Auro-Anastrozole: Uses, Side Effects and Dosage

What AURO-ANASTROZOLE is used for:

AURO-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 AURO-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.

AURO-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 AURO-

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 AURO-ANASTROZOLE should not be used:

• If you are allergic to the active ingredient

  anastrozole or any nonmedicinal ingredients of AURO-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 nonmedicinal ingredients are:

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate and titanium dioxide.

What dosage forms AURO-ANASTROZOLE comes in:

Each AURO-ANASTROZOLE tablet contains 1 milligram of anastrozole.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

AURO-ANASTROZOLE should not be given to premenopausal women.

AURO-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.

AURO-ANASTROZOLE should be prescribed by a doctor experienced in the use of anti-cancer drugs.

BEFORE you use AURO-ANASTROZOLE talk to your doctor or pharmacist:

• If you have any disorder or disease which affects your heart, liver or kidneys.
• AURO-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 AURO-ANASTROZOLE.

AURO-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.

BEFORE you use AURO-ANASTROZOLE talk to your doctor or pharmacist:

• If you take medicine containing estrogen (a female sex hormone). It may oppose the effect of

AURO-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 AURO-ANASTROZOLE .

Usual dose:

Follow your doctor’s instructions about when and how to take your AURO-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 AURO-ANASTROZOLE be taken for 5 years.

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 you take more than your normal dose of AURO-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 .

Like all medicines, AURO-ANASTROZOLE can have side effects.

Contact your doctor immediately if any of the following happens to you. You may need furthr 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 AURO-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 AURO-ANASTROZOLE tablets in the original container.
• Do not use AURO-ANASTROZOLE after the expiry date on the blister package.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

Auro Pharma Inc.

3700 Steeles Avenue West, Suite # 402 Woodbridge, ON, L4L 8K8 CANADA

Call toll-free at 1-855-648-6681 www.auropharma.ca

Date of Preparation: April 11, 2013