METHYLPHENIDATE HYDROCHLORIDE (LA)- methylphenidate hydrochloride capsule, extended release
Mayne Pharma

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MEDICATION GUIDE

METHYLPHENIDATE HYDROCHLORIDE (METH-il-FEN-i-date HYE-droe-KLOR-ide) EXTENDED-RELEASE CAPSULES (LA) CII

Rx Only

Read the Medication Guide that comes with methylphenidate hydrochloride extended-release capsules (LA) 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 extended-release capsules (LA).
What is the most important information I should know about Methylphenidate Hydrochloride Extended-Release Capsules (LA)?
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 extended-release capsules (LA).
Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules (LA).
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 hydrochloride extended-release capsules (LA).
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 extended-release capsules (LA), 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 the 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 hydrochloride extended-release capsules (LA).

What are Methylphenidate Hydrochloride Extended-Release Capsules (LA)?

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

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

Methylphenidate hydrochloride extended-release capsules (LA) are a federally controlled substance (CII) because they can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release capsules (LA) in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules (LA) 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 Extended-Release Capsules (LA)? Methylphenidate hydrochloride extended-release capsules (LA) should not be taken if you or your child:

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

Methylphenidate hydrochloride extended-release capsules (LA) may not be right for you or your child. Before starting methylphenidate hydrochloride extended-release capsules (LA) 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 Hydrochloride Extended-Release Capsules (LA) 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 extended-release capsules (LA) 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 extended-release capsules (LA).

Your doctor will decide whether methylphenidate hydrochloride extended-release capsules (LA) 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 s tart any new medicine while taking methylphenidate hydrochloride extended-release capsules (LA) without talking to your doctor first.

How should Methylphenidate Hydrochloride Extended-Release Capsules (LA) be taken?

What are possible side effects of Methylphenidate Hydrochloride Extended-Release Capsules (LA)?

See " What is the most important information I should know about Methylphenidate Hydrochloride Extended-Release Capsules (LA) " 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.

How should I store Methylphenidate Hydrochloride Extended-Release Capsules (LA)?

General information about Methylphenidate Hydrochloride Extended-Release Capsules (LA) Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride extended-release capsules (LA) for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release capsules (LA) 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 extended-release capsules (LA). If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate hydrochloride extended-release capsules (LA) that was written for healthcare professionals. For more information about methylphenidate hydrochloride extended-release capsules (LA) call 1-844-825-8500.

What are the ingredients in Methylphenidate Hydrochloride Extended-Release Capsules (LA)?

Active Ingredient: methylphenidate hydrochloride, USP

Inactive Ingredients: sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10 mg capsule contains FD&C Green #3, FD&C Red #40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol.

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

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

Manufactured by:
Catalent Pharma Solutions
Winchester, KY 40391 USA

Distributed by:
Mayne Pharma
Greenville, NC 27834 USA

Revised – November 2017

DP22487

Revised: 10/2019
Mayne Pharma