RELEXXII (Page 8 of 9)

17 PATIENT COUNSELING INFORMATION

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

Priapism

Advise patients, caregivers, and family members 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 (5.4)].

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud’s Phenomenon]

Instruct patients beginning treatment with RELEXXII ® 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 RELEXXII ® .

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

General Considerations

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for RELEXXII ® . The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Administration Instructions

Patients should be informed that RELEXXII ® should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.

Driving or Operating Heavy Machinery

Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Patients should be cautioned accordingly until they are reasonably certain that RELEXXII ® does not adversely affect their ability to engage in such activities.

Distributed by:

Vertical Pharmaceuticals, LLC

Alpharetta, GA 30005

1-770-509-4500

www.verticalpharma.com

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200301-03

Patent numbers:

US 9,855,258

US 9,827,234

US 9,707,217

US 10,265,308

US 10,695,336

MEDICATION GUIDE

RELEXXII ® ([RE-LEX-EE])

(methylphenidate hydrochloride) extended-release tablets, USP CII

Read the Medication Guide that comes with RELEXXII ® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with RELEXXII ® .

What is the most important information I should know about RELEXXII ® ?

The following have been reported with use of methylphenidate HCl and other stimulant medicines:

1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting RELEXXII ® .

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with RELEXXII ® .

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking RELEXXII ® .

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking RELEXXII ® , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Painful and prolonged erections (priapism)

Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

4. Circulation problems in fingers and toes

[Peripheral vasculopathy, including Raynaud’s phenomenon]:

  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking RELEXXII ® .

What Is RELEXXII ® ?

RELEXXII® isa central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). RELEXXII ® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

RELEXXII ® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

RELEXXII ® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep RELEXXII ® in a safe place to prevent misuse and abuse. Selling or giving away RELEXXII ® may harm others, and is against the law.

Tell your doctor if you or your child has (or has a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Who should not take RELEXXII ® ?

RELEXXII ® should not be taken if you or your child:

  • is very anxious, tense, or agitated
  • has an eye problem called glaucoma
  • has tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard-to-control repeated movements or sounds.
  • is taking or has taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
  • is allergic to anything in RELEXXII ® . See the end of this Medication Guide for a complete list of ingredients.

RELEXXII ® should not be used in children less than 13 years old because it has not been studied in this age group.

RELEXXII ® may not be right for you or your child. Before starting RELEXXII ® , tell your or your child’s doctor about all health conditions (or a family history of) including:

  • heart problems, heart defects, or high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • tics or Tourette’s syndrome
  • seizures or have had an abnormal brain wave test (EEG)
  • circulation problems in fingers and toes
  • esophagus, stomach, or small or large intestine problems

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can RELEXXII ® be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. RELEXXII ® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking RELEXXII ® .

Your doctor will decide whether RELEXXII ® can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • antidepression medicines including MAOIs
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking RELEXXII ® without talking to your doctor first.

How should RELEXXII ® be taken?

  • Take RELEXXII ® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or divide the tablets. Swallow RELEXXII ® whole with water or other liquids. Tell your doctor if you or your child cannot swallow RELEXXII ® whole. A different medicine may need to be prescribed.
  • RELEXXII ® can be taken with or without food.
  • Take RELEXXII ® once each day in the morning. RELEXXII ® is an extended-release tablet. It releases medication into your or your child’s body throughout the day.
  • The RELEXXII ® does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.
  • From time to time, your doctor may stop RELEXXII ® treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking RELEXXII ® . Children should have their height and weight checked often while taking RELEXXII ® . RELEXXII ® treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much RELEXXII ® or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of RELEXXII ® ?

See “What is the most important information I should know about RELEXXII ® ?” for information on reported heart and mental problems.

Other serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision
  • blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing in any of these organs

Common side effects include:

  • decreased appetite
  • headache
  • dry mouth
  • nausea
  • trouble sleeping
  • anxiety
  • dizziness
  • weight loss
  • stomach ache
  • irritability
  • increased sweating

Stimulants may impair the ability of you or your child to operate potentially hazardous machinery or vehicles. You or your child should exercise caution until you or your child is reasonably certain that RELEXXII ® does not adversely affect your or your child’s ability to engage in such activities.

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Vertical Pharmaceuticals, LLC at 1-770-509-4500.

How should I store RELEXXII ® ?

Store RELEXXI ® in a safe place at room temperature, 59 to 86°F (15 to 30°C). Protect from moisture.

  • Keep RELEXXII ® and all medicines out of the reach of children.

General information about RELEXXII ®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RELEXXII ® for a condition for which it was not prescribed. Do not give RELEXXII ® to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about RELEXXII ® , if you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about RELEXXII ® that was written for healthcare professionals. For more information about RELEXXII ® call 1-770-509-4500.

What are the ingredients in RELEXXII ® ?

Active Ingredient: methylphenidate HCl

Inactive Ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin, and FD&C Blue #1 Aluminum Lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:

Vertical Pharmaceuticals, LLC

Alpharetta, GA 30005

1-770-509-4500

www.verticalpharma.com

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