Details for: AURO-FINASTERIDE 1MG
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02428148 | AURO-FINASTERIDE 1MG | FINASTERIDE | 1 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) - Assessing the Potential Risk of Seizures
Summary Safety Review - Finasteride - Assessing the Potential Risk of Suicidal Thoughts and Behaviour (Suicidality)
Summary Safety Review - Proscar and Propecia (finasteride) - Assessing the potential risk of suicidal thoughts and/or behaviour (suicidal ideation)
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AURO-FINASTERIDE 1 mg IS FOR USE BY MEN ONLY.
AURO-FINASTERIDE 1 mg is used for the treatment of male pattern hair loss (also known as androgenetic alopecia).
What it does
AURO-FINASTERIDE 1 mg 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 AURO-FINASTERIDE 1 mg if you think you are allergic to any of its ingredients.
Women and children should not take AURO-FINASTERIDE 1 mg. Do not take AURO-FINASTERIDE 1 mg if you are or may potentially be pregnant (see WARNINGS AND PRECAUTIONS, Pregnancy).
What the medicinal ingredient is
finasteride
What the non-medicinal ingredients are
Cellulose microcrystalline, docussate sodium, lactose monohydrate, magnesium stearate, opadry brown 20A565004, sodium starch glycolate and starch pregelatinised.
Coating Ingredients:
Opadry brown 20A565004:
It contains hypromellose, hydroxy propyl cellulose, talc, titanium dioxide, red iron oxide, & yellow iron oxide.
What dosage form it comes in
1 mg Tablets: Brown colored, film coated, biconvex, octagonal shaped tablets, debossed with ‘J’ on one side and ‘81’ on the other side. Available in blister pack of 4 x 7’s tablets and HDPE bottles of 30’s, 100’s & 1000’s tablets.
Warnings and precautions
BEFORE you use AURO-FINASTERIDE 1 mg 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 (5 times the dose of AURO-FINASTERIDE 1 mg) may increase the chance of a more serious form of prostate cancer.
Pregnancy
Women who are or may potentially be pregnant must not use AURO-FINASTERIDE 1 mg. They should also not handle crushed or broken tablets of AURO-FINASTERIDE 1 mg. If the active ingredient in AURO-FINASTERIDE 1 mg 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 1 mg 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 1 mg, a physician should be consulted.
Interactions with this medication
AURO-FINASTERIDE 1 mg 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.
AURO-FINASTERIDE 1 mg 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 AURO-FINASTERIDE 1 mg.
Proper use of this medication
Take AURO-FINASTERIDE 1 mg as your physician has prescribed.
Usual Dose
Take one tablet of AURO-FINASTERIDE 1 mg 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
If you think you have taken too AURO-FINASTERIDE 1 mg, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
When can I expect to see results from using AURO-FINASTERIDE 1 mg?
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 AURO-FINASTERIDE 1 mg?
AURO-FINASTERIDE 1 mg can only work over the long term if you continue taking it.
Side effects and what to do about them
Like any medicine, AURO-FINASTERIDE 1 mg 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;
- muscle injury, muscle pain, muscle weakness, abnormal test results (CK elevation).
- problems with ejaculation that continued after stopping the medication;
- testicular pain;
- blood in semen;
- 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;
- changes in mood, which can include suicidal thoughts.
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.
| 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, and 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 1 mg, contact your physician or pharmacist.
How to store
Store at room temperature (15°C to 30°C). Protect from moisture.
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling 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 1 mg:
- 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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer's website www.auropharma.ca, 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 6, 2019