INHIBACE PLUS® 5/12.5mg Blister of 28 Tabs
SIZE: 28 Tablets
INDICATIONS: INHIBACE PLUS® is indicated for treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate
DIRECTIONS: INHIBACE PLUS® is not for initial therapy. You must first be stabilized on the individual components (cilazapril and
hydrochlorothiazide) of INHIBACE PLUS®.
INDICATIONS AND CLINICAL USE
INHIBACE PLUS® (cilazapril and hydrochlorothiazide) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. In using INHIBACE PLUS® consideration should be given to the risk of angioedema.
Cilazapril should normally be used in those patients in whom treatment with diuretic or beta-blocker was found ineffective or has been associated with unacceptable adverse effects. INHIBACE PLUS® is not indicated for initial therapy. Patients in whom cilazapril and diuretic are initiated simultaneously can develop symptomatic hypotension.
Patients should be titrated on the individual drugs. If the fixed combination represents the dosage determined by this titration, the use of INHIBACE PLUS® may be more convenient in the management of patients. If during maintenance therapy dosage adjustment is necessary, it is
advisable to use individual drugs. The safety and efficacy of INHIBACE PLUS® in congestive heart failure and renovascular hypertension have not been established and therefore, its use in these conditions is not recommended.
The safety and efficacy of concomitant use of cilazapril with antihypertensive agents other than thiazide diuretics have not been established.
Although clinical experience has not identified differences in response between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
The safety and effectiveness of the use of INHIBACE PLUS® in children have not been established. Therefore, use in this age group is not recommended
INHIBACE® (cilazapril) is contraindicated in:
- Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
- Patients with hereditary/idiopathic angioedema or a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor.
- Patients with anuria
- Patients with ascites
- Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception
- Nursing Women
- Combination with aliskiren-containing drugs in patients with:
- diabetes mellitus (type 1 or type 2)
- moderate to severe renal impairment (GFR < 60 ml/min/1.73 m2)
- Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency as INHIBACE PLUS® contains lactose
- Concomitant use with drug products containing a neprilysin inhibitor (e.g., sacubitril/valsartan). Do not administer INHIBACE PLUS® within 36 hours of switching to or from sacubitril/valsartan, a drug product containing a neprilysin inhibitor
The use of INHIBACE PLUS® (cilazapril and hydrochlorothiazide) is contraindicated during pregnancy. When used in pregnancy, angiotensin-converting enzyme (ACE) inhibitors can cause injury or even death of the developing fetus. Pregnant women should be informed of the potential hazards to the fetus and must not take INHIBACE PLUS® during pregnancy. Patients planning pregnancy should be changed to alternative
antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is detected, INHIBACE PLUS® should be discontinued as soon as possible and, if appropriate, alternative therapy should be started.
Please refer to the product monograph for a complete list of warnings and precautions
INHIBACE PLUS® (cilazapril and hydrochlorothiazide) has been evaluated for safety in 4,102 individuals (3,992 patients treated for essential hypertension and 110 normal volunteers enrolled in pharmacokinetic studies). In controlled clinical trials, 1,097 patients received the combination,
cilazapril and hydrochlorothiazide, 225 received placebo, 437 received cilazapril alone and 340 received hydrochlorothiazide alone.
The most serious adverse reactions reported included hypotension (0.3%) and angioedema (0.1%). The most frequent adverse reactions reported for the cilazapril/hydrochlorothiazide combination were: headache (5.5%), dizziness (3.9%), fatigue (2.8%), coughing (2.6%), and somnolence (1.2%). Discontinuation of treatment due to adverse events occurred in 2.7% of patients.
Adverse events that have occurred have been those that were previously reported with cilazapril or hydrochlorothiazide when used separately for the treatment of hypertension. Please refer to the product monograph for a complete list of adverse reactions
ABOUT THE DISEASE
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FREQUENTLY ASKED QUESTIONS
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
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.
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
- 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
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.
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®