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Details for: APO-FINASTERIDE

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02365383APO-FINASTERIDEFINASTERIDE5 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Finasteride - Assessing the Potential Risk of Serious Muscle-Related Side Effects
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

If you think you have taken too much APOFINASTERIDE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.
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.

Serious side effects, how often they happen and what to do about them
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:

This leaflet was prepared by
Apotex Inc.
Toronto, Ontario
M9L 1T9.

Last revised: January 17, 2020

Date modified: