Patient Medication Information: uses, side effects, how to take - Mylan-Finasteride Hg
ABOUT THIS MEDICATION
MYLAN-FINASTERIDE HG IS FOR USE BY MEN ONLY.
What the medication is used for:
MYLAN-FINASTERIDE HG is used for the treatment of male pattern hair loss (also known as androgenetic alopecia).
What it does:
MYLAN-FINASTERIDE HG 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 MYLAN-FINASTERIDE HG if you think you are allergic to any of its ingredients.
Women and children should not take MYLAN-FINASTERIDE HG. Do not take MYLAN-FINASTERIDE HG 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: Anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, docusate sodium, magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.
What dosage form it comes in:
Each film-coated tablet of MYLAN-FINASTERIDE HG contains 1 mg of finasteride.
WARNINGS AND PRECAUTIONS
BEFORE you use MYLAN-FINASTERIDE HG talk to your physician or pharmacist about any medical problems you have or have had, especially liver disease, and about any allergies.
Finasteride 5 mg (finasteride at 5 times the dose of MYLAN-FINASTERIDE HG) may increase the chance of a more serious form of prostate cancer.
Pregnancy
Women who are or may potentially be pregnant must not use MYLAN-FINASTERIDE HG. They should also not handle crushed or broken tablets of MYLAN-FINASTERIDE HG. If the active ingredient in MYLAN-FINASTERIDE HG 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 HG 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 HG, a physician should be consulted.
INTERACTIONS WITH THIS MEDICATION
Finasteride 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.
Finasteride 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 finasteride.
PROPER USE OF THIS MEDICATION
Take MYLAN-FINASTERIDE HG as your physician has prescribed.
Usual dose: Take one tablet of MYLAN-FINASTERIDE HG 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 MYLAN-FINASTERIDE HG?
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 MYLAN-FINASTERIDE HG?
MYLAN-FINASTERIDE HG can only work over the long term if you continue taking it.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medicine, finasteride 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 finasteride 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 OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | 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 HG contact your physician or pharmacist.
HOW TO STORE IT
Store MYLAN-FINASTERIDE HG at room temperature (15°C - 30°C) and protect from light to prevent discoloration. Keep blister in the outer carton until all tablets are used.
KEEP MYLAN-FINASTERIDE HG 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
Etobicoke, Ontario M8Z 2S6
Date of Revision: July 11, 2014
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca