How does this medication work? What will it do for me?

This combination product contains two active medications: cilazapril and hydrochlorothiazide. Cilazapril belongs to the class of medications called ACE inhibitors. It works by relaxing blood vessels and helping the heart to pump blood that carries oxygen to the different parts of the body more efficiently. Hydrochlorothiazide belongs to the class of medications called thiazide diuretics or "water pills," which help control blood pressure by getting rid of excess salt and water.

This combination medication is used to treat mild-to-moderate high blood pressure. This combination medication is prescribed when your doctor feels it is appropriate for you to be taking both medications. You should already be taking each medication individually before starting this combination medication. It may take up to 2 weeks to see the full effects of this medication.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each pink, oval, biconvex, film-coated tablet, engraved "APO" on one side and "5" bisect "12.5" on the other side, contains cilazapril 5 mg (as cilazapril monohydrate) and hydrochlorothiazide 12.5 mg. Nonmedicinal ingredients: cornstarch, hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, red ferric oxide, sodium stearyl fumarate, and titanium dioxide.

How should I use this medication?

The usual recommended dose of this medication is one tablet taken once a day, with or without food. The dose will depend on your response to the medication, and on your liver and kidney function. This medication should be taken at the same time each day, preferably in the morning. This combination medication is used to make dosing more convenient for people who are already taking both of these medications, cilazapril and hydrochlorothiazide, separately.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take cilazapril - hydrochlorothiazide if you:

  • are allergic to cilazapril, hydrochlorothiazide, or any ingredients of the medication
  • are allergic to other ACE inhibitors (e.g., fosinopril, enalapril, ramipril, quinapril)
  • are allergic to sulfonamide medications (e.g., sulfamethoxazole) or thiazide diuretics
  • are pregnant or may become pregnant
  • are breast-feeding
  • cannot produce urine
  • have had a history of angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) after taking an ACE inhibitor
  • have fluid built up in the liver
  • have diabetes or moderate-to-severe kidney dysfunction and are taking the medication aliskiren
  • have problems with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • cold-like symptoms (e.g., runny nose, nasal congestion, sneezing)
  • constipation
  • cough (dry, persistent)
  • decreased appetite
  • diarrhea
  • dizziness
  • drowsiness
  • flushing
  • headache
  • increased frequency of urination
  • increased sweating
  • nausea
  • rash, itching
  • taste changes
  • trouble sleeping
  • unusual tiredness
  • vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • chest pain
  • fast or irregular heartbeat
  • muscle pain or cramps
  • numbness or tingling in hands, feet, or lips
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heart beat)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
  • signs of liver problems such as abdominal pain, nausea or vomiting, itching skin, yellow eyes or skin
  • signs of low blood pressure such as dizziness, lightheadedness, or fainting
  • skin rash (with or without itching), fever, or joint pain
  • symptoms of lupus (e.g., fever, fatigue, joint and muscle pain, general feeling of being unwell)
  • sudden vision changes (e.g., blurred vision, eye pain, pressure in the eye)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest, nausea, vomiting, sweating, anxiety)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • symptoms of a serious allergic reaction, including angioedema (e.g., hives; swelling of the face, mouth, hands, or feet; and difficulty breathing)
  • signs of a stroke (e.g., numbness or weakness in arm, leg, or any part of the body, loss of coordination, vision changes, sudden headache, difficulty speaking or breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of cilazapril. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Angioedema: Angioedema (a serious allergic reaction which causes the area around the face, throat, and tongue to swell) may occur with use of this medication. If you experience difficulty breathing or swelling of the face, tongue, or throat, stop taking this medication at once and get immediate medical attention. Other ACE inhibitors should not be taken in the future. People who have had angioedema caused by other substances may be at increased risk of angioedema while taking this medication.

Cholesterol: Increases in cholesterol and triglyceride levels may occur when taking hydrochlorothiazide. Your doctor will monitor you for these changes while you are taking this medication.

Cough: People taking cilazapril may develop a dry, persistent cough that usually disappears only after stopping this medication.

Diabetes: Cilazapril - hydrochlorothiazide may make it more difficult to control your blood sugar if you have diabetes. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: When you first start taking cilazapril – hydrochlorothiazide, you may experience drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Fluid and electrolyte balance: Your levels of electrolytes such as potassium, sodium, magnesium, and chloride may change due to this medication. Your doctor may periodically arrange for tests to check to see if these are in balance. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible.

Gout: Some people taking hydrochlorothiazide may experience episodes of gout. If this occurs while you are taking this medication, contact your doctor. If you have a history of gout, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: This medication may affect kidney function for certain people. Taking aliskiren may further increase the risk of kidney problems. If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Let your doctor know if you notice any decrease in urine output, or increased swelling of the lower limbs, which may indicate an accumulation of fluid due to decreased urination.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication may worsen liver function. People with liver disease or poor liver function should be closely monitored by their doctor while taking this medication. If you notice any signs of liver problems (e.g., abdominal pain, itchy skin, yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.

Low blood pressure: Occasionally, blood pressure drops too low after taking this medication. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur for those who take aliskiren, other medications for blood pressure, have a salt-restricted diet, are on dialysis, have diarrhea or are vomiting, or have been sweating excessively and not drinking enough liquids. To reduce the risk of dizziness, get up slowly from a lying or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Surgery: It is important that your physician and anesthesiologist know that you are taking this medication before you undergo any surgical procedures requiring general anesthesia.

White blood cells: In rare cases, a low white blood cell count has been reported for people taking this medication. Your doctor may occasionally monitor your level of white blood cells by performing blood tests. Low white blood cell levels may increase your risk for infection. If you notice any signs of infection (e.g., fever, sore throat), contact your doctor as soon as possible.

Pregnancy: ACE inhibitors such as cilazapril may cause severe harm or death to the developing baby if taken by the mother during pregnancy. This medication should not be used during pregnancy. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: Hydrochlorothiazide passes into breast milk. It is not known if cilazapril passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. Its use by this age group is not recommended.

What other drugs could interact with this medication?

There may be an interaction between cilazapril - hydrochlorothiazide and any of the following:

  • acetylsalicylic acid (ASA)
  • aclinidium
  • alcohol
  • aldesleukin
  • aliskiren
  • allopurinol
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • alpha agonists (e.g., clonidine, methyldopa)
  • amifostine
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • other angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • aprotinin
  • atropine
  • azathioprine
  • azelastine
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • belladonna
  • benztropine
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • beta 2 agonists (e.g., salbutamol, formoterol, terbutaline)
  • brimonidine
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • calcium supplements
  • carbamazepine
  • cholestyramine
  • ciprofloxacin
  • inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclobenzaprine
  • cyclophosphamide
  • cyclosporine
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • diazoxide
  • digoxin
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • disopyramide
  • dofetilide
  • duloxetine
  • eplerenone
  • everolimus
  • flavoxate
  • glycopyrrolate
  • grass pollen allergen extract
  • guanfacine
  • heparin
  • ipratropium
  • iron dextran
  • ketotifen
  • levodopa
  • lithium
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • methylphenidate
  • minoxidil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • multivitamins with minerals
  • narcotic medications (e.g., morphine, codeine, fentanyl, oxycodone)
  • nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
  • nonsteroidal anti-inflammatory medications (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)
  • norepinephrine
  • orphenadrine
  • oxcarbazepine
  • oxybutynin
  • pentoxyifylline
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • potassium pills or potassium supplements
  • porfimer
  • pregabalin
  • rituximab
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • scopolamine
  • sirolimus
  • sodium phosphates
  • temsirolimus
  • tetracycline
  • tiotropium
  • tizanidine
  • tolterodine
  • topiramate
  • tranylcypromine
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • tubocurarine
  • vitamin D analogues (e.g., alfacalcidol, calcitriol, cholecalciferol)
  • medications that increase potassium levels (e.g., potassium supplements, spironolactone, amiloride, triamterene, and salt substitutes containing potassium)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than the ones listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.