Dutasteride belongs to a class of medications known as 5-alpha-reductase inhibitors. It is used to relieve symptoms of Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates. BPH is a noncancerous enlargement of the prostate gland that usually occurs in men after the age of 50.

Dutasteride works to reduce the production of dihydrotestosterone (DHT), a hormone that causes enlargement of the prostate gland. Dutasteride relieves symptoms of BPH by reducing the size of the prostate and improving the flow of urine.

This medication improves symptoms associated with BPH, such as:

• decreased urine flow
• difficulty urinating
• getting up to urinate during the night
• hesitation at the start of urination

Dutasteride may be prescribed along with another medication called Tamsulosin in order to decrease the symptoms of BPH.

It may take 6 months or more to see the full effects of Sandoz Dutasteride. Dutasteride reduces the likelihood of prostate surgery for men with BPH. It must be taken on a regular basis to be effective. If the medication is stopped, the prostate will start to grow again.

Sandoz Dutasteride may be available under multiple brand names and/or in several different forms. Any specific brand name of Sandoz Dutasteride may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Sandoz Dutasteride may not be used for all of the conditions discussed here.

Your doctor may have suggested Sandoz Dutasteride for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Sandoz Dutasteride, speak to your doctor. Do not stop taking Sandoz Dutasteride without consulting your doctor.

Do not give Sandoz Dutasteride to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of dutasteride is 0.5 mg once daily, with or without food. Swallow the capsule whole.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use Sandoz Dutasteride exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue on with your regular schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Sandoz Dutasteride at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Sandoz Dutasteride. If you are concerned about side effects, discuss the risks and benefits of Sandoz Dutasteride with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• breast enlargement or tenderness
• decreased sexual desire or ability
• Erectile Dysfunction (difficulty getting or keeping an erection)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• rash, Hives, or itching
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• sudden chest tightness
• swelling of the eyelids, face, lips

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sandoz Dutasteride.

Each beige-to-yellow, oblong soft gelatin capsule, with "D 0.5" imprinted in black, with welding seam, containing a clear oily liquid absent of any visible particles, contains dutasteride 0.5 mg. Nonmedicinal ingredients:  glycerol monocaprylocaprate and butylhydroxytoluene. Capsule shell: gelatin (from certified, BSE-free, nonporcine sources), glycerol, glycine, titanium dioxide, iron oxide yellow, citric acid. Edible black ink: isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac, and black iron oxide as the colourant.

Do not take Sandoz Dutasteride if you:

• are allergic to dutasteride or any ingredients of the medication
• are allergic to medications in the same family (e.g., Finasteride)
• are a woman or child

There may be an interaction between dutasteride and any of the following:

• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole)
• boceprevir
• chloramphenicol
• Cimetidine
• ciprofloxacin
• clarithromycin
• conivaptan
• Cyclosporine
• delavirdine
• Diltiazem
• grapefruit juice
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• milk thistle
• nefazodone
• nelfinavir
• nicardipine
• Propranolol
• protease inhibitors (e.g., indinavir, ritonavir, saquinavir)
• St. John's wort
• telaprevir
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Blood donation: Men taking Sandoz Dutasteride should not donate blood until at least 6 months have passed following their last dose. This is to prevent pregnant women from being exposed to dutasteride during a blood transfusion.

Liver disease: If you have liver disease or decreased liver function, discuss with your doctor how Sandoz Dutasteride may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Dutasteride, and whether any special monitoring is needed.

Prostate Cancer: Dutasteride may be linked to an increased risk of developing a rare type of cancer called high-grade prostate cancer. The risk of developing this cancer while taking Sandoz Dutasteride is still considered very small. Note that dutasteride is not approved to treat prostate cancer. If you experience worsening symptoms or symptoms that do not improve within 6 months, discuss this with your doctor. PSA test: Dutasteride can decrease PSA (prostate specific antigen) levels by up to 50%. Doctors often measure PSA levels to test for prostate cancer. PSA levels can still be measured for this purpose, but your doctor will need to adjust the results in order for the test to be accurate. If you are having a PSA test, ensure your doctor knows that you are taking dutasteride.

Women and children: Dutasteride is intended for use by men only. Women and children must avoid contact with the medication, as it is absorbed through the skin. If contact occurs, wash the exposed area immediately with soap and water.

Pregnancy: Sandoz Dutasteride is intended for use by men only. Women who may be pregnant must avoid touching any pills of dutaseride (even ones that are not leaking). Pregnant women or women who may be pregnant should not handle dutasteride because the medication can be absorbed through the skin and may cause abnormalities in the baby. If a pregnant woman accidentally comes in contact with the capsules, she should wash the contact area immediately with soap and water.

Breast-feeding: Dutasteride is not intended for use by women. It is not known if dutasteride passes into breast milk. Do not handle this medication if you are breast-feeding because the medication can be absorbed through the skin and may affect the baby.

Children: Sandoz Dutasteride is not intended for use by children. The safety and effectiveness of dutasteride have not been established for use by people in this age group.