Details for: SANDOZ ALFUZOSIN
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02304678 | SANDOZ 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 Sandoz 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
Sandoz 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, Sandoz 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 Sandoz 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
colloidal hydrated silica, ethylcellulose, hydrogenated castor oil, hydroxypropyl methylcellulose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, yellow ferric oxide.
What dosage form it comes in
Prolonged-release tablets. Each tablet contains 10 mg alfuzosin hydrochloride.
Warnings and precautions
Sandoz Alfuzosin is not indicated as a treatment to lower
blood pressure.
Sandoz 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 Sandoz 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 Sandoz Alfuzosin.
Interactions with this medication
Sandoz 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 Sandoz 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 Sandoz 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 SANDOZ
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 Sandoz 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, Sandoz Alfuzosin may cause side
effects. Most side effects are mild.
Side effects due to Sandoz Alfuzosin may include dizziness and
headache. In some cases, side effects may decrease or disappear
while the patient continues to take Sandoz Alfuzosin.
You may experience dizziness or fainting caused by a decrease
in blood pressure after taking Sandoz 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
Sandoz Alfuzosin. 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 Sandoz Alfuzosin . 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 Sandoz Alfuzosin.
| 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 talk with your doctor or pharmacist |
|---|---|---|---|
| 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 Sandoz Alfuzosin, contact your doctor or pharmacist.
How to store
Sandoz Alfuzosin tablets should be stored at room
temperature (15-30°C).
Keep Sandoz Alfuzosin out of reach 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/healthcanada/services/drugs-health-products/medeffectcanada/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
This document, plus the full product monograph prepared for health professionals can be obtained by contacting the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
Or by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: April 3, 2019