IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
FINASTERIDE - ORAL
COMMON BRAND NAME(S): Proscar
USES: Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. It may be used alone or taken in combination with other medications to reduce symptoms of BPH and may also reduce the need for surgery.
Finasteride may improve symptoms of BPH and provide benefits such as decreased urge to urinate, better urine flow with less straining, less of a feeling that the bladder is not completely emptied, and decreased nighttime urination.
This medication works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate.
Women and children should not use this medication.
Finasteride is not FDA-approved for prevention of prostate cancer. Talk to your doctor about the risks and benefits of this medication.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking finasteride and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth, with or without food, usually once a day, or as directed by your doctor.
If the tablet is crushed or broken, it should not be handled by a woman who is pregnant or by a woman who may become pregnant (see also Precautions section).
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Do not stop taking this medication without consulting your doctor.
It may take 6-12 months to notice a benefit.
Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: Decreased sexual ability/desire may occur. In some men, this medication can decrease the amount of semen released during sex. This is harmless. Finasteride may also increase hair growth. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: lump in the breast, nipple discharge, breast enlargement/tenderness/pain, pain in the testicles, inability to urinate.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking finasteride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, prostate cancer, infections, urinary problems.
Finasteride should not be used in children.
The drug can be absorbed through the skin. If the film coating of the tablet has been broken or the tablet crushed, it should not be handled by a woman who is pregnant or planning to become pregnant. Exposing a developing male infant to finasteride can result in abnormalities of the genitals.
Finasteride is not recommended for use in women and must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.
This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.
This medication can affect the results of the blood test used to detect prostate cancer (prostatic-specific antigen or PSA levels). Make sure laboratory personnel and your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (e.g., prostate exams, PSA levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Keep all appointments with your doctor and the laboratory. You should have a complete physical examination. Follow your doctor's instructions for examining your breasts and testicles, and report any lumps immediately.
Although early improvement is often seen, at least 6 to 12 months of therapy may be necessary in some patients to assess whether or not a benefit has occurred. Therefore, it is important to keep regular doctor appointments and get blood tests as scheduled to make sure this medication is working.
Many men are born with the condition this drug mimics (prostate glands that are smaller than usual) and lead normal lives with normal sex drives.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store US product at room temperature below 86 degrees F (30 degrees C) away from light and moisture in a tightly closed container.
Store Canadian product at room temperature between 59 to 86 degrees F (15 to 30 degrees C) away from light and moisture in a tightly closed container.
Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised June 2011 Copyright(c) 2011 First DataBank, Inc.