Patient Medication Information: uses, side effects, how to take - Riva-Anastrozole
Serious Warnings and Precautions
- RIVA-ANASTROZOLE should not be taken by premenopausal women.
You will be carefully monitored by a healthcare professional while taking RIVA-ANASTROZOLE if you have:
- Liver and/or kidney problems;
- Osteoporosis (bone thinning) or risk factors for osteoporosis.
What is RIVA-ANASTROZOLE used for?
RIVA-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.
How does RIVA-ANASTROZOLE work?
In hormone sensitive breast cancer, estrogens stimulate tumour growth. Following menopause, estrogens continue to be produced in small amounts in other body tissues such as the breasts, muscle and fat.
Anastrozole belongs to a group of medicines called aromatase inhibitors. It blocks the action of aromatase, an enzyme needed in the production of estrogens. This may help reduce the growth of breast cancer and delay the breast cancer from recurring.
Adjuvant therapy: 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.
Adjuvant therapy is given to prevent or delay these cells from multiplying and spreading. The purpose of adjuvant therapy with RIVA-ANASTROZOLE is to help to delay the breast cancer from recurring.
What are the ingredients in RIVA-ANASTROZOLE?
Medicinal ingredient: anastrozole
Non-medicinal ingredients: hypromellose, lactose monohydrate, macrogol 300, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide
RIVA-ANASTROZOLE comes in the following dosage form:
Tablets: 1 mg
Do not use RIVA-ANASTROZOLE if:
- you are allergic to anastrozole or any other ingredients of RIVA-ANASTROZOLE. If you think you may be allergic, ask your healthcare professional for advice.
you are pregnant or breast-feeding.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RIVA-ANASTROZOLE. Talk about any health conditions or problems you may have, including if you:
- have any disorder or disease which affects your heart, liver or kidneys.
- have a disorder or a disease which affects bone density. RIVA-ANASTROZOLE lowers the level of female hormones which may cause a loss of mineral content of bones. This might make the bones weaker and lead to a broken bone. You should talk to your healthcare professional about your osteoporosis risk before using RIVA-ANASTROZOLE.
Other warnings you should know about:
Muscle and bone problems: RIVA-ANASTROZOLE may cause joint stiffness, arthritis or muscle pain.
Tendon disorders: RIVA-ANASTROZOLE may cause inflammation in tendons (connective tissues that connect muscles to bones). At any sign of tendon pain or swelling, rest the painful area and contact your healthcare professional.
Driving and using machines: RIVA-ANASTROZOLE is unlikely to affect your ability to drive a car or use machines. However, some patients may feel weak or sleepy. If this happens, avoid driving or using machinery.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with RIVA-ANASTROZOLE:
- Medicine containing estrogen (a female sex hormone). It may oppose the effect of RIVA-ANASTROZOLE. Some herbal products contain estrogen.
- Tamoxifen, used to treat patients with early-stage, locally advanced or metastatic breast cancer.
Please note that these statements may also apply to medicine used some time ago.
How to take RIVA-ANASTROZOLE:
- Take RIVA-ANASTROZOLE exactly as your healthcare professional has told you.
- Swallow the tablet with fluids.
- Try to take your tablet at the same time each day.
Usual dose:
The usual dose is 1 mg (one tablet) once a day.
Take RIVA-ANASTROZOLE for as long as your healthcare professional tells you to.
Overdose:
If you think you, or a person you are caring for, have taken too much RIVA-ANASTROZOLE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you forget to take RIVA-ANASTROZOLE, and your next dose is in:
- Less than 12 hours, skip the dose you have missed.
- 12 hours or more, take the last missed dose as soon as you remember.
What are possible side effects from using RIVA-ANASTROZOLE?
These are not all the possible side effects you may have when taking RIVA-ANASTROZOLE. If you experience any side effects not listed here, tell your healthcare professional.
- Hot flushes
- Joint pain, joint stiffness or broken bones
- 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 liver function (shown in blood tests)
- Bone pain
- Muscle pain
- Loss of appetite
- Vomiting
- Sleepiness/tiredness
- Trigger finger
- High blood cholesterol (shown in blood tests)
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Depression: feeling sad, sleeping a lot more or a lot less than usual, changes in weight, withdrawal from social situations, family gatherings and activities with friends, reduced sex drive, and thoughts of death or suicide. | |||
| Osteoporosis (bone loss, thin and fragile bones): broken bones, pain, back pain that is worse with standing or walking. | |||
| COMMON | |||
| Ischemic heart disease (reduced blood flow in the vessels of the heart): chest pain. | |||
| UNCOMMON | |||
| Hepatitis (inflammation of the liver): general feeling of being unwell, with or without yellowing of the skin and eyes, and pain in the upper abdomen on the right side. | |||
| Tendon disorders including tendonitis (inflammation of the tendon) and tenosynovitis (inflammation of the tissue around the tendon): pain, swelling and tenderness near a joint. | |||
| Vaginal bleeding (usually in the first weeks of treatment) | |||
| RARE | |||
| Tendon tears: feel a snap or pop when the tear happens, severe pain, swelling. | |||
| VERY RARE | |||
| Allergic reactions: swelling of the face, lips, tongue and/or throat, with or without difficulty in swallowing and/or breathing. | |||
Stevens-Johnson syndrome (Severe skin reactions): lesions, ulcers, blisters. | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store RIVA-ANASTROZOLE at room temperature, between 15°C to 30°C.
- Keep your RIVA-ANASTROZOLE tablets in the original container.
- Do not use RIVA-ANASTROZOLE after the expiry date on the packaging.
- Keep out of reach and sight of children.
If you want more information about RIVA-ANASTROZOLE:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.labriva.com or by calling 1-800-363-