Consumer Information for: TEVA-TERAZOSIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

TEVA-TERAZOSIN is used to treat:

  • Hypertension (high blood pressure)
  • Benign prostatic hyperplasia (enlargement of the prostate gland)

TEVA-TERAZOSIN is for symptomatic benign prostatic hyperplasia (BPH) and not for prostate cancer. It is possible for men to have both BPH and prostate cancer at the same time. TEVA-TERAZOSIN is not a treatment for prostate cancer.

Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). These checks, including Prostate Specific Antigen (PSA), should continue while you are taking TEVA-TERAZOSIN.

What it does

TEVA-TERAZOSIN works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

TEVA-TERAZOSIN also blocks smooth muscle receptors of the bladder neck and the prostate called alpha-1 adrenoceptors. This blockade causes the smooth muscles of the bladder neck and prostate to relax and decreases muscle tone. This can lead to a rapid improvement in urine flow and symptoms within a 2 week period.

When it should not be used

TEVA-TERAZOSIN should not be used if you are allergic to any component of TEVA-TERAZOSIN, including active ingredient and non-active ingredients.

What the medicinal ingredient is

terazosin hydrochloride

What the non-medicinal ingredients are

TEVA-TERAZOSIN (terazosin hydrochloride) Tablets:
1 mg - corn starch, lactose monohydrate, magnesium stearate, povidone, talc.

2 mg - corn starch, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, povidone, talc.

5 mg - corn starch, D&C red #30 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, povidone, talc.

10 mg - corn starch, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum, lake, lactose monohydrate, magnesium stearate, povidone, talc.

What dosage form it comes in

TEVA-TERAZOSIN is available as a tablet in the following strengths:
1 mg, 2 mg, 5 mg and 10 mg.

Warnings and precautions

Serious Warnings and Precautions

  • TEVA-TERAZOSIN should not be used if you have been diagnosed with micturition syncope (fainting shortly after or during urination).

BEFORE you use TEVA-TERAZOSIN talk to your doctor or pharmacist if:

  • you have low blood pressure;
  • you are using sildenafil (e.g., Viagra®), tardenafil (e.g., Cialis®) or vardenafil (Levitra®);
  • you have liver problems;
  • you have kidney problems;
  • you have had or will have prostate surgery;
  • you have pancreatic cancer;
  • you are pregnant or nursing.

During initiation of TEVA-TERAZOSIN therapy, after your TEVA-TERAZOSIN dose has been increased, or after interruption of therapy when treatment with TEVA-TERAZOSIN is resumed you should not drive, operate heavy machinery, or do any hazardous task, until you are used to the effects of TEVA-TERAZOSIN . In these cases, for 12 hours after taking TEVA-TERAZOSIN , you should avoid situations where injury could result should fainting occur. If you begin to feel dizzy, sit or lie down until you feel better.

Interactions with this medication

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including natural health products, prescription and non-prescription medicines.

In general, you should avoid the use of phosphodiesterase (PDE5) inhibitors such as sildenafil (e.g., Viagra®), tardenafil (e.g., Cialis®) or vardenafil (Levitra®) when taking TEVA-TERAZOSIN due to the risks of developing serious hypotension (low blood pressure).

Administration of TEVA-TERAZOSIN with verapamil (e.g., Isoptin®, Tarka® or Chronovera®) to hypertensive patients may result in low blood pressure and/or a rapid heart beat.

Do not take these drugs with TEVA-TERAZOSIN without your doctor’s advice.

Chronovera®, Cialis®, Levitra® and Viagra® are trademarks of their respective owners.
Proper use of this medication

Usual Dose

Follow your doctor’s instructions very carefully about how to take TEVA-TERAZOSIN . The starting dose is 1 mg at bedtime. The 1 mg dose should be maintained during the first week of treatment, and should be taken every day as prescribed by your doctor. Your doctor will then gradually increase the strength of your prescription to 2 mg, 5 mg, or 10 mg depending on how well you respond. The maximum recommended daily dose is 20 mg per day.

You should see an effect on your symptoms in 2 to 4 weeks. While taking TEVA-TERAZOSIN , you should have regular check-ups to evaluate your progress regarding your BPH and to monitor your blood pressure.

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.

If you or someone you know accidentally takes more than the stated dose, tell your doctor or hospital how much was taken and show them the tablets. Treat even small overdose seriously.

Missed Dose

If you forgot to take a dose, take another as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all.

Never double-up on a missed dose

. Talk to your doctor if you have not taken TEVA-TERAZOSIN for a few days. You may have to restart at the 1 mg dose. Be cautious about possible dizziness.

Side effects and what to do about them

Along with its needed effects, a medicine may cause some unwanted effects. These are referred to as “side effects”. Although not all of these side effects may occur, if they do occur they may need medical attention.

TEVA-TERAZOSIN can cause a sudden drop in blood pressure after the very first dose. You may feel dizzy, faint, or "light-headed", particularly after you get up from bed or from a chair. This is more likely to occur after you have taken the first dose, but can occur at any time while you are taking the drug. It can also occur if you stop taking the drug and then restart treatment.

Because of this effect, your doctor may have told you to take TEVA-TERAZOSIN at bedtime. If you take TEVA-TERAZOSIN at bedtime but need to get up from bed to go to the bathroom, get up slowly and cautiously until you are sure how the medicine affects you. It is also important to get up slowly from a chair or bed at any time until you learn how you react to TEVA-TERAZOSIN .

Other side effects with TEVA-TERAZOSIN include back pain, constipation, diarrhea, drowsiness or sleepiness, dry mouth, flatulence, headache, impotence, indigestion, libido decreased, nasal congestion, nausea, urinary frequency, urinary incontinence primarily reported in postmenopausal women, weakness or weight gain.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and seek immediate emergency medical attention
Abnormal, irregular or rapid heartbeat (palpitation)     ✔
Allergic reaction Swollen mouth, lips,tongue, eyes, extremities, throat or difficulty swallowing or breathing (signs of angioedema). Intestinal angioedema may also occur and is characterized by abdominal pain (with or without nausea or vomiting). If you notice swelling or feel pain in these areas, inform your doctor immediately. You should also inform your doctor if you have unexplained fever, rash or itching.     ✔
Anxiety     ✔
Blurred or hazy vision     ✔
Chest pain     ✔
Decreased blood pressure or low blood pressure     ✔
Depression ✔    
Difficulty breathing or shortness of breath     ✔
Drowsiness or sleepiness     ✔
Fainting     ✔
Joint inflammation or joint pain ✔    
Permanent erection     ✔
“Puffiness” of the feet or hands, swelling ✔    
Rash     ✔
Sweating     ✔
Unknown bruising or increased bleeding after a cut     ✔
Urinary tract infection ✔    
Vomiting     ✔
Weakness     ✔

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

How to store

Keep TEVA-TERAZOSIN and all other medicines out of reach of children.

Store between 15 - 30°C and protect from light and high humidity.

Do not take your tablets after the expiry date shown on the label. It is important to keep the TEVA-TERAZOSIN in the original package.

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 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 at:
1-800-268-4127 ext. 1255005 (English)
1-877-777-9117 (French)
or druginfo@tevacanada.com

This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
Canada M1B 2K9

Last revised: December 19, 2014

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