AG-Finasteride: Uses, Side Effects and Dosage

What is AG-Finasteride used for?

AG-Finasteride is used in adults to:

• treat and control symptoms of Benign Prostatic Hyperplasia (BPH). BPH is a condition in men in which the prostate gland is enlarged. AG-Finasteride can also be taken with doxazosin (an alpha blocker) to reduce symptoms related to BPH.

• reduce the risk of urinary system problems, such as:

  • a sudden inability to pass urine
  • the need for surgery (the removal of part or all of the prostate gland).

AG-Finasteride is not approved for the prevention of prostate cancer.

How does AG-Finasteride work?

AG-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 other symptoms related to BPH.

What are the ingredients in AG-Finasteride?

Medicinal ingredient: finasteride

Non-medicinal ingredients: FD&C Blue No. 2 Aluminum Lake, hydroxypropyl methylcellulose, iron oxide yellow, lactose monohydrate, lauroyl macrogolglycerides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate and titanium dioxide.

AG-Finasteride comes in the following dosage forms:

Tablet 5 mg

Do not use AG-Finasteride if:

• you are allergic to finasteride, any ingredient in AG-Finasteride or component of its container.

• are a woman or child. Women who are or may potentially be pregnant must not use AG-Finasteride.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Finasteride. Talk about any health conditions or problems you may have.

Other warnings you should know about

Monitoring and testing

• AG-Finasteride may increase your chance of a more serious form of prostate cancer. You may undergo a blood test called Prostate-Specific Antigen (PSA) test. The PSA test is for the screening of prostate cancer. AG-Finasteride can alter PSA values. If you have a PSA test done, you should tell the healthcare professional administering the test that you are taking AG-Finasteride.
• Your healthcare professional will check your PSA levels at least six months after you begin treatment and periodically after.
• You should monitor your breasts regularly. Speak to your healthcare provider immediately if you notice any changes. This may include lumps, pain or nipple discharge, breast enlargement, and tenderness.

Pregnancy

• Women who are or may be pregnant must not use AG-Finasteride.
• They should also not handle crushed or broken tablets of AG-Finasteride. A male baby may be harmed if a pregnant woman is exposed to the medicinal ingredient in AG-Finasteride. It may cause the male baby to be born with abnormalities of the sex organs. A pregnant woman may be exposed if absorbed through the skin. AG-Finasteride tablets are coated to prevent contact with the medicinal ingredient during normal handling (i.e. tablets are not broken or crushed).
• Speak to a healthcare professional if a pregnant woman comes into contact with the active ingredient in AG-Finasteride.

Behaviour and mood changes

• There have been reports that AG-Finasteride may cause changes in mood including extreme sadness (depression), injuries from hurting yourself on purpose (self-harm injury), and thoughts of suicide (suicidal ideation). These mental health problems may continue even after you stop treatment.
• Tell your healthcare professional if you have had these behaviour and mood changes before. They should check your mental health before, during and after your treatment with AG-Finasteride.
• If you feel sad, want to hurt yourself, or end your own life or if others around you notice changes in your behaviour, get medical help right away.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Combination therapy of AG-Finasteride and doxazosin may increase the chances of dizziness, postural hypotension (dizziness upon standing), weakness, impotence and abnormal ejaculation.

How to take AG-Finasteride:

• Take AG-Finasteride exactly as your healthcare professional has prescribed.

• Take by mouth with or without food.

Usual dose:

Take one 5 mg tablet once a day.

Overdose:

Missed dose:

If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using AG-Finasteride?

These are not all the possible side effects you may have when taking AG-Finasteride. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• blood in semen;
• breast swelling and / or tenderness;
• impotence (an inability to have an erection);
• less desire to have sex;
• male infertility;
• muscle injury, muscle pain, muscle weakness, abnormal test results (CK elevation);
• problems with ejaculation that continued after stopping the medication;
• problems with ejaculation, such as a decrease in the amount of semen released during sex;
• testicular pain.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature, 15-30°C, and protect from light.

If you want more information about AG-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/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-450-449-9272.

Angita Pharma Inc.

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Revised: OCT 29, 2024