Patient Medication Information: uses, side effects, how to take - Mylan-Finasteride
ABOUT THIS MEDICATION
MYLAN-FINASTERIDE IS FOR USE BY MEN ONLY.
What the medication is used for:
MYLAN-FINASTERIDE is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. MYLAN-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 MYLAN-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.
MYLAN-FINASTERIDE is not approved for the prevention of prostate cancer.
What it does:
MYLAN-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. MYLAN-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 MYLAN-FINASTERIDE if you think you are allergic to any of its ingredients.
Women and children should not take MYLAN-FINASTERIDE. Women who are or may potentially be pregnant must not use MYLAN-FINASTERIDE (See WARNINGS AND PRECAUTIONS, Pregnancy).
What the medicinal ingredient is:
finasteride
What the important nonmedicinal ingredients are:
colliodal silicon dioxide, croscarmellose sodium, docusate sodium, FD&C blue 2 aluminum lake, glycerol triacetate, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, polydextrose, sodium lauryl sulphate, starch (corn), titanium dioxide.
What dosage forms it comes in:
Each film coated tablet of MYLAN-FINASTERIDE contains 5 mg of finasteride. Available in bottles of 30 tablets, 100 tablets and blister cartons of 30 tablets.
WARNINGS AND PRECAUTIONS
Pregnancy: Women who are or may potentially be pregnant must not use MYLAN-FINASTERIDE. They should also not handle crushed or broken tablets of MYLAN-FINASTERIDE. If the active ingredient in MYLAN-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.
MYLAN-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 MYLAN-FINASTERIDE, a physician should be consulted.
You must see your physician regularly while taking MYLAN-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. MYLAN-FINASTERIDE can alter PSA values. You should tell your physician that you are taking MYLAN-FINASTERIDE. For more information, talk to your physician.
MYLAN-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 MYLAN-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 MYLAN-FINASTERIDE 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, MYLAN-FINASTERIDE may cause side effects. Side effects due to MYLAN-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
- 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 | |||||
| Symptoms/Effects | Talk with your physician or pharmacist | Stop taking drug and seek immediate medical attention | |||
| 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 MYLAN-FINASTERIDE, contact your physician or pharmacist.
HOW TO STORE IT
Store at room temperature (15°C – 30°C) and protect from light.
KEEP MYLAN-FINASTERIDE AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
Reporting Form and sending it by:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). 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
This document can be found at: www.mylan.ca
The full product monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Last revised: July 03, 2014
Mylan Pharmaceuticals ULC
85 Advance Rd.
Etobicoke, Ontario
M8Z 2S6
1-800-575-1379