Details for: APO-ANASTROZOLE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02374420 | APO-ANASTROZOLE | ANASTROZOLE | 1 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
APO-ANASTROZOLE is used for the treatment of postmenopausal women with hormone receptor positive breast cancer in the following conditions:
- adjuvant treatment for early breast cancer
- advanced breast cancer
What it does
In hormone sensitive breast cancer, estrogens fuel tumour growth. Following menopause, estrogens are still produced in small amounts in other tissues of the body such as the breasts, muscle and fat. These estrogens are produced when androgens (hormones produced by the adrenal glands) interact with aromatase, a naturally occurring enzyme in the body.
APO-ANASTROZOLE belongs to a group of medicines called aromatase inhibitors and works by inhibiting the aromatase enzyme, thereby, suppressing the production of estrogens that can stimulate tumour growth. Suppressing the production of estrogens may help reduce the growth of breast cancer and delay the breast cancer from recurring.
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. The purpose of adjuvant therapy with APO-ANASTROZOLE is to help to delay the breast cancer from recurring. Cytotoxic chemotherapy, radiation, and hormonal treatment are three common forms of adjuvant treatment.
When it should not be used
- If you are allergic to the active ingredient anastrozole or any nonmedicinal ingredients of APOANASTROZOLE. If you think you may be allergic, ask your doctor for advice
- If you are pregnant or breast-feeding.
What the medicinal ingredient is
Anastrozole
What the non-medicinal ingredients are
Anhydrous lactose, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
What dosage form it comes in
Each APO-ANASTROZOLE tablet contains 1 milligram of anastrozole
Warnings and precautions
Serious Warnings and Precautions
APO-ANASTROZOLE should not be given to premenopausal women
APO-ANASTROZOLE should not be given to children.
Patients with liver and/or kidney problems, and patients with osteoporosis or at risk for osteoporosis should be carefully monitored by the doctor.
APO-ANASTROZOLE should be prescribed by a doctor experienced in the use of anti-cancer drugs
Before starting APO-ANASTROZOLE talk to your doctor or pharmacist:
- If you have any disorder or disease which affects your heart, liver or kidneys.
- APO-ANASTROZOLE lowers the level of female hormones and this may lead to a loss of mineral content of bones, which might decrease their strength and lead to a broken bone. You should talk to your doctor about your osteoporosis risk before using APO-ANASTROZOLE.
APO-ANASTROZOLE tablets are unlikely to affect your ability to drive a car or to operate machinery. However, some patients may occasionally feel weak or sleepy. If this happens, you should not drive or operate machinery.
Interactions with this medication
BEFORE you use APO-ANASTROZOLE talk to your doctor or pharmacist:
- If you take medicine containing estrogen (a female sex hormone). It may oppose the effect of APOANASTROZOLE. Some herbal products contain estrogen.
- If you are currently taking tamoxifen.
- If you are taking or have recently taken other medicines, even those not prescribed by a docto
Please note that these statements may also apply to medicine used some time ago
Proper use of this medication
Usual Dose
Follow your doctor’s instructions about when and how to take your APO-ANASTROZOLE tablets. The usual dose is one tablet once a day. Swallow the tablet with fluids. Try to take your tablet at the same time each day.
For adjuvant treatment of early breast cancer, currently it is recommended that APO-ANASTROZOLE be taken for 5 years
Overdose
If you take more than your normal dose of APOANASTROZOLE, contact your doctor, pharmacist, regional poison control centre or nearest hospital.
Missed Dose
Take the last missed dose as soon as you remember, as long as it is at least 12 hours before the next dose is due
If it is less than 12 hours to the next dose, do not take the dose you have missed.
Side effects and what to do about them
Like all medicines, APO-ANASTROZOLE can have side effects.
Contact your doctor immediately if any of the following happens to you. You may need further examinations or treatment
- Severe skin reactions (Stevens-Johnson syndrome) with lesions, ulcers or blisters. This type of skin reaction is very rare.
- Allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing and/or breathing.
- Chest pain or angina, as a result of ischemic heart disease (reduced blood flow in the vessels of the heart).
- Inflammation of the liver (hepatitis). Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes) and pain in the upper abdomen on the right side.
- If you experience nausea, vomiting and thirst, you should tell your doctor. These symptoms may indicate possible increased blood calcium levels
| Symptom / effect | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist | |
|---|---|---|---|
| Very Common (greater than or equal to 10 of every 100 patients are likely to have these events) | |||
| Hot flushes | ✔ | ||
| Joint pain, joint stiffness or broken bones | ✔ | ||
| Common (greater than or equal to 1 of every 100 patients, but less than 10 of every 100 patients, are likely to have these events) | |||
| Weakness | ✔ | ||
| Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand) | ✔ | ||
| Tickling, tingling or numbness of skin, loss/ lack of taste | ✔ | ||
| Vaginal dryness | ✔ | ||
| Hair thinning (alopecia) | ✔ | ||
| Rash | ✔ | ||
| Nausea | ✔ | ||
| Diarrhea | ✔ | ||
| Headache | ✔ | ||
| Changes in blood tests of liver function | ✔ | ||
| Bone pain | ✔ | ||
| Muscle pain | ✔ | ||
| Uncommon (greater than or equal to 1 of every 1000 patients, but less than 10 of every 1000 patients, are likely to have these events) | |||
| Vaginal bleeding | ✔ | ||
| Loss of appetite | ✔ | ||
| High blood cholesterol | ✔ | ||
| Vomiting | ✔ | ||
| Sleepiness/tiredness | ✔ | ||
| Trigger finger | ✔ | ||
| Hepatitis | ✔ | ✔ | |
| Very Rare (less than 1 of every 10 000 patients are likely to have these events) | |||
| Severe skin reactions | ✔ | ✔ | |
| Allergic reactions | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking APO-ANASTROZOLE, contact your doctor or pharmacis
How to store
- Keep out of reach and sight of children.
- Store at room temperature, 15°C to 30°C.
- Keep your APO-ANASTROZOLE tablets in the original container.
- Do not use APO-ANASTROZOLE after the expiry date on the blister package.
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 three 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
Address Locator: 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at: http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9
Last revised: June 19, 2014