Letrozole (Actavis Pharma): Uses, Side Effects and Dosage

When it should not be used:

LETROZOLE should not be used in children and adolescents under 18 years of age.

Do not take LETROZOLE if you:

• have ever had an unusual or allergic reaction to letrozole or any other ingredient in LETROZOLE ;
• still have menstrual periods;

• are pregnant or breast-feeding, as LETROZOLE may harm your baby.

What the medicinal ingredient is:

Letrozole

What the nonmedicinal ingredients are:

LETROZOLE also contain the following nonmedicinal ingredients needed to make the tablets: cellulose compounds (microcrystalline cellulose and hypromellose), maize starch, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate, colloidal anhydrous silica, talc and titanium dioxide

What dosage forms it comes in:

LETROZOLE (letrozole) 2.5 mg

LETROZOLE is supplied as film-coated tablets. The film-coated tablets are yellow, round, biconvex, film coated tablets marked with “LT” on one side and plain on other side.

LETROZOLE is supplied in blister packs containing 30 tablets.

Serious Warnings and Precautions

• LETROZOLE should be used under the supervision of a doctor experienced in the use of anti-cancer drugs.
• LETROZOLE reduces blood estrogen levels which may cause a reduction in bone mineral density and a potential increase in bone loss (osteoporosis) and/or bone fractures.

The use of aromatase inhibitors, including LETROZOLE, may increase the risk of cardiovascular events compared to tamoxifen, such as heart attacks and stroke. Women at risk of heart disease should be carefully monitored by their doctor.

You should not use LETROZOLE if you may become pregnant, are pregnant and/or breastfeeding. There is a potential risk of harm to you and the fetus, including risk of fetal malformations. If you have the potential to become pregnant (this includes women who are perimenopausal or

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

who recently became postmenopausal), you should discuss with your doctor about the need for effective contraception.

If there is exposure to LETROZOLE during pregnancy, you should contact your doctor immediately to discuss the potential of harm to your fetus and potential risk for loss of the pregnancy.

LETROZOLE should not be used in children and adolescents under 18 years of age.

Before you take LETROZOLE:

Tell your doctor if you:

• have a serious kidney or serious liver disease
• are taking hormone replacement therapy;
• are taking other medication to treat your cancer;

• have a personal or family history of osteoporosis or

  have ever been diagnosed with low bone density or have a recent history of fractures (in order for your doctor to assess your bone health on a regular basis);

• have a personal or family history of high blood

  cholesterol or lipid levels. LETROZOLE may increase lipid levels;

• have or have had cardiovascular or heart disease

  including any of the following: heart attack, stroke or uncontrolled blood pressure. LETROZOLE may increase the risk of cardiovascular or heart diseases;

• have an intolerance to milk sugar (lactose);
• have pain in bones, or joints or muscles.

Driving a vehicle or using machinery:

LETROZOLE is unlikely to affect your ability to drive a car or to use machinery. However, some patients may occasionally feel tired, dizzy, sleepy or experience visual disorders. If this happens, you should not drive or operate any tools or machinery until you feel normal again.

Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the-counter medicines, vitamins or natural health products during your treatment with LETROZOLE. This includes in particular:

• Tamoxifen
• Other anti-estrogens or estrogen-containing therapies.

These substances may diminish the action of LETROZOLE.

PROPER USE OF THIS MEDICATION

Usual dose:

The usual dosage is one tablet of LETROZOLE to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take LETROZOLE with or without food. It is best to take LETROZOLE at about the same time every day.

Overdose:

If overdosage is known or suspected, contact your doctor or the nearest poison control centre for advice immediately. Show the pack of tablets. Medical treatment may be necessary.

Missed Dose:

If you forget to take a dose of LETROZOLE, don't worry, take the missed dose as soon as you remember. However, if it is almost time for the next dose (e.g. within 2 or 3 hours), skip the missed dose and go back to your regular dosage schedule. Do not take a double dose to make up for the one that you missed.

As with all medicines, patients taking LETROZOLE may experience side effects. Most side effects that have been observed were mild to moderate and will generally disappear after a few days to a few weeks of treatment. Check with your doctor if the unwanted effects do not go away during treatment or become bothersome.

Some side effects, such as hot flushes, hair loss or vaginal bleeding may be due to the lack of estrogen in your body.

Very common side effects (they affect more than 10 in every 100 patients)

• increased level of cholesterol

  (hypercholesterolemia)

• hot flushes
• increased sweating
• night sweats
• fatigue (including weakness and malaise (generally feeling unwell))
• pain in bones and joints (arthralgia).

Common side effects (they affect between 1 to 10 in every 100 patients)

• headache
• rash
• dizziness
• gastrointestinal disorders (such as, nausea,

INTERACTIONS WITH THIS MEDICATION

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

vomiting, indigestion, constipation, diarrhea)

• increase in or loss of appetite
• increased blood sugar (hyperglycaemia)
• urinary incontinence
• pain in muscles
• bone loss (osteoporosis)
• bone fractures
• depression
• weight increase
• anxiety
• insomnia
• hair loss
• vaginal bleeding
• dry skin
• raised blood pressure (hypertension)
• abdominal pain.

Uncommon side effects (they affect between 1 to 10 in every 1000 patients)

• nervous disorders (such as nervousness, irritability, drowsiness)
• pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• reduced sense of touch (dysaesthesia)
• eye irritation
• palpitations, rapid heart rate
• itchy rash (urticaria), rapid swelling of face, lips, tongue, throat (angioedema)
• severe allergic reaction (anaphylactic reaction)
• vaginal disorders (such as discharge or dryness)
• joint stiffness (arthritis)
• breast pain
• fever
• thirst, taste disorder, dry mouth
• dryness of mucous membranes
• weight decrease
• urinary tract infection, increased frequency of urination
• cough

• abnormal liver function test results (blood test

  disorders).

Side effects with frequency not known

• trigger finger, a condition in which your finger or thumb catches in a bent position.

If any of these affects you severely, tell your doctor.

If you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking LETROZOLE, contact your doctor or pharmacist.

Store your tablets in a dry place at room temperature 15°C to 30°C. Avoid places where the temperature may rise above 30°C. Protect from moisture.

Keep this medicine out of the reach and sight of children and pets.

Expiry date:

Do not take LETROZOLE after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month. Remember to take any unused medication back to your pharmacist.

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, Ontario 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.

MORE INFORMATION

This document and a full Product Monograph, prepared for Health Professionals are available by contacting the sponsor, Actavis Pharma Company. at:

Actavis Pharma Company

6733 Mississauga Road, Suite 400

Mississauga, Ontario

L5N 6J5

Last revised: October 30, 2014

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