Apo-Terazosin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-TERAZOSIN is used to treat:

• Hypertension (high blood pressure)

• Benign prostatic hyperplasia (enlargement of

  the prostate gland)

APO-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. APO-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 APO-TERAZOSIN.

What it does:

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

APO-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:

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

What the medicinal ingredient is:

terazosin hydrochloride

What the non-medicinal ingredients are:

APO-TERAZOSIN tablets also contain lactose, magnesium stearate, microcrystalline cellulose and starch. The following colouring agents are also used in the manufacture of one or more strengths of APO-TERAZOSIN tablets: D&C yellow #10 Aluminum Lake (2 mg), FD&C yellow #6 Aluminum Lake (2 mg), red ferric oxide (5 mg), ferric-ferrous oxide (5 mg), FD&C blue #1 Aluminum Lake (10 mg), and FD&C blue #2 Aluminum Lake (10 mg).

What dosage forms it comes in:

APO-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

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

BEFORE you use APO-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 APO-TERAZOSIN therapy, after your APO-TERAZOSIN dose has been increased, or after interruption of therapy when treatment with T APO-TERAZOSIN is resumed you should not drive, operate heavy machinery, or do any hazardous task, until you are used to the effects of APO-TERAZOSIN. In these cases, for 12 hours after taking APO-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 APO-TERAZOSIN due to the risks of developing serious hypotension (low blood pressure).

Administration of APO-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 APO-TERAZOSIN without your doctor’s advice.

PROPER USE OF THIS MEDICATION

Usual dose:

Follow your doctor’s instructions very carefully about how to take APO-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 APO-TERAZOSIN, you should have regular check-ups to evaluate your progress regarding your BPH and to monitor your blood pressure.

Overdose:

If you think you have taken too much APO-TERAZOSIN, contact your healthcare professional, 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 overdoses seriously.

Missed Dose:

If you forget 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 APO-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.

APO-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 APO-TERAZOSIN at bedtime. If you take APO-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 APO-TERAZOSIN.

Other side effects with APO-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.

IMPORTANT: PLEASE READ

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

HOW TO STORE IT

Keep APO-TERAZOSIN and all other medicines out

of reach and sight of children. APO-TERAZOSIN tablets should be stored at 15°C to 30°C.

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

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about APO-TERAZOSIN:

• Talk to your healthcare professional

• Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website

  (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Apotex Inc.

Toronto, Ontario

M9L 1T9.

Last revised: September 16, 2021