Consumer Information for: TEVA-LISINOPRIL (TYPE Z) (2024)

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

Your doctor has prescribed you TEVA-LISINOPRIL (TYPE Z) for one of the following reasons:

  • Your blood pressure is too high (hypertension);

  • You have a heart condition known as heart failure, where the heart does not pump your blood around your body as well as it should;

  • You have had a heart attack (myocardial infarction) that may lead to a weakening of the heart. TEVA- LISINOPRIL (TYPE Z) slows the weakening down.
What it does

TEVA-LISINOPRIL (TYPE Z) is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.

This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking TEVA-LISINOPRIL (TYPE Z) regularly even if you feel fine.

TEVA-LISINOPRIL (TYPE Z) works by widening your blood vessels, which helps reduce your blood pressure and makes it easier for your heart to pump blood to all parts of your body.

When it should not be used

Do not take TEVA-LISINOPRIL (TYPE Z) if you:

  • Are allergic to lisinopril or to any non-medicinalingredient in the formulation.
  • Have experienced an allergic reaction (angioedema) withitching, hives, feeling dizzy, swelling of the hands, feet orankles, face, lips, tongue, throat, or sudden difficultybreathing or swallowing to any ACE inhibitor or withouta known cause. Be sure to tell your doctor, nurse orpharmacist that this has happened to you.
  • Have been diagnosed with hereditary angioedema: anincreased risk of getting an allergic reaction that is passeddown through families. This can be triggered by differentfactors, such as surgery, flu, or dental procedures.
  • Are taking Sacubitril/Valsartan, due to the increased riskof serious allergic reaction which causes swelling of theface or throat (angioedema) when taken with TEVA-LISINOPRIL(TYPE Z).
  • Are pregnant or intend to become pregnant. TakingTEVA-LISINOPRIL (TYPE Z) during pregnancy cancause injury or even death to your baby.
  • Are breastfeeding. TEVA-LISINOPRIL (TYPE Z)passes into breast milk.
  • Are already taking a blood pressure-lowering medicinecontaining aliskiren and you have one of the followingconditions:
    • diabetes with end organ damage
    • kidney disease
    • high potassium levels
    • heart failure combined with low blood pressure
  • Are taking an angiotensin receptor blocker (ARB),another medicine to treat your high blood pressure, oranother ACE inhibitor and have one of the followingconditions:
    • diabetes with end organ damage
    • kidney disease
    • high potassium levels
    • heart failure combined with low blood pressure
    • You can recognize ARBs because theirmedicinal ingredient ends in “-SARTAN”.
  • Are less than 6 years old.

  • Are 6 to 16 years old with severe kidney problems.
What the medicinal ingredient is

Lisinopril dihydrate

What the non-medicinal ingredients are

Colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, starch.

Each pale pink 5 mg tablet and 10 mg tablet also contains: FD&C
Blue #1 Lake, FD&C Red #3, FD&C Yellow #6.
Each deep pink 20 mg tablet also contains: FD&C Blue #1 Lake,
FD&C, Red #3, FD&C Yellow #6 Lake.

What dosage form it comes in

TEVA-LISINOPRIL (TYPE Z) tablets are supplied in 3 strengths: 5 mg, 10 mg and 20 mg.

Warnings and precautions

Serious Warnings and Precautions – Pregnancy

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

BEFORE you use TEVA-LISINOPRIL (TYPE Z) talk to your doctor, nurse or pharmacist if you:

  • Are allergic to any drug used to lower blood pressure.

  • Have recently received or are planning to get allergy shotsfor 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.

  • 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 (aspecific kind of “water pill”).

  • Are on a low-salt diet.

  • Are taking a medicine that contains aliskiren, used tolower high blood pressure. The combination with TEVA-LISINOPRIL(TYPE Z) is not recommended.

  • Are taking an angiotensin receptor blocker (ARB). Youcan recognize an ARB because its medicinal ingredientends in “-SARTAN”.

  • Are receiving gold (sodium aurothiomalate) injections.Are taking drugs such as:
    • Temsirolimus and everolimus (used to treatcancer),
    • Sirolimus (used to prevent organ rejection after atransplant),
    • A neutral endopeptidase inhibitor.
    • Taking ACE inhibitors, such as TEVA-LISINOPRIL(TYPE Z) with these types ofdrugs may increase your chances of having anallergic reaction (angioedema).

Your doctor may check your kidney function, blood pressure, andthe amount of electrolytes (e.g. potassium) in your blood at regularintervals.

You may become sensitive to the sun while taking TEVA-LISINOPRIL(TYPE Z). Exposure to sunlight should beminimized 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(TYPE Z).

Driving and using machines: Before you perform tasks whichmay require special attention, wait until you know how yourespond to TEVA-LISINOPRIL (TYPE Z). Dizziness,lightheadedness, or fainting can especially occur after the firstdose and when the dose is increased.

Interactions with this medication

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

The following may interact with TEVA-LISINOPRIL (TYPE Z):

  • Agents increasing serum potassium, such as a saltsubstitute that contains potassium, potassiumsupplements, or a potassium-sparing diuretic (a specifickind of “water pill”).

  • Allopurinol used to treat gout.

  • Drugs to treat diabetes such as:
    • Insulin,
    • Oral medications (such as sulphonylureas).

  • Your dose of these types of drugs may need to bechanged when taking them in combination with TEVALISINOPRIL(TYPE Z).

  • Temsirolimus and everolimus (drugs to treat cancer).

  • Gold for the treatment of rheumatoid arthirits.

  • Lithium used to treat bipolar disease.

  • Non-steroidal anti-inflammatory medicines (NSAIDs),used to reduce pain and swelling. Examples includeibuprofen, naproxen, and celecoxib.

  • Blood pressure-lowering drugs, including diuretics(“water pills”), aliskiren-containing products orangiotensin receptor blockers (ARBs).

  • Sirolimus, a drug used to prevent the organ rejectionafter a transplant.

  • Tissue plasminogen activator (tPA) that is used todissolve blood clots that have formed in blood vessels.
Proper use of this medication

Take TEVA-LISINOPRIL (TYPE Z) exactly as prescribed. It isrecommended to take your dose at about the same time every day.Swallow the tablet with a drink of water. It does not matter if youtake TEVA-LISINOPRIL (TYPE Z) before or after food.
Do not stop taking your tablets if you are feeling well, unless yourdoctor tells you.

Usual dose

Adults
High blood pressure:
the usual recommended starting dose is 10mg taken once daily.

Heart failure: the usual recommended starting dose is 2.5 mg takenonce a day. The usual long-term dose is 5 to 35 mg taken oncedaily.

Following a heart attack: the usual recommended starting dose is 5mg on day 1 and day 2, then 10 mg taken once a day.

Children (6 years of age or older)
Children weighing 20 to less than 50 kg:
the recommended startingdose is 2.5 mg. The maximum dose is 20 mg.

Children weighing 50 kg or more: the recommended starting doseis 5 mg. The maximum dose is 40 mg.

Overdose

If you think you have taken too much TEVA-LISINOPRIL(TYPE Z) contact your doctor, nurse, pharmacist, hospitalemergency department or regional Poison control Centreimmediately, even if there are no symptoms.

Missed Dose

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

Side effects and what to do about them

Side effects may include:

  • dizziness (or light-headedness), drowsiness, fatigue,headache, tiredness, weakness (loss of strength)
  • cough, running nose
  • itching, psoriasis, sinus pain, skin rash, wheezing
  • abdominal pain, diarrhea, nausea, stomach pain andindigestion, vomiting
  • confusion, feeling sleepy or difficulty in going to sleep,mood changes (including signs of depression), seen and/orheard hallucinations, strange dreams
  • changes in the way things smell or taste, dry mouth,numbness or tingling in the fingers or toes
  • rapid heartbeat
  • impotence
  • hair loss
  • anemia

In patients with high blood pressure, fainting is uncommon.However, fainting may become common in patients with heartfailure.

In patients with coronary heart disease, an excessive drop in bloodpressure may be experienced.

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

TEVA-LISINOPRIL (TYPE Z) can cause abnormal blood testresults. Your doctor will decide when to perform blood tests andwill 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 seek immediate medical help
Common
Low Blood Pressure: Dizziness, fainting, lightheadedne ssMay occur when you go from lying or sitting to standing up.
Increased levels of potassium in the blood: irregular heartbeat, muscle weakness and generally feeling unwell
Uncommon
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing
Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue
Liver and Pancreas Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite
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
Serious Skin Reactions (Steven- Johnson Syndrome, Toxic Epidermal Necrolysis):
any combination of itchy skin rash, redness, blistering and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills headache, cough, body aches or joint pain.
How to store

Keep TEVA-LISINOPRIL (TYPE Z) out of the reach and sight of children.

Store between 15°C and 30°C. Blister packs should be stored between 15°C and 25°C and protected from high humidity.
Keep your tablets in the container they came in.

Do not take your tablets after the expiry date on the container.

Return any unused TEVA-LISINOPRIL (TYPE Z) tablets to your pharmacist.

Reporting side effects

You can report any suspected side effects associated with the useof health products to Health Canada by:

NOTE: Contact your health professional if you need informationabout how to manage your side effects. The Canada VigilanceProgram does not provide medical advice.

More information

This document plus the full product monograph, prepared forhealth professionals can be found by contacting Teva CanadaLimited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:

Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com

Last revised: December 11, 2017

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Consumer Information for: TEVA-LISINOPRIL (TYPE Z) (2024)
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