Phenazo: Uses, Side Effects and Dosage

What the medication is used for:

Your health care provider has prescribed PHENAZO for you for one or more of the following medical conditions:

• Pain, burning, urgency, frequency, and other discomforts resulting from lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.

PHENAZO is indicated for short-term use and can only relieve symptoms; it is not a treatment for the underlying cause of the symptoms.

What it does:

PHENAZO is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is unknown.

When it should not be used:

DO NOT TAKE PHENAZO if you have any of the following medical conditions:

• hypersensitive to the drug or its ingredients
• kidney disorders
• severe liver disease

PHENAZO should NOT be used in patients under 16 years of age since the safety and effectiveness have NOT been established.

What the medicinal ingredient is:

Phenazopyridine Hydrochloride 100mg and 200 mg

What the important nonmedicinal ingredient are:

FD&C Blue No. 1 Aluminum Lake (200mg), FD&C Red No. 40 Aluminum Lake (200mg), FD&C Yellow No. 6 Aluminum Lake (200mg), Hydroxypropyl Methylcellulose (200mg), Lactose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil (200mg), Polyethylene Glycol (200mg), Povidone (200mg), Shellac Glaze (100mg), Sodium Lauryl Sulphate (200mg), Sodium Starch Glycolate, Stearic Acid (200mg), Talc, Titanium Dioxide (200mg).

What dosage forms it comes in:

Each Tablet contains 100 mg or 200mg of Phenazopyridine Hydrochloride

If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than PHENAZO:

• hypersensitive to the drug or its ingredients
• kidney problems
• severe liver disease

Phenazopyridine produces an orange to red colour in the urine and feces and may cause staining. Staining of contact lenses has also been reported. If your skin or the whites of your eyes develop a yellowish tone, it may indicate that your kidneys are not eliminating the medication as they should. Notify your doctor immediately. If you are older, your doctor will watch you more closely, since the kidneys work less effectively as we age.

Before taking this medication, tell your health care provider if you have any of the following:

• G-6-PD deficiency
• renal insufficiency
• severe liver disease
• Any other medical problem

Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):

• Ciprofloxacin

No other interactions have been reported

Usual Dose

ABOUT THIS MEDICATION

WARNING AND PRECAUTIONS

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

Take PHENAZO only as directed by your health care provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much PHENAZO may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases.

If you will be using PHENAZO for more than 2 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours. PHENAZO is NOT recommended for use in patients under 16 years of age since safety and effectiveness have NOT been established.

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the pack or bottle, ask your doctor or pharmacist for help.

Take PHENAZO exactly as your doctor has prescribed.

PHENAZO must be taken after meals.

Missed Dose

If a dose is missed, you should take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Overdose

If you take more than the prescribed dose, contact your health care provider immediately.

PHENAZO may cause some side effects, especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.

PHENAZO may turn your skin or the whites of your eyes to a yellowish tone. If you have such symptoms check with your health care provider.

Check with your health care provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.

This is NOT a complete list of side effects. If you develop any other symptoms while taking PHENAZO, see your health care provider. These side effects are rare.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom

STOP taking PHENAZO and talk to your physician or pharmacist

STOP taking PHENAZO and get emergency medical attention IMMEDIATELY

Headaches, stiff neck

Shortness of breath, wheezing, any trouble breathing or chest tightness

Skin rash, hives, swelling or itching

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.

Keep the tablets in a dry place at normal room temperature (15- 30°C) in the packaging that they come in.

Keep out of reach of children.

This document plus the full product monograph prepared for health professionals can be obtained by contacting the sponsor, Bausch Health, Canada Inc. at 1-800-361-4261.

Bausch Health, Canada Inc.

2150 St-Elzear Blvd. West

Laval, Quebec

H7L 4A8

www.bauschhealth.ca

Last revised: November 20, 2020

Blurred vision, or any visual disturbance
nausea, vomiting and diarrhea.
Yellow discoloration of the skin or whites of the eyes with or without itchy skin

MORE INFORMATION

HOW TO STORE IT

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 (http://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.