you should contact your physician immediately.

Missed dose:

No specific drug interaction studies have been done for ODAN-TIMOLOL

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 ODAN- 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 ODAN- TIMOLOL with another eye

  drop, 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.

It is important to apply ODAN- TIMOLOL as prescribed by your 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 plastic sealing tape between the bottle and the cap is unbroken (Fig.1).
2. 2. To break the seal and open the bottle, unscrew the cap by turning as indicated by the arrow (Fig. 2).
3. 3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye (Fig. 3).

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

1. 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 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.

2. 5.

   After using ODAN- TIMOLOL, press a finger into the

   corner of your eye, by the nose (as shown) for 2 minutes. This helps keep ODAN- TIMOLOL in your eye.

3. 6.

   Repeat steps 3 to 5 with the other eye if instructed to do so

   by your physician.

4. 7.

   Replace the cap by turning until it is firmly touching the

   bottle. Do not overtighten the cap.

5. 8.

   After you have used all doses, there will be some ODAN-

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

6. 9.

   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 ODAN- TIMOLOL.

   • 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 muscle pain; abdominal pain;

     nausea; vomiting; 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.
   • ODAN- 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 ODAN- TIMOLOL that may affect some patients’ ability to drive and use machines.

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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

KEEP ALL MEDICINES OUT OF REACH OF CHILDREN. This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Odan Laboratories Ltd at:

1-800-387-9342

or

www.odanlab.com

Odan laboratories Ltd.

Pointe-Claire, Quebec, H9R 2Y6

Last revised: September 22, 2015

HOW TO STORE IT

MORE INFORMATION

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.