Consumer Information for: TEVA-LISINOPRIL/HCTZ (TYPE P)

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

TEVA-LISINOPRIL/HCTZ (TYPE P) lowers high blood pressure.

What it does

TEVA-LISINOPRIL/HCTZ (TYPE P) 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 TEVA-LISINOPRIL/HCTZ (TYPE P) regularly, even if you feel fine.

When it should not be used

Do not take TEVA-LISINOPRIL/HCTZ (TYPE P) 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 in 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 TEVA-LISINOPRIL/HCTZ (TYPE P) during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. TEVA-LISINOPRIL/HCTZ (TYPE P) 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 ingredient is

Lisinopril and hydrochlorothiazide

What the non-medicinal ingredients are

Corn starch, dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized corn starch, FD & C Blue #2 Aluminum Lake (10/12.5 mg tablet), yellow iron oxide (20/12.5 mg and 20/25 mg tablet) and red iron oxide (20/25 mg tablet).

What dosage form it comes in

Tablets; 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg

Warnings and precautions

Serious Warnings and Precautions – Pregnancy

TEVA-LISINOPRIL/HCTZ (TYPE P) should not be used during pregnancy. If you discover that you are pregnant while taking TEVA-LISINOPRIL/HCTZ (TYPE P), stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use TEVA-LISINOPRIL/HCTZ (TYPE P) 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 TEVA-LISINOPRIL/HCTZ (TYPE P) 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 TEVA-LISINOPRIL/HCTZ (TYPE P) 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 TEVA-LISINOPRIL/HCTZ (TYPE P).

You may become sensitive to the sun while taking TEVALISINOPRIL/HCTZ (TYPE P). 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 TEVA-LISINOPRIL/HCTZ (TYPE P).

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to TEVA-LISINOPRIL/HCTZ (TYPE P). Dizziness, light-headedness, 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 TEVALISINOPRIL/HCTZ (TYPE P):

  • 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.
  • Nonseteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen and celecoxib.
  • Blood pressure lowering drugs, including diuretics (‘water pill’), aliskiren-containing products (e.g. Rasilez), or angiotensin receptor blockers (ARBs). When taken in combination with TEVALISINOPRIL/HCTZ (TYPE P), they may cause excessively low blood pressure.
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.

Proper use of this medication

Take TEVA-LISINOPRIL/HCTZ (TYPE P) exactly as prescribed. It is recommended that you take your dose at about the same time everyday.

TEVA-LISINOPRIL/HCTZ (TYPE P) can be taken with or without food. If TEVA-LISINOPRIL/HCTZ (TYPE P) 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 TEVALISINOPRIL/HCTZ (TYPE P) contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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, light-headedness, 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.

TEVA-LISINOPRIL/HCTZ (TYPE P) 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 only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and see immediate medical help
Common
Low blood pressure: dizziness, fainting, lightheadedness 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, hand or feet, sudden difficulty swallowing or breathing.     ✔
Kidney disorder: decreased urination, nausea, vomiting, swelling of extremities, fatigue   ✔  
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   ✔  
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     ✔
Unknown
Eye Disorders: Myopia: sudden near sightedness or blurred vision
Glaucoma: increased pressure in your eyes, eye pain		     ✔
Anemia: fatigue, loss of energy, weakness, shortness of breath   ✔  
Inflammation 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 TEVALISINOPRIL/HCTZ (TYPE P), contact your doctor, nurse or pharmacist.

How to store

Store between 15°C - 30°C. Protect from light and moisture.

Keep out of reach and sight of children.

Reporting 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 three 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 ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 found by contacting Teva Canada Limited, at:

1-800-268-4127 ext. 1255005 (English)
1-877-777-9117 (French)
or druginfo@tevacanada.comdruginfo@tevacanada.com

This leaflet was prepared by Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9

Last revised: January 21, 2014

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