Details for: APO-ALFUZOSIN
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02315866 | APO-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 APO-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
APO-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, APO-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 APOALFUZOSIN (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 (Kaletra® ; Norvir® ) or itraconazole (Sporanox® ).
What the medicinal ingredient is
alfuzosin
What the non-medicinal ingredients are
dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, magnesium stearate, polyvinyl acetate phthalate and yellow ferric oxide
What dosage form it comes in
Prolonged-release tablets. Each tablet contains 10 mg alfuzosin hydrochloride.
Warnings and precautions
APO-ALFUZOSIN is not indicated as a treatment to lower blood pressure.
APO-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 APO-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 APOALFUZOSIN.
Interactions with this medication
APO-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 APO-ALFUZOSIN include:
- Alpha1-blockers for high blood pressure or prostate problems
- Anti-infection drugs: ketoconazole, itraconazole (Sporanox®) and ritonavir (Kaletra®; Norvir®)
- Drugs for high blood pressure
- Drugs for heart problems (nitrates)
- Sildenafil (Viagra®, Revatio®)
Sporanox® is manufactured by Janssen-Ortho Inc. Kaletra® and Norvir® are manufactured by Abbott Laboratories Ltd.
Viagra™ and Revatio™ are manufactured by Pfizer Canada Inc
Proper use of this medication
Usual Dose
Follow your doctor’s instructions very carefully about how to take APO-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 APO-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 APO-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.
Missed Dose
Side effects and what to do about them
Like all prescription drugs, APO-ALFUZOSIN may cause side effects. Most side effects are mild. Side effects due to APO-ALFUZOSIN may include dizziness and headache. In some cases, side effects may decrease or disappear while the patient continues to take APO-ALFUZOSIN.
You may experience dizziness or fainting caused by a decrease in blood pressure after taking APOALFUZOSIN. 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, generalized itching or abdominal pain.
Cases of priapism (painful erection greater than 6 hours) have been rarely reported with the use of APO-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 APO-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 | ✔ | ||
| Vomiting | ✔ | ||
| Uncommon | |||
| Fainting | ✔ | ||
| Liver disease | ✔ | ||
| Priapism/erection lasting longer than 4 hours | ✔ | ||
| Irregular heart beat | ✔ | ||
| Low Blood Pressure: dizziness, fainting, lightheaderness | ✔ | ||
| 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 APO-ALFUZOSIN, contact your doctor or pharmacist.
How to store
APO-ALFUZOSIN tablets should be stored at room temperature (15°C to 30°C).
Keep APO-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/healthcanada/services/drugs-healthproducts/medeffect-canada/adverse-reactionreporting.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
If you want more information about APOALFUZOSIN:
- 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/dpdbdpp/index-eng.jsp). Find the Patient Medication Information the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: April 12, 2019