Consumer Information for: AURO-ALFUZOSIN

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

Your doctor has prescribed AURO-ALFUZOSIN because you have a medical condition called benign prostatic hyperplasia (BPH) or acute urinary retention (AUR) related to BPH. This occurs in men.

What it does

AURO-ALFUZOSIN relaxes muscles in the prostate, bladder neck and base. This results in improved urine flow, and reduced BPH symptoms.

When taken during catheterization for sudden acute urinary retention, AURO-ALFUZOSIN may help you pass urine after catheter removal. Urinary catheters are flexible tubes placed in the bladder to drain urine.

When it should not be used
  • If you have ever had an allergic reaction to alfuzosin hydrochloride or to any ingredient in AURO-ALFUZOSIN (see below “What the important nonmedicinal ingredients are:”).
  • If you have a moderate to severe decrease in liver function.
  • If you take other alpha1-blockers for high blood pressure or prostate problems.
  • If you take ketoconazole, ritonavir or itraconazole.

What the medicinal ingredient is

Alfuzosin hydrochloride

What the non-medicinal ingredients are

Hypromellose, Hydrogenated Vegetable oil, Povidone, Calcium Hydrogen Phosphate Anhydrous, Carbomer, Silica Colloidal Anhydrous, Magnesium Stearate, Propylene Glycol and Titanium Dioxide.

What dosage form it comes in

Each prolonged-release tablet contains 10 mg of Alfuzosin as Alfuzosin hydrochloride.

Warnings and precautions

AURO-ALFUZOSIN is not indicated as a treatment to lower blood pressure.

AURO-ALFUZOSIN is not indicated nor recommended for use in women and children.

Prostate cancer and BPH cause many of the same symptoms. Prior to starting AURO-ALFUZOSIN, your doctor will examine you to rule out the presence of prostate cancer.

You (in particular, if you are receiving drugs to lower blood pressure) may experience low blood pressure and feel dizzy at the start of treatment, especially when getting up from a lying or sitting position or if you are elderly. In such cases, lie down until the symptoms have completely disappeared.

Tell your doctor or pharmacist, before using the medication, if:

  • you suffer liver or kidneys problems
  • you suffer from heart problems
  • you have ever had a reaction to the ingredients of this medication
  • you have had low blood pressure or signs of low blood pressure [fainting, dizziness] after taking another medicine
  • you or any family members have a condition known as congenital prolongation of the QT interval
  • you have suffered from QT prolongation following the administration of any drug
  • you have a family history of sudden death at an age < 50 years
  • you have suffered from electrolytes disturbances
If you will have eye surgery, you must inform your eye surgeon that you are currently using AURO-ALFUZOSIN.
Interactions with this medication

AURO-ALFUZOSIN is metabolized by specific enzymes in the liver. It is not known how combined use of any drugs, herbal products metabolized by the same enzymes or grapefruit juice may influence the efficacy or unwanted side effects of these drugs or herbal medicines.

Before using any prescription, over-the-counter medicines or herbal products, check with your doctor or your pharmacist.

Drugs that interact with AURO-ALFUZOSIN include:

  • Alpha1-blockers for high blood pressure or prostate problems
  • Anti-infection drugs: ketoconazole, itraconazole and ritonavir
  • Drugs for high blood pressure
  • Drugs for heart problems (nitrates)
  • Sildenafil
Proper use of this medication

Usual Dose

Follow your doctor’s instructions very carefully about how to take AURO-ALFUZOSIN.

The recommended dosage is one tablet (10 mg) daily to be taken right after the same meal each day or from the first day of catheterization. The tablet should be swallowed whole.

DO NOT CHEW, CRUSH, POUND, GRIND OR CRUNCH THE TABLET AS HIGH BLOOD LEVELS OF AURO-ALFUZOSIN MAY OCCUR.

If you interrupt your treatment for several days or more, resume treatment after consulting with your doctor.

Overdose

If you have taken too much AURO-ALFUZOSIN, immediately see your doctor or go to your nearest hospital emergency department or contact poison control centre. Show the doctor your bottle of tablets. Do this even if there are no signs of discomfort or poisoning. Overdose of alfuzosin may lead to low blood pressure.

If you think you have taken too much AURO-ALFUZOSIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Side effects and what to do about them

Like all prescription drugs, AURO-ALFUZOSIN may cause side effects. Most side effects are mild.

Side effects due to AURO-ALFUZOSIN may include dizziness and headache. In some cases, side effects may decrease or disappear while the patient continues to take AURO-ALFUZOSIN.

You may experience dizziness or fainting caused by a decrease in blood pressure after taking AURO-ALFUZOSIN. However, these effects are usually transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. In such cases, lie down until the symptoms have completely disappeared. Although these symptoms are unlikely, do not drive, operate machinery or perform hazardous tasks for 12 hours after the initial dose.

Cases of liver disorder have been observed in patients taking alfuzosin hydrochloride. You should inform your doctor if you experience symptoms such as nausea, fatigue, jaundice (yellow colour to the skin and/or eyes), dark urine, light-coloured stools, generalised itching or abdominal pain.

Cases of priapism (painful erection greater than 6 hours) have been rarely reported with the use of alfuzosin hydrochloride. If you experience painful erection lasting more than 4 hours, you should contact your doctor immediately. If priapism is not immediately treated, penile tissue damage and erectile dysfunction could result.

Cases of atrial fibrillation (irregular heart beat) have been reported with the use of alfuzosin hydrochloride.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
Common
Headache ✔    
Dizziness ✔    
Vomiting ✔    
Uncommon
Fainting   ✔  
Liver disease   ✔  
Priapism / erection lasting longer than 4 hours     ✔
Irregular heart beat     ✔
Low Blood Pressure: dizziness, fainting, lightheadedness ✔    
Stroke: blurred vision, difficulty speaking, weakness on one side of your face or body.     ✔

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

How to store

Store at room temperature (15°C to 30°C).

Keep AURO-ALFUZOSIN out of reach and sight of children.

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 three 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

If you want more information about AURO-ALFUZOSIN:

This leaflet was prepared by

Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada

Date of Revision: April 5, 2019.

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