Patient Medication Information: uses, side effects, how to take - Mylan-Anastrozole
ABOUT THIS MEDICATION
ABOUT THIS MEDICATION
What MYLAN-ANASTROZOLE is used for:
MYLAN-ANASTROZOLE is used for the treatment of postmenopausal women with hormone receptor positive breast cancer in the following conditions:
- advanced breast cancer
What MYLAN-ANASTROZOLE 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.
MYLAN-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.
When MYLAN-ANASTROZOLE should not be used:
- If you are allergic to the active ingredient anastrozole or any nonmedicinal ingredients of MYLAN-ANASTROZOLE. 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, USP
What the important nonmedicinal ingredients are:
anhydrous lactose, hydroxypropyl methylcellulose, magnesium stearate, and sodium starch glycolate. The film coating contains hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, titanium dioxide, and triacetin.
What dosage forms MYLAN-ANASTROZOLE comes in: Each MYLAN-ANASTROZOLE tablet contains 1 milligram of anastrozole, USP.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
MYLAN-ANASTROZOLE should not be given to premenopausal women.
MYLAN-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.
MYLAN-ANASTROZOLE should be prescribed by a doctor experienced in the use of anti-cancer drugs.
BEFORE you use MYLAN-ANASTROZOLE talk to your doctor or pharmacist:
- If you have any disorder or disease which affects your heart, liver or kidneys.
- MYLAN-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 MYLAN-ANASTROZOLE.
MYLAN-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 MYLAN-ANASTROZOLE
BEFORE you use MYLAN-ANASTROZOLE talk to your doctor or pharmacist:
- If you take medicine containing estrogen (a female sex hormone). It may oppose the effect of MYLAN-ANASTROZOLE. 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 doctor.
Please note that these statements may also apply to medicine used some time ago.
PROPER USE OF MYLAN-ANASTROZOLE PROPER USE OF MYLAN-ANASTROZOLE
Usual dose:
Follow your doctor’s instructions about when and how to take your MYLAN-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.
Overdose:
If you take more than your normal dose of MYLAN-ANASTROZOLE, 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
DE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, MYLAN-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.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your
doctor or pharmacist in all cases
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 √ √
Stop taking drug and call your doctor or pharmacist
This is not a complete list of side effects. For any
unexpected effects while taking MYLAN-ANASTROZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
HOW TO STORE IT
- Keep out of reach and sight of children.
- Store at room temperature, 15°C to 30°C.
- Keep your MYLAN-ANASTROZOLE
tablets in the original container.
- Do not use MYLAN-ANASTROZOLE
after the expiry date on the bottle, carton or blisters.
MORE INFORMATION
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals
ULC at: 1-800-575-1379
Etobicoke, Ontario M8Z 2S6
Date of Revision: June 13, 2014
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca
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. |