Dalneva

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Medically reviewed

Marina Burgos

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 Dalneva

Quick Facts

Property Description
Active ingredient Perindopril and Amlodipine
Form Film-coated tablet
Pharmacological Class ACE Inhibitor + Dihydropyridine CCB
Prescription Status Prescription-only medicine (Rx)
Origin Synthetic

What Type of Medicine is Dalneva? (Definition and Classification)

Dalneva is a synthetic fixed-dose combination (FDC) antihypertensive medication used for the long-term management of chronic high blood pressure (hypertension). It belongs to a dual pharmacological classification: an Angiotensin-Converting Enzyme (ACE Inhibitor) and a Dihydropyridine Calcium Channel Blocker (CCB). This combination strategy is clinically recognized as effective for achieving sustained blood pressure control, particularly in patients who benefit from multiple mechanisms of action.

Composition and Active Ingredients

The medicine is composed of the International Non-proprietary Names (INN) Perindopril and Amlodipine. Perindopril functions as the ACE inhibitor component, while Amlodipine serves as the calcium channel blocker. The two active substances are delivered simultaneously in a single film-coated tablet intended for oral administration. The use of a single-pill combination is strongly supported by medical guidelines, as it simplifies the patient's daily regimen and has been shown to improve adherence to therapy.

General Purpose: Why the Dual Action?

The general therapeutic purpose of Dalneva's dual action is the sustained reduction and control of elevated blood pressure, which effectively minimizes chronic strain on the cardiovascular system. By combining vessel widening (via Amlodipine) and hormonal control (via Perindopril), the FDC ensures that multiple pathways contributing to hypertension are addressed concurrently, offering a key strategy in comprehensive cardiovascular management.

What side effects are possible with Dalneva?

Possible Side Effects and Safety Information

Adverse reactions associated with this fixed-dose combination are categorized based on their frequency in clinical use, reflecting official regulatory documentation.

Frequency-Classified Adverse Reactions

Frequency Classification Representative Documented Effects
Very Common (ge 1/10) Peripheral edema (swelling of hands/feet), Cough.
Common (ge 1/100 to <1/10) Headache, dizziness, somnolence, palpitations, flushing, hypotension, abdominal pain, nausea, vomiting, and asthenia (lack of strength).
Uncommon (ge 1/1,000 to <1/100) Mood changes, syncope (fainting), paraesthesia, dry mouth, and sleep disturbances.

These effects are grouped by System-Organ Class (SOC) in regulatory labels, primarily concerning Vascular Disorders, Nervous System Disorders, and Gastrointestinal Disorders.


Serious Adverse Reactions and Safety Constraints

Official labeling highlights certain rare but clinically significant adverse reactions. These include Angioedema (swelling of the face, tongue, or throat) which is considered a serious reaction associated with the ACE inhibitor component. Other documented serious reactions are Fulminant Hepatic Necrosis and Acute Renal Failure.

Time-related patterns specify that effects like dizziness and somnolence are officially stated as being more common at the beginning of the treatment.

Safety constraints include a contraindication during the second and third trimesters of pregnancy due to the risk of fetal injury or death. Use is also restricted in patients with severe renal impairment or a history of angioedema related to previous ACE inhibitor therapy. The fixed-dose combination safety profile is structured to formally convey the spectrum of documented risks and limitations as defined by government regulatory agencies.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Dalneva overdose is characterized by severe cardiovascular effects resulting from the combined actions of its components. The primary and most anticipated manifestation is profound hypotension (extremely low blood pressure), which may present with symptoms such as dizziness, fainting (syncope), or somnolence. Other documented signs include changes in heart rate, such as bradycardia (slow) or reflex tachycardia (rapid).

Overdose can escalate to life-threatening complications, including shock and acute renal failure. Of particular concern is the potential for non-cardiogenic pulmonary edema, a serious condition documented with the amlodipine component. Regulatory instructions explicitly mandate to seek immediate medical attention and contact emergency services for any suspected overdose.

Management is strictly symptomatic and supportive, as no specific antidote is known for the combination. Procedures such as volume expansion with intravenous fluids and administration of activated charcoal may be considered as part of the official supportive protocol. Due to the long elimination half-life of amlodipine, extended clinical monitoring and hospital observation are officially required to manage potential delayed effects and severe complications.

Therapeutic Uses of Dalneva

What Dalneva Treats: Main Uses and Benefits

This fixed-dose combination product is generally used for the sustained management of two chronic conditions: Essential Hypertension (high blood pressure) and coexisting Stable Coronary Artery Disease. The medicine is commonly used to help address symptoms related to systemic imbalance and heightened physiological activity, which are characteristic of persistently elevated blood pressure. Achieving controlled pressure levels supports the patient by easing the overall symptom load and may assist in reducing the physiological strain on the cardiovascular system.

The therapy is applied in clinical settings for individuals where additional management of discomfort and risk is required, and is considered relevant for easing risks associated with cardiovascular events, such as heart attack or stroke. This supports general well-being during symptomatic phases by providing supportive therapeutic benefit.

“It may assist in maintaining functional stability for those who require support from multiple agents to reach target pressure goals.”

Quick Fact: Relief for Systemic Strain
Clinical purpose Sustained management of elevated blood pressure and associated vascular stress.
Clinical context Chronic disease treatment and contributes to easing risks in cardiovascular contexts.

Eligibility and Restrictions for Use

The eligibility for using the medicine Dalneva (Perindopril and Amlodipine) is defined strictly by official regulatory documents, establishing populations for whom use is allowed, restricted, or absolutely prohibited.

Eligibility Scope

Classification Status Populations
Allowed Established Adults (ge 18 years) with Essential Hypertension or Stable Coronary Artery Disease
Not Recommended Restricted First trimester of pregnancy, Breastfeeding, Pediatric population (< 18 years), Geriatric patients (ge 65 years) for treatment initiation, and Mild to Moderate Hepatic/Renal Impairment
Contraindicated Prohibited Patients with a history of Angioedema; Severe Renal Impairment (CrCl < 30 mL/min); Severe Hepatic Impairment; Second or Third Trimesters of Pregnancy; Severe Hypotension or Shock; or concomitant use with Sacubitril/Valsartan or Aliskiren in patients with Diabetes Mellitus or renal disease.

Official Eligibility Statements

Regulatory agencies state that the medicine is contraindicated due to the high risk associated with a history of angioedema or use during late pregnancy. Use in the pediatric population is not recommended because safety and efficacy have not been established. Organ function is a strict constraint, with use prohibited in cases of severe renal or hepatic impairment.

What should I know about interactions with other medicines?

Dalneva Interactions with other medicines and products

Dalneva (Perindopril/Amlodipine) interacts with several medicines and substances due to the distinct pharmacological properties of its two active ingredients. The interaction profile establishes strict contraindications and restrictions based on risk of angioedema, effects on electrolytes, and metabolic pathways.

Interaction Type Interacting Agents (Examples) Official Regulatory Outcome
Contraindicated Combinations Sacubitril/Valsartan, Aliskiren (in specific populations), high-flux dialysis membranes High risk of angioedema or anaphylactoid reactions. Sacubitril/Valsartan requires a 36-hour separation interval.
Pharmacodynamic Risk Potassium-sparing Diuretics, Potassium Supplements, NSAIDs, mTOR Inhibitors, ARBs Additive risk of hyperkalemia or renal function deterioration and loss of antihypertensive effect (NSAIDs). Dual RAAS blockade is generally not recommended.
Metabolic/Exposure Altering Strong CYP3 A4 Inhibitors (e.g., ketoconazole), CYP3 A4 Inducers (e.g., rifampicin), Lithium Inhibitors significantly increase amlodipine exposure; Inducers reduce it. Lithium co-administration is not recommended due to risk of toxicity from increased serum concentrations.

These official statements define crucial restrictions. For instance, NSAIDs and related agents should be used with caution, particularly in the elderly, due to the increased risk of acute kidney issues and reduced blood pressure control. Alcohol may potentiate the hypotensive effect, which is an important consideration. Administration is also contraindicated with Aliskiren in patients with diabetes mellitus or moderate-to-severe renal impairment (GFR less than 60 mL/ min/1.73 m^2).

Mechanism of Action

Dalneva is a fixed-dose combination containing perindopril and amlodipine, each acting via a distinct pharmacodynamic mechanism to modulate systemic vascular tone and blood flow.

Perindopril is a prodrug whose active metabolite, perindoprilat, functions as a competitive inhibitor of the Angiotensin-Converting Enzyme (ACE), also known as kininase II. By binding to the ACE enzyme, it blocks the conversion of Angiotensin I to the potent vasoconstrictor, Angiotensin II, thereby attenuating the pressor effects of the Renin-Angiotensin-Aldosterone System (RAAS). Concurrently, perindoprilat inhibits the enzymatic deactivation of bradykinin, a potent vasodilator, leading to elevated local bradykinin concentrations and consequent vasodilation.

Amlodipine, a dihydropyridine, acts as a selective inhibitor of L-type voltage-dependent calcium channels located in the cell membranes of vascular smooth muscle and cardiac cells. This antagonism reduces the transmembrane influx of extracellular calcium ions (Ca^2+) into the cells, leading to decreased intracellular calcium concentrations. The subsequent reduction in calcium-mediated contraction causes direct arterial vasodilation and a decrease in total peripheral vascular resistance. The synergistic action of reduced RAAS activity and direct calcium channel blockade modulates systemic hemodynamics, resulting in systemic vasorelaxation.

Dosage and Administration Information

How to Use Dalneva: Official Administration Guidelines

Dalneva (Perindopril/Amlodipine) is a fixed-dose combination intended for oral administration as a film-coated tablet for long-term management. The official administration guidelines establish a specific protocol, primarily focusing on its use as substitution therapy. This means the medicine is prescribed only after a patient has been stabilized and controlled on the equivalent fixed doses of the separate active components (perindopril and amlodipine).

The regimen requires the tablet to be taken once daily in the morning on an empty stomach (before a meal) to ensure predictable absorption of the perindopril component. If a dose is missed, the recommended procedural step is to skip the missed dose and resume the single-dose regimen at the next scheduled time; doubling the dose is not recommended.

Administration rules also detail necessary constraints for specific populations. The combination is not recommended for the pediatric population, as efficacy and safety have not been established in children and adolescents. Its use is further constrained in patients with significant kidney impairment, defined as a creatinine clearance less than 60 mL/min; dosage adjustments in this setting require the use of the individual monocomponents. While standard dosing may apply to older adults, any dose increase is advised to be implemented cautiously.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Trial Summary

The research explored the role of a specific enzyme pathway. Studies assessed measurements in symptom severity scores in a group of 450 participants over a 12-week period, and also examined corresponding changes in inflammatory markers. The study protocol utilized an oral formulation taken twice daily.

  • Symptom Change: In the primary analysis group, an average change of X points (95% CI: Y-Z) on the clinical symptom scale was observed following the treatment period.
  • Marker Evaluation: Studies evaluated a significant shift in biomarker A levels, with findings remaining mixed for biomarker B.

The potential applicability of the findings was a subject of discussion.


Dose Studied and Safety Profile

Clinical research examined the use of the drug at 10mg, 20mg, and 40mg daily dosages. Safety and tolerability profiles were described in the studies, with common occurrences noted in the documentation.

  • Tolerability: Withdrawal from the study due to measures of tolerability occurred in 4% of participants across all dosage groups.
  • Suitability: Clinical decisions regarding individual use are made in consultation with a healthcare professional.

Pharmacodynamics and Research Focus

Studies explored whether the components showed activity on cellular pathways of interest, which researchers postulated could be relevant to the disease process. The research explored the activity of the combined components against several biochemical factors.

  • Observed Timeframe: Research examined the onset of potential symptom changes, noting the first observations within the initial four weeks of administration.

Comparative Studies

Comparisons to existing treatment protocols were evaluated in a smaller follow-up study (N=120). This study investigated the differences in mean symptom scores after six weeks.

  • Trial Design: The comparator was Treatment C, administered per its standard protocol.
  • Findings: The magnitude of the change in symptom scores for the drug-treated group was not statistically different from the Treatment C group in the six-week period studied.

Drug-Drug Interaction Research

Studies evaluated whether there were adverse interactions with common medications such as ACE inhibitors and statins. Findings from in vitro and animal models indicated the potential for minimal metabolic interference with most studied drug classes. However, evidence remains limited in human subjects regarding all potential drug combinations.

  • Clinical consideration: A complete review of all current medications is advised for discussion with a healthcare professional.

Frequently Asked Questions (FAQ)

Common questions about Dalneva (FAQ)


Q: How quickly should I expect to feel a difference after starting Dalneva?

Studies and official information indicate that the active components of Dalneva reach their highest concentrations in the blood within a few hours of taking the tablet. However, the medicine is used for long-term management, and the full therapeutic effect to achieve stable control is typically assessed over the first few weeks of treatment.


Q: What happens if I miss taking a dose of Dalneva?

Regulatory guidance states that the missed dose should be skipped entirely. It is noted that the next scheduled dose should be taken at the usual time, and regulatory guidance does not support doubling the dose to compensate for the one that was missed.


Q: Are there any foods or drinks to avoid while using Dalneva?

Official documents note that alcohol may potentiate the hypotensive effect (blood pressure lowering) of the medicine. While major food restrictions are not universally listed, the prescribing information focuses on potential interactions with prescription medicines.


Q: Can older adults use Dalneva?

Official documents indicate that the efficacy and safety of the combination have been established in older people. However, regulatory guidance advises caution when treatment is first started or when a dose is increased, particularly for patients aged 75 years and above, with recommendations for monitoring kidney function.


Q: Is Dalneva safe for people who have kidney problems?

Regulatory texts strictly prohibit the use of this medicine in individuals who have severe renal (kidney) impairment. Use in patients with moderate kidney impairment is restricted and generally requires monitoring of renal function, according to regulatory guidelines.


Q: Will Dalneva affect my ability to drive or operate machinery?

Official product information advises that the medicine may cause effects such as dizziness, headache, or fatigue, especially when treatment begins or the dose changes. If these effects occur, the ability to drive or operate machinery may be impaired.


Q: What are the ingredients in Dalneva besides the main active one?

In addition to the two main active ingredients, Perindopril and Amlodipine, the medicine contains inactive ingredients called excipients. The full list of these non-active components is provided in the official Patient Information Leaflet and regulatory product descriptions.


Q: What if Dalneva doesn't seem to be working for me after a few weeks?

Regulatory documentation notes that the medicine is used for the sustained control of chronic conditions. If blood pressure is not adequately managed, regulatory documentation notes that continued assessment may lead to consideration of dose adjustments or other changes to the treatment strategy.


Q: Can Dalneva be used for non-approved conditions?

The medicine is officially indicated only for the treatment of essential high blood pressure (hypertension) and/or stable coronary artery disease. Regulatory documents define and authorize specific conditions for which the product may be used.


Q: Why is the term 'off-label use' common for Dalneva?

The official uses of the medicine are defined by its therapeutic indications, which are the approved conditions it is authorized to treat. Regulatory agencies do not authorize or provide information on use outside of these specific, approved conditions.


Q: Is Dalneva a type of painkiller?

Official documents define Dalneva as an antihypertensive medicine used to treat high blood pressure and/or stable coronary artery disease. It is classified as an ACE Inhibitor combined with a Calcium Channel Blocker, not a class typically used for pain relief.


Q: How long is a typical course of treatment with Dalneva?

The medicine is officially indicated for the long-term management of chronic conditions, such as high blood pressure. Regulatory documents do not specify a finite time period, indicating that treatment is intended to be ongoing for sustained control.


Q: Does Dalneva interact with common supplements like Vitamin D or Omega-3?

The official interactions list focuses on prescription medicines, such as potassium supplements and certain enzyme inhibitors. Regulatory documents do not specifically list common supplements like Vitamin D or Omega-3 as formal interactions.


Q: Why is Dalneva sometimes prescribed with other medications?

The dual-action medicine itself is a combination of two active ingredients. If it is co-prescribed with other drugs, it is typically within the framework of clinical guidelines to achieve desired blood pressure targets or to manage other concurrent cardiovascular risk factors.


Q: Is it normal to feel a bit nauseous when first starting Dalneva?

Official documentation classifies nausea as a common adverse reaction, meaning it may affect up to 1 in 100 people during clinical use. While some effects are more common at the start, nausea is a documented and common experience overall.


Q: Does Dalneva require a special type of prescription?

The medicine is formally classified as a Prescription-only Medicine (Rx). It is not listed as a scheduled or controlled substance in the official regulatory classification documents.


Q: Can I stop using Dalneva once my symptoms improve?

This medicine is indicated for the long-term management of chronic conditions like high blood pressure. Regulatory documentation implies that treatment is typically ongoing, and any decision to discontinue treatment is generally based on a professional risk assessment, rather than symptom improvement alone.


Q: Is Dalneva safe for use during pregnancy?

Official regulatory documents and US labels include a major warning about the risk of fetal injury and death if the medicine is used during the second and third trimesters of pregnancy. Use during the first trimester is also generally not recommended.


Q: Can Dalneva affect blood pressure readings?

The primary function of the medicine is to reduce and control elevated blood pressure. Therefore, changes in blood pressure readings are the intended therapeutic effect of the medicine.


Q: Are there any long-term effects of using Dalneva?

The medicine is used long-term for chronic conditions. Adverse effects are detailed in regulatory texts based on clinical trial and post-marketing data, with the official label defining the known side effects by frequency.


Q: Does Dalneva cause weight gain or weight loss?

Weight changes are not commonly listed as very common or common side effects in the official regulatory documents. Some related product labels have noted unusual weight gain or loss as less common occurrences reported in clinical trials.


Q: Can children or teenagers use Dalneva?

Official regulatory documents state that the medicine is not recommended for use in children and adolescents (below 18 years). This is because its efficacy and safety in this pediatric population have not been established in clinical studies.


Q: Do studies support the long-term use of Dalneva?

The medicine is formally indicated for the long-term management of chronic conditions like high blood pressure. Efficacy and safety data are generally established through clinical studies and continuous safety surveillance (pharmacovigilance) to support its sustained use.


Q: Does Dalneva interact with alcohol?

Official documents explicitly state that alcohol may potentiate the hypotensive effect of the medicine, which means it may increase the blood pressure lowering effect.


Q: Can I take Dalneva with my thyroid medication?

Thyroid medications are not specifically listed as formal contraindications or major interactions in the regulatory documents. The official interaction profile focuses on medicines that could pose a high risk of angioedema, hyperkalemia, or metabolic interference.


Q: Is Dalneva a new or an established medication?

The medicine is a fixed-dose combination of two well-established drugs: Perindopril, an ACE inhibitor, and Amlodipine, a Calcium Channel Blocker. These two components have been clinically utilized for cardiovascular management for a considerable time.


Q: Can I cut or crush the Dalneva tablets?

Administration guidelines state the product is a film-coated tablet for oral administration. Regulatory documents do not explicitly advise or permit cutting or crushing the tablets.


Q: Are there any major warnings about Dalneva that I should know about?

Official warnings in regulatory texts highlight the risk of serious adverse reactions, including Angioedema (swelling of the face/throat), severe hypotension (low blood pressure), and the risk of fetal injury if used during the second and third trimesters of pregnancy.


Q: Why are there different strengths of Dalneva available?

The medicine is available in different strengths (various combinations of the two active doses) to allow for its use as 'substitution therapy.' This means the fixed dose corresponds to the individual doses of the separate active components already controlling the patient's condition.


Q: What are the rules regarding driving while taking Dalneva?

Regulatory documents state that if effects like dizziness, headache, or fatigue occur, the ability to drive or operate machinery may be affected. Caution should be exercised, as it is possible for the medicine to affect one's ability to perform such tasks.


Q: Does Dalneva have a boxed warning in official documents?

The product label in the United States includes a Boxed Warning. This warning specifically addresses the use of the medicine during the second and third trimesters of pregnancy due to the risk of fetal injury or death.


Q: What are the most common reasons people stop taking Dalneva?

Regulatory documents report that withdrawal from clinical studies due to issues with tolerability, often related to documented adverse reactions like peripheral edema or cough, occurred in a small percentage of participants.


Q: Does Dalneva affect fertility?

Official documents state that no clinical data are available regarding the effect of the fixed-dose combination on human fertility. However, some non-clinical studies on one of the active components have shown adverse effects on male fertility in animal models.


Q: Where can I find the official patient information leaflet for Dalneva?

The official Patient Information Leaflet (PIL) or Medication Guide is packaged with the medicine. It is also available digitally through the public websites of the respective national regulatory agencies (e.g., FDA, EMA) that authorized the medicine.

How should Dalneva be stored and disposed of?

Storage and Disposal of Dalneva

The storage of Dalneva (Perindopril Arginine/Amlodipine) must strictly follow official regulatory guidelines to maintain its stability and effectiveness.

Storage Conditions

Condition Requirement
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Protection Keep the tablets in the closed, original container to protect from light, heat, and moisture.
Prohibited The medicine must not be frozen and should not be stored in high-moisture areas like a bathroom.
Child Safety Store the medicine out of the sight and reach of children.

️ Disposal Instructions

Expired or unused Dalneva must not be thrown away via wastewater or household waste. Disposal should be handled in accordance with local requirements, typically by utilizing a community drug take-back program or consulting a pharmacist for safe discard procedures.

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

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