Apo-Cilazapril-HCTZ

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.

Take cilazapril–hydrochlorothiazide with a glass of water. Swallow the tablets whole. Do not chew or crush the tablets.

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.

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

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

• are taking the medication sacubitril

• cannot produce urine

• have had a history of angioedema (a serious allergic reaction which causes swelling of the hands, feet, ankles, face, lips, tongue, or throat) after taking an ACE inhibitor

• have hereditary angioedema or have angioedema with no known cause

• 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

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

• joint pain

• nausea

• rash, itching

• swollen mouth

• taste changes

• trouble sleeping

• unusual tiredness

• vomiting

• weakness

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)

• 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

• signs of non-melanoma skin cancer (e.g., discoloured patches or lumps on the skin that change slowly over time)

• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

• 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

• 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)

• symptoms of a serious allergic reaction, including angioedema (e.g., hives; swelling of the face, mouth, hands, or feet; and difficulty breathing)

• symptoms of acute respiratory distress (ARDS; e.g., shortness of breath, chest tightness, cough, wheezing, fever, weakness, confusion)

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.

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.

January 31, 2019

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

Allergic reaction: Some people who are allergic to sulfonamide medications also experience allergic reactions to hydrochlorothiazide. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially to sulfonamide antibiotics or diabetes medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

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.

Breathing problems: Although uncommon, hydrochlorothiazide has been linked to very severe cases of fluid build-up in the lungs. This condition often develops within a couple of hours of taking the medication and starts with shortness of breath, dizziness, and sometimes fever. It can progress to respiratory failure if it is not treated. Seek medical attention immediately if you develop shortness of breath 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.

Lupus: There have been reports of a worsening or activation of lupus in people taking hydrochlorothiazide. If you have lupus, 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.

Sensitivity to sunlight: This medication may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight for long periods of time, particularly between the hours of 10 am and 2 pm, while you are taking this medication. Wear a broad-spectrum sunscreen and lip balm with an SPF of 30 or higher. If you notice any unusual skin rash or peeling, contact your doctor immediately. ****

Skin cancer: Long-term use of hydrochlorothiazide has been connected to an increased risk of developing non-melanoma skin cancer. This often appears as a lump or discoloured patch of skin that slowly changes appearance or size. Check your skin regularly for unusual growths or discolouration and report any changes to your doctor as soon as possible. Talk to your doctor about any concerns you may have.

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.

Vision changes: Hydrochlorothiazide occasionally causes vision changes including increased eye pressure and myopia (nearsightedness). If you experience any eye symptoms, such as pain or change in vision, contact your doctor as soon as possible.

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 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 and are taking this medication, it may affect your baby. 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. Children should not take this medication.

Seniors: Seniors may be at an increased risk of experiencing side effects of this medication due to decreased kidney and liver function.

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

• acetylsalicylic acid (ASA)

• aclidinium

• alcohol

• aldesleukin

• aliskiren

• allopurinol

• alpha-blockers (e.g., alfuzosin, doxazosin, tamsulosin)

• aminolevulinic acid

• amiodarone

• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)

• other angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)

• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)

• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)

• antipsychotics (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)

• apomorphine

• atropine

• azathioprine

• barbiturates (e.g., butalbital, phenobarbital)

• benztropine

• beta 2 agonists (e.g., salbutamol, formoterol, terbutaline)

• bismuth subsalicylate

• bortezomib

• brimonidine

• bromocriptine

• buprenorphine

• butorphanol

• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)

• calcium supplements

• cholestyramine

• clidinium

• colesevelam

• colestipol

• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)

• cyclobenzaprine

• cyclophosphamide

• darifenacin

• desmopressin

• diabetes medications (e.g., acarbose, canagliflozin, dulaglutide, gliclazide, insulin, metformin, sitagliptin)

• diazoxide

• digoxin

• dimenhydrinate

• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)

• disopyramide

• drospirenone

• duloxetine

• everolimus

• fesoterodine

• flunarizine

• glycopyrrolate

• grass pollen allergen extract

• heparin

• ipratropium

• ivabradine

• ketotifen

• lanthanum

• levodopa

• lithium

• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)

• medications that increase potassium levels (e.g., potassium supplements, spironolactone, amiloride, triamterene, and salt substitutes containing potassium)

• methylphenidate

• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)

• multivitamins with minerals

• nabilone

• narcotic medications (e.g., morphine, codeine, fentanyl, oxycodone, tapentadol, tramadol)

• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)

• nonsteroidal anti-inflammatory medications (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)

• obinutuzumab

• orphenadrine

• oxybutynin

• pentoxifylline

• pergolide

• phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)

• pizotifen

• polyethylene glycol

• pramipexole

• pregabalin

• primidone

• propiverine

• ranolazine

• riociguat

• ropinirole

• rotigotine

• sacubitril

• scopolamine

• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)

• sirolimus

• sodium phosphates

• solifenacin

• sotalol

• tacrolimus

• tiotropium

• tizanidine

• tolterodine

• topiramate

• tretinoin

• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)

• trihexyphenidyl

• trimethoprim

• trospium

• umeclidinium

• vitamin D analogues (e.g., alfacalcidol, calcitriol, cholecalciferol)

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.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apo-Cilazapril-HCTZ