IMPORTANT SAFETY INFORMATION

ADIPEX-P is contraindicated in patients who are pregnant or nursing and in patients with a history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension), hyperthyroidism, glaucoma, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, agitation, drug abuse history, and during or within 14 days use of monoamine oxidase inhibitors (MAOIs).

The safety and efficacy of combination therapy with ADIPEX-P and any other drug products for weight loss, including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of ADIPEX-P and these drug products is not recommended.

Primary pulmonary hypertension (PPH) and serious regurgitant cardiac valvular disease have been reported in patients receiving a combination of phentermine and fenfluramine or dexfenfluramine. The possibility of an association between PPH or valvular heart disease and the use of ADIPEX-P alone cannot be ruled out. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for possible presence of pulmonary edema.

Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, ADIPEX-P should be discontinued.

ADIPEX-P may impair the ability of a patient to operate machinery or drive a motor vehicle.

Patients should be informed about the risk of abuse and dependence. The least amount of medication should be prescribed or dispensed at one time to minimize possibility of overdosage.

Inform patients that ADIPEX-P should not be used with alcohol.

For some diabetic patients, a reduction in the dose of insulin or other oral hypoglycemic medication may be required.

Exercise caution when prescribing phentermine for patients with even mild hypertension.

Avoid use in patients with renal impairment with eGFR less than 15 mL/min/m2 or end-stage renal disease requiring dialysis.

Adverse events include cardiovascular and central nervous system effects, gastrointestinal disturbances, urticaria, impotence, and changes in libido.

Please read the full Prescribing Information.

PI: Rev. AB 9/2020

ADI-40093 June 2021

For Consumers

What are ADIPEX-P^® (phentermine hydrochloride) tablets or capsules, CIV?

ADIPEX-P is a prescription medicine used for a short period of time (a few weeks), as part of a weight reduction treatment plan that includes exercise, behavioral changes, and a low-calorie diet, for obese people with a body mass index greater than or equal to 30 kg/m2 or a body mass index greater than or equal to 27 kg/m2 and other risk factors (e.g., controlled high blood pressure, diabetes, high cholesterol).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ADIPEX-P?

Use with Other Medicines for Weight Loss. Taking ADIPEX-P with other drugs used for weight loss is not recommended.

Primary Pulmonary Hypertension. A rare but often fatal disease of the lungs, has been reported in patients taking phentermine and phentermine-like products. Tell your doctor if you have shortness of breath, chest or heart pain, or experience fainting or swelling in your lower legs. Contact your doctor immediately if you experience any decrease in the amount of exercise you are normally able to tolerate.

Heart Valve Disease. Serious heart valve problems or disease have been reported in patients taking phentermine or other phentermine-like products for weight loss. The possibility of an association cannot be ruled out.

Tolerance. There is the potential for tolerance to develop, where the same dose might not work as well as it did in the beginning. If this happens, the recommended dose should not be increased, but instead the drug should be discontinued.

Motor Impairment. ADIPEX-P may impair your ability to operate machinery or drive a motor vehicle.

Risk of Abuse and Dependence. Keep ADIPEX-P in a safe place to prevent theft, accidental overdose, misuse or abuse.

Use With Alcohol. Do not use ADIPEX-P with alcohol as it may result in an adverse drug reaction.

Patients with High Blood Pressure. ADIPEX-P may cause an increase in blood pressure. Tell your doctor if you have or have had high blood pressure.

Patients with Diabetes. A decrease in the dose of insulin or other oral hypoglycemic medications may be required. Talk to your physician if you are taking medications for diabetes.

Patients with Renal Impairment. Avoid use if you have impaired kidney function or are on dialysis.

Who should not take ADIPEX-P?

Do not take ADIPEX-P if you:

• Have a history of heart disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled high blood pressure)
• Are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days
• Have thyroid problems (hyperthyroidism)
• Have glaucoma (increased pressure in the eyes)
• Have experienced agitated states or have a history of drug abuse
• Are pregnant or are nursing
• Are allergic to sympathomimetic amines such as phentermine, or any of the ingredients

What should I tell my doctor before taking ADIPEX-P?

Tell your doctor about all of your medical conditions and about all of the medications you are taking, including prescription, over-the-counter medicine, vitamins and herbal treatments.

What are the potential side effects of ADIPEX-P?

Some side effects of ADIPEX-P include pulmonary hypertension, heart disease, palpitations, increased heart rate or blood pressure, insomnia, restlessness, dry mouth, diarrhea, constipation, and changes in sexual drive. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of ADIPEX-P. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.

Please read the full Prescribing Information.

PI: Rev. AB 9/2020

ADI-40094 June 2021