METHYLPHENIDATE HYDROCHLORIDE (CD)- methylphenidate hydrochloride capsule, extended release 
Teva Pharmaceuticals USA, Inc.

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MEDICATION GUIDE
Methylphenidate Hydrochloride (meth'' il fen'' i date hye'' droe klor' ide)
Extended-Release Capsules (CD) CII

What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (CD)?

Methylphenidate hydrochloride extended-release capsules (CD) can cause serious side effects, including:

  • Abuse and dependence. Methylphenidate hydrochloride extended-release capsules (CD), other methylphenidate containing medicines, and amphetamines have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check your child for signs of abuse and dependence before and during treatment with methylphenidate hydrochloride extended-release capsules (CD).
    • Tell your healthcare provider if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
    • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • Heart-related problems, including:
        
    • sudden death in children who have heart problems or heart defects
    • increased blood pressure and heart rate

    Your healthcare provider should check your child carefully for heart problems before starting treatment with methylphenidate hydrochloride extended-release capsules (CD).

    Tell your healthcare provider if your child has any heart problems, heart defects, high blood pressure, or has a family history of these problems.

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

    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 (CD).

  • 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 (CD), especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What are methylphenidate hydrochloride extended-release capsules (CD)?

Methylphenidate hydrochloride extended-release capsules (CD) 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 (CD) may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if methylphenidate hydrochloride extended-release capsules (CD) 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 (CD) 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 (CD) in a safe place to protect it from theft. Never give your methylphenidate hydrochloride extended-release capsules (CD) to anyone else, because it may cause death or harm them. Selling or giving away methylphenidate hydrochloride extended-release capsules (CD) may harm others and is against the law.

Who should not take Methylphenidate hydrochloride extended-release capsules (CD)?

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

  • is allergic to methylphenidate hydrochloride or any of the ingredients in methylphenidate hydrochloride extended-release capsules (CD). See the end of this Medication Guide for a complete list of ingredients in methylphenidate hydrochloride extended-release capsules (CD).
  • 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 (CD) 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 (CD) tell your healthcare provider about all your child’s medical conditions, including: if your child:

  • has heart problems, 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
  • is pregnant or plan to become pregnant. It is not known if methylphenidate hydrochloride extended-release capsules (CD) will harm the unborn baby.
         
    • There is a pregnancy registry for females who are exposed to methylphenidate hydrochloride extended-release capsules (CD) during pregnancy. The purpose of the registry is to collect information about the health of females exposed to methylphenidate hydrochloride extended-release capsules (CD) and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release capsules (CD), 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 (CD).

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 (CD) 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 (CD). Your healthcare provider will decide whether methylphenidate hydrochloride extended-release capsules (CD) 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 (CD) without talking to your healthcare provider first.

How should methylphenidate hydrochloride extended-release capsules (CD) be taken?

  • Take methylphenidate hydrochloride extended-release capsules (CD) exactly as prescribed by your healthcare provider.
  • Your healthcare provider may change the dose if needed.
  • Take methylphenidate hydrochloride extended-release capsules (CD) 1 time each day in the morning before breakfast.
  • Swallow methylphenidate hydrochloride extended-release capsules (CD) whole with water or other liquids.
  • If methylphenidate hydrochloride extended-release capsules (CD) 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.
  • Your healthcare provider may sometimes stop methylphenidate hydrochloride extended-release capsules (CD) treatment for a while to check ADHD symptoms.
  • If your child takes too much methylphenidate hydrochloride extended-release capsules (CD), call your poison control center at 1-800-222-1222 or go to your nearest hospital emergency room right away.

What should be avoided during treatment with methylphenidate hydrochloride extended-release capsules (CD)?
Avoid drinking alcohol during treatment with methylphenidate hydrochloride extended-release capsules (CD). This may cause a faster release of the methylphenidate hydrochloride extended-release capsule (CD) medicine.

What are the possible side effects of methylphenidate hydrochloride extended-release capsules (CD)?
Methylphenidate hydrochloride extended-release capsules (CD) can cause serious side effects, including:

  • See “What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (CD)?”
  • 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 (CD).

  • 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 (CD). Methylphenidate hydrochloride extended-release capsules (CD) treatment may be stopped if your child is not growing or gaining weight.

The most common side effects of methylphenidate hydrochloride extended-release capsules (CD) include anorexia and trouble sleeping.

These are not all the possible side effects of methylphenidate hydrochloride extended-release capsules (CD).

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 methylphenidate hydrochloride extended-release capsules (CD)?

  • Store methylphenidate hydrochloride extended-release capsules (CD) at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store methylphenidate hydrochloride extended-release capsules (CD) in a safe place, like a locked cabinet. Protect from light and moisture.
  • Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules (CD) by a medication take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride extended-release capsules (CD) 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 (CD) in the household trash.

Keep methylphenidate hydrochloride extended-release capsules (CD) and all medicines out of the reach of children

General information about the safe and effective use of methylphenidate hydrochloride extended-release capsules (CD).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride extended-release capsules (CD) for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release capsules (CD) 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 (CD) that was written for healthcare professionals.

What are the ingredients in methylphenidate hydrochloride extended-release capsules (CD)?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.

Brands listed are the trademarks of their respective owners.

Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054

For more information call Teva at 1-888-838-2872.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                                                                                       Rev. K 5/2022

Revised: 5/2022
Teva Pharmaceuticals USA, Inc.