MEDICATION GUIDE

Methylphenidate hydrochloride extended-release capsules may cause serious side effects, including:

• Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release capsules, has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride extended-release capsules, 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 methylphenidate hydrochloride extended-release capsules or when it is used in ways that are not approved, such as snorting or injection.

• Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride extended-release capsules and will monitor your child during treatment.
• Methylphenidate hydrochloride extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
• Do not give methylphenidate hydrochloride extended-release capsules to anyone else. See “What is methylphenidate hydrochloride extended-release capsules?” for more information.

  Keep methylphenidate hydrochloride extended-release capsules in a safe place and properly dispose of any unused medicine. See “How should I store methylphenidate hydrochloride extended-release capsules?” for more information.

  Tell your healthcare provider if your child has 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 your child carefully for heart problems before starting treatment with methylphenidate hydrochloride extended-release capsules. Tell your healthcare provider if your child has any heart problems, heart disease, or heart defects.

  Call your healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with methylphenidate hydrochloride extended-release capsules.

  • Increased blood pressure and heart rate.

    Your healthcare provider should check your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules.

  • 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 your child has, or about a family history of, suicide, bipolar illness, or depression.

Call your healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with methylphenidate hydrochloride extended-release capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Methylphenidate hydrochloride extended-release capsules are a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 15 years of age. Methylphenidate hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if methylphenidate hydrochloride extended-release capsules are safe and effective for use in children younger than 6 years of age or older than 15 years of age.

Methylphenidate hydrochloride extended-release capsules are a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep methylphenidate hydrochloride extended-release capsules in a safe place to protect it from theft. Never give your methylphenidate hydrochloride extended-release capsules to anyone else, because it may cause death or harm them. Selling or giving away methylphenidate hydrochloride extended-release capsules may harm others and is against the law.

Your child should not take methylphenidate hydrochloride extended-release capsules if your child:

• is allergic to methylphenidate hydrochloride or any of the ingredients in methylphenidate hydrochloride extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in methylphenidate hydrochloride extended-release capsules.
• has a rare inherited problem with the breaking down, absorbing, and processing of certain types of sugar in the body. Methylphenidate hydrochloride extended-release capsules contain a type of sugar called sucrose.
• is taking, or has stopped taking within the past 14 days, a medicine called a monoamine oxidase inhibitor (MAOI).

Before starting methylphenidate hydrochloride extended-release capsules tell your healthcare provider about all your child’s medical conditions, including if your child:

• has heart problems, heart disease, heart defects, or high blood pressure
• has mental problems including psychosis, mania, bipolar illness, or depression or has a family history of suicide, bipolar illness, or depression
• has 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
• is pregnant or plan to become pregnant. It is not known if methylphenidate hydrochloride extended-release capsules will harm the unborn baby.

• There is a pregnancy registry for females who are exposed to methylphenidate hydrochloride extended-release capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to methylphenidate hydrochloride extended-release capsules and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
  • is breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride extended-release capsules.

Tell your healthcare provider about all the medicines that your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Methylphenidate hydrochloride extended-release capsules 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 methylphenidate hydrochloride extended-release capsules. Your healthcare provider will decide whether methylphenidate hydrochloride extended-release capsules can be taken with other medicines.

Especially tell your healthcare provider if your child takes a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Know the medicines that your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist. Your child should not start taking any new medicines during treatment with methylphenidate hydrochloride extended-release capsules without talking to your healthcare provider first.

• Take methylphenidate hydrochloride extended-release capsules exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose if needed.
• Take methylphenidate hydrochloride extended-release capsules 1 time each day in the morning before breakfast.
• Swallow methylphenidate hydrochloride extended-release capsules whole with water or other liquids.
• If methylphenidate hydrochloride extended-release capsules cannot be swallowed whole, the capsule may be opened and the contents sprinkled onto a tablespoonful of applesauce.

• Follow with a drink of water or other liquid.
• Do not chew the applesauce and medicine mixture.
• Swallow all the applesauce and medicine mixture right away. Do not store the applesauce and medicine mixture.

If your child takes too much methylphenidate hydrochloride extended-release capsules, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Avoid drinking alcohol during treatment with methylphenidate hydrochloride extended-release capsules. This may cause a faster release of the methylphenidate hydrochloride extended-release capsules medicine.

Methylphenidate hydrochloride extended-release capsules may cause serious side effects, including:

• See “What is the most important information I should know about methylphenidate hydrochloride extended-release capsules?”
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If your child develops 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 your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

  Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on the fingers or toes during treatment with methylphenidate hydrochloride extended-release capsules.

  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with methylphenidate hydrochloride extended-release capsules. Methylphenidate hydrochloride extended-release capsules 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 methylphenidate hydrochloride extended-release capsules.

The most common side effects of methylphenidate hydrochloride extended-release capsules include anorexia and trouble sleeping. These are not all the possible side effects of methylphenidate hydrochloride extended-release capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store methylphenidate hydrochloride extended-release capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).
• Store methylphenidate hydrochloride extended-release capsules in a safe place, like a locked cabinet. Protect from light and moisture.
• Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules 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 methylphenidate hydrochloride extended-release capsules 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 methylphenidate hydrochloride extended-release capsules in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep methylphenidate hydrochloride extended-release capsules and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release capsules to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about methylphenidate hydrochloride extended-release capsules that is written for healthcare professionals.

Active Ingredient: Methylphenidate hydrochloride, USP

Inactive Ingredients: sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin, and titanium dioxide.

The individual capsules contain the following coloring agents:

10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide

20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3

30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide

40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40

50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide

For more information about methylphenidate hydrochloride extended-release capsules call 1-877-835-5472.

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

Manufactured by:
Amneal Pharmaceuticals of New York, LLC
Brookhaven, NY 11719

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807