MEDICATION GUIDE

METHYLIN may cause serious side effects, including:

• Abuse, misuse, and addiction. METHYLIN has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of METHYLIN, 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 METHYLIN or when it is used in ways that are not approved, such as snorting or injection.
  • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with METHYLIN and will monitor you or your child during treatment.
  • METHYLIN may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
  • Do not give METHYLIN to anyone else. See “What is METHYLIN?” for more information.
  • Keep METHYLIN in a safe place and properly dispose of any unused medicine. See “How should I store METHYLIN?” for more information.
  • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

• Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.

  Your healthcare provider should check you or your child carefully for heart problems before starting treatment with METHYLIN. 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 have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with METHYLIN.

  Your healthcare provider should check you or your child carefully for heart problems before starting treatment with METHYLIN. Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or have a family history of these problems.
  Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with METHYLIN.
  Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with METHYLIN.

• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) 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 during treatment with METHYLIN, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Do not take METHYLIN if you or your child are:

• allergic to methylphenidate hydrochloride or any of the ingredients in METHYLIN. See the end of this Medication Guide for a complete list of ingredients in METHYLIN.
• taking, or have stopped taking within the past 14 days, a medicine called a monoamine oxidase inhibitor (MAOI).

Before taking METHYLIN tell your healthcare provider about all your medical conditions, including if you or your child:

• have heart problems, heart disease, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers and toes
• have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
• are pregnant or plan to become pregnant. It is not known if METHYLIN will harm the unborn baby.
  • There is a pregnancy registry for females who are exposed to METHYLIN during pregnancy. The purpose of the registry is to collect information about the health of females exposed to METHYLIN and their baby. If you or your child becomes pregnant during treatment with METHYLIN, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
• are breastfeeding or plan to breastfeed. METHYLIN passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with METHYLIN.

Tell your healthcare provider about all the medicines that you take or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
METHYLIN and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with METHYLIN. Your healthcare provider will decide whether METHYLIN can be taken with other medicines.
Especially tell your healthcare provider if you or your child take a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
Know the medicines that you take or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist. Do not start any new medicine during treatment with METHYLIN without talking to your healthcare provider first.

How should METHYLIN be taken?

• Take METHYLIN exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose if needed.
• Children 6 years of age and older:
  • Take METHYLIN by mouth 2 times a day before breakfast and lunch, 30 to 45 minutes before a meal, as prescribed by your healthcare provider.
• Adults:
  • Take METHYLIN by mouth 2 or 3 times a day, 30 to 45 minutes before a meal, as prescribed by your healthcare provider.
  • For adults who have sleep problems when METHYLIN is taken late in the day, take your last dose of METHYLIN before 6 p.m.
• If you or your child take too much METHYLIN, 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 the possible side effects of METHYLIN?
METHYLIN may cause serious side effects, including:

• See “What is the most important information I should know about METHYLIN?”
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon).
  Signs and symptoms may include:
  • fingers or toes may feel numb, cool, painful
  • 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, or if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with METHYLIN.

• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with METHYLIN. METHYLIN treatment may be stopped if your child is not growing or gaining weight.
  

• 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.

• 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 METHYLIN.

The most common side effects of METHYLIN include:

• increased heart rate
• headache
• anxiety
• weight loss
• dry mouth
• stomach pain
• irregular heart beat (palpitations)
• trouble sleeping
• sweating
• decreased appetite
• nausea

These are not all the possible side effects of METHYLIN.
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 METHYLIN?

• Store METHYLIN at room temperature between 68°F to 77°F (20°C to 25°C).
  Store METHYLIN in a safe place, like a locked cabinet.
• Protect from light and moisture.
• Dispose of remaining, unused, or expired METHYLIN 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 METHYLIN 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 METHYLIN in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep METHYLIN and all medicines out of the reach of children.