Details for: ACT EXEMESTANE
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02390183 | ACT EXEMESTANE | EXEMESTANE | 25 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ACT EXEMESTANE 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.
ACT EXEMESTANE 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
ACT EXEMESTANE interferes with a substance called aromatase which is needed to make the female sex hormone, estrogen, especially in postmenopausal women. ACT EXEMESTANE 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 it should not be used
If you are allergic to exemestane or any other ingredient in ACT EXEMESTANE tablets.
What the medicinal ingredient is
The active ingredient is exemestane.
What the non-medicinal ingredients are
Butylated hydroxyanisole, butylated hydroxytoluene, colloidal anhydrous silica, crospovidone, hydroxypropylcellulose, lecithin, magnesium stearate, mannitol, polysorbate, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, xanthan gum.
What dosage form it comes in
ACT EXEMESTANE tablets are available in unit dose blisters. Each tablet contains 25 mg of exemestane.
Warnings and precautions
Serious Warnings and Precautions
ACT EXEMESTANE is not recommended in pre-menopausal women as safety and efficacy have not been established in this group of patients.
The use of estrogen lowering agents, including ACT EXEMESTANE, 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 ACT EXEMESTANE.
ACT EXEMESTANE should be administered under the supervision of a qualified physician experienced in the use of anti-cancer agents.
The use of aromatase inhibitors, including ACT EXEMESTANE, 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 ACT EXEMESTANE, 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 ACT EXEMESTANE talk to your doctor or pharmacist:
- If you have previously had an allergic reaction to exemestane or any of the other ingredients of ACT EXEMESTANE (listed above).
- If you are still having your period
- If you are pregnant or likely to be pregnant or breastfeeding.
- If you are taking ACT EXEMESTANE 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 ACT EXEMESTANE, do not drive or operate machinery.
If you need to go into hospital while taking ACT EXEMESTANE, 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:
ACT EXEMESTANE 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 ACT EXEMESTANE.
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 ACT EXEMESTANE, 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
ACT EXEMESTANE, like all other medicines, may cause unwanted effects in some people.
Many women can take ACT EXEMESTANE 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)
have also been reported in patients: depression, high blood pressure, high cholesterol, pruritus and urticaria (hives and itchiness).
| Symptom / effect | Talk to your doctor or pharmacist Only if severe | Talk to your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Pain in muscles, bones and joints | ✔ | ||
| Vaginal bleeding | ✔ | ||
| Uncommon | |||
| Chest pain in association with shortness of breath and sensation of fullness / heaviness | ✔ | ✔ | |
| Burning stomach pain, heart burn, nausea or vomiting that could progress to blood in stools, black tarry stools or vomiting of blood (gastric ulcer) | ✔ | ✔ | |
| Hypersensitivity (including anaphylactic reactions) | ✔ | ✔ | |
| Very Rare | |||
| Allergic reaction (skin rash / swelling / difficulty breathing) | ✔ | ||
| Yellowing of the skin or eyes, nausea, loss of appetite, darkcoloured urine (signs of hepatitis) | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking ACT EXEMESTANE contact your doctor or pharmacist.
How to store
- Keep them in the original package and store them at 15°C - 30°C. Protect from light. 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 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 side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about ACT EXEMESTANE:
- Talk to your health care 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://health-products.canada.ca/dpdbdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Last revised: January 31, 2020