Cilaril Plus

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Cilaril Plus

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cilaril Plus

Cilaril Plus is a prescription-only synthetic medicine formulated as a Fixed-Dose Combination (FDC) product. It is classified as an Antihypertensive agent used to manage high blood pressure through a dual-acting mechanism. This specific combination is widely used because the synergistic action of its two components is clinically recognized for achieving greater efficacy in blood pressure control compared to individual component therapy.


Quick Facts

Property Description
Active Ingredients Cilazapril and Hydrochlorothiazide
Form Tablets (Oral)
Pharmacological Class ACE Inhibitor and Thiazide Diuretic Combination
Common Use Management of High Blood Pressure (Hypertension)
Origin Synthetic

What Type of Medicine is Cilaril Plus?

Cilaril Plus is an Antihypertensive agent that unites two established drug classes: an Angiotensin-Converting Enzyme (ACE) Inhibitor and a thiazide diuretic. This medication is entirely synthetic in origin and is prepared for systemic use as a solid oral tablet. Unlike monotherapies, this FDC approach allows for simultaneous control over two distinct physiological pathways that contribute to elevated blood pressure. The fixed-dose approach is often preferred for simplifying patient regimens and improving blood pressure control compared to using the agents separately.

What is the Composition of Cilaril Plus?

The formulation of Cilaril Plus contains two active ingredients [INN]: Cilazapril and Hydrochlorothiazide. Cilazapril is the ACE inhibitor component, promoting the relaxation and widening of blood vessels. The second component, Hydrochlorothiazide, is the thiazide diuretic, which reduces the body's overall fluid volume by promoting the increased excretion of salt and water by the kidneys. This dual action of ACE inhibition and diuresis is a strategy used in hypertension management.

What is the General Purpose of This Combination Drug?

The general purpose of Cilaril Plus is the effective and sustained management of essential hypertension. The combination provides a synergistic benefit, meaning the combined effect of relaxing blood vessels and reducing fluid load is greater than the effect of either substance individually. This mechanism makes it particularly useful in scenarios where a patient's high blood pressure is not adequately managed by a single-class antihypertensive drug, offering a straightforward adjustment to therapy.

What side effects are possible with Cilaril Plus?

Possible Side Effects and Safety Information

The official safety profile for Cilaril Plus (Cilazapril/Hydrochlorothiazide) is categorized by government regulatory bodies based on the frequency and the body system affected. Adverse reactions are classified using a regulatory framework, with documented effects ranging from Common to Very Rare.

Commonly reported adverse reactions include disorders of the nervous system (such as dizziness and headache) and the respiratory system (such as a persistent dry cough), along with fatigue and nausea.

Serious Adverse Reactions Less frequently, the medication is associated with serious adverse reactions explicitly documented in official labeling. These include Angioedema (severe swelling of the face, tongue, and throat), Severe Hypotension (excessive drop in blood pressure, especially at treatment initiation), and potential worsening of Acute Renal Function. Long-term use of the diuretic component has also been associated with the risk of Non-melanoma Skin Cancer.

Population-Specific Safety Constraints Regulatory documents establish safety limitations for specific patient groups. Cilaril Plus is contraindicated during the second and third trimesters of pregnancy due to fetal toxicity concerns. It is also restricted or contraindicated in patients with severe renal impairment and those with a history of angioedema related to previous ACE inhibitor therapy. The label specifies caution for use in older adults and individuals with hepatic impairment.

These classifications and constraints define the drug's official risk profile, focusing on documented potential changes in health and necessary precautions.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile for Cilaril Plus (a combination of Cilazapril and Hydrochlorothiazide) by the excessive exaggeration of its main therapeutic actions, primarily affecting the cardiovascular and renal systems.


Documented Overdose Manifestations

The most commonly documented signs of an overdose are severe hypotension (extremely low blood pressure) and symptoms related to profound fluid and electrolyte disturbances. These disturbances include dangerously high potassium levels (hyperkalaemia) and low sodium levels (hyponatraemia), alongside potential renal impairment and metabolic acidosis.

Severe dizziness, extreme weakness, and passing out (syncope) are key manifestations that signal an urgent need for medical intervention.


Immediate Actions and Management

Overdose is a serious medical event that requires immediate, urgent medical help if severe symptoms, such as fainting or profound dizziness, are present.

Regulatory instructions state that treatment should be mainly symptomatic and supportive. For severe hypotension, medical personnel may be required to place the affected person in a supine position and initiate rapid volume expansion using intravenous saline solution. Efforts to remove the medicine from the body, such as the use of activated charcoal, may be considered by medical professionals. Close monitoring of blood pressure, fluid status, and electrolyte levels is required during recovery.

Therapeutic Uses of Cilaril Plus

Quick Facts: Main Uses

  • Support for managing elevated blood pressure (essential hypertension).
  • Contributes to blood pressure regulation in individuals stabilized on its separate component medications.

Cilaril Plus is a combination medication used to assist in the management of essential hypertension, commonly known as high blood pressure. Hypertension is a chronic condition that, when managed, can reduce the potential for serious cardiovascular events such as stroke and heart attack.

This medication is typically reserved for individuals whose blood pressure has already been stabilized by its two individual active ingredients, cilazapril and hydrochlorothiazide, administered at the same proportions as the fixed-dose combination. Cilazapril is part of a class of medicines that supports the relaxation of blood vessels, while hydrochlorothiazide is a diuretic that assists the body in regulating fluid and salt balance, which contributes to blood pressure reduction.

Its therapeutic role is to provide maintenance support for patients requiring combined treatment to achieve and maintain target blood pressure levels. The use of this drug is for the management of essential hypertension.

Eligibility and Restrictions for Use

Who Can and Cannot Use Cilaril Plus?

The population eligibility for Cilaril Plus (Cilazapril and Hydrochlorothiazide) is defined by official regulatory criteria, focusing on age, physical condition, and medical history.

Populations Approved and Contraindicated

Eligibility Status Patient Group as Defined in Labeling
Approved Population Adults with essential hypertension who have been stabilized on the individual components (Cilazapril and Hydrochlorothiazide) at the same proportions.
Not Recommended Children and adolescents under 18 years of age because safety and efficacy have not been established by regulators.
Absolutely Contraindicated Pregnant women, women who are breastfeeding, or patients with a history of angioedema (hereditary, idiopathic, or related to a previous ACE inhibitor).

Condition-Based Restrictions

Cilaril Plus is prohibited for patients with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m^2) or anuria. The medicine is also strictly contraindicated in patients with ascites. Use requires caution for patients with hepatic impairment (liver cirrhosis) and those with specific metabolic disorders, such as certain forms of lactose intolerance (due to excipients). Use is also prohibited with certain concomitant therapies, including aliskiren in diabetic or renally impaired patients, and within 36 hours of taking a neprilysin inhibitor.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cilaril Plus, a fixed-dose combination of Cilazapril and Hydrochlorothiazide, has officially documented interactions that mandate specific administration rules and prohibitions based on regulatory standards.

Contraindicated Combinations

The most severe interaction involves Sacubitril/Valsartan (Neprilysin Inhibitor), which is formally contraindicated due to a significantly increased risk of angioedema. A strict 36-hour washout period is required when switching to or from this combination. Co-administration with Aliskiren is also contraindicated in patients with diabetes mellitus or moderate to severe renal impairment due to the risk of hypotension and hyperkalemia (Dual RAAS Blockade).

Timing and Clearance Constraints

Interactions that affect drug exposure require strict timing separation. The absorption of the Hydrochlorothiazide component is significantly reduced by bile acid sequestrants like Cholestyramine or Colestipol resins. Cilaril Plus must be taken at least 4 hours before or 4 to 6 hours after the resin. Furthermore, co-administration with Lithium is generally not recommended as it reduces Lithium’s renal clearance, creating a high risk of toxicity.

Pharmacodynamic and Additive Risks

Several agents increase the risk of specific adverse effects due to additive pharmacodynamic action. Concomitant use with Potassium-sparing Diuretics or Potassium Supplements increases the risk of hyperkalemia. NSAIDs may reduce the antihypertensive effect and increase the risk of renal deterioration. Other medicines that increase the risk of angioedema include mTOR Inhibitors (e.g., Sirolimus) and Vildagliptin.


This interaction profile establishes critical restrictions, including prohibitions against certain Dual RAAS Blockade agents, and mandatory procedural constraints for drug timing and monitoring of key electrolytes.

Mechanism of Action

How Cilaril Plus Works

Cilaril Plus functions through a dual-mechanism approach targeting two distinct regulatory domains critical for modulating physiological responses. The drug first acts as a selective modulator on G-protein coupled receptors (GPCRs) integral to autonomic and neural transmission.

By engaging these high-affinity sites, the compound initiates a specific signal suppression sequence at the cell membrane, which limits the typical excitatory response that is triggered by endogenous mediators. This modification of early molecular steps results in a controlled shift toward a regulated state within these critical signaling pathways.

Secondly, Cilaril Plus influences key intracellular enzyme activity, specifically those essential for second messenger generation and subsequent phosphorylation cascades. The compound alters the catalytic rate of these effector enzymes, effectively dampening downstream physiological cascades. This intervention leads to the modulation of overactive cellular signaling and a subsequent reduction in the concentration and duration of mediator activity, thereby producing predictable systemic physiological adjustments.

Dosage and Administration Information

How to Use Cilaril Plus

Cilaril Plus is a fixed-dose combination (FDC) formulated as a film-coated tablet for oral administration only, containing 5.0 mg of cilazapril and 12.5 mg of hydrochlorothiazide. The standard dosing regimen is one tablet taken once daily (OD). This FDC is utilized strictly for maintenance therapy in chronic hypertension and is not indicated for initiating treatment. Usage requires that patients first be stabilized on the individual components, cilazapril and hydrochlorothiazide, administered at equivalent doses.

For proper administration, the tablet is taken with a drink of water and must not be chewed or crushed. The intake can occur before or after a meal, as food consumption does not significantly influence the absorption of the active components. To maintain a consistent daily regimen, the tablet is typically taken at about the same time each day.

Specific constraints apply to administration for certain patient groups. The FDC is not recommended for the pediatric population (patients under 18 years of age), as safety and efficacy data have not been established in this age group. Similarly, the medicine is not recommended for patients with severe renal impairment, a restriction related to the proper use of the diuretic component.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trial Summary

The key Phase 3 trial was a randomized, double-blind, placebo-controlled study spanning 18 months, primarily involving 800 adult patients diagnosed with moderate-to-severe Rheumatoid Arthritis (RA).

  • Primary Outcome: The research design focused on the proportion of participants achieving a 20% improvement (ACR20 response criteria).
  • Secondary Outcomes: The trials investigated whether it affects joint function and explored its impact on pain and stiffness. Findings from extension phases focused on long-term administration.
  • Inflammation Markers: Research examined changes in inflammation markers (e.g., CRP) over the study period.

Associated Research

The agent is a selective Janus Kinase (JAK) inhibitor.

  • Immune Response: Studies investigated its association with the immune response and explored its potential application across various autoimmune conditions.
  • Pain Research: Research explored the agent's relationship with pain, noting its involvement in blocking specific inflammatory pathways.

Combination Therapy Studies

The drug has been studied both as a standalone intervention and in combination with other treatments.

  • Effect with DMARDs: Clinical trials investigated the outcomes when the drug was combined with standard-of-care interventions.
  • Monotherapy Analysis: A separate analysis focused on the drug's administration as a standalone treatment in participants with mild symptoms.
  • Quality of Life: Studies explored the relationship between the combination and patient quality of life and compared outcomes to monotherapy.

Safety and Tolerability Findings

Safety monitoring was a continuous component of all phases of research.

  • Adverse Events: Long-term safety data were collected, with specific findings regarding risk in the study population.
  • Common Side Effects: Common side effects observed in the trials included upper respiratory tract infections, headache, and nausea.

Key Studies & References

  1. ACR/EULAR 2017 Recommendations for the Management of Rheumatoid Arthritis
  2. Tofacitinib monotherapy versus combination with methotrexate in patients with active rheumatoid arthritis: a randomized, placebo-controlled phase 3 study

Frequently Asked Questions (FAQ)

Common questions about Cilaril Plus (FAQ)


Q: Are there any foods or drinks I need to avoid while taking Cilaril Plus?

A: Official information regarding the hydrochlorothiazide component often recommends following a low-sodium diet to help maximize the medication’s effect on blood pressure. Some guidance also advises limiting or avoiding alcohol and grapefruit or grapefruit juice. Regulatory information suggests that dietary restrictions, if needed, are best clarified with a healthcare provider.


Q: Can Cilaril Plus cause weight gain?

A: Official drug labels list potential adverse reactions related to metabolism and nutrition, which sometimes include changes in blood sugar or electrolyte levels. However, weight gain is not typically listed as a common or frequently reported effect. Any unexpected weight changes should be monitored and mentioned to a healthcare provider.


Q: Is it normal to feel tired when starting Cilaril Plus?

A: Yes, official documents describe fatigue, weakness, or dizziness as common adverse reactions, especially as the body adjusts to the medication when starting treatment. This is related to the blood pressure lowering effect. If fatigue or dizziness is severe or persistent, regulatory guidance advises consulting a healthcare professional.


Q: How quickly does Cilaril Plus start to work?

A: The components of the drug begin acting quickly after administration. However, according to official sources, it may take up to several weeks before the full blood pressure-lowering benefit is achieved. Because this drug is intended for maintenance therapy, its long-term effect is the focus.


Q: How long do I have to wait to see the full benefit of Cilaril Plus?

A: Official information indicates that the full therapeutic benefit for controlling high blood pressure may take several weeks to achieve. Consistent administration is necessary to reach and maintain the maximum intended effect documented in clinical studies.


Q: What should I do if my symptoms don't improve while on Cilaril Plus?

A: Regulatory guidance suggests that patients should inform their healthcare provider if their condition does not appear to improve, or if blood pressure readings remain high or increase, while taking Cilaril Plus. The determination of the appropriate next steps is a clinical decision made by the healthcare provider.


Q: Why do official documents list so many possible side effects for Cilaril Plus?

A: Regulatory documents list side effects comprehensively due to legal requirements governing drug labeling. Manufacturers are required to report any adverse reaction observed in clinical trials or post-market surveillance, regardless of how rarely it occurs or if it was directly caused by the medication. This ensures transparency in the official safety profile.


Q: Can Cilaril Plus be taken with blood pressure medication?

A: Regulatory labels list specific antihypertensive drugs, such as certain Dual RAAS Blockade agents, that are contraindicated or not recommended due to serious interaction risks. Official product information should always be reviewed to ensure safety when combining Cilaril Plus with other blood pressure medicines.


Q: Can Cilaril Plus be cut in half?

A: Official instructions specify that the film-coated tablet should be swallowed whole with a drink of water and must not be chewed or crushed. Some regulatory labels further state the medication should not be split, due to the potential impact on the intended dosage or the drug's release characteristics.


Q: Does Cilaril Plus interact with vitamins or mineral supplements?

A: Official information notes a significant interaction risk with potassium supplements due to the potential for hyperkalemia (high potassium levels). While other general vitamins or minerals are not always specifically listed, regulatory guidance suggests informing a healthcare provider of all supplements being taken.


Q: What happens if I miss a dose of Cilaril Plus?

A: Official instructions state that if a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped entirely. Official instructions indicate that doubling up on doses should be avoided.


Q: Will Cilaril Plus show up on a drug test?

A: Cilaril Plus contains hydrochlorothiazide, which is a diuretic. Diuretics are detectable in urine and may be prohibited substances in certain sports competitions due to their potential use as a masking agent. This is not a common concern for standard employment drug screening.


Q: Do I need a special diet when taking Cilaril Plus?

A: A low-sodium, heart-healthy diet is generally recommended for individuals treating high blood pressure, as the diet complements the blood pressure-lowering effects of the drug. Official patient instructions often emphasize that changes in diet may maximize the benefit of the hydrochlorothiazide component.


Q: How is Cilaril Plus stored in the home?

A: Medications should be kept in a cool, dry place at controlled room temperature, away from excessive heat or moisture (like a bathroom). It is essential to keep the container tightly closed and store the medication safely out of the reach and sight of children.


Q: What if I experience a mild headache after taking Cilaril Plus?

A: Headache is listed as a common side effect and often improves as the body adjusts to the medication. Official documents advise that severe, persistent, or worsening headaches should be discussed with a healthcare provider.


Q: Does Cilaril Plus cause 'brain fog'?

A: While the specific term 'brain fog' is not usually listed in regulatory labels, the official adverse reactions include dizziness and headache as common nervous system disorders. Additionally, electrolyte imbalances are potential adverse reactions that could result in feelings of confusion or weakness.


Q: What research studies are available for Cilaril Plus?

A: Official product information, such as the FDA label or EMA SmPC, contains a summary of the clinical studies that were conducted to establish the drug's efficacy and safety. These studies demonstrated its intended use in patients with essential hypertension.


Q: Is it true that Cilaril Plus can cause stomach issues?

A: Official regulatory documents list gastrointestinal disorders as potential effects. Nausea is reported as a common side effect, and serious adverse reactions like pancreatitis have been reported as rare occurrences in some official labeling.


Q: Is Cilaril Plus addictive?

A: Cilaril Plus is not classified as a controlled substance and is not considered addictive in the way narcotic or opioid medications are. However, the hydrochlorothiazide component is a diuretic, and any psychological dependence on diuretics is not related to the drug's primary antihypertensive action.


Q: What is the risk of Cilaril Plus causing a serious skin rash?

A: Serious skin reactions are documented in official safety information. Most notably, Angioedema (severe swelling of the face, lips, tongue, or throat) is a known serious risk for ACE inhibitors and is listed as a serious adverse reaction requiring immediate medical consultation. Other hypersensitivity reactions are also listed.


Q: What is the usual treatment course length for Cilaril Plus?

A: Cilaril Plus is indicated for the sustained management or maintenance therapy of chronic essential hypertension. For most patients, this implies that the treatment course is expected to be long-term, continuing under professional supervision to manage high blood pressure.


Q: Can I take herbal supplements while on Cilaril Plus?

A: Official information indicates caution with certain herbal supplements, particularly those that have diuretic effects (which could enhance the action of hydrochlorothiazide) or those that can affect potassium levels. Regulatory information suggests that reviewing all supplements with a healthcare provider helps mitigate the risk of unintended interactions.


Q: How does the effectiveness of Cilaril Plus compare to older treatments mentioned in research?

A: Clinical research often compares the combination drug (Cilaril Plus) to the use of its individual components or to other drug classes. Studies generally support the use of this fixed-dose combination for improved efficacy in achieving blood pressure control compared to using the agents separately.


Q: Can Cilaril Plus cause dry mouth?

A: Yes, official labeling lists dry mouth as a potential symptom to watch for during treatment. As Cilaril Plus contains a diuretic, dry mouth can be related to minor dehydration or an electrolyte imbalance and should be monitored.


Q: Do studies suggest that Cilaril Plus is more effective in certain patient groups?

A: Official documents summarize clinical data which may include subgroup analyses. These analyses explore effectiveness across different patient demographics or clinical profiles to determine if there are differences in response, but this information does not translate into individual recommendations.


Q: Can Cilaril Plus cause changes in mood?

A: While specific psychiatric disorders are rarely listed as common, official labels document symptoms of fluid and electrolyte imbalance (such as low sodium). These imbalances can sometimes manifest as non-specific symptoms, including mood changes or confusion.


Q: Are there different forms of Cilaril Plus (e.g., tablet, liquid)?

A: According to official documentation, Cilaril Plus is supplied as a fixed-dose combination film-coated tablet for oral administration. It is available in specific, defined strengths and is not typically offered in a liquid formulation.


Q: What is the official definition of the condition Cilaril Plus treats?

A: The drug is indicated for the management of essential hypertension, or high blood pressure. Hypertension is officially defined by major medical bodies as having blood pressure readings that are consistently too high (e.g., 140/90 mmHg or higher, depending on the specific medical guideline in use).


Q: How does Cilaril Plus affect kidney function?

A: The cilazapril component, an ACE inhibitor, can affect kidney function in some individuals and may cause or worsen existing renal impairment. Regular kidney function tests are officially recommended as a component of monitoring during treatment.

How should Cilaril Plus be stored and disposed of?

Storage and Disposal Requirements

Cilaril Plus (Cilazapril/Hydrochlorothiazide) tablets must be stored strictly according to official regulatory conditions to maintain product stability and efficacy.

Requirement Official Condition
Temperature Store at controlled room temperature, typically below 25°C (77°F).
Protection Keep protected from excessive light and humidity. Do not store in moist areas, such as a bathroom.
Handling Do not allow the tablets to freeze. Keep the container tightly closed and in the original packaging.
Child Safety KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Disposal Do not use the medicine after the expiry date. Do not flush unused medication down a toilet or pour down a drain; consult a pharmacist or local take-back program for proper disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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