NERKARDOU 5 MG ODF ( BISOPROLOL FUMARATE ) 30 ORAL DISSOLVABLE FILMS

NERKARDOU® Oral Dissolvable Films

Bisoprolol Fumarate Oral Dissolvable Films

Available Strengths: 2.5 mg, 5 mg, 10 mg

Medical Description

NERKARDOU® Oral Dissolvable Films contain bisoprolol fumarate, a highly selective β1-adrenergic receptor blocker (beta-blocker) indicated for the management of cardiovascular diseases, particularly hypertension and chronic stable heart failure (where approved and used according to guideline-directed therapy). The innovative orally dissolving film (ODF) formulation rapidly disintegrates on the tongue without the need for water, providing a convenient option for patients who have difficulty swallowing conventional tablets while maintaining systemic absorption of bisoprolol.

Bisoprolol selectively blocks cardiac β1-receptors, resulting in a reduction in heart rate, myocardial contractility, and cardiac output, thereby decreasing myocardial oxygen demand and lowering blood pressure. Long-term therapy also reduces activation of the sympathetic nervous system and contributes to improved cardiovascular outcomes in appropriately selected patients.

Therapeutic Indications

NERKARDOU® may be prescribed for:

• Hypertension
• Chronic Stable Heart Failure (as part of guideline-directed combination therapy)
• Chronic Stable Angina Pectoris
• Heart rate control in selected patients when clinically appropriate

Treatment should always follow current evidence-based cardiovascular guidelines and physician assessment.

Mechanism of Action

Bisoprolol is a cardioselective β1-adrenergic receptor antagonist that:

• Reduces heart rate (negative chronotropic effect)
• Decreases myocardial contractility (negative inotropic effect)
• Lowers myocardial oxygen consumption
• Reduces blood pressure
• Suppresses excessive sympathetic stimulation
• Improves ventricular filling by prolonging diastole
• Helps reduce the risk of cardiovascular complications associated with uncontrolled hypertension and chronic heart failure.

Clinical Benefits

Evidence from major clinical trials and international guidelines demonstrates that bisoprolol can:

• Effectively lower blood pressure
• Reduce resting and exercise heart rate
• Improve symptoms of chronic heart failure
• Reduce hospitalizations due to heart failure
• Improve exercise tolerance in appropriate patients
• Improve long-term survival in patients with chronic heart failure receiving optimal medical therapy
• Decrease myocardial oxygen demand in chronic stable angina

Advantages of Oral Dissolvable Film

• Dissolves quickly on the tongue without water
• Easy administration for patients with dysphagia
• Convenient for elderly patients
• Portable and discreet dosage form
• May improve medication adherence
• Accurate unit-dose administration

►Adult Use

Hypertension

Typical starting dose:

• 5 mg once daily

Dose may be adjusted according to blood pressure response.

Usual maintenance dose:

• 5–10 mg once daily

Maximum recommended dose:

• 20 mg/day (depending on local prescribing information and clinical judgment)

Chronic Stable Heart Failure

Treatment should be initiated only in clinically stable patients under physician supervision using gradual dose titration.

Typical titration:

• 1.25 mg once daily
• 2.5 mg once daily
• 3.75 mg once daily
• 5 mg once daily
• 7.5 mg once daily
• 10 mg once daily (target maintenance dose in many patients)

Dose increases should occur only if previous doses are well tolerated.

Chronic Stable Angina

Typical dosage:

• 5–10 mg once daily

Dose adjustments depend on heart rate, symptoms, and tolerability.

►Pediatric Use

The safety and efficacy of bisoprolol in children have not been firmly established, and routine pediatric use is not generally recommended unless specifically prescribed by a pediatric cardiologist for specialized indications.

Administration

• Place the oral film on the tongue.
• Allow it to dissolve completely.
• Swallow normally after dissolution.
• Water is generally not required.
• Take once daily, preferably at the same time each day.
• May be taken with or without food.

Contraindications

NERKARDOU® should not be used in patients with:

• Hypersensitivity to bisoprolol
• Severe bradycardia
• Second- or third-degree atrioventricular block (without a pacemaker)
• Sick sinus syndrome
• Cardiogenic shock
• Acute decompensated heart failure
• Severe hypotension
• Severe peripheral arterial disease (in certain patients)
• Untreated pheochromocytoma
• Severe bronchospastic disease requiring caution

Warnings and Precautions

Use with caution in patients with:

• Asthma or COPD
• Diabetes mellitus (may mask symptoms of hypoglycemia)
• Peripheral vascular disease
• Thyroid disorders
• Prinzmetal angina
• Renal impairment
• Hepatic impairment
• Elderly patients
• Planned surgery or anesthesia

Do not discontinue bisoprolol abruptly, as sudden withdrawal may worsen angina, precipitate myocardial infarction, or trigger arrhythmias. Dose reduction should be gradual under medical supervision.

Drug Interactions

Use cautiously with:

• Verapamil
• Diltiazem
• Digoxin
• Clonidine
• Other antihypertensive agents
• Antiarrhythmic drugs
• Insulin and oral antidiabetic medications
• NSAIDs
• Rifampicin
• CYP-modifying drugs with clinical relevance

Common Adverse Effects

Most adverse effects are mild and improve with continued therapy.

Common reactions include:

• Bradycardia
• Fatigue
• Dizziness
• Headache
• Cold hands and feet
• Hypotension
• Gastrointestinal discomfort
• Sleep disturbances

Less commonly:

• Depression
• Bronchospasm (particularly in susceptible patients)
• Worsening heart failure
• Sexual dysfunction

Seek immediate medical attention if severe dizziness, fainting, breathing difficulty, or signs of an allergic reaction occur.

Use During Pregnancy and Breastfeeding

• Use during pregnancy only if the expected maternal benefit outweighs potential fetal risks.
• Beta-blockers may affect fetal growth and neonatal heart rate or blood glucose.
• Breastfeeding decisions should be individualized, as limited data are available regarding bisoprolol excretion into human milk.

Storage

• Store below 25°C.
• Protect from moisture and direct sunlight.
• Keep films in the original packaging until use.
• Keep out of the reach of children.

Monitoring

Patients receiving bisoprolol may require periodic monitoring of:

• Blood pressure
• Heart rate
• Symptoms of heart failure
• Renal function (when indicated)
• Blood glucose in diabetic patients

​Patient Disclaimer

NERKARDOU® (Bisoprolol Fumarate) Oral Dissolvable Films is a prescription medicine and should only be used under the supervision of a qualified healthcare professional. Do not start, stop, or change the dose without consulting your physician. Sudden discontinuation may lead to serious cardiovascular complications. Always follow your healthcare provider's instructions and read the patient information leaflet before use.

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