Inhibace Plus: Uses, Side Effects and Dosage

What is INHIBACE PLUS used for?

• INHIBACE PLUS is used in adults to lower high blood pressure.

How does INHIBACE PLUS work?

INHIBACE PLUS contains a combination of two medicinal ingredients:

• Cilazapril is an angiotensin-converting enzyme (ACE) inhibitor. It helps to lower blood pressure.
• Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This also helps to lower blood pressure.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking INHIBACE PLUS regularly even if you feel fine.

What are the ingredients in INHIBACE PLUS?

Medicinal ingredients: cilazapril monohydrate and hydrochlorothiazide.

Non-medicinal ingredients: cornstarch, hydroxypropyl methylcellulose, lactose, red iron oxide, sodium stearyl fumarate, talc, and titanium dioxide.

INHIBACE PLUS comes in the following dosage forms:

Serious Warnings and Precautions

Tablets; 5 mg of cilazapril (as cilazapril monohydrate) and 12.5 mg of hydrochlorothiazide.

Do not use INHIBACE PLUS if:

• you are allergic to cilazapril, hydrochlorothiazide, or to any other ingredients in INHIBACE PLUS.
• you are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
• you have a personal or family history of angioedema (allergic reaction causing swelling of the hands, feet, ankles, face, lips, tongue, or throat; or sudden difficulty breathing or swallowing). Be sure to tell your healthcare professional that this has happened to you.
• you have difficulty urinating or produce no urine.
• you have a build up of fluid in your abdomen (ascites).
• you are taking a medicine containing a neprilysin inhibitor (e.g., sacubitril/valsartan) used to treat heart failure. This can increase the risk of angioedema. Do not take INHIBACE PLUS for at least 36 hours before or after you take sacubitril/valsartan.

• you are pregnant, intend to become pregnant, or are able to become pregnant and are not using adequate birth control. Taking INHIBACE PLUS during pregnancy can cause injury and even death to your baby.

• you are breastfeeding. INHIBACE PLUS passes into breast milk.

• you are lactose intolerant (unable to digest the lactose milk sugar) or have one of the following rare hereditary diseases:

  • galactose intolerance,
  • lapp lactase deficiency,
  • glucose-galactose malabsorption.

INHIBACE PLUS contains lactose, a type of milk sugar.

• you are taking a medicine containing aliskiren (such as RASILEZ) used to lower blood pressure, and you have diabetes or kidney disease.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take INHIBACE PLUS. Talk about any health conditions or problems you may have, including if you:

• use drugs used to lower blood pressure.
• are allergic to penicillin.
• have recently received or are planning to get allergy shots for bee or wasp stings.
• have heart or blood vessel problems.
• have liver problems.
• have diabetes.
• have kidney problems.
• are on dialysis.
• have gout.
• are at a higher risk of developing skin cancer. You may be at a higher risk if you have light coloured skin, have a personal or family history of skin cancer, get sunburned easily, or are taking medicines that suppress your immune system.
• have a collagen vascular disease (a class of autoimmune diseases in which the body’s immune system attacks it own skin, tissues, and organs). This can include lupus (e.g., systemic lupus erythematosus) or scleroderma (a skin condition leading to hardening or thickening of the skin).
• are on low-density lipoprotein (LDL) apheresis with dextran sulfate (a treatment used to remove LDL cholesterol from the blood).
• are dehydrated or recently suffered from excessive vomiting, diarrhea, or sweating.
• have experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop any severe shortness of breath or difficulty breathing after taking INHIBACE PLUS, seek medical attention immediately.
• are on a low-salt diet.
• have low sodium levels in your blood.
• are at a higher risk of developing hypotension (low blood pressure).
• have been treated with other vasodilators (used to dilate blood vessels).
• have a history of bronchial asthma.
• have porphyria (build up of chemicals in the body called porphyrin).
• are planning to have a surgery or receive an anesthetic.
• have low potassium in the blood (hypokalemia).

Other warnings you should know about:

Risk of skin cancer: INHIBACE PLUS contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking INHIBACE PLUS for many years (more than 3) or at a high dose. While taking INHIBACE PLUS:

• Make sure to regularly check your skin for any new lesions (e.g., lump, bump, sore, or patch). Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back. Tell your healthcare professional right away if you become more sensitive to the sun or UV light, or if you develop an unexpected skin lesion during the treatment.
• Limit your exposure to the sun and to indoor tanning until you know how you respond. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.

Eye problems: Hydrochlorothiazide in INHIBACE PLUS can cause sudden eye disorders:

• Myopia: sudden nearsightedness or blurred vision.
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
• Choroidal effusion: abnormal buildup of liquid in your eye that may result in vision changes.

If your vision changes, stop taking INHIBACE PLUS and seek immediate medical help. These eye disorders are related and can develop within hours to weeks of starting INHIBACE PLUS.

Driving and using machines: Before you drive or perform tasks, that may require special attention, wait until you know how you respond to INHIBACE PLUS. Dizziness, light-headedness, or fainting can occur especially after the first dose and when the dose is increased.

Check-ups and testing: You may have regular visits with your healthcare professional, before, during and after your treatment. These tests may be used to monitor your health such as:

• your kidney function
• your liver function
• your blood pressure
• the profile of your blood
• your glucose levels if you have diabetes
• your electrolyte levels.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with INHIBACE PLUS:

• adrenocorticotropic hormone (ACTH) used to treat West Syndrome.
• medicines that may increase the levels of potassium in the blood (e.g., medicines that contain trimethoprim, co-trimoxazole also known as trimethoprim/sulfamethoxazole, ciclosporin, heparin, potassium supplements, potassium sparing diuretics and salt substitutes that contain potassium).

• other antihypertensive medicines used to treat high blood pressure such as:

  • guanethidine;
  • methyldopa;
  • beta-blockers;
  • vasodilators;
  • calcium channel blockers;
  • angiotensin converting enzyme (ACE) inhibitors;
  • angiotensin II receptor blockers (ARBs);
  • direct renin inhibitors;
  • diuretics also known as “water pill” (e.g., spironolactone, triamterene, amiloride, or eplerenone);
  • ganglionic blocking agents or adrenergic neuron blocking agents;
  • sympathomimetics;
  • dual blockade of the renin-angiotensin-system (RAS).
• alcohol.
• barbiturates used to help with sleep.
• narcotics used to help reduce intense pain.
• amphotericin B used to treat fungal infections.
• antineoplastic used to treat cancer (e.g., cyclophosphamide and methotrexate).
• antidepressants used to treat depression (e.g., selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, sertraline, and tricyclic antidepressants such as amitriptyline, clomipramine and imipramine).
• antidiabetic and hypoglycemic medicines used to treat diabetes (e.g., insulin, alogliptin, linagliptin, saxagliptin, and sitagliptin).
• bile acid resins used to lower cholesterol (e.g., cholestyramine and colestipol).
• calcium or vitamin D supplements.
• corticosteroids used to treat joint pain and swelling.
• digoxin used to treat certain heart conditions.
• medicines that slow down or speed up bowel function (e.g., atropine, metoclopramide, and domperidone).
• anticonvulsants used to treat epilepsy (e.g., carbamazepine and topiramate).

• medicines that may cause abnormal heart rhythms such as:

  • antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, defetilide, and ibutilide);
  • antipsychotics (e.g., thioridazine, chlorpromazine, trifluoperazine, sulpiride, tiapride, haloperidol, and droperidol);
  • other medicinal products (e.g. bepridil, cisapride, diphemanil, halofantrine, ketanserin, pentamidine, and terfenadine).
• medicines used to treat gout (e.g., allopurinol, uricosurics, xanthine oxidase inhibitors, and probenecid).
• lithium used to treat bipolar disease.
• nonsteroidal anti-inflammatory drugs (NSAIDs) used to reduce pain and swelling. (e.g., aspirin, acetylsalicylic acid, ibuprofen, naproxen, and celecoxib).
• muscle relaxants used to relieve muscle spasms (e.g., tubocurare).
• gold (sodium aurothiomalate) and gold salts used to treat autoimmune conditions such as rheumatoid arthritis and psoriatic arthritis.
• tetracycline antibiotics used to treat bacterial infections.
• amantadine used to treat the flu and reduce symptoms of Parkinson’s disease.
• iodine containing contrast media used for medical imaging.
• mammalian target of rapamycin (mTOR) inhibitors used to prevent organ rejection after a transplant (e.g., sirolimus, everolimus, and temsirolimus).
• anesthetics used during surgery.
• pressor amines used to increase blood pressure (e.g., norepinephrine).

How to take INHIBACE PLUS:

• INHIBACE PLUS is not for initial therapy. You must first be stabilized on the individual components of INHIBACE PLUS (i.e., cilazapril and hydrochlorothiazide).
• Take INHIBACE PLUS exactly as prescribed by your healthcare professional.
• It is recommended to take your dose at about the same time every day.
• Swallow INHIBACE PLUS whole with a full glass of water. Do NOT chew or crush the tablet.

• INHIBACE PLUS can be taken with or without food. If INHIBACE PLUS causes upset stomach, take it with food.

Usual dose:

Your healthcare professional will decide the best dose for you. This will depend on your current treatment with the individual components of INHIBACE PLUS (i.e., cilazapril and hydrochlorothiazide).

Overdose:

Missed Dose:

If you miss a dose, do not take the missed dose. Instead, take your next scheduled regular dose. Do not double your dose at any time.

What are possible side effects from using INHIBACE PLUS?

These are not all the possible side effects you may have when taking INHIBACE PLUS. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• abdominal pain,
• change in the way things taste,
• constipation,
• decreased appetite,
• diarrhea,
• dizziness,
• drowsiness,
• dry cough,
• dry or swollen mouth,
• feeling tired,
• flushing,
• headache,
• itching,
• joint pain,
• muscle cramps,
• nausea,
• pins and needles sensation,
• rash,
• runny or blocked nose,
• sneezing,
• sweating more than usual,
• trouble sleeping,
• upset stomach,
• vomiting,
• weakness.

INHIBACE PLUS 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

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Storage:

Store INHIBACE PLUS tablets between 15-30°C.

Keep container tightly closed.

Keep out of reach and sight of children.

Return all unused or expired tablets to your healthcare professional for safe disposal. Do not throw them away with your household waste.

If you want more information about INHIBACE PLUS:

• Talk to your healthcare professional
• 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) or by calling the importer (Xediton Pharmaceuticals Inc) at 1-888-XEDITON (933-4866).

Last Revised 15 August, 2022

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^PrINHIBACE PLUS^® is a registered trademark of CHEPLAPHARM Arzneimittel GmbH, used under license.

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CHEPLAPHARM Arzneimittel GmbH

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