Consumer Information for: PMS-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

pms-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

pms-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 pms-CILAZAPRIL regularly even if you feel fine.

When it should not be used

Do not take pms-CILAZAPRIL if you:

  • Are allergic to cilazapril or to any non-medicinal ingredient in the formulation.
  • Are allergic (hypersensitive) to other ACE inhibitor medicines. These include captopril, enalapril, lisinopril and ramipril.
  • 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 pms-CILAZAPRIL during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. 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 pms-CILAZAPRIL
What the medicinal ingredient is

Cilazapril

What the non-medicinal ingredients are

Colloidal Silicon Dioxide, Crospovidone, FD&C Blue#1 Aluminum Lake (5 mg), FD&C Red #40 Aluminum Lake (5 mg), FD&C Yellow# 6 Aluminum Lake (5 mg), Iron Oxide Yellow (1 mg), Iron Oxide Red (2.5 mg), Lactose Monohydrate Spray Dried, Polyethylene glycol, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol-part Hydrolyzed, Titanium Dioxide, and Talc

What dosage form it comes in

Tablets: 1 mg, 2.5 mg & 5 mg.

Warnings and precautions

Serious Warnings and Precautions - Pregnancy

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

BEFORE you use pms-CILAZAPRIL talk to your doctor, nurse 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 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. pms-CILAZAPRIL is not recommended for use in children.
  • Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with pms-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 pms-CILAZAPRIL

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

Driving and using machines
You may feel dizzy while taking pms-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 may interact with pms-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 pms-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 pms-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 pms-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 pharmacis

Overdose

If you think you have taken too much pms-CILAZAPRIL contact your health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
If you take more pms-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

pms-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, nurse, or pharmacist Only if severe Talk with your doctor, nurse, or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
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, headache.     ✔
Heart attack: chest pain and pressure (can be radiating from the left arm), heart palpitations, nausea, vomiting, trouble breathing, sweating, anxiety.   ✔  
A 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. If you have any unexpected effects while taking this pms-CILAZAPRIL, contact your doctor or pharmacist.

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

How to store
  • Do not use this product after the expiry date written on the package.
  • Store between 15°C and 30°C in a tightly closed container.
  • Keep this and all medicines in a safe place away from 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:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at 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 obtained by contacting Pharmascience Inc., at 1-888-550-6060

This leaflet was prepared by
        Pharmascience Inc.
        Montreal, Canada
        H4P 2T4

www,pharmascience.com

Last revised: October 05, 2015

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