Patient Medication Information: uses, side effects, how to take - Auro-Alfuzosin
ABOUT THIS MEDICATION
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 important nonmedicinal ingredients are:
Hypromellose, Hydrogenated Vegetable oil, Povidone, Calcium Hydrogen Phosphate Anhydrous, Carbomer, Silica Colloidal Anhydrous, Magnesium Stearate, Propylene Glycol and Titanium Dioxide.
What dosage forms 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.
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.
| 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. |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||||
| Only if severe | In all cases | |||||||
| 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 IT
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 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
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 AURO-ALFUZOSIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Revision: April 5, 2019.