Benadip 5/10

• Hypertension (high blood pressure)
• Patients whose blood pressure is not adequately controlled with either monotherapy

Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals. While the mechanism through which Benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin aldosterone system, Benazepril has an antihypertensive effect even in patients with low-renin hypertension.

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Adult Dose:

• Amlodipine 2.5-10 mg and Benazepril 10-80 mg once daily
• Usually started after monotherapy failure or when Amlodipine causes edema
• Discontinue as soon as pregnancy is detected
• Caution in elderly, renal or hepatic impairment, congestive heart failure, severe aortic stenosis
• Symptomatic hypotension may occur in patients with salt/volume depletion
• ACE inhibitors may cause cholestatic jaundice and fulminant hepatic necrosis; discontinue if jaundice or elevated liver enzymes
• Monitor renal function and serum potassium periodically
• Angioedema of face, extremities, lips, tongue, glottis, larynx and intestinal angioedema may occur
• Persistent dry cough may occur

Renal Dose: Dose adjustment may be needed for renal impairment.

• Ankle swelling
• Headache
• Tiredness
• Palpitations
• Increased potassium level in blood
• Sleepiness
• Cough
• Taste change
• Flushing (sense of warmth in the face, ears, neck and trunk)
• Decreased blood pressure
• Upset stomach

[CONSULT YOUR DOCTOR] Amlodipine + Benazepril Hydrochloride is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby (Pregnancy Category D - second and third trimesters). However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. When pregnancy is detected, discontinue as soon as possible. Please consult your doctor.

[UNSAFE] Amlodipine + Benazepril Hydrochloride may cause side effects which could affect your ability to drive. May cause dizziness, headaches, nausea or tiredness, all of which could affect your ability to concentrate and drive.

Get up slowly when rising from a sitting or lying position. Let your doctor know if you are pregnant or planning for pregnancy.

Caution in patients with severe renal disease, hepatic impairment, high potassium levels, or those undergoing surgery. ACE inhibitor-induced cough should be reported to your doctor. During surgery or anesthesia, hypotension may occur.

Human overdoses with any combination of Amlodipine and Benazepril have not been reported. In scattered reports of human overdoses with Benazepril and other ACE inhibitors, there are no reports of death. Overdose may cause hypotension. Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.