Details for: FINASTERIDE
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02350270 | FINASTERIDE | FINASTERIDE | 5 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) - Assessing the Potential Risk of Seizures
Summary Safety Review - Finasteride - Assessing the Potential Risk of Suicidal Thoughts and Behaviour (Suicidality)
Summary Safety Review - Proscar and Propecia (finasteride) - Assessing the potential risk of suicidal thoughts and/or behaviour (suicidal ideation)
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
FINASTERIDE is used to treat symptoms of benign
prostatic hyperplasia (BPH) in men with an enlarged
prostate. FINASTERIDE may also be used to reduce
the risk of developing sudden inability to pass urine
and the need for surgery.
FINASTERIDE is not approved for the prevention of
prostate cancer.
What it does
FINASTERIDE lowers levels of a key hormone called DHT (dihydrotestosterone), which is a major cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. FINASTERIDE will help reduce the risk of developing a sudden inability to pass urine (acute urinary retention) and the need for surgery.
When it should not be used
Do not take FINASTERIDE if you think you are
allergic to any of its ingredients.
Women and children should not take
FINASTERIDE. Women who are or may potentially
be pregnant must not use FINASTERIDE (see
WARNINGS AND PRECAUTIONS, Pregnancy).
What the medicinal ingredient is
finasteride
What the non-medicinal ingredients are
lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and opadry blue (hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 Indigo Carmine Aluminum Lake 11%-14%).
What dosage form it comes in
Each tablet of FINASTERIDE contains 5 mg of finasteride.
Warnings and precautions
Pregnancy: Women who are or may potentially be
pregnant must not use FINASTERIDE. They should
also not handle crushed or broken tablets of
FINASTERIDE. If the active ingredient in
FINASTERIDE is absorbed after oral use or through
the skin by a woman who is pregnant with a male
baby, it may cause the male baby to be born with
abnormalities of the sex organs.
FINASTERIDE tablets are coated and will prevent
contact with the active ingredient during normal
handling provided that the tablets are not broken or
crushed. If a woman who is pregnant comes into
contact with the active ingredient in FINASTERIDE,
a physician should be consulted.
You must see your physician regularly while taking
FINASTERIDE.
Follow your physician's advice about when to have
these checkups.
About Prostate Specific Antigen (PSA). Your
physician may have done a blood test called PSA for
the screening of prostate cancer. FINASTERIDE can
alter PSA values. You should tell your physician
that you are taking FINASTERIDE. For more
information, talk to your physician.
FINASTERIDE may increase the chance of a more
serious form of prostate cancer.
Interactions with this medication
Tell your physician or pharmacist about all the medicines you take. This includes prescription and non-prescription medicines, and herbal supplements.
Proper use of this medication
Take FINASTERIDE as your physician has prescribed.
Usual Dose
5 mg tablet once daily with or without food.
Missed Dose
If you miss a dose, do not take an extra one. Just take the next tablet as usual.
Overdose
Side effects and what to do about them
Like any medicine, FINASTERIDE may cause side effects. Side effects due to FINASTERIDE may include:
- impotence (an inability to have an erection)
- less desire to have sex.
- problems with ejaculation, such as a decrease in the amount of semen released during sex.
In addition, some men may have breast swelling
and/or tenderness.
Some men have also reported the following:
- allergic reactions such as rash, itching, hives, swelling of the lips, tongue, throat and face
- testicular pain
- blood in semen
- an inability to have an erection that continued after stopping the medication
- muscle injury, muscle pain, muscle weakness, abnormal test results (CK elevation)
- problems with ejaculation that continued after stopping the medication
- male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication.
- depression
- decrease in sex drive that continued after stopping the medication
- changes in mood, which can include suicidal thoughts.
In rare cases, male breast cancer has been reported.
You should promptly report to your physician any
changes in your breasts such as lumps, pain or nipple
discharge.
| Symptom / effect | Talk with your physician or pharmacist Only if severe | Talk with your physician or pharmacist In all cases | Stop taking drug and call your physician or pharmacist |
|---|---|---|---|
| Rare | |||
| Allergic reactions including rash, hives, swelling of the lips, tongue, throat and face. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking FINASTERIDE, contact your physician or pharmacist.
How to store
Store at temperature (15°C -30°C) and protect from
light.
KEEP FINASTERIDE AND ALL MEDICINES
OUT OF THE REACH OF CHILDREN.
Reporting side effects
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 of side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca
This leaflet was prepared by:
Pro Doc Ltée, Laval, Québec, H7L 3W9
Last revised: February 19, 2021