Details for: RIVA-FINASTERIDE
Company: LABORATOIRE RIVA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02455013 | RIVA-FINASTERIDE | FINASTERIDE | 5 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
RIVA-FINASTERIDE is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. RIVA-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 RIVA-FINASTERIDE along with another medicine, called doxazosin (an alphablocker), 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.
RIVA-FINASTERIDE is not approved for the prevention of prostate cancer.
What it does
RIVA-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. RIVA-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 RIVA-FINASTERIDE if you think you are allergic to any of its ingredients.
Women and children should not take RIVA-FINASTERIDE. Women who are or may potentially be pregnant must not use RIVA-FINASTERIDE (see WARNINGS AND PRECAUTIONS, Pregnancy).
What the medicinal ingredient is
finasteride
What the non-medicinal ingredients are
microcrystalline cellulose, hydroxyl propyl methyl cellulose, polyethylene glycol, coloring agents (FD&C blue 2 aluminum lake, titanium dioxide, iron oxide yellow), pregelatinized starch, lauroyl macrogoglycerides, lactose monohydrate, magnesium stearate and sodium starch glycolate.
What dosage form it comes in
Each film coated tablet contains 5 mg of finasteride.
Warnings and precautions
Pregnancy: Women who are or may potentially be pregnant must not use RIVA-FINASTERIDE. They should also not handle crushed or broken tablets of RIVA-FINASTERIDE. If the active ingredient in RIVA-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.
RIVA-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 RIVA-FINASTERIDE, a physician should be consulted.
You must see your physician regularly while taking RIVAFINASTERIDE. 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. RIVA-FINASTERIDE can alter PSA values. You should tell your physician that you are taking RIVAFINASTERIDE. For more information, talk to your physician
RIVA-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 RIVA-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 RIVA-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 much RIVA-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, RIVA-FINASTERIDE may cause side effects. Side effects due to RIVA-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. | ✔ | ||
How to store
Store at room temperature (15°C-30°C) and protect from light.
KEEP RIVA-FINASTERIDE AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.
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/medeffectcanada/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 RIVA-FINASTERIDE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); or by calling the sponsor Laboratoire Riva Inc. at 1-800-363-7988.
This leaflet was prepared by:
Laboratoire Riva Inc.
660 Boul. Industriel,
Blainville, Quebec
J7C 3V4
Last revised: February 18, 2020