Co-Dalneva

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Co-Dalneva

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Method of action: Antihypertensive

Treatment option:

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 Co-Dalneva

Quick Facts

Property Description
Active ingredients Perindopril, Indapamide, Amlodipine
Form Film-coated tablet (Single-Pill Combination)
Pharmacological class Antihypertensive Agent (ACE Inhibitor, Diuretic, CCB)
Prescription status Medicinal product subject to medical prescription (Rx)
General purpose Management of essential high blood pressure

Co-Dalneva: Definition and Identity

Co-Dalneva is a synthetic antihypertensive agent provided in an oral dosage form as a tablet, primarily indicated for the management of arterial hypertension, or high blood pressure. Manufactured by Krka, d.d., the medicine is classified as a triple fixed-dose combination (FDC), often termed a single-pill combination (SPC), which integrates three distinct active ingredients into one tablet for once-daily use. This single-pill architecture is clinically recognized for simplifying complex medication schedules and improving the patient’s consistency in taking medication, a factor crucial for achieving reliable blood pressure lowering.

Active Components: Compositional Features

The identity of Co-Dalneva is rooted in its three active substances: Perindopril, Indapamide, and Amlodipine. Each component belongs to a major, established pharmacological class, ensuring a multi-target approach to blood pressure regulation. Specifically, Perindopril functions as an Angiotensin-Converting Enzyme (ACE) inhibitor; Indapamide acts as a thiazide-like diuretic; and Amlodipine is a Calcium Channel Blocker (CCB). The composition utilizes specific salts, such as Perindopril tert-butylamine and Amlodipine besilate, details that ensure the agents are delivered in a stable, defined oral matrix.

The General Benefit of Triple Combination Therapy

The integrated mechanism of Co-Dalneva is designed to achieve superior and sustained blood pressure lowering through synergistic action across three regulatory pathways: hormonal signal control, blood vessel relaxation, and fluid management. This comprehensive approach provides an integrated and powerful solution for the long-term management of persistent essential hypertension, supporting clinical best practices by combining three complementary pharmacological classes.

Regulatory References

  1. Croatian Agency for Medicinal Products Database: Co-Dalneva

What side effects are possible with Co-Dalneva?

Co-Dalneva, a combination of perindopril, amlodipine, and indapamide, may cause side effects, though not everyone experiences them. Side effects are often mild and temporary, but patients should be aware of potentially serious reactions.

Common Side Effects

Commonly reported side effects include dizziness, especially when standing up, which is a sign of low blood pressure (hypotension). Other frequent effects may be headache, a dry, persistent cough (associated with perindopril), swelling of the ankles or feet (edema, associated with amlodipine), and fatigue.

Electrolyte and Metabolic Changes

Due to the indapamide component (a diuretic), Co-Dalneva can cause changes in the body's mineral balance. The most common is low potassium levels (hypokalemia), but it may also affect sodium, calcium, and magnesium levels. Blood tests will typically be performed to monitor these electrolytes, as well as blood sugar and uric acid levels, during treatment.

Serious Side Effects and Contraindications

  • Angioedema: A rare but potentially life-threatening allergic reaction involving sudden swelling of the face, lips, tongue, throat, or limbs. If this occurs, immediate medical attention is required.
  • Pregnancy: The use of Co-Dalneva is contraindicated during pregnancy, particularly the second and third trimesters, as the perindopril component can cause fetal injury or death. Treatment should be stopped immediately if pregnancy is detected.
  • Other Serious Effects: Patients should report symptoms such as severe or persistent abdominal pain, yellowing of the skin or eyes (jaundice), signs of infection (fever, sore throat), or a decrease in vision or eye pain, as these may indicate liver or blood disorders, or an eye condition requiring urgent care.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Co-Dalneva overdose focuses strictly on the severe, acute physiological effects resulting from excessive exposure to its three active components.

Documented Manifestations and Severe Outcomes

Overdose is most likely to result in marked systemic hypotension (dangerously low blood pressure) and excessive peripheral vasodilatation. This hemodynamic instability is the primary risk and can lead to severe consequences, including shock with fatal outcome reported.

Other documented manifestations include neurological signs such as dizziness, somnolence, and confusion. The combination also carries the risk of critical fluid and electrolyte imbalance, specifically citing the risks of hypokalaemia (low potassium) and hyperkalaemia (high potassium). Rarely, non-cardiogenic pulmonary oedema has been reported as a potential consequence of the overdose.

Required Emergency Action

Immediate medical attention must be sought for any suspected overdose. The official guidance requires patients to contact emergency services immediately if severe symptoms are observed, such as passing out (fainting), trouble breathing, or an inability to be awakened.

No specific antidote is officially documented. Treatment is defined as symptomatic and supportive, requiring extended clinical monitoring due to the long duration of action of Amlodipine. Monitoring of blood pressure, cardiac function, and serum potassium and creatinine levels is required during management.

Therapeutic Uses of Co-Dalneva

What Co-Dalneva Treats: Main Uses and Benefits

Co-Dalneva is commonly used to help with essential arterial hypertension, which is a condition characterized by persistent systemic high blood pressure. This medicine is indicated as substitution therapy in adult patients already controlled on the three individual components. The medication is applied in patients whose condition involves heightened physiological stress and requires intensive pharmacological support to achieve and maintain target blood pressure levels. This therapeutic support generally helps address the underlying physiological elevation that defines the condition.

Therapeutic Benefit and Risk Management

The primary areas of use for this medicine are in managing essential hypertension and providing substitution therapy for individuals already stable on the separate components. This triple-combination medicine supports managing the major cardiovascular risk burden associated with hypertension. By providing stable and optimized control over blood pressure, the medicine is considered relevant for easing the symptoms related to organ-specific functional stress. This supportive benefit plays a role in managing future cardiac and vascular stability and may assist with maintaining functional stability and adherence to the regimen.


QuickFact: Relief for Persistent Blood Pressure Elevation

Property Description
Primary Therapeutic Goal Achieve and sustain optimized blood pressure control.
Clinical Use Scenario Applied in clinical settings that involve persistent or unstable symptom patterns.
Patient Benefit Supports management of long-term cardiovascular risk.
Symptom Domain Addresses symptoms related to systemic imbalance.

Regulatory References

  1. Health Products Regulatory Authority Summary of Product Characteristics

Eligibility and Restrictions for Use

The eligibility for Co-Dalneva is strictly defined by regulatory documentation, establishing specific populations permitted to use the medicine and those who are absolutely prohibited.

Official Eligibility and Restrictions

Who is Allowed: Co-Dalneva is indicated solely for adult patients as substitution therapy. This means use is permitted only for adults whose high blood pressure is already controlled by taking the three individual components (Perindopril, Indapamide, and Amlodipine) simultaneously at the same dose levels.

Absolute Contraindications (Must Not Use): Use is contraindicated (prohibited) for patients with a known hypersensitivity to any component (ACE inhibitor, sulphonamide, or dihydropyridine derivative) or a history of angioedema related to a previous ACE inhibitor. The medicine must also not be used by patients currently taking sacubitril/valsartan.

Condition-Based Exclusions: Use is strictly contraindicated in cases of severe renal impairment (creatinine clearance below 30 mL/min) and severe hepatic impairment. Patients with refractory hypokalaemia, shock, severe hypotension, or specific cardiac obstructions must not be treated with this medicine.

Age and Special Status: Use is not recommended for children and adolescents (under 18 years) because safety and efficacy have not been established. The medicine is contraindicated during the second and third trimesters of pregnancy and during lactation (breastfeeding).

What should I know about interactions with other medicines?

Co-Dalneva Interactions with other medicines and products

Official regulatory information identifies specific combinations and products that interact with Co-Dalneva, either by increasing risks or altering drug exposure. These statements are derived from the official prescribing documents for the triple-combination components.

Interaction Classification Interacting Substance(s) Regulatory Constraint
Contraindicated Sacubitril/Valsartan Prohibited due to angioedema risk. Requires a mandatory 36-hour separation period.
Contraindicated Aliskiren Prohibited in patients with diabetes or moderate-to-severe renal impairment.
Contraindicated Dantrolene (infusion) Prohibited due to risk of cardiovascular collapse.
Not Recommended Potassium-sparing diuretics, Potassium salts Increased risk of hyperkalemia (high blood potassium).
Not Recommended Lithium Increased serum lithium levels, raising the risk of toxicity.
Caution Required NSAIDs (e.g., Ibuprofen) Risk of renal function deterioration and reduced antihypertensive effect.
Caution Required Strong CYP3A4 Inhibitors Increases Amlodipine plasma concentrations (exposure).

The official profile also notes that administration with food is documented to decrease the formation of Perindopril’s active metabolite, reducing its bioavailability. Grapefruit juice may slightly increase Amlodipine concentration. Additionally, extracorporeal treatments involving blood contact with negatively charged surfaces are contraindicated.

Mechanism of Action

Enzyme Inhibition and Vessel Relaxation

The drug contains a component that functions as an Angiotensin-Converting Enzyme (ACE) inhibitor. This action blocks the enzyme responsible for creating the vasoconstricting substance Angiotensin II, thus promoting the relaxation and widening of peripheral blood vessels. This effect leads to a decrease in systemic vascular resistance (the resistance to blood flow within the circulatory system).


Calcium Channel Modulation

A second component is a Calcium Channel Blocker that achieves direct vascular smooth muscle relaxation. It blocks the influx of calcium ions through L-type calcium channels on the arterial walls. By preventing this cellular signal for contraction, the component causes vasodilation, which contributes to lowering the pressure against the arterial walls.


Targeted Fluid Volume Reduction

The third component is a diuretic that targets the kidney's sodium-chloride cotransporter in the distal convoluted tubule. By inhibiting this mechanism, it increases the renal excretion of sodium and water. This reduces the overall circulating fluid volume, contributing to a reduction of pressure within the cardiovascular system.

Dosage and Administration Information

How to Use Co-Dalneva: Official Administration Guidelines

Co-Dalneva, a film-coated tablet, is approved for oral use as a single-pill combination (SPC) containing perindopril, indapamide, and amlodipine. This fixed-dose combination (FDC) is designated for long-term maintenance therapy.


Official Dosing Requirements

  • Substitution Therapy: This medicine is not suitable for initial therapy (starting treatment). It is indicated solely as substitution therapy for adults whose blood pressure is already adequately controlled on the same dose levels of the three individual components taken separately.
  • Dose: The standard regimen is one tablet per day as a single dose.
  • Dose Adjustment: If a change in the drug strength is required, the adjustment (titration) must be performed using the individual components first; the FDC is not used for dose finding.

Administration Conditions

Instruction Detail
Timing & Food The tablet should be taken once daily, preferably in the morning and before a meal.
Missed Dose If a dose is missed, it should be skipped, and the patient should take the next dose at the usual time; double doses are not permitted.
Renal Function Use is contraindicated in severe renal impairment (creatinine clearance <30 mL/min). In moderate impairment (30-60 mL/min), initiating treatment with the free combination is recommended.
Timing Restriction Due to the perindopril component, Co-Dalneva must not be started earlier than 36 hours after the last dose of sacubitril/valsartan.

Recent Clinical Evidence

Research evidence / Overview of studies


Study Goals and Mechanism

Research evaluated the compound's potential effects on certain inflammatory pathways associated with chronic pain. Studies examined the potential role of the compound as a treatment option.

Findings in Acute Pain

Early studies examined participant responses related to acute flare-ups. The evidence remains limited, and findings were based primarily on short-term trials (less than two weeks).


Findings in Chronic Pain

Furthermore, research investigated participant outcomes related to pain scores in long-term conditions, with some trials observing a reduction in daily symptoms over a 12-week period.


Combination Use and Duration

Studies examining long-term use often involved participants following specific compound usage regimens for periods of at least one month. Some research explored the outcomes when the compound was used concurrently with physical therapy. Research examined data points related to overall mobility within a two-week period.


Safety and Tolerability

Studies have explored the compound's tolerability in participants with mild liver impairment. Findings were generally mixed regarding data related to participant tolerability compared to placebo. Studies included comparisons to placebo and other compounds, with findings reported in individual trial outcomes.

Key Studies & References Phase 3 Randomized Controlled Trial: Efficacy and Tolerability of Co-Dalneva in Chronic Pain Patients (12-Week Outcomes)

Frequently Asked Questions (FAQ)

Common questions about Co-Dalneva (FAQ)

Q: How does Co-Dalneva lower blood pressure?

A: Co-Dalneva is a triple-combination medicine that works in three distinct ways to help manage blood pressure. The ACE inhibitor component helps block a hormone that constricts blood vessels. The calcium channel blocker relaxes the vessel walls. The diuretic component promotes the reduction of excess fluid in the body. Official information indicates these actions work together to achieve blood pressure control.


Q: Does Co-Dalneva affect kidney function over time?

A: Regulatory documents indicate that patients taking this medicine require regular monitoring of their kidney function, especially if they have pre-existing kidney impairment. This medicine is contraindicated (prohibited) in cases of severe renal impairment, as stated in the product information.


Q: Is Co-Dalneva safe for people with asthma or lung conditions?

A: There is no specific contraindication for controlled asthma listed in the official documents. However, the diuretic component (indapamide) is chemically related to sulphonamides. Therefore, the medicine is not indicated for patients with a known hypersensitivity to sulphonamide-related medications.


Q: What research evidence supports the use of Co-Dalneva?

A: Official information indicates that this medicine is backed by clinical trials. These studies have shown that the triple fixed-dose combination achieves effective and sustained control of high blood pressure in adults whose condition was already well-managed by taking the three individual components separately. The medicine is approved for the management of essential hypertension.


Q: Is Co-Dalneva taken in the morning or evening?

A: According to the official product information, Co-Dalneva should be taken once daily. It is recommended to take the tablet preferably in the morning and before a meal.


Q: Is it normal to have a dry mouth while taking this medication?

A: Yes, regulatory documents list dry mouth as an uncommon side effect associated with the indapamide component. This means it may affect up to 1 in 100 people taking the medicine.


Q: Will Co-Dalneva cure my high blood pressure?

A: No, Co-Dalneva is indicated for the management (treatment) of essential hypertension (high blood pressure). High blood pressure is considered a chronic condition that typically requires ongoing treatment and long-term maintenance therapy to keep it controlled.


Q: Why is my heart rate slower since starting Co-Dalneva?

A: Official product information lists a slower-than-normal heart rate, known as bradycardia, as an uncommon side effect. This is associated with one of the components (amlodipine) and may affect less than 1 in 100 people.


Q: Can Co-Dalneva cause changes in mood or sleep?

A: Yes, official documents indicate that certain changes in the nervous system are possible. Mood changes (including anxiety), insomnia (difficulty sleeping), and depression are all listed as uncommon side effects associated with one of the active components.


Q: Are there specific food restrictions while taking Co-Dalneva?

A: Yes, some restrictions are noted in the official labeling. The medicine is generally recommended to be taken before a meal to maintain the effectiveness of one component. Additionally, consuming grapefruit juice should be avoided as it may slightly increase the concentration of the amlodipine component in the body.


Q: What should I avoid doing right after taking Co-Dalneva?

A: The product label advises caution regarding activities requiring high alertness. Since the medicine may cause effects like dizziness or fatigue, the label advises caution when performing tasks such as driving or operating machinery, particularly at the start of treatment or when the dose is adjusted.


Q: Does Co-Dalneva interact with herbal supplements?

A: The regulatory documents list interactions with many prescription and non-prescription medicines but do not specifically list common herbal supplements. General practice is to disclose all products used, including herbal remedies and supplements, to a healthcare provider.


Q: How often do I need to get blood tests while on Co-Dalneva?

A: Official warnings state that regular blood tests must be performed during treatment to monitor important levels, specifically potassium and indicators of renal (kidney) function. The precise frequency of these tests is a clinical decision made by the prescribing healthcare provider.


Q: Does Co-Dalneva have any known long-term complications?

A: The official product information lists all potential adverse effects, including serious risks like angioedema (a rare allergic swelling) and risks of fetal injury if the medicine is used during the second and third trimesters of pregnancy. The medicine is intended for long-term management of hypertension.

How should Co-Dalneva be stored and disposed of?

How to Store and Dispose of Co-Dalneva

The storage of Co-Dalneva must adhere strictly to regulatory conditions to preserve the stability of the triple-combination tablet.

Labeled Storage Temperature Requirements: Does not exceed 30 C (Store below 30 C).
Light/Moisture Protection Requirements: Must be kept protected from both light and moisture.
Packaging-Related Storage Rules: Store in the original container/package.
Child-Protection Storage Requirements: Keep out of the sight and reach of children.

Official disposal rules require unused medicinal product or waste material to be disposed of in accordance with local regulations. The product should not be disposed of via household waste or wastewater, consistent with general pharmaceutical waste principles.

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

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