BisoHexal

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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 BisoHexal

Property Description
Active ingredient Bisoprolol fumarate
Form Film-coated tablets
Pharmacological class Beta-adrenergic blocking agent (Beta-blocker)
Common use Management of cardiovascular conditions
Origin Synthetic compound

What Type of Medicine is BisoHexal?

BisoHexal is a prescription-only medicine containing the active component Bisoprolol fumarate, classifying it within the major pharmacological class of Beta-adrenergic blocking agents, widely known as beta-blockers. It is a synthetic compound specifically designed for modulating cardiovascular activity. The specific brand formulation is produced by Hexal AG, a German pharmaceutical manufacturer.

The active ingredient is a beta1-selective (cardioselective) adrenoceptor blocking agent. This distinction indicates that the medicine is designed to primarily target the heart with a high degree of precision, a property recognized for providing a more focused effect on cardiac function compared to older, non-selective agents.


Composition and General Purpose of Bisoprolol Fumarate

The composition of BisoHexal centers on the active substance Bisoprolol fumarate, which is bound within a matrix of solid excipients to form the film-coated tablets. This stable salt formulation is provided for the oral route of administration, ensuring consistent absorption.

The general purpose of the medicine is to help the cardiovascular system operate under reduced strain. Bisoprolol achieves this by acting as a sympatholytic agent, which systematically dampens the body's overstimulating responses on the heart. Bisoprolol is recognized as effective in reducing the workload on the heart muscle. This means the medication helps the heart beat more slowly and less forcefully, contributing to the long-term stabilization and efficiency of the circulatory system. This principle is typically applied in the management of chronic conditions where the heart requires long-term, stable support.

Regulatory References

  1. Bisoprolol: MedlinePlus Drug Information

What side effects are possible with BisoHexal?

Possible Side Effects and Safety Information

BisoHexal (bisoprolol fumarate) is generally well-tolerated, but like all medications, it can cause side effects. It is important to discuss any concerns with your healthcare provider.


Common Side Effects (May Affect Up to 1 in 10 People)

The most frequently reported side effects are generally mild and temporary, especially at the start of treatment. These may include:

  • Fatigue and tiredness
  • Dizziness or light-headedness
  • Headache
  • Feeling of coldness or numbness in the hands and feet
  • Gastrointestinal issues like nausea, vomiting, diarrhea, or constipation

Serious Warnings and Contraindications

Do not stop taking BisoHexal abruptly without consulting your doctor, especially if you have coronary artery disease. Sudden discontinuation may acutely worsen your heart condition, potentially leading to a heart attack, severe chest pain (angina), or serious heart rhythm changes.

BisoHexal is generally contraindicated in patients with:

  • Acute heart failure or decompensated heart failure (where symptoms are suddenly worse)
  • Certain severe heart rhythm disturbances (e.g., second- or third-degree atrioventricular block, sick sinus syndrome)
  • Very slow heart rate (bradycardia)
  • Very low blood pressure (hypotension)
  • Severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD)
  • Severe blood circulation disorders in the limbs (e.g., Raynaud's syndrome)

Consult a doctor immediately if you experience signs of a severe reaction, such as shortness of breath, swelling of the face or throat, chest pain, or an irregular heartbeat.

Overdose and Emergency Response

The regulatory documentation for BisoHexal (bisoprolol fumarate) outlines specific signs and actions required in the event of an overdose. Overdosage is primarily characterized by the exaggerated pharmacological effects of beta-blockade on the cardiovascular system.

Documented Overdose Manifestations and Outcomes

The officially documented clinical presentations include marked bradycardia (excessively slow heart rate), severe hypotension (dangerously low blood pressure), and atrioventricular conduction disturbances. Severe, life-threatening outcomes documented in regulatory sources include cardiogenic shock and overt cardiac failure. Non-cardiac manifestations may include bronchospasm, profound fatigue, or progression to seizures and coma. A population-specific consideration noted is the increased risk of hypoglycemia (low blood sugar) in children following an overdose.


Emergency Actions and Supportive Management

Immediate medical attention is required for any suspected overdosage. Individuals must contact emergency services immediately if severe or life-threatening symptoms occur. The regulatory profile notes that no specific antidote is known, thereby mandating specialized symptomatic and supportive treatment. Procedures described in official labeling include the necessity of continuous cardiac monitoring and the potential use of sympathomimetic agents to counter severe cardiovascular depression. Gastric decontamination measures, such as activated charcoal, may also be considered in management.

Therapeutic Uses of BisoHexal

BisoHexal, which contains bisoprolol fumarate, is commonly used to help with conditions characterized by periods of heightened symptoms in the cardiovascular system. Its effects are centered on the heart, where its action helps to slow the rate and reduce the force of cardiac contraction, which contributes to easing the overall workload on the heart.

This medication is considered relevant in clinical settings that involve acute or unstable symptom patterns. The main conditions for which it is prescribed include the management of high blood pressure, the long-term management of chronic stable heart failure, and the easing of stable chronic angina pectoris. These uses are applied in addressing symptom clusters that may become intense or disruptive. This approach helps to manage these conditions, supports patients during episodes of heightened discomfort, and assists with maintaining functional stability.

For patients, this medicine provides support that helps ease the overall symptom burden. It may assist with the systemic imbalance associated with these conditions, supporting general well-being during symptomatic phases.

Quick Fact: Relief for symptoms related to heightened physiological activity

Eligibility and Restrictions for Use

Official Eligibility Rules for BisoHexal

Eligibility Status Official Regulatory Classification
Adult Use Allowed for approved conditions (Hypertension, Chronic Stable Angina, Stable Chronic Heart Failure)
Pediatric Use Use is not recommended; safety and efficacy have not been established in children and adolescents.
Absolute Contraindication Use is prohibited in patients with cardiogenic shock, acute or decompensated heart failure, severe bronchial asthma, severe hypotension, marked sinus bradycardia, second or third degree AV block (without a pacemaker), or severe peripheral arterial occlusive disease.

Condition-Specific Limitations

Eligibility is limited or conditional for patients with certain physiological impairments. In cases of severe renal impairment (e.g., creatinine clearance < 20 mL/min) or severe hepatic impairment, regulatory documents state that the daily dose must not exceed 10 mg. Caution is also required for patients with diabetes mellitus due to the potential for masking signs of hypoglycemia, and for those experiencing strict fasting.

Pregnancy and Lactation Status

The use of BisoHexal during pregnancy is restricted and generally advised only if the benefit is clearly needed. For breastfeeding, use requires caution, and some regulatory guidelines note that other agents may be preferred, reflecting the need to weigh potential risks against benefits.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Bisoprolol fumarate (BisoHexal), based on government regulatory information.


Documented Pharmacodynamic and Pharmacokinetic Interactions

The most significant interactions involve additive effects on heart function and conduction. Co-administration with other beta-blocking agents, including eye drops, is officially contraindicated due to the risk of excessive sympathetic suppression. Similarly, the use of calcium antagonists of the verapamil-type and diltiazem-type is restricted, especially when administered intravenously, as this may lead to profound hypotension and atrioventricular (AV) block.

Interacting Substance/Class Official Interaction Description
Digitalis glycosides (e.g., Digoxin) Additive effect in depressing AV conduction and decreasing heart rate.
Non-steroidal anti-inflammatory drugs (NSAIDs) May reduce the blood pressure-lowering (hypotensive) effect of Bisoprolol.
Insulin and oral antidiabetic medicines Risk of enhanced sugar-lowering effect and masking of hypoglycaemia symptoms (e.g., fast heartbeat).
Rifampin (antibiotic) Increases metabolic clearance, resulting in a shortened elimination half-life of Bisoprolol (Pharmacokinetic interaction).
Monoamine oxidase inhibitors (MAOIs) Restricted use (excluding MAO-B inhibitors) due to potential for enhanced hypotensive effect.

Timing and Population Notes

A specific timing rule applies to the discontinuation of the centrally-acting medicine Clonidine, which must be withdrawn several days after Bisoprolol fumarate therapy is stopped. Additionally, regulatory labels note that in patients with significant renal or hepatic dysfunction, the drug's half-life may be increased, which affects the context of its interactions.

Mechanism of Action

BisoHexal functions as a highly selective antagonist, interfering with mechanisms initiated by overactive sympathetic signaling by occupying beta1-adrenergic receptors . This action prevents natural signaling molecules (catecholamines) from binding and initiating their cascade, thereby directly influencing core regulatory systems where interference with specific signaling pathways is required. By suppressing the downstream molecular steps of beta1 activation in the heart, BisoHexal modifies early molecular steps that influence the heart's natural rhythm and contractility. This results in an altered signaling dynamic within targeted pathways, contributing to a reduction in the rate and force of myocardial contraction and resulting in reduced myocardial workload and oxygen consumption. Furthermore, the drug acts in systems where specific transmitters dominate, such as the beta1 receptors in the kidney which regulate renin release. By engaging mechanisms that influence feedback regulation within this pathway, the drug reduces the signaling intensity of neurohormonal mediator activity, which affects systemic vascular resistance and cardiac output.

Dosage and Administration Information

BisoHexal is provided as film-coated tablets solely for oral administration and is generally taken once daily in the morning, which helps establish a consistent administration pattern. The tablets may be swallowed whole with liquid, and intake is permitted with or without food.


The dosing regimen is separated based on the condition being addressed. For Hypertension and Stable Angina Pectoris, treatment typically initiates at 5 mg once daily, with the potential to adjust the dose upwards to a maximum recommended dose of 20 mg once daily. Conversely, the use for Chronic Stable Heart Failure requires a distinct, highly controlled procedure: therapy starts at a low dose of 1.25 mg once daily, followed by a gradual up-titration over several weeks to months, typically aiming for a maximum of 10 mg once daily.


Special procedural conditions apply to ensure proper use. For patients with severe renal or hepatic impairment (creatinine clearance < 20 mL/min), the daily dose is not to exceed 10 mg. Furthermore, BisoHexal is intended for long-term therapy, and if discontinuation is necessary, it is not to be stopped abruptly. Instead, the protocol involves a gradual dose reduction (tapering) over a defined period to avoid abrupt systemic changes. Use in children and adolescents is not generally recommended due to insufficient data.

Recent Clinical Evidence

Research Evidence / Overview of Studies for BisoHexal

This section outlines the types of scientific research that was studied for BisoHexal (Bisoprolol fumarate) and what those studies explored, focusing only on the available evidence structure and what remains uncertain. It is a neutral summary of research patterns and is not a substitute for medical advice.


Evidence for Use in Chronic Stable Heart Failure

Research for BisoHexal in the context of chronic stable heart failure was evaluated in large, long-term Randomized Controlled Trials ( RCTs) and subsequent systematic reviews, applied in studies examining adults with established stable heart failure characterized by reduced pumping function. Researchers focused on study outcomes that documented events such as survival and rates of hospitalization for heart problems, which are outcomes monitoring physiological strain. Other trials measured changes in functional status and heart pumping ability over defined time intervals. The majority of the key research is primarily centered on patients with reduced pumping function ( HFrEF). Data for certain groups remain insufficient regarding outcomes in heart failure where the pumping function is preserved ( HFpEF).


Evidence for Use in Managing High Blood Pressure

For managing high blood pressure ( hypertension), research was studied for adults using various trial designs, including randomized double-blind trials. Research examined outcomes related to blood pressure reduction and careful monitoring of outcomes reflecting systemic or functional imbalance by measuring changes in heart rate. Studies report how blood pressure and heart rate changes evolved over typical short-term treatment evaluation periods, often around 12 weeks. Research describes patterns observed in the studies related to heart rate measurements. Comparative evidence is lacking for some long-term outcomes against all other first-line BP medication classes.


What is Still Uncertain About BisoHexal Research

The evidence highlights what is known, but also shows what is still uncertain. Long-term effects are not fully established for all endpoints in all indications, particularly where the research relies on less-controlled real-world data. Research findings describe group patterns, not personal outcomes, as study results reflect the specific conditions under which they were conducted.

Key Studies & References

  1. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial
  2. Chronic heart failure in adults: diagnosis and management (NICE Guideline NG106)
  3. PRODUCT MONOGRAPH PrM-BISOPROLOL Bisoprolol Fumarate Tablets 5 mg and 10 mg
  4. Bisoprolol: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about BisoHexal (FAQ)


Q: How quickly does BisoHexal start to work?

According to official product information, the medicine’s concentration typically peaks in the blood within two to four hours after taking a single dose. The maximum effect on the heart rate is generally seen within one to four hours. The medicine is intended to support the typical once-daily dosing regimen.


Q: What is the expected duration of BisoHexal's effect after taking a tablet?

The elimination half-life of the medicine is described as being between nine and twelve hours. This indicates that the effects of a single dose typically persist for up to 24 hours. This sustained action is the physiological basis that supports the once-daily administration pattern.


Q: What happens if a dose of BisoHexal is missed?

If a dose is forgotten, regulatory consumer information suggests taking it as soon as the patient remembers. If it is almost time for the next scheduled dose, information indicates that the missed dose is typically skipped entirely. Official guidelines describe avoiding taking a double dose to compensate for the one that was missed.


Q: Does BisoHexal interact with over-the-counter pain relievers?

Official documents describe interactions with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, which may reduce the intended blood pressure-lowering effect. Official warnings are also described regarding some cold and flu medications, as their ingredients (sympathomimetics) may have their own effects on blood pressure.


Q: Can BisoHexal be taken with cold and flu medications?

Official warnings are described because some cold and flu medications, specifically those containing sympathomimetic agents (such as decongestants), could potentially lead to an exaggerated change in blood pressure. Regulatory content discusses checking the ingredients of such products.


Q: What is the difference between BisoHexal and Bisoprolol?

Bisoprolol fumarate is the name of the active pharmaceutical ingredient, which is the generic chemical substance responsible for the therapeutic effect. BisoHexal, on the other hand, is the registered brand name under which the medication is commercially supplied and marketed by the manufacturer.


Q: Does BisoHexal cause or worsen shortness of breath?

Shortness of breath is a symptom that may be listed as a sign of a serious reaction, potentially indicating the worsening of an underlying heart condition. Severe bronchial asthma and severe chronic obstructive pulmonary disease (COPD) are already stated as specific conditions where the medicine should not be used. Therefore, if shortness of breath occurs, it is listed as a symptom that should be promptly reported to a healthcare provider.


Q: Can BisoHexal interact with medications for depression or anxiety?

Regulatory information notes a restriction on the co-administration of BisoHexal with older types of depression medication called Monoamine Oxidase Inhibitors (MAOIs). This is due to the potential for the combined use to create an enhanced blood pressure-lowering effect.


Q: Is BisoHexal commonly associated with low blood pressure?

As a treatment for hypertension, the medicine is intended to achieve a reduction in blood pressure. However, official safety documentation lists very low blood pressure (severe hypotension) as a serious adverse event and a contraindication for use. This means while a lowering effect is expected, severe hypotension is a warning sign.


Q: Can BisoHexal be taken with other heart medications?

Official regulatory documents list specific heart medications that are contraindicated, such as other beta-blocking agents and certain calcium channel blockers of the verapamil and diltiazem type. These restrictions are in place due to the risk of additive effects on heart rhythm and electrical conduction.


Q: Does BisoHexal affect sleep or cause insomnia?

Sleep disturbances have been reported in both clinical studies and post-market experience. These disturbances can include difficulty sleeping (insomnia) or, less commonly, an increase in drowsiness (somnolence). These effects are generally recognized in the official product information.


Q: Is weight gain a reported effect of BisoHexal?

Weight changes have been reported as a side effect. More importantly, unusual weight gain is also listed as a symptom that is described as needing to be promptly reported to a healthcare provider, as it may be a sign of a more serious condition like worsening heart failure.


Q: Are there common interactions between BisoHexal and herbal supplements?

Official documents note that there is very limited data available regarding the interaction between bisoprolol and herbal remedies or nutritional supplements. Consistent with standard medical practice, official documents describe the importance of informing a healthcare provider of all products, including herbal or non-prescription items, that are currently being taken.


Q: Does BisoHexal interact with alcohol?

Official information indicates that taking the medicine in combination with alcohol may lead to additive effects in reducing blood pressure. This effect can potentially increase the occurrence of symptoms like dizziness, lightheadedness, and fainting.


Q: Is it necessary to have regular blood tests while on BisoHexal?

Regulatory consumer guidance suggests that regular blood tests may be requested by a healthcare provider while a person is taking this medicine. This monitoring helps assess functions like blood cells, as well as the health of the kidney and liver systems.


Q: How is BisoHexal typically eliminated from the body?

The medicine is generally cleared from the body through a balanced process involving both the liver and the kidneys. Approximately 50% of the dose is excreted unchanged via the kidneys, and the remaining 50% is metabolized by the liver into compounds that are no longer active.


Q: Does taking BisoHexal require special precautions before surgery?

Yes, official documents describe the need for special precautions before general anesthesia. The presence of a beta-blocker may interact with anesthetic agents, and it is noted that the anesthetist should be informed that the patient is taking BisoHexal.


Q: Are there specific restrictions on driving while taking BisoHexal?

Side effects such as dizziness, fatigue, or light-headedness may impact one's ability to drive or operate machinery. Regulatory documents discuss the importance of understanding personal reactions to the medication before engaging in tasks that require mental alertness.


Q: Does BisoHexal have an effect on cholesterol levels?

Changes in blood lipids are reported as a potential side effect in the official product documentation. This means that changes in levels of cholesterol and triglycerides have been noted in clinical trial settings.


Q: Are there known issues with BisoHexal and thyroid conditions?

Regulatory information notes that BisoHexal may mask some of the symptoms associated with an overactive thyroid gland (hyperthyroidism). Therefore, official documents note that patients with this condition are managed with caution when using the medicine.

How should BisoHexal be stored and disposed of?

Storage and Disposal Instructions for BisoHexal

The storage and disposal of BisoHexal (Bisoprolol Fumarate) are governed by official regulatory documentation to maintain product stability and safety.

Storage Requirements

Condition Requirement
Temperature Store below 25°C and do not freeze.
Protection Keep in the original package to protect the tablets from light.
Safety Must be kept out of the sight and reach of children.
Stability For certain packaging (e.g., HDPE bottle), the in-use shelf life is 6 months after opening.

Disposal

Any unused or expired BisoHexal must be disposed of in accordance with local requirements. Consult a healthcare professional or pharmacist for instructions on discarding medicine safely.

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

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