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MEDICATION GUIDE
RITALIN® (rit-ah-lin)
(methylphenidate hydrochloride)
tablets, for oral use, CII
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What is the most important information I should know about RITALIN?
RITALIN may cause serious side effects, including:
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Abuse, misuse, and addiction. RITALIN has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of RITALIN, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of RITALIN or when it is used in ways that are not approved, such as snorting or injection.
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- Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with RITALIN and will monitor you or your child during treatment.
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- RITALIN may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
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- Do not give RITALIN to anyone else. See “What is RITALIN?” for more information.
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- Keep RITALIN in a safe place and properly dispose of any unused medicine. See “How should I store RITALIN?” for more information.
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- Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
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Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.
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- Your healthcare provider should check you or your child carefully for heart problems before starting RITALIN.
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- Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
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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.
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Increased blood pressure and heart rate.
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- Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with RITALIN.
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Mental (psychiatric) problems:
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All Patients
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- new or worse behavior and thought problems
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- new or worse bipolar illness
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- new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
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- Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
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Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
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What is RITALIN?
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- RITALIN is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). RITALIN may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
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- RITALIN should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
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- RITALIN is also used in the treatment of a sleep disorder called narcolepsy.
It is not known if RITALIN is safe and effective in children under 6 years of age.
RITALIN 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 in a safe place to protect it from theft. Never give your RITALIN to anyone else, because it may cause death or harm them. Selling or giving away RITALIN may harm others and is against the law.
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Who should not take RITALIN?
RITALIN should not be taken if you or your child:
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- are allergic to methylphenidate hydrochloride, or any of the ingredients in RITALIN. See the end of this Medication Guide for a complete list of ingredients in RITALIN.
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- are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).
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RITALIN may not be right for you or your child. Before starting RITALIN, tell your or your child’s healthcare provider about all health conditions (or a family history of), including:
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- heart problems, heart disease, heart defects, or high blood pressure
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- mental problems, including psychosis, mania, bipolar illness, or depression
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- circulation problems in fingers or toes
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- have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
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- have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome.
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- if you are pregnant or plan to become pregnant. It is not known if RITALIN will harm your unborn baby.
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- There is a pregnancy registry for females who are exposed to ADHD medications, including RITALIN, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to RITALIN and their baby. If you or your child becomes pregnant during treatment with RITALIN, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
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- if you are breastfeeding or plan to breastfeed. RITALIN passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with RITALIN.
Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RITALIN 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.
Your healthcare provider will decide whether RITALIN can be taken with other medicines.
Especially tell your healthcare provider if you or your child takes:
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- anti-depression medicines, including MAOIs
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- blood pressure medicines (anti-hypertensive)
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your healthcare provider and pharmacist.
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- You should not take RITALIN on the day of your operation if a certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation.
Do not start any new medicine while taking RITALIN without talking to your healthcare provider first.
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How should RITALIN be taken?
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- Take RITALIN exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child.
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- RITALIN is usually taken 2 to 3 times a day.
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- Take RITALIN 30 to 45 minutes before a meal.
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- Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking RITALIN.
Children should have their height and weight checked often while taking RITALIN. If you or your child take too much RITALIN, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
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What are the possible side effects of RITALIN?
RITALIN may cause serious side effects, including:
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- see “What is the most important information I should know about RITALIN?” for information on reported heart and mental problems.
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painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a healthcare provider immediately.
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circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon):
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- fingers or toes may feel numb, cool, painful
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- fingers or toes may change color from pale, to blue, to red
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.
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Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with RITALIN. RITALIN treatment may be stopped if your child is not growing or gaining weight.
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Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
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New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with RITALIN.
Common side effects include:
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- fast heart beat
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- abnormal heartbeat (palpitations)
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- headache
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- trouble sleeping
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- nervousness
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- sweating a lot
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- decreased appetite
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- dry mouth
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- nausea
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- stomach pain
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store RITALIN?
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- Store RITALIN in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
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- Protect from light.
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- Dispose of remaining, unused, or expired RITALIN by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix RITALIN with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and throw away RITALIN in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
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Keep RITALIN and all medicines out of the reach of children.
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General information about the safe and effective use of RITALIN.
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 that is written for healthcare professionals. Do not use RITALIN for a condition for which it was not prescribed. Do not give RITALIN to other people, even if they have the same symptoms that you have. It may harm them and it is against the law.
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What are the ingredients in RITALIN?
Active ingredient: methylphenidate HCl
Inactive ingredients: D&C Yellow No.10 (5-mg and 20-mg tablets), FD&C Green No.3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets)
Manufactured by
Societal CDMO Gainesville, LLC
Gainesville, GA 30504 for
Sandoz Inc., Princeton, NJ 08540
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For more information and request for additional copies of the Medication Guide, call 1-800-525-8747.
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