Alfuzosin (Sivem Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed 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:

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, 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 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

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

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 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 ALFUZOSIN.

INTERACTIONS WITH THIS MEDICATION

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 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 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 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 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, ALFUZOSIN may cause side effects. Most side effects are mild.

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

You may experience dizziness or fainting caused by a decrease in blood pressure after taking 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.

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

HOW TO STORE IT

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

Keep ALFUZOSIN out of reach and sight of children.

Reporting Side Effects

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sivem Pharmaceuticals ULC at, 1-855-788-3153

Or at www.sivem.ca

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent, Quebec

H4R 2P7

Date of Revision: June 5, 2019