Patient Medication Information: uses, side effects, how to take - Lisinopril Tablets (Sivem Pharmaceuticals)
Serious Warnings and Precautions
LISINOPRIL TABLETS should not be used during pregnancy. Taking it during pregnancy can cause injury or even death to your baby. If you discover that you are pregnant while taking LISINOPRIL TABLETS, stop the medication and contact your healthcare professional as soon as possible.
What is LISINOPRIL TABLETS used for?
LISINOPRIL TABLETS is used in adults:
- To treat high blood pressure (hypertension);
- With other medications to treat heart failure, where the heart does not pump your blood around your body as well as it should;
- To lower the risk of having a heart attack (myocardial infarction) in patients who have already had a heart attack.
LISINOPRIL TABLETS is used in children (6 to 16 years of age) to treat high blood pressure.
How does LISINOPRIL TABLETS work?
LISINOPRIL TABLETS belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.
LISINOPRIL TABLETS works by widening your blood vessels, which makes it easier for your heart to pump blood to all parts of your body. This helps to lower blood pressure.
This medicine does not cure your disease, but helps to control it. Therefore, it is important to continue taking LISINOPRIL TABLETS regularly even if you feel fine.
What are the ingredients in LISINOPRIL TABLETS?
Medicinal ingredients: lisinopril dihydrate
Non-medicinal ingredients: Calcium hydrogen phosphate anhydrous, Ferric oxide red, Magnesium stearate, Maize starch, Mannitol, Starch Pregelatinised
LISINOPRIL TABLETS comes in the following dosage forms:
Tablets: 5 mg, 10 mg and 20 mg.
Do not use LISINOPRIL TABLETS if:
- You are allergic to lisinopril or to any non-medicinal ingredient in the formulation.
- You have a family history of angioedema (allergic reaction), or have ever had an allergic reaction to any other ACE inhibitor. Be sure to tell your healthcare professional that this has happened to you.
- You are taking sacubitril/valsartan (Entresto®), due to the increased risk of serious allergic reaction which causes swelling of the face or throat (angioedema) when taken with LISINOPRIL TABLETS.
- You are pregnant or intend to become pregnant. Taking LISINOPRIL TABLETS during pregnancy can cause injury or even death to your baby.
- You are breastfeeding. LISINOPRIL TABLETS passes into breast milk.
You are already taking a blood pressure-lowering medicine containing aliskiren (such as Rasilez) and you have one of the following conditions:
- diabetes
- kidney disease
- high potassium levels
- heart failure combined with low blood pressure
You 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”.
- You are 6 to 16 years old with severe kidney problems.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LISINOPRIL TABLETS. Talk about any health conditions or problems you may have, including 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, such as Rasilez, used to lower high blood pressure. The combination with LISINOPRIL TABLETS 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.
Other warnings you should know about:
Monitoring: During your treatment with LISINOPRIL TABLETS, your healthcare professional may check your kidney and liver function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Exposure to sunlight: You may become sensitive to the sun while taking LISINOPRIL TABLETS. Limit your exposure to sunlight until you know how you respond.
Use of anesthesia: If you are going to have surgery and will be given an anesthetic, be sure to tell your healthcare professional that you are taking LISINOPRIL TABLETS.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to LISINOPRIL TABLETS. Dizziness, light-headedness, or fainting can occur, especially after the first dose and when the dose is increased.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
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The following may also interact with LISINOPRIL TABLETS:
- 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,
- Medicines known as dipeptidyl peptidase IV (DPP-IV) inhibitors, these include alogliptin, linagliptin, saxagliptin and sitagliptin,
- Other oral medications (such as sulphonylureas).
Your dose of these types of drugs may need to be changed when taking them in combination with LISINOPRIL TABLETS.
- Drugs used to treat cancer such as, temsirolimus and everolimus.
- Gold for the treatment of rheumatoid arthritis.
- Lithium used to treat bipolar disease.
- Non-steroidal anti-inflammatory medicines (NSAIDs), used to reduce pain and swelling. These include ibuprofen, naproxen, and celecoxib.
- Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (such as Rasilez), or angiotensin receptor blockers (ARBs).
- Medicines known as mammalian target of rapamycin (mTOR) inhibitors such as sirolimus, a drug used to prevent the organ rejection after a transplant.
- Medicines known as tissue plasminogen activators (tPA), these are used to dissolve blood clots that have formed in blood vessels.
- Medicines known as neutral endopeptidase (NEP) inhibitors.
How to take LISINOPRIL TABLETS:
- Take LISINOPRIL TABLETS 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 LISINOPRIL TABLETS before or after food.
- Do NOT stop taking LISINOPRIL TABLETS unless your healthcare professional tells you to, even if you are feeling better.
Usual dose:
Your healthcare professional has decided the best dose for you. Take your dose once daily, exactly as your healthcare professional has told you to.
Overdose:
| If you think you, or a person you are caring for, have taken too much LISINOPRIL TABLETS, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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 take a double dose.
What are possible side effects from using LISINOPRIL TABLETS?
These are not all the possible side effects you may have when taking LISINOPRIL TABLETS. If you experience any side effects not listed here, tell your healthcare professional.
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
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. LISINOPRIL TABLETS can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Low Blood Pressure: Dizziness, fainting, light- headedness. May occur when you go from lying or sitting to standing up | √ | ||
| 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, 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 | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, weakness, shortness of breath. | √ | ||
Decreased Platelets: bruising, bleeding, fatigue and weakness, small purple or red dots under the skin | √ | ||
Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | √ | ||
| VERY RARE | |||
Serious Skin Reactions (Stevens-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. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Store your tablets in a cool dry place at a temperature between 15-30 °C. Keep your tablets in the container they came in.
Do not take your tablets after the expiry date on the container. Return any unused LISINOPRIL TABLETS tablets to your healthcare professional.
Keep out of reach and sight of children.
If you want more information about LISINOPRIL TABLETS:
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- Talk to your healthcare professional
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Find the full product monograph that is prepared for healthcare professionals and includes
this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.sivem.ca), or by calling 1 855-788-3153.