Patient Medication Information: uses, side effects, how to take - Teva-Alfuzosin Pr
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed TEVA-ALFUZOSIN PR 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:
TEVA-ALFUZOSIN PR 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, TEVA-ALFUZOSIN PR 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 TEVA-ALFUZOSIN PR (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®).
Sporanox® is manufactured by Janssen-Ortho Inc. Kaletra® and Norvir® are manufactured by Abbott Laboratories Ltd.
What the medicinal ingredient is:
Alfuzosin hydrochloride
What the important nonmedicinal ingredients are:
ethylcellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, povidone and silicon dioxide.
What dosage forms it comes in:
Prolonged-release tablets. Each tablet contains 10 mg alfuzosin hydrochloride.
WARNINGS AND PRECAUTIONS
TEVA-ALFUZOSIN PR is not indicated as a treatment to lower blood pressure.
TEVA-ALFUZOSIN PR is not indicated nor recommended for use in women and children.
Prostate cancer and BPH cause many of the same symptoms. Prior to starting TEVA-ALFUZOSIN PR, 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. 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 TEVA-ALFUZOSIN PR.
INTERACTIONS WITH THIS MEDICATION
TEVA-ALFUZOSIN PR 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 TEVA-ALFUZOSIN PR 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 (ViagraTM, RevatioTM)
Sporanox® is manufactured by Janssen-Ortho Inc.
Kaletra® and Norvir® are manufactured by Abbott Laboratories Ltd. ViagraTM and RevatioTM are manufactured by Pfizer Canada Inc.
PROPER USE OF THIS MEDICATION
Usual dose:
Follow your doctor’s instructions very carefully about how to take TEVA-ALFUZOSIN PR.
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 TEVA-ALFUZOSIN PR 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 TEVA-ALFUZOSIN PR, immediately see your doctor or go to your nearest hospital emergency department or regional 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, TEVA-ALFUZOSIN PR may cause side effects. Most side effects are mild.
Side effects due to TEVA-ALFUZOSIN PR may include dizziness and headache. In some cases, side effects may decrease or disappear while the patient continues to take TEVA-ALFUZOSIN PR.
You may experience dizziness or fainting caused by a decrease in blood pressure after taking TEVA-ALFUZOSIN PR. 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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Headache Dizziness | √ √ | ||
| Uncommon | Fainting Liver disease Priapism/erection lasting longer than 4 hours | √ √ | √ | |
This is not a complete list of side effects. For any unexpected effects while taking TEVA-ALFUZOSIN PR, contact your doctor or pharmacist.
HOW TO STORE IT
| TEVA-ALFUZOSIN PR tablets should be stored at room | |||
| temperature (15-30ºC). Protect from light. | |||
| Keep TEVA-ALFUZOSIN PR out of reach of children. | |||
REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada through the Canad Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance: By toll-free telephone: 866-234-2345 By toll-free fax 866-678-6789 Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca By regular mail: Canada Vigilance National Office Marketed Health Products Safety and Effectiveness Information Bureau Marketed Health Products Directorate Health Products and Food Branch Health Canada Tunney’s Pasture, AL 0701D Ottawa ON K1A 0K9 NOTE: Should you require information related to the management of the side effects, please contact your heal care provider before notifying Canada Vigilance. The Canada Vigilance program does not provide medical adv | a | ||
| th | |||
| ice. | |||
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 5005 (English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9