Patient Medication Information: uses, side effects, how to take - Act Finasteride
ABOUT THIS MEDICATION
ACT FINASTERIDE IS FOR USE BY MEN ONLY.
What the medication is used for:
ACT FINASTERIDE is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ACT 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 ACT 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.
ACT FINASTERIDE is not approved for the prevention of prostate cancer.
What it does:
ACT 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. ACT 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 ACT FINASTERIDE if you think you are allergic to any of its ingredients.
Women and children should not take ACT FINASTERIDE. Women who are or may potentially be pregnant must not use ACT FINASTERIDE (see WARNINGS AND PRECAUTIONS, Pregnancy).
What the medicinal ingredient is:
finasteride
What the nonmedicinal ingredients are:
FD&C blue #2, hypromellose, iron oxide yellow, lactose monohydrate, lauroyl macrogolglycerides, polyethylene
glycol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and titanium dioxide.
What dosage forms it comes in:
ACT FINASTERIDE is available in 5 mg film coated tablets
WARNINGS AND PRECAUTIONS
Pregnancy: Women who are or may potentially be pregnant must not use ACT FINASTERIDE. They should also not handle crushed or broken tablets of ACT FINASTERIDE. If the active ingredient in ACT 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. ACT 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 ACT FINASTERIDE, a physician should be consulted.
You must see your physician regularly while taking ACT 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. ACT FINASTERIDE can alter PSA values. You should tell your physician that you are taking ACT FINASTERIDE. For more information, talk to your physician.
ACT FINASTERIDE may increase the chance of a more serious form of prostate cancer.
Tell your physician or pharmacist about all the medicines you take. This includes prescription and non-prescription medicines, and herbal supplements.
Combination therapy of ACT 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 ACT FINASTERIDE as your physician has prescribed.
Usual dose:
5 mg tablet once daily by mouth with or without food
Missed Dose:
INTERACTIONS WITH THIS MEDICATION IMPORTANT: PLEASE READ
ACT FINASTERIDE Page 31 of 31
If you miss a dose, do not take an extra one. Just take the next tablet as usual.
Overdosage:
In case of drug overdose, contact a health care practitioner, 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, ACT FINASTERIDE may cause side effects. Side effects due to ACT 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
problems with ejaculation that continue 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.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptoms / Effects | Talk with your physician or pharmacist | Stop taking drug and call your physician or pharmacist | |||
Only if severe | In all cases | ||||
| 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 ACT FINASTERIDE, contact your physician or pharmacist.
HOW TO STORE IT
Store at room temperature (15ºC - 30ºC) and protect from light.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
REPORTING SUSPECTED 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:
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- 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 MedEffect™ 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
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga ON
L5N 6J5