What Aromasin is used for and how to use it
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Aromasin - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Breast Cancer
Class: Antineoplastics, Aromatase inhibitors, Hormones/antineoplastics
Form: Tablets
Ingredients: exemestane, mannitol, crospovidone, polysorbate 80, hydroxypropyl methylcellulose, silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethyleneglycol 6000, sucrose, magnesium carbonate, titanium dioxide, methyl-p-hydroxybenzoate, polyvinyl alcohol, cetyl esters wax, talc, carnauba wax, shellac, iron oxides

exemestane

About This Medication

What the Medication is Used For

AROMASIN is used for the adjuvant treatment of early breast cancer in postmenopausal women who had been treated previously with tamoxifen for 2 to 3 years.

AROMASIN is also used to treat advanced breast cancer in postmenopausal women who had been treated previously with antiestrogens (for example, tamoxifen).

Adjuvant means "in addition to". In early breast cancer, this means that additional treatment is required after primary treatment. The reason for this is that after surgery, a small number of cancer cells may remain in the body. These cells can continue to multiply and spread. Adjuvant therapy is given to prevent or delay these cells from multiplying and spreading. Cytotoxic chemotherapy, radiation, and hormonal treatment are three common forms of adjuvant treatment.

What it Does

AROMASIN interferes with a substance called aromatase which is needed to make the female sex hormone, estrogen, especially in postmenopausal women. AROMASIN reduces the amount of estrogen in the body. This is helpful because estrogen may influence the growth of certain types of breast cancer cells.

When the Medication Should not Be Used

If you are allergic to exemestane or any other ingredient in AROMASIN tablets.

What the Medicinal Ingredient Is

The active ingredient is exemestane.

What the Nonmedicinal Ingredients Are

Mannitol, crospovidone, polysorbate 80, hydroxypropyl methylcellulose, silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethyleneglycol 6000, sucrose, magnesium carbonate, titanium dioxide, methyl-p-hydroxybenzoate, polyvinyl alcohol, cetyl esters wax, talc, carnauba wax, shellac and iron oxides.

What Dosage Forms it Comes In

AROMASIN is available in tablets. Each tablet contains 25 mg of exemestane. The tablets are round and off-hite to slightly gray in color.

Warnings and Precautions

Serious Warnings and Precautions

AROMASIN is not recommended in pre-menopausal womenas safety and efficacy have not been established in this group of patients.

The use of estrogen lowering agents, including AROMASIN, may cause bone loss. Women with osteoporosis (brittle bones), or at high risk of osteoporosis should be carefully monitored by their doctor. These women may require treatment for osteoporosis or treatment to prevent osteoporosis while receiving AROMASIN.

AROMASIN should be administered under the supervision of a qualified physician experienced in the use of anti-cancer agents.

The use of aromatase inhibitors, including AROMASIN, may increase the risk of ischemic cardiovascular diseases, such as heart attacks and angina. Women at risk of heart disease should be carefully monitored by their doctor.

The use of aromatase inhibitors, including AROMASIN, may increase the occurrence of high cholesterol. Your physician should continue his/her routine practice of checking lipid and cholesterol levels on a regular basis.

BEFORE you use AROMASIN talk to your doctor or pharmacist:

  • If you have previously had an allergic reaction to exemestane or any of the other ingredients of AROMASIN (listed above).
  • If you are still having your period
  • If you are pregnant or likely to be pregnant or breast-feeding.
  • If you are taking AROMASIN and have been prescribed hormone replacement therapy (HRT) or estrogens, you should discuss this with your doctor.
  • If you have or have had kidney or liver disease
  • If you have or have had cardiovascular or heart disease including any of the following: heart attack, stroke or uncontrolled blood pressure
  • If you have or have had high cholesterol
  • If you have been diagnosed with osteoporosis or have had a bone fracture related to osteoporosis because this medication may cause bone loss.

If you feel drowsy, dizzy or weak while taking AROMASIN, do not drive or operate machinery.

If you need to go into hospital while taking AROMASIN, let the doctor know about your medication.

Interactions With This Medication

If you are taking tamoxifen and warfarin and switch to exemestane, your warfarin dose may need to be adjusted.

Taking other medications: AROMASIN and other medication may affect each other. Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor, including non-prescription drugs or herbal medicines. During treatment do not start taking any new medicine without checking first with your doctor or pharmacist.

Proper Use of This Medication

Usual Dose

Your doctor will discuss with you how long you will take AROMASIN.

The recommended dose is one 25 mg tablet, once daily, by mouth. The tablet should be taken with food (preferably after a meal). Try to take your tablet at the same time each day.

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.

If too many tablets are taken by accident, contact your doctor at once, go to the nearest hospital or call a local poison control centre.

Missed Dose

If you forget to take a dose of AROMASIN, don't worry; take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosage schedule. Do not double dose.

Side Effects and What to Do About Them

AROMASIN, like all other medicines, may cause unwanted effects in some people.

Many women can take AROMASIN without any problems, but some women may have mild to moderate side effects. If you have any of the following side effects, tell your doctor or pharmacist as soon as possible.

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

  • Hot flushes
  • Nausea
  • Fatigue
  • Dizziness
  • Pain in bones and joints (arthralgia)
  • Depression
  • Excessive sweating
  • Headache
  • Abdominal pain

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

  • Bone loss (osteoporosis)
  • Bone fractures
  • Sleeplessness
  • Skin rash
  • Increase of appetite
  • Muscle and joint pain
  • Constipation
  • Weight gain
  • Hair loss
  • Diarrhea
  • Excess fluid usually in the legs
  • Indigestion
  • High blood pressure
  • High cholesterol
  • Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
  • Hives
  • Itchiness
  • Infections of the urinary tract
  • Abnormal liver function test results (blood test disorders)

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

  • Hypersensitivity (including anaphylactic reaction)
  • Burning stomach pain, heart burn, nausea or vomiting that could progress to blood in stools, black tarry stools or vomiting of blood (gastric ulcers)
  • Nerve damage with symptoms such as such as pain, burning, or numbness (neuropathy)

Serious Side Effects how Often They Happen and What to Do About Them

Symptom / effectTalk with your
doctor or
pharmacist
Stop
taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
Common
Pain in muscles, bones and
joints
Т
Vaginal BleedingТ
Uncommon
Chest Pain in association with
shortness of breath and
sensation of fullness/
heaviness
ТТ
Burning stomach pain, heart
burn, nausea or vomiting that
could progress to blood in
stools, black tarry stools or
vomiting of blood (gastric
ulcer)
ТТ
Hypersensitivity (including
anaphylactic reactions)
ТТ
Rare
Allergic Reaction (skin rash/
swelling/difficulty breathing)
Т
Yellowing of the skin or eyes,
nausea, loss of appetite, darkcoloured
urine (signs of
hepatitis)
ТТ

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

How to Store It

  • Keep them in the original package and store them at 15-30°C. Avoid places where the temperature may rise above 30°C.
  • Keep this medicine out of the reach of children.
  • Before use, check the expiry date printed on the pack. Do not use after this date. 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 plus the full product monograph, prepared for health professionals can be found at: www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001