METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- methylphenidate hydrochloride capsule
SpecGx LLC

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MEDICATION GUIDE

Methylphenidate HCl Extended-Release Capsules
(METH il FEN i date)
10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg

CII

Read the Medication Guide that comes with methylphenidate HCl extended-release capsules 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 methylphenidate HCl extended-release capsules.

What is the most important information I should know about methylphenidate HCl extended-release capsules?

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 have 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 methylphenidate HCl extended-release capsules.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate HCl extended-release capsules.

Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking methylphenidate HCl extended-release capsules.

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 have any new or worsening mental symptoms or problems while taking methylphenidate HCl extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation Problems in fingers and toes (Peripheral vasculopathy, including Raynaud’s phenomenon): fingers or toes may feel numb, cool, painful, and/or 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 methylphenidate HCl extended-release capsules.

What are methylphenidate HCl extended-release capsules?

Methylphenidate HCl extended-release capsules are a central nervous system stimulant prescription medicine. They are used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Methylphenidate HCl extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Methylphenidate HCl extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Methylphenidate HCl extended-release capsules are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate HCl extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate HCl extended-release capsules may harm others, and is against the law.

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

Who should not take methylphenidate HCl extended-release capsules?

Methylphenidate HCl extended-release capsules should not be taken if you or your child:

Methylphenidate HCl extended-release capsules should not be used in children less than 6 years old because it has not been studied in this age group.

Methylphenidate HCl extended-release capsules may not be right for you or your child. Before starting methylphenidate HCl extended-release capsules tell your or your child's doctor about all health conditions (or a family history of) including:

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

Can methylphenidate HCl extended-release capsules be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylphenidate HCl extended-release capsules 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 methylphenidate HCl extended-release capsules.

Your doctor will decide whether methylphenidate HCl extended-release capsules can be taken with other medicines.

Especially tell your doctor if you or your child takes:

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 methylphenidate HCl extended-release capsules without talking to your doctor first.

How should methylphenidate HCl extended-release capsules be taken?

What are possible side effects of methylphenidate HCl extended-release capsules?

See "What is the most important information I should know about methylphenidate HCl extended-release capsules?" for information on reported heart and mental problems.

Other serious side effects include:

Common side effects include:

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.

How should I store methylphenidate HCl extended-release capsules?

General information about methylphenidate HCl extended-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate HCl extended-release capsules for a condition for which it was not prescribed. Do not give methylphenidate HCl extended-release capsules 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 methylphenidate HCl extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate HCl extended-release capsules that was written for healthcare professionals. For more information about methylphenidate HCl extended-release capsules, go to www.Mallinckrodt.com or call Mallinckrodt at 1-800-778-7898.

What are the ingredients in methylphenidate HCl extended-release capsules?

Active Ingredient: methylphenidate HCl

Inactive Ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide.

The individual capsules contain the following coloring agents:
10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone
20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone
30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone
40 mg capsules: Yellow Iron Oxide
50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone

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

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.

© 2017 Mallinckrodt.

Manufactured by:
SpecGx LLC
Webster Groves, MO 63119 USA

Rev 09/2017

Mallinckrodt™
Pharmaceuticals

Revised: 1/2018
SpecGx LLC