Patient Medication Information: uses, side effects, how to take - NTP-Finasteride
ABOUT THIS MEDICATION
What the medication is used for:
Your physician has prescribed NTP-FINASTERIDE because you have a medical condition called benign prostatic hyperplasia or BPH. This condition occurs only in men. NTP-FINASTERIDE is available only with your physician's prescription for the treatment of benign prostatic hyperplasia and to reduce the risk of developing a sudden inability to pass urine.
What is BPH?
BPH is an enlargement of the prostate gland. After age 50, most men develop enlarged prostates. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:
- weak or interrupted urinary stream
feeling that you cannot empty your bladder
completely
feeling of delay or hesitation when you start to
urinate
- need to urinate often, especially at night
- feeling that you must urinate right away
Treatment options for BPH
There are three main treatment options for BPH:
Program of monitoring or "Watchful Waiting". If
a man has an enlarged prostate gland and no symptoms or if his symptoms do not bother him, he and his physician may decide on a program of monitoring which would include regular checkups, instead of medication or surgery.
Medication. Your physician may prescribe NTP-
FINASTERIDE for BPH. See "What it does" below.
Surgery. Some patients may need surgery. Your
physician can describe several different surgical procedures for BPH. Which procedure is best depends on your symptoms and medical condition.
What it does:
NTP-FINASTERIDE lowers levels of a key hormone called DHT (dihydrotestosterone), which is a major cause of prostate growth. Lowering 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. NTP-FINASTERIDE will help reduce the risk of developing a sudden inability to pass urine (acute urinary retention) and the need for surgery.
However, not all patients respond and since each case of BPH is different, you should know that:
- Prior to treatment with NTP-FINASTERIDE, you should have a thorough urological evaluation to determine the severity of your condition, and to exclude the need for immediate surgery or the possibility of carcinoma of the prostate.
- Even though the prostate shrinks, you may NOT see an improvement in urine flow or symptoms.
- You may need to take NTP-FINASTERIDE for six (6) months or more to see if it improves your symptoms. Whether or not you notice any improvement or change in symptoms, therapy with NTP-FINASTERIDE may reduce your risk for a sudden inability to pass urine and the need for surgery. However, 85-90% of those patients who do respond to NTP-FINASTERIDE do so during the first 12 months of treatment. Your physician will help you decide how long you should remain on this medication.
When it should not be used:
Women who are or may potentially be pregnant must not use NTP-FINASTERIDE. They should also not handle crushed or broken tablets of NTP-FINASTERIDE. If the active ingredient in NTP-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. NTP-
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 NTP-FINASTERIDE, a physician should be consulted.
What the medicinal ingredient is:
finasteride
What the important nonmedicinal ingredients are:
lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized
starch, sodium lauryl sulfate, sodium starch glycolate and opadry blue (hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue #2 Indigo Carmine Aluminum Lake 11%-14%).
What dosage forms it comes in:
Each tablet of NTP-FINASTERIDE contains 5 mg of finasteride.
WARNINGS AND PRECAUTIONS
NTP-FINASTERIDE is for use by MEN only.
PROPER USE OF THIS MEDICATION
THIS MEDICINE IS PRESCRIBED FOR YOUR SPECIFIC MEDICAL PROBLEM AND FOR YOUR OWN USE. USE ONLY AS SPECIFICALLY DIRECTED AND DO NOT GIVE TO OTHER PEOPLE.
Usual dose:
Follow your physician's advice about how to take NTP-FINASTERIDE. You must take it every day. You may take it with or between meals. To avoid forgetting to take NTP-FINASTERIDE, it may be helpful to take it at the same time every day.
Do not share NTP-FINASTERIDE with anyone else; it was prescribed only for you.
You must see your physician regularly. While taking NTP-FINASTERIDE, you must have regular checkups. Follow your physician's advice about when to have these checkups.
Checking for prostate cancer. Your physician has prescribed NTP-FINASTERIDE
for symptomatic BPH and not for cancer - but a man can have BPH and prostate cancer at the same time. Physicians usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). These checks should continue while you take NTP-FINASTERIDE. NTP-FINASTERIDE is not a treatment for prostate cancer.
About Prostate Specific Antigen (PSA). Your physician may have done a blood test called PSA. NTP-FINASTERIDE
can alter PSA values. For more information, talk to your physician.
Overdose:
In the event of overdosage, contact your doctor,
hospital emergency department, or regional Poison Control Centre immediately.
Missed dose:
Try to take NTP-FINASTERIDE
as your physician has prescribed. However, 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
NTP-FINASTERIDE is generally well tolerated in men.
You should discuss side effects with your physician before taking NTP-FINASTERIDE and any time you think you are having a side effect.
Like any medicine, NTP-FINASTERIDE may have unintended or undesirable effects, so-called side effects. These are uncommon and do not affect most men. Side effects due to NTP-FINASTERIDE may include impotence (an inability to have an erection) or less desire to have sex. Some men may have changes or problems with ejaculation, such as a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to interfere with normal sexual function. In some cases, these side effects disappeared while the patient continued to take NTP-FINASTERIDE. If symptoms persisted, they usually resolved on discontinuing NTP-FINASTERIDE.
In addition, some men may have breast swelling and/or tenderness. Some men have also reported allergic reactions such as rash, itching, hives and swelling of the lips and face; and testicular pain. You should promptly report to your physician any changes in your breasts such as lumps, pain or nipple discharge.
Notify your physician about any illness which may develop during your treatment with NTP-FINASTERIDE and about any new prescription or non-prescription medication you may take. If you require medical help for other reasons, inform the attending physician that you are taking NTP-FINASTERIDE.
HOW TO STORE IT
Store at temperature between 15°C -30°C and protect from light.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN. FOR MORE INFORMATION ABOUT NTP-FINASTERIDE AND BPH, TALK WITH YOUR PHYSICIAN OR YOUR PHARMACIST.
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:
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 0701D 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
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Ltd.
at: 1-800-268-4127 ext. 5005 (English)
or 1-877-777-9117 (French)
or druginfo@TevaCanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9