Ritalin LA

Ritalin LA is a prescription medication used to treat attention-deficit hyperactivity disorder (ADHD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ritalin LA is part of the drug class:

• Centrally acting sympathomimetics

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Ritalin LA is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Ritalin LA in a safe place to prevent misuse and abuse. Selling or giving away Ritalin 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.

Drug Dependence

Ritalin LA should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take in the morning.
• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take Ritalin LA.
• Swallow whole. Do not chew, break, or crush.
• You may sprinkle contents of capsule on applesauce. Do not chew. Swallow right away and follow with water or juice.
• After mixing, take your dose right away. Do not store for future use.
• To gain the most benefit, do not miss doses.
• If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if Ritalin LA stops working well. Do not take more than ordered.
• Do not switch between different forms of this medicine without first talking with the doctor.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with Ritalin LA may cause nervousness, shakiness, and a fast heartbeat.
• If you are taking this medicine and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it. Do not take Ritalin LA after 6 PM.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

Ritalin LA (methylphenidate hydrochloride) extended-release capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Ritalin LA in the treatment of ADHD was established in 1 controlled trial of children aged 6 to 12 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

Ritalin LA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.

Long-Term Use

The effectiveness of Ritalin LA for long-term use, i.e., for more than 2 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Ritalin LA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Agitation

Ritalin LA (methylphenidate hydrochloride) extended-release capsules are contraindicated in marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.

Hypersensitivity to Methylphenidate

Ritalin LA is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product.

Glaucoma

Ritalin LA is contraindicated in patients with glaucoma.

Tics

Ritalin LA is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome (see ADVERSE REACTIONS).

Monoamine Oxidase Inhibitors

Ritalin LA is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result).

Ritalin LA (methylphenidate hydrochloride) extended-release capsules, like other products containing methylphenidate, is a Schedule II controlled substance. (See WARNINGS for boxed warning containing drug abuse and dependence information.)

American Psychiatric Association. Diagnosis and Statistical Manual of Mental Disorders. 4th edition. Washington DC: American Psychiatric Association 1994.

T2016-91
January 2017

Ritalin LA®

(methylphenidate hydrochloride) extended-release capsules CII

What Is Ritalin LA?

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

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

Who should not take Ritalin LA?

Ritalin LA 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 anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  
• are allergic to anything in Ritalin LA. See the end of this Medication Guide for a complete list of ingredients.

Ritalin LA should not be used in children less than 6 years old because it has not been studied in this age group.

Ritalin LA may not be right for you or your child. Before starting Ritalin LA tell your 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)
• circulation problems in fingers or toes

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

Can Ritalin LA 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. Ritalin 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 Ritalin LA.

Your doctor will decide whether Ritalin LA can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
  
• seizure medicines
  
• blood thinner medicines
  
• blood pressure medicines
  
• stomach acid 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 Ritalin LA without talking to your doctor first.

How should Ritalin LA be taken?

• Take Ritalin LA exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• Take Ritalin LA once a day in the morning. Ritalin LA is an extended-release capsule. It releases medicine into your body throughout the day.
• Swallow Ritalin LA capsules whole with water or other liquids. If you cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid. Never chew or crush the capsule or the medicine inside the capsule.
• Ritalin LA should not be taken with alcohol. This may result in a more rapid release of the dose of Ritalin LA
• From time to time, your doctor may stop Ritalin LA treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Ritalin LA. Children should have their height and weight checked often while taking Ritalin LA. Ritalin LA treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much Ritalin LA or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Ritalin LA?

See “What is the most important information I should know about Ritalin LA” 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
  
• 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.

Common side effects include:

• headache
  
• stomach ache
  
• decreased appetite
  
• trouble sleeping

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 Ritalin LA?

• Store Ritalin LA in a safe place at room temperature, 59°F to 86°F (15°C to 30°C).
  
• Keep Ritalin LA and all medicines out of the reach of children.

General information about Ritalin LA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ritalin LA for a condition for which it was not prescribed. Do not give Ritalin 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 Ritalin LA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ritalin LA that was written for healthcare professionals. For more information about Ritalin LA call 1-888-669-6682.

What are the ingredients in Ritalin LA?

Active Ingredient: methylphenidate HCL

Inactive Ingredients: ammonio methacrylate copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only), sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10, 30, and 40 mg capsules).

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 for
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey  07936
By
Recro Gainesville LLC
Gainesville, GA  30504

© Novartis

T2015-94
June 2015