Details for: APO-FINASTERIDE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02365383 | APO-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
Apo-Finasteride Tablets is used to treat symptoms of
benign prostatic hyperplasia (BPH) in men with an
enlarged prostate. Apo-Finasteride Tablets may also be
used to reduce the risk of developing a sudden inability to
pass urine and the need for surgery. Your physician may
prescribe Apo-Finasteride along with another medicine,
called doxazosin (an alpha-blocker), to help you better
control your BPH symptoms.
If your physician has prescribed doxazosin as well, please
read the patient information provided for this product too.
Apo-Finasteride Tablets is not approved for the prevention
of prostate cancer.
What it does
Apo-Finasteride Tablets 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. Apo-Finasteride Tablets 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 Apo-Finasteride Tablets if you think you are
allergic to any of its ingredients.
Women and children should not take Apo-Finasteride
Tablets. Women who are or may potentially be pregnant
must not use Apo-Finasteride Tablets (see WARNINGS
AND PRECAUTIONS, Pregnancy).
What the medicinal ingredient is
finasteride
What the non-medicinal ingredients are
coloring agents (FD&C blue 2 aluminum lake, hydroxyl propyl methyl cellulose, iron oxide yellow, lactose monohydrate, lauroyl macrogoglycerides , magnesium stearate , microcrystalline cellulose, polyethylene glycol , pregelatinized starch, sodium starch glycolate and titanium dioxide.
What dosage form it comes in
Each film coated tablet contains 5 mg of finasteride.
Warnings and precautions
Pregnancy: Women who are or may potentially be
pregnant must not use Apo-Finasteride Tablets. They
should also not handle crushed or broken tablets of ApoFinasteride Tablets. If the active ingredient in ApoFinasteride Tablets 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.
Apo-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 Apo-Finasteride Tablets, a physician should
be consulted.
You must see your physician regularly while taking Apo-Finasteride Tablets. 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. Apo-Finasteride Tablets can alter PSA
values. You should tell your physician that you are taking
Apo-Finasteride Tablets. For more information, talk to
your physician.
Apo-Finasteride Tablets 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.
Combination therapy of Apo-Finasteride and doxazosin
may increase the chances of dizziness, postural
hypotension (dizziness upon standing), weakness,
impotence and abnormal ejaculation.
Proper use of this medication
Take Apo-Finasteride Tablets as your physician has prescribed.
Usual Dose
5 mg tablet once daily by mouth with or without food
Overdose
Missed Dose
If you miss a dose, do not take an extra one. Just take the next tablet as usual.
Side effects and what to do about them
Like any medicine, Apo-Finasteride Tablets may cause side effects. Side effects due to Apo-Finasteride Tablets 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.
- 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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate Only if medical help |
|---|---|---|---|
| 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 Apo-Finasteride Tablets, contact your physician or pharmacist.
How to store
Store at room temperature (15°C to30°C) and protect from
light.
KEEP APO-FINASTERIDE TABLETS AND ALL
MEDICINES OUT OF THE REACH OF CHILDREN.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO-FINASTERIDE:
- Talk to your healthcare professional Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website ( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708
Apotex Inc.
Toronto, Ontario
M9L 1T9.
Last revised: January 17, 2020