Consumer Information for: TEVA-CILAZAPRIL

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-CILAZAPRIL is used to treat the following:

  • Mild to moderate essential high blood pressure (hypertension). The cause of essential high blood pressure is unknown.
  • Heart failure. This is a condition where the heart cannot pump adequate amounts of blood to satisfy the needs of the body.
What it does

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

It works by making your blood vessels relax and widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around your body if you have chronic heart failure.

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

When it should not be used

Do not take TEVA-CILAZAPRIL if you:

  • Are allergic (hypersensitive) to other ACE inhibitor medicines. These include captopril, enalapril, lisinopril and ramipril.
  • Are allergic to cilazapril or to any non-medicinal ingredient in the formulation.
  • 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.
  • Are pregnant or intend to become pregnant. Taking TEVA-CILAZAPRIL during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. TEVA-CILAZAPRIL passes into breast milk.
  • Have a build up of fluid in your abdomen (ascites).
  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
  • Are lactose intolerant or have one of the following rare hereditary diseases:
    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption as lactose is a non-medicinal ingredient in TEVA-CILAZAPRIL
What the medicinal ingredient is

cilazapril

What the non-medicinal ingredients are

TEVA-CILAZAPRIL 1 mg contain: lactose, cornstarch, microcrystalline cellulose, talc, sodium stearyl fumarate, hypromellose, titanium dioxide, macrogol, iron oxide yellow and polysorbate.

TEVA-CILAZAPRIL 2.5 mg contain: lactose, cornstarch, microcrystalline cellulose, talc, sodium stearyl fumarate, hypromellose, titanium dioxide, macrogol and iron oxide red.

TEVA-CILAZAPRIL 5 mg contain: lactose, cornstarch, microcrystalline cellulose, talc, sodium stearyl fumarate, polydextrose, hypromellose, titanium dioxide, glycerol, triacetate, macrogol, and iron oxide red and yellow.

What dosage form it comes in

Tablets; 1 mg, 2.5 mg and 5 mg

Warnings and precautions

Serious Warnings and Precautions - Pregnancy

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

BEFORE you use TEVA-CILAZAPRIL talk to your doctor or pharmacist if you:

  • Are allergic to any drug used to lower blood pressure.
  • Have narrowing of an artery or a heart valve.
  • Have/had a heart attack or a stroke.
  • Have heart failure.
  • Have diabetes, liver or kidney disease.
  • Are on kidney dialysis.
  • Are on LDL apheresis (a treatment to lower the LDL cholesterol in the blood).
  • Are dehydrated or recently suffered from excessive vomiting, diarrhea or sweating.
  • Are on a low salt diet.
  • Are receiving gold (sodium aurothiomalate) injections)
  • Have recently received or are planning to have allergy shots for bee or wasp stings.
  • Have a collagen disease (skin disease) such as lupus (systemic lupus erythematosus) or scleroderma (a skin condition leading to hardening or thickening of the skin).
  • Are less than 18 years old. TEVA-CILAZAPRIL is not recommended for children
  • Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with TEVA-CILAZAPRIL is not recommended.
  • Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take TEVA-CILAZAPRIL.

You may become sensitive to the sun while taking TEVA-CILAZAPRIL. 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-CILAZAPRIL.

Driving and using machines

You may feel dizzy while taking TEVA-CILAZAPRIL. This is more likely to happen when you first start treatment or when the dose is increased. If you feel dizzy, do not drive or use any tools or machines.

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 drugs may interact with TEVA-CILAZAPRIL:

  • Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements or potassium-sparing diuretics (a specific kind of “water pill,” e.g. spirolactone, triamterene, amiloride,
  • eplerenone).
  • Allopurinol used to treat gout.
  • Anesthetics and narcotics (for pain relief)
  • Antipsychotics (for treatment of schizophrenia or bipolar disorder)
  • Anti-diabetic drugs including insulin and oral medicines (e.g. metformin, gliptins, sulfonylureas).
  • Digoxin, a heart medication
  • Gold salts (for the treatment of rheumatoid arthritis).
  • Lithium (used to treat bipolar disorder).
  • Non-steroidal anti-inflammatory drugs’ (NSAIDs), used to reduce pain and swelling. Examples include aspirin, indometacin, naproxen, ibuprofen and celecoxib.
  • Other blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ), angiotensin receptor blockers (ARBs) or other ACE inhibitors (in addition to TEVA-CILAZAPRIL).
  • Steroid medicines (such as hydrocortisone, prednisolone and dexamethasone) or other medications which suppress the immune system.
  • Tricyclic antidepressants (e.g. amitriptyline, clomipramine, imipramine)
  • mTOR inhibitors (e.g. sirolimus, everolimus)
  • DPP-IV inhibitors (e.g. vildagliptin)

Taking TEVA-CILAZAPRIL with food and drink
Tell your doctor or pharmacist if you are taking food supplements that contain potassium.

Proper use of this medication

Take TEVA-CILAZAPRIL exactly as prescribed. It is recommended to take your dose at about the same time every day.

Usual Adult Dose

Follow your doctor’s instructions about how much medicine you should take. If you have any questions, you should consult your doctor or pharmacist.

Overdose

If you think you have taken too much TEVA-CILAZAPRIL, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you take more TEVA-CILAZAPRIL than you should, the following effects may happen: feeling dizzy or light-headed, shallow breathing, cold clammy skin, being unable to move or speak and a slow heart beat.

Missed Dose

If you forget to take a dose, skip the missed dose. Then take the next dose when it is due.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side effects and what to do about them
  • Dizziness, headache, trouble sleeping
  • Drowsiness, feeling tired, weakness
  • Runny or blocked nose, sneezing
  • Rash, itching
  • Abdominal pain, upset stomach, decreased appetite
  • Diarrhea, constipation, nausea, vomiting
  • Muscle cramps and/or joint pain, pins and needles sensation
  • Sweating more than usual, flushing

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

TEVA-CILAZAPRIL 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 or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and seek immediate emergency medical help
Common (affects less than 1 in 10 people)
Low Blood Pressure: Dizziness, fainting, lightheadedness. May occur when you go from sitting to standing up.   ✔ ✔
if actual fainting occurs)
Increased levels of potassium in the blood: irregular heartbeat, muscle weakness and generally feeling unwell   ✔  
Uncommon (affects less than 1 in 100 people)
Angioedema and Severe Allergic Reactions (anaphylaxis): Swelling of the face, eyes, lips, tongue or throat, difficulty swallowing or breathing, rash (including skin rash which may be severe), hives, itching, fever, abdominal cramps, chest discomfort or tightness     ✔
Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat   ✔  
Increased heart rate   ✔  
Chest pain (Angina)     ✔
Breathing problems, including shortness of breath and tightness in the chest     ✔
Rare (affects less than 1 in 1’000 people)
Decreased platelets: bruising, bleeding, fatigue, and weakness   ✔  
Decreased white blood cells: Infections (e.g., sore throat, fever), fatigue, aches, pains and flu-like symptoms.   ✔  
Stroke: weakness ,blurred vision, slurred speech, trouble speaking, face drooping, dizziness, headaches     ✔
Heart attack: chest pain and pressure (can be radiating from the left arm), heart palpitations, nausea, vomiting, trouble breathing, sweating, anxiety.   ✔  
Irregular heartbeat   ✔  
Lupus-like Syndrome: fever, fatigue, joint and muscle pain, generally feeling unwell.   ✔  
Liver Disorder: Yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite.   ✔  
Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting.   ✔  
Kidney Disorder: Change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue.   ✔  
Serious skin reactions (Stevens- Johnson Syndrome, Toxic Epidermal Necrolysis): Any combination of itchy skin rash, redness, blistering and severe peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands, joint pain, yellowing of the skin or eyes, dark urine.     ✔

This is not a complete list of side effects. For any unexpected effects while taking TEVA-CILAZAPRIL, contact your doctor or pharmacist.

If you have any further questions, ask your doctor or pharmacist.

How to store

Store 15ºC -25 ºC. Keep container tightly closed. Protect from moisture.

Keep out of reach and sight of children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

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

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

Last revised: January 20, 2016

Date modified: