17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence

Advise patients that methylphenidate hydrochloride oral solution is a federally controlled substance, and it can be abused and lead to dependence [see Drug Abuse and Dependence (9.1, 9.2, and 9.3)]. Instruct patients that they should not give methylphenidate hydrochloride oral solution to anyone else. Advise patients to store methylphenidate hydrochloride oral solution in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired methylphenidate hydrochloride oral solution by a medicine take-back program if available [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9), How Supplied/Storage and Handling (16)].

Serious Cardiovascular Risks

Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, and stroke with methylphenidate hydrochloride oral solution. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Blood Pressure and Heart Rate Increases

Instruct patients that methylphenidate hydrochloride oral solution can elevate blood pressure and heart rate [see Warnings and Precautions (5.3)].

Psychiatric Risks

Advise patients that methylphenidate hydrochloride oral solution, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Priapism

Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5)].

Circulation Problems in Fingers and Toes (Peripheral Vasculopathy, Including Raynaud’s Phenomenon)

Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride oral solution. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Suppression of Growth

Advise patients that methylphenidate hydrochloride oral solution may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions (5.7)].

Pregnancy Exposure Registry

Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to methylphenidate hydrochloride oral solution during pregnancy [see Use in Specific Populations (8.1)].

Manufactured in India by:

Alkem Laboratories Limited

H.O.: ALKEM HOUSE,

Senapati Bapat Marg, Lower Parel,

Mumbai – 400 013, INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: October, 2021