Urozide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Adults:

• Decreases swelling caused by fluid retention (edema) due

  to heart failure, liver disease, kidney disease, or from the corticosteroid or estrogen therapy.

• Lowers high blood pressure.

• Lowers pregnancy-induced high blood pressure.

What it does:

UROZIDE is a diuretic often called “water pill”. It increases urination. This lowers blood pressure and decreases swelling.

This medicine does not cure high blood pressure or edema. It helps to control them. Therefore, it is important to continue taking UROZIDE regularly even if you feel fine.

When it should not be used:

Do not take UROZIDE if you:

• Are allergic to hydrochlorothiazide or to any non-medicinal ingredient in the formulation.
• Are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
• Have difficulty urinating or produce no urine.
• Are breastfeeding. UROZIDE passes into breast milk.

What the medicinal ingredient is:

Hydrochlorothiazide

What the non-medicinal ingredients are:

Alginic acid, colloidal silicon dioxide, FDC yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, and sodium carboxymethylcellulose.

What dosage forms it comes in:

Tablets: 25 mg, 50 mg, 100 mg

WARNINGS AND PRECAUTIONS

BEFORE you use UROZIDE talk to your doctor, nurse, or pharmacist if you:

• Are allergic to penicillin.
• Have diabetes, liver or kidney disease.
• Have lupus or gout.
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.

Hydrochlorothiazide in UROZIDE can cause Sudden Eye Disorders:

• Myopia: sudden nearsightedness or blurred vision.
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss. These eye disorders are related and can develop within hours to weeks of starting UROZIDE.

You may become sensitive to the sun while taking UROZIDE. Exposure to sunlight should be minimized until you know how you respond.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to UROZIDE. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with UROZIDE:

• Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
• Amphotericin B, an antifungal drug.
• Anticancer drugs, including cyclophosphamide and methotrexate.
• Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
• Antidiabetic drugs, including insulin and oral medicines.
• Bile acid resins used to lower cholesterol.
• Calcium or vitamin D supplements.
• Corticosteroids used to treat joint pain and swelling.
• Digoxin, a heart medication.
• Drugs that slow down or speed up your bowels, including atropine, metoclopramide, and domperidone.
• Drugs used to treat epilepsy, including carbamazepine and topiramate.
• Gout medications, including allopurinol and probenecid.
• Lithium used to treat bipolar disease.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce

pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.

• Other blood pressure lowering drugs. When taken in combination with hydrochlorothiazide, they may cause excessively low blood pressure.
• Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.

PROPER USE OF THIS MEDICATION

Take UROZIDE exactly as prescribed. It is recommended to take your dose at about the same time every day.

UROZIDE can be taken with or without food. If UROZIDE causes upset stomach, take it with food or milk.

In your diet, be sure to include foods that contain potassium such as tomatoes, bananas, and beans.

Usual Adult dose:

• For the treatment of high blood pressure: 50 to 100 mg

  once a day or in divided doses as directed by your doctor. Your doctor may increase or decrease your dose.

• For the treatment of pregnancy-induced high blood

  pressure: The usual dose is a 100 mg. The doctor may briefly increase dosage to 200 mg.

  Doses may be prescribed:

  • once a day, or
  • every 4 days.

• For the treatment of fluid retention (edema) caused by

  premenstrual tension:: 25 to 50 mg once or twice a day.

Usual Infant and Child dose:

• Infants up to 24 months: 12.5 to 37.5 mg twice a day.

• Children 2 to 12 years old: 37.5 to 100 mg twice a day.

Overdose:

If you think you have taken too much UROZIDE contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

Missed Dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• muscle cramps, spasms, and pain, weakness, restlessness
• dizziness, pins and needles in your fingers, headache

• constipation, diarrhea, nausea, vomiting, decreased

  appetite, upset stomach, enlargement of the glands in your mouth

  • reduced libido
  • bleeding under the skin, rash, red patches on the skin

If any of these affects you severely, tell your doctor, nurse or pharmacist.

UROZIDE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking UROZIDE, contact your doctor, nurse, or pharmacist.

HOW TO STORE IT

Keep out of reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

-------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. 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:

Valeant Canada LP

4787 Levy St.

Montreal, QC,

H4R 2P9

1-800-361-4261

Last revised: January 16, 2013