Important Safety Information

NORLIQVA is a calcium channel blocker for the treatment of:

HYPERTENSION
NORLIQVA is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

CORONARY ARTERY DISEASE

• Chronic Stable Angina
• Vasospastic Angina (Prinzmetal’s or Variant Angina)
• Angiographically Documented Coronary Artery Disease In patients without heart failure or an ejection fraction <40%

NORLIQVA is contraindicated in patients with sensitivity to amlodipine.

NORLIQVA may cause the following conditions.

• Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely.
• Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of NORLIQVA, particularly in patients with severe obstructive coronary artery disease.
• Titrate slowly in patients with severe hepatic impairment.

Most common adverse reactions to amlodipine were edema, dizziness, flushing and palpitation which occurred in a dose related manner. Other adverse reactions not clearly dose-related but reported with an incidence >1.0% are fatigue and nausea.

See full Prescribing Information for other possible side effects with NORLIQVA. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Do not exceed doses greater than 20 mg daily of simvastatin.

• CYP3A Inhibitors: Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.
• CYP3A Inducers: No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
• Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
• Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.

NORLIQVA is an oral solution: 1 mg/mL. Adult recommended starting dose: 5 mg orally once daily with a maximum of 10 mg orally once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg orally once daily. Pediatric starting dose: 2.5 mg to 5 mg orally once daily.