Consumer Information for: AURO-FINASTERIDE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
AURO-FINASTERIDE is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. AURO-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 AURO-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.
AURO-FINASTERIDE is not approved for the prevention of prostate cancer.
What it does
AURO-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. AURO-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 AURO-FINASTERIDE if you think you are allergic to any of its ingredients.
Women and children should not take AURO-FINASTERIDE. Women who are or may potentially be pregnant must not use AURO-FINASTERIDE (see WARNINGS AND PRECAUTIONS, Pregnancy).
What the medicinal ingredient is
Finasteride
What the non-medicinal ingredients are
Lactose Monohydrate, Cellulose, Microcrystalline (Avicel PH 101), Sodium Starch Glycolate (Type A, Primogel), Starch, Pregelatinised (Starch 1500), Docusate Sodium, Magnesium Stearate Hydroxy propyl cellulose, Hypromellose 6cp, Titanium Dioxide, Talc, FD&C blue #2, Iron oxide yellow.
What dosage form it comes in
Each film coated tablet of AURO-FINASTERIDE contains 5 mg of finasteride.
Warnings and precautions
Serious Warnings and Precautions
Pregnancy: Women who are or may potentially be pregnant must not use AURO-FINASTERIDE. They should also not handle crushed or broken tablets of AURO-FINASTERIDE. If the active ingredient in AURO-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. AURO-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 AURO- FINASTERIDE, a physician should be consulted.
You must see your physician regularly while taking AURO-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. AURO-FINASTERIDE can alter PSA values. You should tell your physician that you are taking AURO-FINASTERIDE. For more information, talk to your physician.
AURO-FINASTERIDE 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 AURO-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 AURO-FINASTERIDE as your physician has prescribed.
Usual Dose
5 mg tablet once daily by mouth with or without food
Overdose
If you think you have taken too AURO- FINASTERIDE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms
Missed Dose
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
Like any medicine, AURO-FINASTERIDE may cause side effects. Side effects due to AURO- 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, swelling of the lips, tongue, throat and face;
- testicular pain;
- blood in semen;
- an inability to have an erection that continued after stopping the medication;
- muscle injury, muscle pain, muscle weakness, abnormal test results (CK elevation).
- 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;
- changes in mood, which can include suicidal thoughts.
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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Allergic 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 AURO- FINASTERIDE, contact your physician or pharmacist.
How to store
Store at room temperature between 15 and 30°C and protect from light to prevent discoloration.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about AURO-FINASTERIDE:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; the manufacturer's website, or by calling 1- 855-648-6681.
This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: November 12, 2019
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