METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet
METHYLPHENIDATE HYDROCHLORIDE ER- methylphenidate hydrochloride tablet, extended release
Golden State Medical Supply, Inc.

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MEDICATION GUIDE

CII

Methylphenidate HCL tablets USP

Methylphenidate HCL extended-release tablets USP

Read the Medication Guide that comes with Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER 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 Hydrochloride and Methylphenidate Hydrochloride ER.

What is the most important information I should know about Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER?

The following have been reported with use of methylphenidate hydrochloride 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 Hydrochloride and Methylphenidate Hydrochloride ER.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER

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 Methylphenidate Hydrochlorideand Methylphenidate Hydrochloride ER.

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 Hydrochloride and Methylphenidate Hydrochloride ER, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER?

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER is also used in the treatment of a sleep disorder called narcolepsy.

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ERis a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER 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 Hydrochloride and Methylphenidate Hydrochloride ER?

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER should not be taken if you or your child:

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

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER should not be used in children less than 6 years old because it has not been studied in this age group. Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER may not be right for you or your child. Before starting Methylphenidate Hydrochloride) and Methylphenidate Hydrochloride ER you or your child's doctor about all health conditions (or a family history of) including:

•: heart problems, heart defects, 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)

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

Can Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER 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 Hydrochloride and Methylphenidate Hydrochloride ER) 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 Hydrochloride and Methylphenidate Hydrochloride ER.

Your doctor will decide whether Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER 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 Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER without talking to your doctor first.

How should Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER be taken?

•: Take Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
•: Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER is usually taken 2 to 3 times a day.
•: Take Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER 30 to 45 minutes before a meal. The effect of a dose of Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER usually lasts about 8 hours.
•: Do not chew or crush Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER tablets. Swallow Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER whole. A different medicine may need to be prescribed.
•: From time to time, your doctor may stop Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER treatment for a while to check ADHD symptoms.
•: Your doctor may do regular checks of the blood, heart, and blood pressure while taking Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER. Children should have their height and weight checked often while taking Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER. Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER treatment may be stopped if a problem is found during these check-ups.
•: If you or your child takes too much Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER?

See “What is the most important information I should know about Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER?” 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

Common side effects include:

•: headache
•: stomach ache
•: trouble sleeping

•: nausea
•: decreased appetite
•: nervousness

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 Hydrochloride and Methylphenidate Hydrochloride ER?

•: Store Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER in a safe place at room temperature, 68° to 77°F (20° to 25°C).
•: Protect Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER from light.
•: Protect Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER from moisture.
•: Keep Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER and all medicines out of the reach of children.

General information about Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER for a condition for which it was not prescribed. Do not give Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER 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 Hydrochloride and Methylphenidate Hydrochloride ER. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER that was written for healthcare professionals, or you can visit www.Mallinckrodt.com or call 1-800-778-7898.

What are the ingredients in Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER?

Active Ingredient: methylphenidate HCL

Inactive Ingredients:

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc.

Methylphenidate Hydrochloride and Methylphenidate Hydrochloride ER: hydroxypropyl methylcellulose 2208, magnesium stearate, microcrystalline cellulose, and talc. This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by: Mallinckrodt Inc. Hazelwood, MO 63042 USA
Marketed/Packaged by: GSMS, Inc. Camarillo, CA 93012

COVIDIEN™

Mallinckrodt

Rev 04/2010

Revised: 10/2017

Document Id: 564aea23-0cff-4d95-a009-793124089667

Set id: cc0b862e-1c28-4adb-b9b7-e83ef5152cb6

Version: 2

Effective Time: 20171018

Golden State Medical Supply, Inc.