Details for: TEVA-LISINOPRIL (TYPE Z)
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02285118 | TEVA-LISINOPRIL (TYPE Z) | LISINOPRIL | 5 MG | TABLET | ORAL |
| 02285126 | TEVA-LISINOPRIL (TYPE Z) | LISINOPRIL | 10 MG | TABLET | ORAL |
| 02285134 | TEVA-LISINOPRIL (TYPE Z) | LISINOPRIL | 20 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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-medicinal
ingredient in the formulation.
- Have experienced an allergic reaction (angioedema) with itching, hives, feeling dizzy, 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.
- Are taking Sacubitril/Valsartan, due to the increased risk
of serious allergic reaction which causes swelling of the
face or throat (angioedema) when taken with TEVA-LISINOPRIL
(TYPE Z).
- Are pregnant or intend to become pregnant. Taking
TEVA-LISINOPRIL (TYPE Z) during pregnancy can
cause injury or even death to your baby.
- Are breastfeeding. TEVA-LISINOPRIL (TYPE Z)
passes into breast milk.
- Are already taking a blood pressure-lowering medicine
containing aliskiren and you have one of the following
conditions:
- 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, or
another ACE inhibitor and have one of the following
conditions:
- diabetes with end organ damage
- kidney disease
- high potassium levels
- heart failure combined with low blood pressure
- You can recognize ARBs because their medicinal 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 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.
- 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 taking a medicine that contains aliskiren, used to lower high blood pressure. The combination with TEVA-LISINOPRIL (TYPE Z) is not recommended.
- Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
- Are receiving gold (sodium aurothiomalate) injections.
Are taking drugs such as:
- Temsirolimus and everolimus (used to treat cancer),
- Sirolimus (used to prevent organ rejection after a transplant),
- A neutral endopeptidase inhibitor.
- Taking ACE inhibitors, such as TEVA-LISINOPRIL (TYPE Z) with these types of drugs may increase your chances of having an allergic reaction (angioedema).
Your doctor may check your kidney function, blood pressure, and
the amount of electrolytes (e.g. potassium) in your blood at regular
intervals.
You may become sensitive to the sun while taking TEVA-LISINOPRIL
(TYPE Z). 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
(TYPE Z).
Driving and using machines: Before you perform tasks which
may require special attention, wait until you know how you
respond to TEVA-LISINOPRIL (TYPE Z). 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 TEVA-LISINOPRIL (TYPE Z):
- Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind 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 be changed 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 include ibuprofen, naproxen, and celecoxib.
- Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products or angiotensin receptor blockers (ARBs).
- Sirolimus, a drug used to prevent the organ rejection after a transplant.
- Tissue plasminogen activator (tPA) that is used to dissolve blood clots that have formed in blood vessels.
Proper use of this medication
Take TEVA-LISINOPRIL (TYPE Z) exactly as prescribed. It is
recommended to take your dose at about the same time every day.
Swallow the tablet with a drink of water. It does not matter if you
take TEVA-LISINOPRIL (TYPE Z) before or after food.
Do not stop taking your tablets if you are feeling well, unless your
doctor tells you.
Usual dose
Adults
High blood pressure: the usual recommended starting dose is 10
mg taken once daily.
Heart failure: the usual recommended starting dose is 2.5 mg taken
once a day. The usual long-term dose is 5 to 35 mg taken once
daily.
Following a heart attack: the usual recommended starting dose is 5
mg 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 starting
dose is 2.5 mg. The maximum dose is 20 mg.
Children weighing 50 kg or more: the recommended starting dose
is 5 mg. The maximum dose is 40 mg.
Overdose
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:
- 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 and indigestion, vomiting
- confusion, feeling sleepy or difficulty in going to sleep, mood changes (including signs of depression), seen and/or heard 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 heart
failure.
In patients with coronary heart disease, an excessive drop in blood
pressure may be experienced.
If any of these affects you severely, tell your doctor, nurse or
pharmacist.
TEVA-LISINOPRIL (TYPE Z) can cause abnormal blood test
results. Your doctor will decide when to perform blood tests and
will interpret the results.
| 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 ss May 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 use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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.
More information
This document plus the full product monograph, prepared for
health professionals can be found by contacting Teva Canada
Limited 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