Details for: RIVA-DUTASTERIDE
Company: LABORATOIRE RIVA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02427753 | RIVA-DUTASTERIDE | DUTASTERIDE | 0.5 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
RIVA-DUTASTERIDE is used alone (monotherapy) in the
treatment of symptomatic benign prostatic hyperplasia (BPH)
in men with enlarged prostates.
RIVA-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 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.
RIVA-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). RIVA-DUTASTERIDE belongs
to a group of medicines called 5 alpha-reductase enzyme
inhibitors. RIVA-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.
RIVA-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 RIVA-DUTASTERIDE, however, it may take
up to 6 months to know if treatment with RIVA-DUTASTERIDE
will be beneficial.
When it should not be used
- Women and children should never take RIVA-DUTASTERIDE.
- Do not take RIVA-DUTASTERIDE if you are allergic to dutasteride or other alpha-reductase inhibitors or any of the other ingredients of RIVA-DUTASTERIDE.
What the medicinal ingredient is
Dutasteride
What the non-medicinal ingredients are
Nonmedicinal ingredients in your medicine include gelatin
(from certified, BSE-free, non-porcine sources), glycerin,
iron oxide yellow, lecithin, medium chain triglycerides,
purified water, titanium dioxide. The capsules are printed
with edible black ink containing iron oxide black as the
colourant, isopropyl alcohol, N-butyl alcohol, propylene
glycol, shellac.
Each capsule for oral administration contains 0.5 mg of
dutasteride dissolved in a mixture of butylated
hydroxytoluene and mono-and di-glycerides of
caprilic/capric acids.
What dosage form it comes in
Soft gelatin capsules. Each capsule contains 0.5 mg of dutasteride.
Warnings and precautions
Serious Warnings and Precaution
- RIVA-DUTASTERIDE is for use by men only
- Women who are pregnant, or who may become pregnant. Should not handle RIVA-DUTASTERIDE as it may pass through the skin. RIVA-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 RIVA-DUTASTERIDE
and an alpha-blocker, tamsulosin, in
clinical studies than in patients taking RIVA-DUTASTERIDE
. It is not known if taking RIVA-DUTASTERIDE
and an alpha-blocker caused heart failure.
BEFORE you use RIVA-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 RIVA-DUTASTERIDE?
- Do not donate blood while taking MED DUTASTERIDE and for at least 6 months after you have stopped taking RIVA-DUTASTERIDE in order to prevent giving RIVA-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 dutasteride had a serious form of prostate cancer more often than men who did not take dutasteride.
You must see your doctor regularly. While taking RIVA-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 RIVA-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 RIVA-DUTASTERIDE.
RIVA-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 RIVA-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 RIVA-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 RIVA-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
RIVA-DUTASTERIDE. This drink is known to increase the
blood levels of some drugs in the body.
Proper use of this medication
Always take RIVA-DUTASTERIDE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose
Monotherapy: One RIVA-DUTASTERIDE 0.5 mg capsule
once a day.
Combination therapy: One RIVA-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 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 RIVA-DUTASTERIDE
with tamsulosin.
Rare side effects (may affect up to 1 in 1,000 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 and depressed mood and pain and swelling in the
testicles have been reported.
Breast cancer has been reported in patients taking dutasteride
however, the relationship between long-term use of
dutasteride and breast cancer is not known.
*In a small number of people some of these events may
continue after you stop taking dutasteride.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Very Raree | |||
| Allergic Reactions: | |||
| Sudden wheeziness or chest tightness | ✔ | ||
| Swelling of eyelids, face or lips | ✔ | ||
| Lumpy skin rash or “hives” anywhere on the body | ✔ | ||
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 RIVA-DUTASTERIDE, contact your doctor or pharmacist.
How to store
- Store RIVA-DUTASTERIDE capsules 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 side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
Laboratoire Riva Inc. at: 1-800-363-7988
This leaflet was prepared by Laboratoire Riva Inc.
Date of Revision: July 30, 2014.