What Proscar is used for and how to use it
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Proscar - Consumer Medicine Information

Manufacture: Merck and Co., Inc.
Country: Canada
Condition: Benign Prostatic Hyperplasia
Class: 5-alpha-reductase inhibitors
Form: Tablets
Ingredients: finasteride, cellulose and cellulose derivatives, coloring agents (FD&C blue 2 aluminum lake, titanium dioxide, yellow ferric oxide), corn starch, docusate sodium, lactose, magnesium stearate, sodium starch glycolate and talc

Finasteride tablets, USP

About this Medication

PROSCAR IS FOR USE BY MEN ONLY.

What the Medication is Used For

PROSCAR is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. PROSCAR 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 PROSCAR 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.

PROSCAR is not approved for the prevention of prostate cancer.

What it Does

PROSCAR 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. PROSCAR 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 PROSCAR if you think you are allergic to any of its ingredients.

Women and children should not take PROSCAR. Women who are or may potentially be pregnant must not use PROSCAR (see WARNINGS AND PRECAUTIONS, Pregnancy).

What the Medicinal Ingredient Is

finasteride

What the Important Nonmedicinal Ingredients Are

cellulose and cellulose derivatives, coloring agents (FD&C blue 2 aluminum lake, titanium dioxide, yellow ferric oxide), corn starch, docusate sodium, lactose, magnesium stearate, sodium starch glycolate and talc.

What Dosage Forms it Comes In

Each film coated tablet of PROSCAR contains 5 mg of finasteride.

Warnings and Precautions

Pregnancy

Women who are or may potentially be pregnant must not use PROSCAR. They should also not handle crushed or broken tablets of PROSCAR. If the active ingredient in PROSCAR 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. PROSCAR 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 PROSCAR, a physician should be consulted.

You must see your physician regularly while taking PROSCAR. 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. PROSCAR can alter PSA values. You should tell your physician that you are taking PROSCAR. For more information, talk to your physician.

PROSCAR 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 PROSCAR and doxazosin may increase the chances of dizziness, postural hypotension (dizziness upon standing), weakness, impotence and abnormal ejaculation.

Proper Use of This Medication

Take PROSCAR 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

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, PROSCAR may cause side effects. Side effects due to PROSCAR 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;
  • an inability to have an erection that continued after stopping the medication;
  • 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.

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

Symptom/effectTalk with your physician or pharmacistStop taking
drug and
call your
physician or
pharmacist
Only if
severe
In all
cases
RareAllergic 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 PROSCAR , contact your physician or pharmacist.

How to Store It

Store at room temperature (15 °C-30 °C) and protect from light.

KEEP PROSCAR AND 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:

  • 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 or Merck do not provide medical advice.

You can also report any suspected adverse reactions associated with the use of health products to Merck Canada Inc. by one of the following 2 ways:

  • Call toll-free at 1-800-567-2594
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-800-369-3090, or
    • Mail to: Merck Canada Inc.
                     Pharmacovigilance
                     16750 route Transcanadienne Kirkland, QC H9H 4M7

More Information

This document plus the full product monograph, prepared for health professionals can be found at:

www.merck.ca

or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594.