Inhibace Plus® 5/12.5mg, 28 Tabs

DIN

02181479

Size

28 Tablets

SKU

4260095682208

Directions

Dose of INHIBACE PLUS® must be individualized. Please consult your doctor

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INFORMATION FOR THE PATIENT

What the medication is used for:

INHIBACE PLUS® lowers high blood pressure.

INHIBACE PLUS® contains a combination of 2 drugs: cilazapril and hydrochlorothiazide.

  • Cilazapril is an angiotensin-converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’. It lowers blood pressure.
  • Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This lowers 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 it does:

INHIBACE® 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 INHIBACE regularly even if you feel fine

When it should not be used:

Do not take INHIBACE PLUS® if you:

  • Are allergic to cilazapril or hydrochlorothiazide or to any non-medicinal ingredient in the formulation.
  • Are allergic to any other blood pressure medicines of the same class (called ACE inhibitors).
  • Are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
  • 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.
  • Have difficulty urinating or produce no urine.
  • Have a build up of fluid in your abdomen (ascites).
  • Are taking a medicine containing a neprilysin inhibitor (e.g., sacubitril/valsartan), as the risk of angioedema is increased. Do not take INHIBACE PLUS® for at least 36 hours before or after you take sacubitril/valsartan, a medicine used to treat heart failure.
  • Are pregnant or intend to become pregnant. Taking INHIBACE PLUS® during pregnancy can cause injury and even death to your baby.
  • Are breastfeeding. INHIBACE PLUS® passes into breast milk.
  • Are lactose intolerant or have one of the following rare hereditary diseases:
    o Galactose intolerance
    o Lapp lactase deficiency
    o Glucose-galactose malabsorption because lactose is a non-medicinal ingredient in INHIBACE PLUS®.
  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ) and you have diabetes or kidney disease.

What the medicinal ingredient is:

Cilazapril and hydrochlorothiazide

What the nonmedicinal ingredients are:

Cornstarch, hydroxypropyl methylcellulose, lactose, red iron oxide, sodium stearyl fumarate, talc, and titanium dioxide.

What dosage forms it comes in:

Tablets; 5 mg cilazapril and 12.5 mg hydrochlorothiazide, packaged in blisters of 28 tablets

ABOUT THE DISEASE

Hypertension:

Blood pressure is the pressure or force of blood against the walls of blood vessels as it circulates. Blood pressure is most commonly measured in the brachial artery of the arm, and it is expressed as two numbers. Systolic blood pressure (the top or higher number) is the pressure in the artery when the heart contracts and diastolic blood pressure (the bottom or lower number) is the pressure in the artery when the heart relaxes between beats. Blood pressure normally changes throughout the day, but when either systolic or diastolic pressure stays constantly high it is called high blood pressure (hypertension).

  • We refer to optimal blood pressure if systolic blood pressure is below 120 mmHg and diastolic blood pressure is below 80 mmHg.
  • Normal blood pressure is systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 85 mmHg.
  • Normal-high blood pressure is defined as systolic blood pressure 130-139 mmHg and/or diastolic blood pressure 85-89 mmHg.
  • High blood pressure is systolic blood pressure at or above 140 mmHg or diastolic blood pressure at or above 90 mmHg. Individuals with high blood pressure have hypertension. When measured at home, blood pressure above 135 mmHg systolic or 85 mmHg diastolic pressure is considered high
  • Hypertension for individuals with diabetes or chronic kidney disease is defined as blood pressure over 130 mmHg systolic or over 80 mmHg diastolic.

Congestive Heart Failure

Heart failure, sometimes known as congestive heart failure, occurs when your heart muscle doesn’t pump blood as well as it should. Certain conditions, such as narrowed arteries in your heart (coronary artery disease) or high blood pressure, gradually leave your heart too weak or stiff to fill and pump efficiently.

Not all conditions that lead to heart failure can be reversed, but treatments can improve the signs and symptoms of heart failure and help you live longer. Lifestyle changes — such as exercising, reducing sodium in your diet, managing stress, and losing weight — can improve your quality of life.

One way to prevent heart failure is to prevent and control conditions that cause heart failures, such as coronary artery disease, high blood pressure, diabetes, or obesity.

Diagnosis:

  • Blood test
  • X-rays
  • Magnetic Resonance Imaging (MRI)
  • Echocardiogram
  • Electrocardiogram (ECG)
  • Ejection fraction
  • Stress test
  • Cardiac catheterization

PATIENT RESOURCES

PRODUCT MONOGRAPH

Click here to download the Product Monograph

 

PRESCRIBING INFORMATION

Click here to download the prescribing information

 

FREQUENTLY ASKED QUESTIONS

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

How should I use this medication?

INHIBACE PLUS® is not for initial therapy. You must first be stabilized on the individual components (cilazapril and hydrochlorothiazide) of INHIBACE PLUS®. If your dosage matches the dosages in INHIBACE PLUS®, your doctor may prescribe INHIBACE PLUS® taken once a day (instead of each
component as a separate pill).

Take INHIBACE PLUS® exactly as prescribed. It is recommended to take your dose at about the same time every day.

INHIBACE PLUS® tablets must not be chewed or crushed and should always be taken with a full glass of water.

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

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.

What happens if I miss a dose?
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.
What form(s) does this medication come in?
Each pale red, oval-shaped, single-scored, film-coated tablet, engraved “CIL+” on the one half and “5+12.5” on other, contains 5 mg of cilazapril and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: cornstarch, hydroxypropyl methylcellulose, iron oxide, lactose, red iron oxide, sodium stearyl fumarate, talc, and titanium dioxide
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 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
What side effects are possible with this medication?
Side effects may include:

  • Dizziness, headache, trouble sleeping
  • Drowsiness, feeling tired, weakness
  • Dry cough, dry or swollen mouth
  • Runny or blocked nose, sneezing
  • Rash, itching
  • Abdominal pain, upset stomach, decreased appetite
  • Diarrhea, constipation, nausea, vomiting
  • Change in the way things taste
  • 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.

INHIBACE PLUS® can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results

Are there any other precautions or warnings for this medication?
INHIBACE PLUS® contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing nonmelanoma 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. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
  • Limit your exposure to the sun and to indoor tanning.
    Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.
  • Talk to your doctor immediately if you get more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) during the treatment.
What other drugs could interact 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.

Please refer to the patient leaflet for a comprehensive list of drugs that may interact with INHIBACE PLUS®


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