Patient Medication Information: uses, side effects, how to take - Finasteride (Sanis Health, 5 mg)
ABOUT THIS MEDICATION
FINASTERIDE IS FOR USE BY MEN ONLY.
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 a sudden inability to pass urine and the need for surgery. Your physician may prescribe 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.
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 important non-medicinal ingredients are
Docusate sodium, FD& C Blue #2 Aluminum Lake, Hydroxypropyl Cellulose, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose; Pregelatinized
Starch, Sodium Starch Glycolate, Talc, Titanium Dioxide, and Yellow Iron Oxide.
What dosage forms it comes in
Tablets (film-coated): 5 mg.
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.
Combination therapy of 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 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.
IMPORTANT: PLEASE READ
FINASTERIDE Product Monograph Page 31 of 31 Overdose:
if you think you have taken too much FINASTERIDE, contact
a healthcare professional, hospital emergency department or
regional Poison Control Centre immediately, even if there are
no symptoms.
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;
- change 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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptoms / effects | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| 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 IT
Store between 15°C and 30°C. Protect from light to prevent discoloration.
KEEP FINASTERIDE AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.
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 your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about 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.html), or by contacting the sponsor Sanis Health Inc. at:
1-866-236-4076
or quality@sanis.com
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5