Sandoz Dutasteride: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Dutasteride is used alone (monotherapy) in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.

Sandoz Dutasteride is also used in combination with the alpha blocker, tamsulosin, in the treatment of moderate to severe symptomatic BPH in men with enlarged prostates. Combination therapy was also shown to be better than tamsulosin, but not Sandoz Dutasteride at reducing the risk of acute urinary retention (or where patient suddenly cannot urinate at all) and/or the need for BPH related surgery.

Sandoz Dutasteride is not approved for use in the prevention of prostate cancer.

What it does:

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). Sandoz Dutasteride belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors. Sandoz Dutasteride lowers DHT production in the body, leading to a shrinkage of the enlarged prostate in most men, which leads to improvements in BPH symptoms and improved urinary flow, reduced risk of acute urinary retention (or where patient suddenly cannot urinate at all), and reduced risk of the need for BPH related surgery.

Sandoz Dutasteride is also used with another medicine called tamsulosin, an alpha blocker, which acts by relaxing smooth muscle in the prostate and bladder neck at the site of obstruction, resulting in improvements in BPH symptoms and improved urinary flow.

Symptoms of BPH may be seen to improve after 3 months of treatment with Sandoz Dutasteride, however, it may take up to 6 months to know if treatment with Sandoz Dutasteride will be beneficial.

When it should not be used:

• Women and children should never take Sandoz Dutasteride.
• Do not take Sandoz Dutasteride if you are allergic to dutasteride or other alpha-reductase inhibitors or any of the other ingredients of Sandoz Dutasteride.

What the medicinal ingredient is:

Dutasteride

What the important nonmedicinal ingredients are:

Nonmedicinal ingredients in your medicine include butylhydroxytoluene, citric acid, gelatin, glycerol monocaprylocaprate, glycerol, glycine, iron oxide yellow, titanium dioxide and edible black ink containing isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and black iron oxide.

What dosage forms it comes in:

Soft gelatin capsules. Each capsule contains 0.5 mg of dutasteride.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Sandoz Dutasteride is for use by men only

• Women who are pregnant, or who may become pregnant, should not handle Sandoz Dutasteride as it may pass through the skin. Sandoz Dutasteride may affect the normal development of the external genital organs in a male baby.

Heart failure (the heart does not pump blood as well as it should) was reported more often in patients taking Sandoz Dutasteride and an alpha-blocker, tamsulosin, in clinical studies than in patients taking Sandoz Dutasteride. It is not known if taking Sandoz Dutasteride and an alpha-blocker caused heart failure.

BEFORE you use Sandoz Dutasteride, talk to your doctor or pharmacist if:

• You have or have had liver problems.
• You have or have had prostate cancer or urinary tract disease.

What are the special precautions about Sandoz Dutasteride?

• Do not donate blood while taking Sandoz Dutasteride and for at least 6 months after you have stopped taking Sandoz Dutasteride in order to prevent giving Sandoz Dutasteride to a pregnant woman through blood transfusion.
• In a clinical study of men aged 50 to 75 years with a recent negative biopsy for prostate cancer and an increased prostate specific antigen (PSA) blood test, men taking Sandoz Dutasteride had a serious form of prostate cancer more often than men who did not take Sandoz Dutasteride.

You must see your doctor regularly. While taking Sandoz Dutasteride, you must have regular checkups, including digital rectal examination and PSA examination. Follow your doctor’s advice about when to have these checkups.

Checking for prostate cancer

A man can have BPH and prostate cancer at the same time. Prior to treatment with Sandoz Dutasteride, you should have a thorough urological evaluation to determine the severity of your condition, and to rule out the need for immediate surgery or the possibility of prostate cancer.

About Prostate Specific Antigen (PSA)

If a doctor asks you to have a Prostate Specific Antigen (PSA) test which is used for screening prostate cancer, you should tell your doctor that you are taking Sandoz Dutasteride.

Sandoz Dutasteride can lower the PSA test result. A low PSA level may give you a false sense of security about your risk for prostate cancer. Your doctor is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with Sandoz Dutasteride (even if the PSA levels are in the normal range) should be evaluated by your doctor.

INTERACTIONS WITH THIS MEDICATION

Interactions with other medicines

Some medicines can react with Sandoz Dutasteride and may make it more likely that you will have side effects. Some of these medicines may include:

• Verapamil or diltiazem (for high blood pressure).
• Ritonavir (for HIV).
• Ketaconazole (for fungal infections).
• Ciprofloxacin or troleandomycin (for bacterial infections).
• Cimetidine (for heart burn).
• Certain herbal medicines such as St. John’s Wort or Milk Thistle.

Make sure your doctor knows if you are taking any of these, or other medicines. Your dose of Sandoz Dutasteride may need to be reduced. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which you have bought yourself without a prescription.

Do not eat grapefruit or drink grapefruit juice while taking Sandoz Dutasteride. This drink is known to increase the blood levels of some drugs in the body.

PROPER USE OF THIS MEDICATION

Always take Sandoz Dutasteride exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Usual dose:

Monotherapy: One Sandoz Dutasteride 0.5 mg capsule once a day.

Combination therapy: One Sandoz Dutasteride 0.5 mg capsule once a day with one tamsulosin 0.4 mg once a day.

• Swallow the capsule whole. DO NOT chew or open the capsules. Contact with the contents of the capsules may make your mouth or throat sore.

• The capsules can be taken with or without food.

  Do not share your medication with others.

Overdose:

Missed Dose:

If you miss a dose, you can just take the next scheduled dose. Don’t take any extra capsules to make up for doses you forgot to take.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects of Sandoz Dutasteride, taken alone or in combination with tamsulosin, are not being able to achieve or maintain an erection^* (impotence), decrease in libido^* (decreased desire to have sex or a reduced sex drive), changes or problems with ejaculations^* (including a decrease in amount of semen released during sex) and breast swelling or tenderness. If breasts swelling or tenderness becomes troublesome, or if you notice breast lumps or nipple discharge, you should talk to your doctor about these changes. Additionally, some people may experience dizziness when taking Sandoz Dutasteride with tamsulosin.

Rare side effects (may affect up to 1 in 1000 people) of hair loss (usually from the body) or abnormal hair growth have been reported.

Very rare side effects (1 in 10,000 people) of allergic reactions, depressed mood, and pain and swelling in testicles have been reported.

Breast cancer has been reported in patients taking Sandoz Dutasteride however, the relationship between long-term use of Sandoz Dutasteride and breast cancer is not known.

^*In a small number of people some of these events may continue after you stop taking Sandoz Dutasteride

If you notice these side effects and any other side effects not mentioned in this leaflet, tell your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Dutasteride, contact your doctor or pharmacist.

HOW TO STORE IT

• Store Sandoz Dutasteride capsules at controlled room temperature between 15°C and 30°C.
• Keep out of the reach and sight of children.
• Return any cracked or leaking capsules to your pharmacist for replacement.
• Return any unused capsules to a pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:

1-800-361-3062

or by written request at:

145 Jules-Léger

Boucherville QC

J4B 7K8

Or by e-mail at :

medinfo@sandoz.com

Last revised: November 10, 2014