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

Manufacture: Merck and Co., Inc.
Country: Canada
Condition: Androgenetic Alopecia
Class: 5-alpha-reductase inhibitors
Form: Tablets
Ingredients: finasteride, docusate sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, methylhydroxypropylcellulose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, red ferric oxide and yellow ferric oxide

Finasteride tablets, USP

About this Medication

PROPECIA IS FOR USE BY MEN ONLY

What the Medication Is Used For

PROPECIA is used for the treatment of male pattern hair loss (also known as androgenetic alopecia).

What It Does

PROPECIA blocks an important enzyme (Type II 5-alpha reductase) involved in the regulation of the hair follicle and lowers the levels of dihydrotestosterone (DHT) in the scalp, a major cause of male pattern hair loss.

When It Should not be Used

Do not take PROPECIA if you think you are allergic to any of its ingredients.

Women and children should not take PROPECIA. Do not take PROPECIA if you are or may potentially be pregnant (see WARNINGS AND PRECAUTIONS, Pregnancy).

What the Medicinal Ingredient Is

finasteride

What the Important Nonmedicinal Ingredients Are

docusate sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, methylhydroxypropylcellulose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, red ferric oxide and yellow ferric oxide.

What Dosage Form It Comes In

Each film-coated tablet of PROPECIA contains 1 mg of finasteride.

Warnings and Precautions

BEFORE you use PROPECIA talk to your physician or pharmacist about any medical problems you have or have had, especially liver disease, and about any allergies.

PROSCAR (finasteride at 5 times the dose of PROPECIA) may increase the chance of a more serious form of prostate cancer.

Pregnancy

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

Interactions with this Medication

PROPECIA usually does not interfere with other medicines. However, you should always tell your physician about all medicines you are taking or plan to take, including those obtained without prescription.

PROPECIA can affect a blood test called PSA (prostate-specific antigen) used for the screening of prostate cancer. If you have a PSA test done, you should tell your physician that you are taking PROPECIA.

Proper Use of this Medication

Take PROPECIA as your physician has prescribed.

Usual Dose

Take one tablet of PROPECIA every day, 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.

When can I expect to see results from using PROPECIA?

Male pattern hair loss is a condition that develops over a long period of time. On average, healthy hair grows only about 1 cm each month. Therefore, it will take time to see any effect. In general, daily use for three months or more may be necessary before you notice that hair growth is increased or further hair loss is prevented.

How long do I need to use PROPECIA?

PROPECIA can only work over the long term if you continue taking it.

Side Effects and what to Do About Them

Like any medicine, PROPECIA may cause side effects.

Common side effects

  • less desire to have sex
  • difficulty in achieving an erection.
  • problems with ejaculation, such as a decrease in the amount of semen released during sex (this does not appear to interfere with normal sexual function).

In clinical studies, these side effects disappeared in men who stopped taking PROPECIA and in most men who continued treatment.

In general use, the following have been reported infrequently:

  • breast enlargement (swelling) and/or tenderness;
  • depression;
  • decrease in sex drive that continued after stopping the medication;
  • allergic reactions including rash, itching, hives, and swelling of the lips, tongue, throat and face;
  • problems with ejaculation that continued after stopping the medication;
  • testicular pain;
  • difficulty in achieving 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;
  • male breast cancer.

Talk to your doctor about any changes in your breast such as lumps, pain or nipple discharge. Tell your physician or pharmacist promptly about these or any other unusual symptoms.

Serious Side Effects, how Оften they Happen and what to Do About Them

Symptom/effect 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, tongue, throat and face

This is not a complete list of side effects. For any unexpected effects while taking PROPECIA, contact your physician or pharmacist.

How to Store It

Store PROPECIA in a dry place at room temperature (15 °C-30 °C) and protect from moisture. Keep blister in the outer carton until all tablets are used.

KEEP PROPECIA 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.