Consumer medicine information

1. Why am I using PROPECIA?

PROPECIA contains the active ingredient finasteride. PROPECIA is used to treat men with male pattern hair loss to increase hair growth on the scalp and to prevent further hair loss.
For more information, see Section 1. Why am I using PROPECIA? in the full CMI.

2. What should I know before I use PROPECIA?

Do not use if you have ever had an allergic reaction to PROPECIA or any of the ingredients listed at the end of the CMI.
PROPECIA is for use in men only. Do not give PROPECIA to children or women.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use PROPECIA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PROPECIA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use PROPECIA?

• The dose is one tablet taken once each day

5. What should I know while using PROPECIA?

6. Are there any side effects?

Common side effects include difficulty achieving an erection or less desire for sex, that continues after stopping PROPECIA. Serious side effects include allergic reactions, breast swelling, tenderness, lumps or pain, discharge from the nipples, male breast cancer, hives or nettle rash, skin rash or itchiness, testicle pain, blood in the semen and depression.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Finasteride.

2 Qualitative and Quantitative Composition

Each film-coated tablet of Propecia contains 1 mg of finasteride.
List of excipients with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Propecia 1 mg. A tan, octagonal, film-coated convex tablet embossed "P" logo on one side and "PROPECIA" on the other side.

4 Clinical Particulars

4.9 Overdose

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in side effects.
No specific treatment for overdosage with Propecia is recommended. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No evidence of mutagenicity was observed in an in vitro bacterial mutagenesis assay, a mammalian cell mutagenesis assay, or in an in vitro alkaline elution assay. In an in vitro chromosome aberration assay, when Chinese hamster ovary cells were treated with high concentrations (450-550 micromol) of finasteride, there was a slight increase in chromosome aberrations. These concentrations are in excess of the peak plasma concentrations in men given a total dose of 1 mg and are not achievable in a biological system. In an in vivo chromosome aberration assay in mice, no treatment related increases in chromosome aberration were observed with finasteride at the maximum tolerated dose.
Carcinogenicity. In a 24 month carcinogenicity study in rats there was an increase in the incidence of thyroid follicular adenomas in male rats receiving 160 mg/kg/day finasteride (statistically significant trend test). This oral dose produced an exposure in rats of more than 800 times that observed in humans at the recommended dose (based on AUC_{(0-24 hrs)} values). The effect of finasteride on the thyroid in rats appears to be due to an increased rate of thyroxine clearance and not a direct effect of the drug. These observations seen in the rat are thought not relevant to man.
In a 19 month carcinogenicity study in mice, a statistically significant increase in the incidence of testicular Leydig cell adenoma was observed at an oral dose of 250 mg/kg/day (estimated exposure of more than 1700 times that observed in humans at the recommended dose); no adenomas were seen in mice given 2.5 or 25 mg/kg/day.
In mice at an oral dose of 25 mg/kg/day (estimated exposure about 90 times that in humans at the recommended dose) and in rats at an oral dose of ≥ 40 mg/kg/day, (estimated exposure about 300 times that in humans at the recommended dose), an increase in the incidence of Leydig cell hyperplasia was observed. A positive correlation between the proliferative changes of the Leydig cells and the increase in serum luteinising hormone (LH) levels (2-3 fold above control) has been demonstrated in both rodent species treated with high doses of finasteride. This suggests the Leydig cell changes are secondary to elevated serum LH levels and not due to a direct effect of finasteride.
No drug related Leydig cell changes were seen in either rats or dogs treated with finasteride for one year at respective oral doses of 20 mg/kg/day (estimated exposure more than 220 times that in humans at the recommended dose) and 45 mg/kg/day (estimated exposure more than 2600 times that in humans at the recommended dose) or in mice treated for 19 months at an oral dose of 2.5 mg/kg/day (estimated exposure about 9 times that in humans at the recommended dose).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Finasteride is a white, crystalline solid. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.
Finasteride is described chemically as: N-(1,1-dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide.
Finasteride has a molecular weight of 372.55. Its empirical formula is C₂₃H₃₆N₂O₂.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFINAST.gif CAS number. 98319-26-7.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PROPECST.gif