Patient Medication Information: uses, side effects, how to take - Prinzide (Merck Canada, 20 mg / 12.5 mg, 10 mg / 12.5 mg)
ABOUT THIS MEDICATION
What the medication is used for:
PRINZIDE® lowers high blood pressure.
What it does:
PRINZIDE®contains a combination of 2 drugs, lisinopril and hydrochlorothiazide:
lisinopril is an angiotensin converting enzyme (ACE)
inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’. It lowers blood pressure.
Hydrochlorothiazide is a diuretic or “water pill” that
increases urination. This lowers blood pressure.
This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking PRINZIDE® regularly even if you feel fine.
When it should not be used:
Do not take PRINZIDE® if you:
Are allergic to lisinopril and 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 experienced an allergic reaction (angioedema) with
swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any ACE inhibitor or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
Have been diagnosed with hereditary angioedema: an
increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.
- Have difficulty urinating or produce no urine.
Are pregnant or intend to become pregnant. Taking
PRINZIDE® during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. PRINZIDE® passes into breast milk.
Are already taking a blood pressure-lowering medicine
that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
What the medicinal ingredients are:
lisinopril and hydrochlorothiazide
What the non-medicinal ingredients are:
calcium phosphate, corn starch, magnesium stearate, and mannitol.
PRINZIDE® 10 mg/12.5 mg tablets contain indigotine on aluminum substrate.
PRINZIDE® 20 mg/12.5 mg tablets contain iron oxide.
What dosage forms it comes in:
Tablets 10 mg/12.5 mg and 20 mg/12.5 mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions - Pregnancy PRINZIDE® should not be used during pregnancy. If you discover that you are pregnant while taking PRINZIDE®, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
BEFORE you use PRINZIDE® talk to your doctor, nurse, or pharmacist if you:
Are taking a medicine that contains aliskiren, such as
Rasilez, used to lower high blood pressure. The combination with PRINZIDE® is not recommended.
- Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”
- Are allergic to any drug used to lower blood pressure or penicillin.
- Have recently received or are planning to get allergy shots for bee or wasp stings.
- Have narrowing of an artery or a heart valve
- Have had a heart attack or stroke
- Have heart failure
- Have diabetes, liver or kidney disease.
- Have lupus or gout.
- Are on dialysis.
- Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).
- Are on a low-salt diet.
- Are receiving gold (sodium aurothiomalate) injections.
- Are less than 18 years old.
Hydrochlorothiazide in PRINZIDE® 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 PRINZIDE®.
You may become sensitive to the sun while taking PRINZIDE®. Exposure to sunlight should be minimized until you know how you respond.
If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking PRINZIDE®.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to PRINZIDE®. 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 PRINZIDE®:
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 bowel function,
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.
Blood pressure lowering drugs, including diuretics (“water
pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin receptor blockers (ARBs). When taken in combination with PRINZIDE®, they may cause excessively low blood pressure.
Skeletal muscle relaxants used to relieve muscle spasms,
including tubocurare.
PROPER USE OF THIS MEDICATION
Take PRINZIDE® exactly as prescribed. It is recommended to take your dose at about the same time everyday.
PRINZIDE® can be taken with or without food. If PRINZIDE® causes upset stomach, take it with food or milk. Usual Adult dose:
Patients should be individually titrated for each component.
Overdose:
If you think you have taken too much PRINZIDE® 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:
- sudden difficulty in breathing or swallowing
- swelling of the face, eyes, lips, tongue and/or throat, hands or feet
- increased risk of angioedema to ACE inhibitors for Black patients
- dizziness, lightheadedness, or fainting following exercise, and/or when it is hot and you have lost a lot of water by sweating
- drowsiness, fatigue, weakness
- dry cough, sore throat
- chest pain
- rash
- headache
- abdominal pain, upset stomach, decreased appetite, constipation
- flu-like symptoms such as fever, malaise muscle pain, rash, itching, abdominal pain, nausea,
- vomiting, diarrhea, jaundice, loss of appetite
- muscle pain
- impotence
- palpitations
- tingling of the skin
If any of these affects you severely, tell your doctor, nurse or pharmacist.
PRINZIDE® can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor, nurse, or pharmacist | Stop taking drug and seek immediat e medical help | ||
| Only if severe | In all cases | |||
| Common | Low Blood Pressure: dizziness, fainting, lightheadedn ess May occur when you go from lying or sitting to standing up. | √ | ||
Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | √ | |||
| Uncommon | Allergic Reaction: rash, hives, swelling of the face, lips, eyes, tongue or throat, hands or feet, sudden difficulty swallowing or breathing | √ | ||
Kidney Disorder: decreased urination, nausea, vomiting, swelling of extremities, fatigue | √ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Symptom / effect Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite Increased blood sugar: frequent urination, thirst, and hunger Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | Talk with your doctor, nurse, or pharmacist | Stop taking drug and seek immediat e medical help | ||
| Only if severe | In all cases | |||
| √ | ||||
| √ | ||||
| √ | ||||
| Rare | Decreased Platelets: bruising, bleeding, fatigue and weakness | √ | ||
Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | √ | |||
| Very rare | Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes | √ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor, nurse, or pharmacist | Stop taking drug and seek immediat e medical help | ||
| Only if severe | In all cases | |||
| Unknown | Eye disorders:
sudden near sightedness or blurred vision
increased pressure in your eyes, eye pain | √ | ||
| Anemia: fatigue, loss of energy, weakness, shortness of breath | √ | |||
Inflammatio n of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | √ | |||
This is not a complete list of side effects. For any unexpected effects while taking PRINZIDE®, contact your doctor, nurse, or pharmacist.
HOW TO STORE IT
Store your tablets at 15°C–30°C in a tightly closed container, away from heat and direct light, and out of damp places, such as the bathroom or kitchen.
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.
You can also report any suspected adverse reactions associated with the use of PRINZIDE® to Merck Canada Inc., by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-800-369-3090, or
Mail to: Merck Canada Inc.
Pharmacovigilance
P.O. Box 1005
Pointe-Claire–Dorval, QC H9R 4P8
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at http://www.merck.ca or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594
Last revised: June 13, 2013
® Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.
© 2011, 2013, Merck Canada Inc., a subsidiary of Merck & Co., Inc. All rights reserved.
