RITALIN LA- methylphenidate hydrochloride capsule, extended release
Sandoz Inc
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MEDICATION GUIDE
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What is the most important information I should know about RITALIN LA? RITALIN LA may cause serious side effects, including:
o Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with RITALIN LA and will monitor you or your child during treatment. o RITALIN LA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. o Do not give RITALIN LA to anyone else. See “What is RITALIN LA?” for more information. o Keep RITALIN LA in a safe place and properly dispose of any unused medicine. See “How should I store RITALIN LA?” for more information. o Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Your healthcare provider should check you or your child carefully for heart problems before starting RITALIN LA. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking RITALIN LA.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with RITALIN LA.
All Patients o new or worse behavior and thought problems o new or worse bipolar illness o new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN LA, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
What is RITALIN LA? RITALIN LA is a central nervous system (CNS) 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. It is not known if RITALIN LA is safe and effective in children under 6 years of age. RITALIN LA is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep RITALIN LA in a safe place to protect it from theft. Never give your RITALIN LA to anyone else because it may cause death or harm them. Selling or giving away RITALIN LA may harm others and is against the law. |
Who should not take RITALIN LA? RITALIN LA should not be taken if you or your child:
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RITALIN LA may not be right for you or your child. Before starting RITALIN LA, tell your or your child’s healthcare provider about all health conditions (or a family history of), including:
Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter 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 healthcare provider will decide whether RITALIN LA can be taken with other medicines. Especially tell your healthcare provider 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 healthcare provider and pharmacist.
Do not start any new medicine while taking RITALIN LA without talking to your healthcare provider first. |
How should RITALIN LA be taken?
Your healthcare provider 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. If you or your child take too much RITALIN LA, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
What are possible side effects of RITALIN LA?
Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your healthcare provider right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking RITALIN LA.
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 RITALIN LA?
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General information about the safe and effective use of RITALIN LA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about RITALIN LA that is written for healthcare professionals. 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 symptoms. It may harm them and it is against the law. |
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 only). Manufactured by Societal CDMO Gainesville, LLC Gainesville, GA 30504 for Sandoz Inc., Princeton, NJ 08540 For more information, call 1-800-525-8747. |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 12/2023 |