Camoval 5/160

• Hypertension (high blood pressure) - especially in patients whose blood pressure is not adequately controlled on monotherapy
• Patients likely to need multiple antihypertensive agents

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has 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.

Valsartan is an angiotensin II type 1 (AT1) receptor antagonist. It produces its blood pressure lowering effects by inhibiting angiotensin II-induced vasoconstriction, aldosterone release and renal reabsorption of sodium.

Adult Dose:

• Recommended dose: 1 tablet once daily
• Initial therapy: Usually 5/80 mg once daily, titrate up to maximum 10/320 mg as needed
• May be switched from monotherapy when not adequately controlled
• Caution in patients with impaired liver or renal function, CHF, sick-sinus syndrome, severe ventricular dysfunction, hypertrophic cardiomyopathy, severe aortic stenosis
• During second and third trimesters of pregnancy, associated with fetal injury including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death
• Discontinue as soon as pregnancy is detected

Renal Dose: No dose adjustment needed for mild to moderate renal impairment. Contraindicated in severe renal impairment (GFR <30 ml/min).

Hepatic Dose: Caution in hepatic impairment. Contraindicated in severe hepatic impairment, biliary cirrhosis or cholestasis.

• Peripheral edema (swelling of hands, ankles, or feet) - lower incidence with combination than amlodipine alone
• Headache
• Dizziness
• Tiredness
• Palpitations
• Increased potassium level in blood
• Sleepiness
• Taste change
• Flushing (sense of warmth in the face, ears, neck and trunk)
• Upset stomach
• Nasal congestion, sore throat, difficulty swallowing
• Upper respiratory tract infection

[CONSULT YOUR DOCTOR] Amlodipine + Valsartan is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby (Pregnancy Category D - second and third trimesters, Category C - first trimester). When pregnancy is detected, discontinue as soon as possible. Please consult your doctor.

[UNSAFE] Amlodipine + Valsartan 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. Avoid consuming alcohol as it may enhance the blood pressure lowering effect. If you experience ankle or foot swelling, raise your legs while sitting and talk to your doctor if it does not go away.

Serious Warnings:

• Do not use during pregnancy - can cause serious harm to unborn baby
• Caution in patients with severe aortic stenosis, severe obstructive coronary artery disease
• Heart failure patients need monitoring of kidney function and potassium
• Tell your doctor if you go for kidney dialysis
• Caution in hepatic or renal impairment

Amlodipine: Overdosage may cause excessive peripheral vasodilation and marked hypotension. Administration of activated charcoal significantly decreases amlodipine absorption. Hemodialysis is not likely to be of benefit.

Valsartan: Overdose most likely causes peripheral vasodilation, hypotension, tachycardia, or bradycardia. Valsartan is not removed by hemodialysis.

Store below 30°C, protect from light and moisture, and keep out of the reach of children.