Patient Medication Information: uses, side effects, how to take - Teva-Anastrozole (Teva Canada, PM 00054719)
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-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.
TEVA-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 TEVA-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 TEVA-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
What the important nonmedicinal ingredients are:
Hypromellose, Lactose Monohydrate, Macrogol, Magnesium Stearate, Maize Starch, Microcrystalline Cellulose, Povidone, Silica Colloidal Anhydrous, Sodium Starch Glycolate, Talc and Titanium dioxide.
What dosage forms it comes in:
Each TEVA-ANASTROZOLE tablet contains 1 milligram of anastrozole.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
TEVA-ANASTROZOLE should not be given to premenopausal women. TEVA-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. TEVA-ANASTROZOLE should be prescribed by a doctor experienced in the use of anti-cancer drugs. |
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BEFORE you use TEVA-ANASTROZOLE talk to your doctor or pharmacist:
- If you have any disorder or disease which affects your heart, liver or kidneys.
- TEVA-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 TEVA-ANASTROZOLE.
TEVA-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 TEVA-ANASTROZOLE talk to your doctor or pharmacist:
- If you take medicine containing estrogen (a female sex hormone). It may oppose the effect of TEVA-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 THIS MEDICATION
Usual dose:
Follow your doctor’s instructions about when and how to take your TEVA-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 TEVA-ANASTROZOLE be taken for 5 years.
Overdose:
If you think you have taken too much TEVA- ANASTROZOLE, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms. |
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, TEVA-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 | 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 | √ | |||
| 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 TEVA-ANASTROZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep out of reach and sight of children.
- Store at room temperature, 15 to 30°C.
- Keep your TEVA-ANASTROZOLE tablets in the original container.
- Do not use TEVA-ANASTROZOLE after the expiry date on the blister package.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Should you require information related to the management of the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
If you want more information about TEVA-ANASTROZOLE
- Talk with your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.tevacanada.com or by calling 1-800-268-4128 ext. 3.
Teva Canada Limited 30 Novopharm Court Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com