Napibradine 5 Mg Tablets

Napibradine 5 Mg Tablets

Description:

Napibradine 5 mg tablets are a prescription cardiovascular medicine containing ivabradine, a selective heart rate–lowering agent used in the management of chronic stable angina pectoris and certain chronic heart failure patients. Ivabradine works by selectively inhibiting the cardiac pacemaker if current in the sinoatrial node, slowing the heart rate without affecting myocardial contractility or intracardiac conduction. This targeted action helps reduce the frequency of angina attacks, improve exercise tolerance, and optimize heart rate control in patients with coronary artery disease and normal sinus rhythm. Napibradine 5 mg film-coated tablets are intended for adult use under medical supervision.

Indications:

• Chronic stable angina pectoris in adult patients with coronary artery disease and normal sinus rhythm who are unable to tolerate or have an inadequate response to first-line therapies (such as beta-blockers), as determined by a physician.
• May be used as part of a comprehensive treatment plan to reduce angina episodes and improve exercise capacity in patients with stable coronary artery disease (as per physician’s prescription and local approved indications).
• Heart rate control in selected patients with elevated resting heart rate and chronic coronary artery disease, according to physician guidance.

Active Ingredients / Key Components:

• Ivabradine – 5 mg per film-coated tablet.
• Excipients: The full list of inactive ingredients (excipients, coloring agents, coating materials, preservatives, etc.) is not available in the provided information. Please refer to the official package leaflet for a complete excipient list.

Dosage & Administration / How to Use:

• Napibradine 5 mg tablets must be used exactly as prescribed by a cardiologist or healthcare professional. Do not self-medicate or adjust the dose without medical advice.
• Typical adult dosing regimens for ivabradine in chronic stable angina are individualized based on resting heart rate, clinical response, and tolerability. The exact starting dose, titration schedule, and maximum dose should be determined by the treating physician according to current clinical guidelines and local product labeling.
• Tablets are usually taken orally twice daily (morning and evening), with meals, unless your doctor advises otherwise. Swallow the tablet whole with a glass of water; do not crush or chew.
• If you miss a dose, take the next scheduled dose at the usual time. Do not double the dose to make up for a missed tablet.
• Duration of therapy is long-term and depends on your condition, heart rate response, and medical evaluation. Regular follow-up and heart rate monitoring are essential.
• Use in children and adolescents: Safety and dosing in pediatric patients depend on official approved indications and must only be done under specialist supervision.

Clinical Benefits:

• Helps reduce resting and exercise-induced heart rate through selective inhibition of the cardiac pacemaker if current in the sinus node.
• Decreases the frequency and severity of angina attacks in patients with chronic stable angina pectoris.
• Improves exercise tolerance and physical activity capacity by optimizing heart rate control and reducing myocardial oxygen demand.
• Provides heart rate reduction without negatively impacting myocardial contractility or atrioventricular conduction, preserving overall cardiac function.

Warnings & Contraindications:

• Use only under medical supervision and strictly according to your doctor’s prescription.
• Contraindicated in patients with hypersensitivity to ivabradine or any component of the formulation.
• Contraindicated in patients with acute myocardial infarction, severe hypotension, severe hepatic impairment, cardiogenic shock, sick sinus syndrome, sinoatrial block, or third-degree atrioventricular block (unless a functioning pacemaker is present), and in resting heart rate below the threshold specified in the official labeling.
• Not recommended in unstable angina or acute heart failure unless specifically prescribed by a cardiologist according to approved indications.
• Use with caution in patients with moderate hepatic impairment, conduction disturbances, or a history of syncope or bradycardia.
• Drug interactions: Strong cyp3a4 inhibitors (such as certain azole antifungals, macrolide antibiotics, HIV protease inhibitors, and some calcium channel blockers like verapamil or diltiazem) can significantly increase ivabradine serum concentration and are generally contraindicated or require extreme caution. Always inform your doctor about all medications, supplements, and herbal products you are taking.
• Avoid concomitant use with other medicines that markedly slow heart rate unless closely supervised by a physician.
• Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding. Ivabradine is generally not recommended during pregnancy and lactation unless the potential benefit justifies the potential risk.
• Use with caution in patients with low blood pressure, arrhythmias, conduction disorders, or chronic eye conditions, and in those with a history of visual disturbances.
• May cause transient visual phenomena (phosphenes); caution is advised when driving or operating machinery, especially at night or when sudden changes in light intensity occur.
• Consult your doctor before use if you have liver disease, kidney disease, conduction abnormalities, or are taking other cardiovascular medications.
• Keep out of reach of children.
• This product is a prescription medicine and should not be used to self-diagnose or self-treat heart conditions.

Side Effects:

• Common side effects may include bradycardia (slow heart rate), headache, dizziness, and visual disturbances such as brief episodes of increased brightness or luminous visual phenomena (phosphenes), especially with sudden changes in light intensity.
• Other possible side effects can include fatigue, palpitations, arrhythmias, hypotension, and gastrointestinal discomfort (nausea, abdominal pain). Not all patients will experience these effects.
• Serious side effects may include severe bradycardia, symptomatic hypotension, syncope, or significant cardiac arrhythmias. Seek immediate medical attention if you experience chest pain worsening, severe dizziness, fainting, irregular heartbeat, or sudden vision changes.
• If any side effect persists, worsens, or you notice any unusual symptoms, contact your doctor or pharmacist promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date printed on the pack. Store at the temperature conditions specified on the original packaging and protect from excessive heat and moisture.

Specifications:

• Product form: Film-coated tablet.
• Strength: 5 mg ivabradine per tablet.
• Pack size: 30 film-coated tablets per pack (as per product name napibradine 5 mg 30 f.c. tabs.).
• Intended use: Prescription cardiovascular medicine for adults, as directed by a physician.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.