Details for: ALFUZOSIN
Company: SIVEM PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02447576 | ALFUZOSIN | ALFUZOSIN HYDROCHLORIDE | 10 MG | TABLET (EXTENDED-RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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
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
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
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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Headache | ✔ | ||
| Dizziness | ✔ | ||
| 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 ALFUZOSIN, contact your doctor or pharmacist.
How to store
Store at room temperature (15°C to 30°C).
Keep 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 (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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
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
This leaflet was prepared by:
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
Date of Revision: June 5, 2019