Teva-Latanoprost/Timolol: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What TEVA-LATANOPROST/TIMOLOL is used for:

TEVA-LATANOPROST/TIMOLOL is used to reduce eye pressure in patients with open angle glaucoma ocular hypertension. Both these conditions are related to an increase in pressure within the eye and eventually they may affect your eyesight.

What TEVA-LATANOPROST/TIMOLOL does:

TEVA-LATANOPROST/TIMOLOL is a combination of an ophthalmic prostaglandin drug (latanoprost) and an ophthalmic beta-blocking drug (timolol), both of which lower the pressure within the eye in different ways. The prostaglandin drug works by increasing the natural outflow of fluid from inside the eye. The betablocking drug works by decreasing the fluid production in the eye.

When TEVA-LATANOPROST/TIMOLOL should not be used:

• if you have a reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.

• if you have heart problems such as a sinus

  bradycardia (low heart beat), sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac (heart) failure, or cardiogenic shock.

• if you have known hypersensitivity to latanoprost, timolol, benzalkonium chloride or any other ingredient in the product. (See What the medicinal ingredients are).

What the medicinal ingredient is:

Each millilitre (mL) contains 50 micrograms of latanoprost and 5 milligrams of timolol as timolol maleate.

What the important nonmedicinal ingredients are:

Benzalkonium chloride (preservative), sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injection, hydrochloric acid and sodium hydroxide.

What dosage forms it comes in:

TEVA-LATANOPROST/TIMOLOL is supplied in a 5 mL plastic ophthalmic dispenser bottle with a dropper tip, screw cap and tamper proof overcap.

W

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RNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS

Before using TEVA-LATANOPROST/TIMOLOL, talk to your doctor or pharmacist if :

• You are allergic to any of the ingredients in

  TEVA-LATANOPROST/TIMOLOL.

• -You have a respiratory disease such as asthma, have a history of asthma, or have chronic obstructive pulmonary disease (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough).
• You have disturbances of heart rate such as slow heart beat (bradycardia).
• You have certain heart diseases or conditions – symptoms can include chest pain or tightness, breathlessness or choking, heart failure, low blood pressure (hypotension).
• You have problems with your blood pressure or thyroid function.

• You have poor blood circulation disease

  (peripheral arterial disease such as Raynaud’s disease or Raynaud’s syndrome).

• You have diabetes or have low blood sugar levels.
• You have or have had muscle weakness or have been diagnosed as having myasthenia gravis.
• You are using any other eye drops or taking any other medication.

• You are pregnant, think you might be pregnant or you are planning a pregnancy.

• You are breast feeding.

• You have or have had herpes simplex keratitis

  (inflammation of the cornea caused by the herpes simplex virus

• Your eyes are sensitive to light
• You are planning a surgery
• You have kidney or liver disease

Tell your doctor before you have an operation that you are using TEVA-LATANOPROST/TIMOLOL as Timolol Maleate may change effects of some medicines used during anaesthesia.

TEVA-LATANOPROST/TIMOLOL contains a preservative (benzalkonium chloride) that may be absorbed by contact lenses.

The preservative may form a precipitate with an ingredient (thimerosal) present in several contact lens soaking solutions. If you wear contact lenses, remove them before using TEVA-

LATANOPROST/TIMOLOL. Wait 15 minutes after applying the eye drops before putting your lenses back in. If you are using more than one type of eye drop medication, wait at least 5 minutes between each different eye drop.

INTERACTIONS WITH THIS MEDICATION

TEVA-LATANOPROST/TIMOLOL can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes or other medicines including:

• calcium channel blockers, beta-adrenergic

  blocking agent

• antiarrhythmics ( e.g. amiodarone, quinidine),
• monoamine oxidase inhibitors
• narcotics
• digitalis, fluoxetine, paroxetine

PROPER USE OF THIS MEDICATION

Always use TEVA-LATANOPROST/TIMOLOL exactly as your doctor has told you.

Usual adult dose:

One drop of TEVA-LATANOPROST/TIMOLOL should be dropped into the affected eye(s) once daily.

Do not allow the dropper tip of the bottle to touch the eye or other surrounding structures, because this could contaminate the tip with common bacteria known to cause eye infections. Serious damage to the eye with subsequent loss of vision may result if you use eye drop solutions that have become contaminated. If you experience any type of eye condition or have surgery, immediately seek your doctor's advice concerning the continued use of the bottle you are using.

If you forget to use your eye drops at the usual time, wait until it is time for your next dose. If you put too many drops in your eye(s), you may feel some slight irritation.

Follow these steps to help you use TEVA-LATANOPROST/TIMOLOL properly:

1. 1. Wash your hands and sit or stand comfortably. If you wear contact lenses, remove them before using your eye drops.
2. 2. Twist off the outer protective cap from the bottle.
3. 3. Unscrew the inner cap of the bottle.
4. 4. Once the bottle is opened, hold it in one hand and steady your thumb against your brow or the bridge of your nose.
5. 5. Use your index finger to gently pull down the lower eyelid of the affected eye(s) to create a pocket for the drop.
6. 6. Gently press, or lightly tap, the side of the bottle to allow only a single drop to fall into the pocket. Do not let the tip of the bottle touch your eye.
7. 7. Close your eye for 2 to 3 minutes.
8. 8. If your doctor has told you to use drops in both eyes, repeat the process for the other eye. TEVA-LATANOPROST/TIMOLOL should be used until your doctor tells you to stop.

TEVA-LATANOPROST/TIMOLOL is not recommended for use in children.

Overdose:

In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre, even if there are nosymptoms.

Missed Dose:

If you forget one dose of TEVA-

LATANOPROST/TIMOLOL, continue with the next dose as normal. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

In some patients, TEVA-

LATANOPROST/TIMOLOL may cause a gradual change in eye color by increasing the amount of brown pigment in the iris (the colored part of the eye). This change may not be noticeable for several months to years. This effect may be more noticeable in patients with eye colors that are mixtures of green and brown, blue/gray and brown, or yellow and brown. The brown pigment may gradually spread outward toward the outside edge of the iris. However, the entire iris or parts of it may become more brownish in appearance. This change may be more noticeable if you are only treating one eye. Therefore, there is the potential for permanent difference in the colour between the treated and the untreated eyes. Your doctor will examine you regularly to make sure that your medication is working and look for changes in eye color. If you should experience any changes in eye color, your doctor can stop treatment. However, any color change that has already occurred may be permanent, even after the medication is stopped.

TEVA-LATANOPROST/TIMOLOL may also cause your eye lashes to darken, appear thicker and longer than they usually do. A very small number of people may notice their eye lid skin looks darker after using TEVA-LATANOPROST/TIMOLOL for some time. These changes may be more noticeable if you are only treating one eye.

When using TEVA-LATANOPROST/TIMOLOL, you might feel as if there is something in your eye(s). Your eye(s) might water and become red. As with other eye drops, if your vision is blurred when you first put your drops in, wait until this wears off before you drive or operate machinery. A few people using TEVA-LATANOPROST/TIMOLOL have developed a skin rash.

A few people may experience changes in their vision, sometimes in combination with a red and sore/painful eye. These changes do not always occur right after administering the drops, and if they occur, you may find that reading and seeing fine details more difficult. Although unlikely, if you experience any of these changes, stop using TEVA-

LATANOPROST/TIMOLOL and contact your doctor immediately.

TEVA-LATANOPROST/TIMOLOL may cause the following side effects as well.

C

ommon side effects: eye irritation, including burning and stinging, inflammation of the eye lid and eye pain, upper respiratory tract infection.

Effects on the body: headache and skin rash, loss of appetite, sore muscles, low blood sugar in diabetics, dry eyes, nervous system effects including anxiety, nervousness, dizziness, confusion, disorientation, insomnia, hallucinations.

Be sure to tell your doctor (or pharmacist) if you notice any other unwanted side effects.

This is not a complete list of side effects. For any unexpected effects while taking TEVA-

LATANOPROST/TIMOLOL, contact your doctor or pharmacist.

HOW TO STORE IT

Always keep medicine well out of the reach of children.

Before TEVA-LATANOPROST/TIMOLOL is first opened, keep it in a fridge (between 2°C and 8°C), out of direct light.

Once the bottle has been opened, TEVA-

LATANOPROST/TIMOLOL should be stored in the refrigerator immediately after use. TEVA-LATANOPROST/TIMOLOL must be used within 4 weeks after opening the bottle. Discard the bottle and/or unused contents after 4 weeks. TEVA-LATANOPROST/TIMOLOL should not be used after the expiry date on the bottle.

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 0701E 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 the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:

1-800-268-4127 ext. 5005 (English);

1-877-777-9117 (French)

or druginfo@tevacanada.com

Last revised: September 26, 2012