Propecia

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

PROPECIA (finasteride) tablets contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).

The chemical name of finasteride is N-tert-Butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. The empirical formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:

Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.

PROPECIA (finasteride) tablets are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, yellow ferric oxide, and red ferric oxide.

PROPECIA® is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.

Efficacy in bitemporal recession has not been established.

PROPECIA is not indicated for use in women.

1-10%

Erectile dysfunction (1.3-8.1%)

Decrease libido (1.8-6.4%)

Breast enlargement (0.5-1.8%)

Ejaculation disorder (0.8-1.2%)

<1%

Breast tenderness (0.4-0.7%)

Rash (0.5%)

Postmarketing Reports

Neoplasms: Male breast cancer

Breast disorders: Breast tenderness and enlargement

Nervous system/psychiatric: Depression

Hypersensitivity reactions: Rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face)

Reproductive system: Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain

Finasteride should never be taken by a woman or a child. Finasteride can be absorbed through the skin, and women or children should not be permitted to handle finasteride tablets.

Although finasteride is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Finasteride tablets should not be handled by a woman who is pregnant or who may become pregnant.

If a woman accidentally comes into contact with this medication from a broken or crushed tablet, wash the area with soap and water right away.

Before taking finasteride, tell your doctor if you have ever had an allergic reaction to this medication, or to a similar medicine called dutasteride (Avodart).

Using finasteride may increase your risk of developing prostate cancer. Your doctor will perform tests to make sure you do not have other conditions that would prevent you from safely using finasteride.

Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.

• Merck Sharp & Dohme Corp.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Propecia there are no specific foods that you must exclude from your diet when receiving Propecia.

If you take too much Propecia, call your local Poison Control Center or seek emergency medical attention right away.

Note: Women who are pregnant or may become pregnant should not use finasteride or handle the crushed or broken tablets. Finasteride can cause birth defects in male babies.

Finasteride is used to treat men with benign prostatic hyperplasia (BPH) and male pattern hair loss, also called androgenetic alopecia. BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Finasteride will make these symptoms less severe and reduce the chance that prostate surgery will be needed. It may be used alone or in combination with other medicines such as an alpha-blocker (doxazosin, Cardura®) to treat BPH. For men with hair loss, finasteride will increase the number of scalp hairs but will not increase the amount of body hair.

Finasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow or hair loss in males. It will increase testosterone levels in the body, which decreases prostate size and increases hair growth on the scalp. The effect of finasteride on the prostate and scalp will only last as long as the medicine is taken. When it is stopped, the prostate begins to grow again and the hair will be lost.

This medicine is available only with your doctor's prescription.

Take Propecia exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Propecia can be taken with or without food. Take the medicine at the same time each day.

It is important to use Propecia regularly to get the most benefit. You may need to take Propecia daily for three months or more before you see a benefit. Propecia can only work over the long term if you continue taking it. If the drug has not worked for you in twelve months, further treatment is unlikely to be of benefit. If you stop taking Propecia, you will likely lose the hair you have gained within 12 months of stopping treatment. You should discuss this with your doctor.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested often. Your doctor will also test your prostate specific antigen (PSA) to check for prostate cancer. Visit your doctor regularly.

Store Propecia at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Propecia is not expected to produce life-threatening symptoms.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.