Consumer Information for: DOM-FINASTERIDE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Dom-FINASTERIDE is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Dom-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 Dom-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.
Dom-FINASTERIDE is not approved for the prevention of prostate cancer.
What it does
Dom-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. Dom-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 Dom-FINASTERIDE if you think you are allergic to
any of its ingredients.
Women and children should not take Dom-FINASTERIDE.
Women who are or may potentially be pregnant must not use
Dom-FINASTERIDE (see WARNINGS AND PRECAUTIONS,
Pregnancy).
What the medicinal ingredient is
Finasteride
What the non-medicinal ingredients are
Docusate Sodium, FD& C Blue #2 Aluminum Lake, Hydroxypropyl Cellulose, Hypromellose, Lactose, Magnesium Stearate, Microcrystalline Cellulose; Pregelatinised Starch, Sodium Starch Glycolate, Talc, Titanium Dioxide, Yellow Iron Oxide.
What dosage form it comes in
Tablets (film-coated): 5 mg.
Warnings and precautions
Pregnancy: Women who are or may potentially be pregnant must
not use Dom-FINASTERIDE. They should also not handle
crushed or broken tablets of Dom-FINASTERIDE. If the active
ingredient in Dom-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.
Dom-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 Dom-
FINASTERIDE, a physician should be consulted.
You must see your physician regularly while taking Dom-
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.
Dom-FINASTERIDE can alter PSA values. You should tell your
physician that you are taking Dom-FINASTERIDE. For more
information, talk to your physician.
Dom-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.
Combination therapy of Dom-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 Dom-FINASTERIDE as your physician has prescribed.
Usual Dose
5 mg tablet once daily by mouth 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, Dom-FINASTERIDE may cause side effects. Side effects due to Dom-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 and swelling of the lips and face
- testicular pain
- an inability to have an erection 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
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 doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Rare | |||
| Allergic reactions including rash, hives, and swelling of the lips and face | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Dom-FINASTERIDE, contact your physician or pharmacist.
How to store
Store between 15°C and 30°C. Protect from light to prevent
discoloration.
KEEP Dom-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 3 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
Dom-FINASTERIDE IS FOR USE BY MEN ONLY
This document plus the full product monograph, prepared for
health professionals, can be obtained by contacting the sponsor
Dominion Pharmacal at 1-888-550-6060.
This leaflet was prepared by
Dominion Pharmacal
Montreal Quebec
H4P 2T4
Last revised: March 17, 2017
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