Details for: ACH-FINASTERIDE
Company: ACCORD HEALTHCARE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02355043 | ACH-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
ACH-Finasteride is used to treat symptoms of benign
prostatic hyperplasia (BPH) in men with an enlarged
prostate. ACH-Finasteride 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
ACH-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.
ACH-Finasteride is not approved for the prevention of
prostate cancer.
What it does
ACH-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. ACH-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 ACH-Finasteride if you think you are
allergic to any of its ingredients.
Women and children should not take ACH-Finasteride.
Women who are or may potentially be pregnant must
not use ACH-Finasteride (see WARNINGS AND
PRECAUTIONS, Pregnancy).
What the medicinal ingredient is
finasteride
What the non-medicinal ingredients are
microcrystalline cellulose, hydroxyl propyl methyl cellulose, polyethylene glycol, coloring agents (FD&C blue 2 aluminum lake, titanium dioxide, iron oxide yellow), pregelatinized starch, lauroyl macrogoglycerides, lactose monohydrate, magnesium stearate and sodium starch glycolate.
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 ACH-Finasteride. They should
also not handle crushed or broken tablets of ACHFinasteride. If the active ingredient in ACH-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.
ACH-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 ACH-Finasteride, a
physician should be consulted.
You must see your physician regularly while taking
ACH-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. ACH-Finasteride can alter PSA
values. You should tell your physician that you are
taking ACH-Finasteride. For more information, talk to
your physician.
ACH-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 nonprescription medicines, and herbal supplements.
Combination therapy of ACH-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 ACH-Finasteride 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, ACH-Finasteride may cause side effects. Side effects due to ACH-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.
- 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.
You should promptly report to your physician any changes in your breasts such as lumps, pain or nipple discharge.
| 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 talk with your doctor 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 ACH-Finasteride, contact your physician or pharmacist.
How to store
Store at room temperature (15°C-30°C) and protect
from light.
KEEP ACH-FINASTERIDE 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 ACH-Finasteride:
- 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 calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.
Accord Healthcare Inc.
3535 boul. St-Charles, Suite 704
Kirkland, QC H9H 5B9
Canada
Last revised: December 10, 2019