Details for: ACT DUTASTERIDE
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02412691 | ACT 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
ACT DUTASTERIDE is used alone (monotherapy) in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.
ACT 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.
ACT 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). ACT DUTASTERIDE belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors. ACT 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.
ACT 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 ACT DUTASTERIDE, however, it may take up to 6 months to know if treatment with ACT DUTASTERIDE will be beneficial
When it should not be used
- Women and children should never take ACT DUTASTERIDE.
- Do not take ACT DUTASTERIDE if you are allergic to dutasteride or other alpha-reductase inhibitors or any of the other ingredients of ACT DUTASTERIDE.
What the medicinal ingredient is
dutasteride
What the non-medicinal ingredients are
Nonmedicinal ingredients in your medicine include butylated hydroxytoluene, gelatin, glycerine, iron oxide yellow, mono- and di-glycerides of caprilic/capric acids, purified water, and titanium dioxide.The capsules are printed with edible black ink containing: ammonium hydroxide 28% iron oxide black, isopropyl alcohol, nbutyl alcohol, propylene glycol and shellac. Soy Lecithin and medium chain triglycerides may be present in trace amounts.
What dosage form it comes in
Soft gelatine capsules. Each capsule contains 0.5 mg of dutasteride.
Warnings and precautions
Serious Warnings and Precautions
Heart failure (the heart does not pump blood as well as it should) was reported more often in patients taking ACT DUTASTERIDE and an alpha-blocker, tamsulosin, in clinical studies than in patients taking ACT DUTASTERIDE. It is not known if taking ACT DUTASTERIDE and an alpha-blocker caused heart failure.
BEFORE you use ACT 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 ACT DUTASTERIDE?
- Do not donate blood while taking ACT DUTASTERIDE and for at least 6 months after you have stopped taking ACT DUTASTERIDE in order to prevent giving ACT 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 ACT 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 ACT 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 ACT DUTASTERIDE. ACT 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 ACT 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 ACT 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 ACT 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 ACT DUTASTERIDE. This drink is known to increase the blood levels of some drugs in the body.
Proper use of this medication
Always take ACT DUTASTERIDE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual Dose
Monotherapy: One ACT DUTASTERIDE 0.5 mg capsule once a day.
Combination therapy: One ACT 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
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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 ACT 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 ACT 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, 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 ACT DUTASTERIDE.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Rare | |||
| 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 ACT DUTASTERIDE, contact your doctor
or pharmacist.
How to store
- Store ACT DUTASTERIDE capsules between 15ºC and 30ºC.
- 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, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 by contacting the sponsor, Teva Canada Limited by;
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada,
M1B 2K9
Last revised: January 03, 2018