Patient Medication Information: uses, side effects, how to take - Accel-Anastrozole Tablets
ABOUT THIS MEDICATION
What Accel-Anastrozole Tablets are used for:
Accel-Anastrozole Tablets are used for the treatment of postmenopausal women with hormone receptor positive breast cancer in the following conditions:
- advanced breast cancer
What Accel-Anastrozole Tablets do:
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.
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 Accel-Anastrozole Tablets should not be used:
- If you are allergic to the active ingredient anastrozole or any nonmedicinal ingredients of Accel-Anastrozole Tablets. 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 important nonmedicinal ingredients are:
lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate, hypromellose, macrogol 300 and titanium dioxide.
What dosage forms Accel-Anastrozole Tablets comes in:
Each Accel-Anastrozole Tablet contains 1 milligram of anastrozole.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Accel-Anastrozole Tablets should not be given to premenopausal women.
Accel-Anastrozole Tablets 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.
Accel-Anastrozole Tablets should be prescribed by a doctor experienced in the use of anti-cancer drugs.
BEFORE you use Accel-Anastrozole Tablets talk to your doctor or pharmacist:
- If you have any disorder or disease which affects your heart, liver or kidneys.
- Accel-Anastrozole Tablets 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 Accel-Anastrozole Tablets.
Accel-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 ACCEL-ANASTROZOLE | ||
| TABLETS |
BEFORE you use Accel-Anastrozole Tablets talk to your doctor or pharmacist:
- If you take medicine containing estrogen (a female sex hormone). It may oppose the effect of Accel-Anastrozole Tablets. 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.
| IMPORTANT:PLEASE READ |
PROPER USE OF ACCEL-ANASTROZOLE TABLETS
Usual dose:
Follow your doctor's instructions about when and how to take your Accel-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 Accel-Anastrozole Tablets be taken for 5 years.
Overdose:
If you take more than your normal dose of Accel-Anastrozole Tablets, 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.
Like all medicines, Accel-Anastrozole Tablets 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.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom / effect
Talk with
your doctor or pharmacist
in all cases
Stop taking drug and seek immediate emergency medical attention Very Common (greater than or equal to 10 of every 100 patients are likely to have these events)
Hot flushes √ 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 √ Joint pain, joint stiffness
or broken bones
√
Carpal tunnel syndrome
(tingling, pain, coldness,
weakness in parts of the
hand)
√
Vaginal dryness √ Hair thinning (alopecia) √ Rash √ Nausea √ Diarrhea √ Headache √ Changes in blood tests of
liver function
√
Bone 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 Accel-Anastrozole Tablets, contact your doctor or pharmacist
HOW TO STORE IT
- Keep out of reach and sight of children.
- Store at room temperature, 15°C to 30°C.
- Keep your Accel-Anastrozole Tablets in the original container.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| IMPORTANT:PLEASE READ |
- Do not use Accel-Anastrozole Tablets after the expiry date on the blister package.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at
http://www.accelpharma.com
or by contacting the sponsor, Accel Pharma Inc. at: 1-877-827-1306
Last revised: November 30, 2012
REPORTING SUSPECTED SIDE EFFECTS
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:
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. |