Bio-Letrozole: Uses, Side Effects and Dosage

What is Bio-LETROZOLE used for?

Bio-LETROZOLE is used to treat breast cancer in women who have gone through menopause (cessation of periods). It is used to treat:

• hormone receptor-positive invasive early breast cancer after surgery, or
• hormone receptor-positive invasive early breast cancer after 5 years of tamoxifen therapy or
• advanced breast cancer as a first treatment, or

• breast cancer that has spread to other sites in the body (metastatic) after:

  • disease progression (means that previous treatments did not work well enough and the cancer got worse); or
  • relapse (means that the cancer comes back after previous treatment), previously treated with anti estrogens.

How does Bio-LETROZOLE work?

Estrogen is a normally occurring female sex hormone. It stimulates normal breast tissue and the growth of some types of breast cancer.

Bio-LETROZOLE is an aromatase inhibitor. It acts by binding to aromatase, which is a substance needed to make estrogen. As a result, this lowers the levels of estrogen in the body. It also reduces the growth of some types of breast cancer.

Serious Warnings and Precautions

• Bio-LETROZOLE should be used under the supervision of a doctor experienced in the use of anti-cancer drugs.
• Bio-LETROZOLE may cause osteoporosis (weakened bones) and / or broken bones.

What are the ingredients in Bio-LETROZOLE?

Medicinal ingredient: Letrozole

Non-medicinal ingredients: Colloidal Anhydrous Silica, Hypromellose (HPMC 6CPS), Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose PH102, Sodium Starch Glycolate (Type A).

Film coating contains ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol 6000, tartrazine and titanium dioxide.

Bio-LETROZOLE comes in the following dosage forms:

Tablets, 2.5 mg

Do not use Bio-LETROZOLE if:

• you have ever had an unusual or allergic reaction to letrozole or any other ingredient in Bio-LETROZOLE.
• you still have menstrual periods.
• you can still become pregnant, or are pregnant. It may harm you and the baby or make you lose the pregnancy.
• you are breastfeeding
• you are under 18 years of age.
• you have hormone-receptor negative breast cancer

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Bio-LETROZOLE. Talk about any health conditions or problems you may have, including if you:

• have or have had any disorder or disease which affects your liver or kidneys.
• have taken or are taking hormone replacement therapy.
• have taken or are taking other medication to treat your cancer.
• have a personal or family history of osteoporosis or have ever been diagnosed with low bone density or have a recent history of fractures (in order for your doctor to assess your bone health on a regular basis).
• have a personal or family history of high blood cholesterol or lipid levels.
• have or have had cardiovascular or heart disease including any of the following: heart attack, stroke or uncontrolled blood pressure.

Other warnings you should know about:

Pregnancy:

• If you are perimenopausal or have recently entered menopause, you may still be able to get pregnant. If this applies to you, you will need to use effective birth control while you are taking Bio-LETROZOLE for at least 20 days after stopping your treatment. Ask your doctor about options for effective birth control.
• If you get pregnant while take Bio-LETROZOLE contact your healthcare professional right away.

Fertility: Bio-LETROZOLE may reduce fertility in males. This means it may be harder for you to father a child in the future.

Check-ups and testing: You will have blood tests done during your treatment to check your cholesterol and hormones levels. Your hormone levels may be checked before you start taking Bio-LETROZOLE and regularly during the first 6 months of treatment. Your healthcare professional will also monitor your bone health during your treatment.

Driving a vehicle or using machinery: Bio-LETROZOLE may make you feel tired, dizzy or sleepy If this happens, you should not drive or operate any tools or machinery until you feel normal again.

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 Bio-LETROZOLE:

• medicines used to treat bacterial, fungal, yeast or viral infections (including HIV) such as clarithromycin, rifampicin telithromycin, ketoconazole, itraconazole, voriconazole and ritonavir.
• a medicine used to treat lymphoma called methoxsalen
• a medicine used in the treatment of breast cancer called tamoxifen
• a medicine used to prevent blood clots called clopidogrel
• medicines used to treat seizures such as phenytoin, carbamazepine and phenobarbital
• an herbal remedy used to treat depression called St. John’s Wort
• other anti-estrogens or therapies that contain estrogen

How to take Bio-LETROZOLE:

• Take 1 tablet once per day with or without food, at about the same time each day.

• Swallow tablet whole with a small glass of water.

Usual dose: 1 tablet (2.5 mg) per day

Overdose:

Missed Dose:

If you forget to take a dose of Bio-LETROZOLE, take it as soon as you remember. If it is almost time

If you think you, or a person you are caring for, have taken too much Bio-LETROZOLE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

for your next dose (e.g. within 2 or 3 hours), skip it and continue with your regular dosage schedule. Do not take a two doses at once to make up for the one that you missed.

What are possible side effects from using Bio-LETROZOLE?

These are not all the possible side effects you may have when taking Bio-LETROZOLE. If you experience any side effects not listed here, tell your healthcare professional.

Some side effects, such as hot flushes, hair loss or vaginal bleeding may be due to the lack of estrogen in your body.

• hot flushes
• increased sweating
• night sweats
• fatigue (including weakness and generally feeling unwell)
• headache
• rash
• dizziness, vertigo
• nausea, vomiting, indigestion, constipation, diarrhea
• increase in or loss of appetite
• leaking urine by accident (urinary incontinence)
• weight increase
• anxiety
• insomnia
• hair loss
• vaginal bleeding
• dry skin
• abdominal pain
• back pain
• fall
• palpitations (rapid heart rate)
• nervous disorders (such as nervousness, irritability, drowsiness)
• pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• reduced sense of touch
• eye irritation
• vaginal disorders (such as discharge or dryness)
• breast pain
• fever
• thirst, taste disorder, dry mouth
• dryness of mucous membranes
• weight decrease
• cough
• trigger finger, a condition in which your finger or thumb catches in a bent position.

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.

Storage:

Store at room temperature 15 to 30 °C. Protect from light and moisture. Keep out of the reach and sight of children and pets.

Expiry date:

Do not take Bio-LETROZOLE after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month. Remember to take any unused medication back to your pharmacist.

If you want more information about Bio-LETROZOLE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by contacting the manufacturer Biomed Pharma.

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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Biomed Pharma

info@biomed-pharma.ca

+1 (888) 731-6703

Last revised: NOV 20, 2024