SPL MEDGUIDE

Methylphenidate Hydrochloride (METH-il-FEN-i-date-hye-droe-KLOR-Ide) oral solution, CII

What is the most important information I should know about methylphenidate hydrochloride oral solution?

Methylphenidate hydrochloride oral solution can cause serious side effects, including:

• Abuse, misuse, and addiction. methylphenidate hydrochloride oral solution has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride oral solution, 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 oral solution 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 methylphenidate hydrochloride oral solution and will monitor you or your child during treatment.
• Methylphenidate hydrochloride oral solution may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
• Do not give methylphenidate hydrochloride oral solution to anyone else. See "What is methylphenidate hydrochloride oral solution?"for more information.
• Keep methylphenidate hydrochloride oral solution in a safe place and properly dispose of any unused medicine. See "How should I store methylphenidate hydrochloride oral solution?" 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 methylphenidate hydrochloride oral solution. 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 methylphenidate hydrochloride oral solution.

• Increased blood pressure and heart rate.
• Your healthcare provider should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride oral solution.
• 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 methylphenidate hydrochloride oral solution, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is methylphenidate hydrochloride oral solution?

Methylphenidate hydrochloride oral solution is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Methylphenidate hydrochloride oral solution may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if methylphenidate hydrochloride oral solution is safe and effective for use in children under 6 years of age.

Methylphenidate hydrochloride oral solution 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 methylphenidate hydrochloride oral solution in a safe place to protect it from theft. Never give your methylphenidate hydrochloride oral solution to anyone else, because it may cause death or harm them.

Selling or giving away methylphenidate hydrochloride oral solution may harm others and is against the law.

Do not take methylphenidate hydrochloride oral solution if you or your child are:

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

Before taking methylphenidate hydrochloride oral solution 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 methylphenidate hydrochloride oral solution will harm the unborn baby.
• There is a pregnancy registry for females who are exposed to methylphenidate hydrochloride oral solution during pregnancy. The purpose of the registry is to collect information about the health of females exposed to methylphenidate hydrochloride oral solution and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride oral solution, 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. methylphenidate hydrochloride passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride oral solution.

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.

Methylphenidate hydrochloride oral solution 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 oral solution. Your healthcare provider will decide whether methylphenidate hydrochloride oral solution 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 methylphenidate hydrochloride oral solution without talking to your healthcare provider first.

How should methylphenidate hydrochloride oral solution be taken?

•  Take methylphenidate hydrochloride oral solution exactly as prescribed by your healthcare provider.
•  Your healthcare provider may change the dose if needed.
•  Children 6 years of age and older:
•   Take methylphenidate hydrochloride oral solution by mouth 2 times a day before breakfast and lunch, 30 to 45 before a meal, as prescribed by your healthcare provider.
•   Adults:
•   Take methylphenidate hydrochloride oral solution by mouth 2 or 3 times a day, 30 to 45 before a meal, as prescribed by your healthcare provider.
•   For adults who have sleep problems when methylphenidate hydrochloride oral solution is taken late in the day, take your last dose of methylphenidate hydrochloride oral solution before 6 p.m.
•   Your healthcare provider may sometimes stop methylphenidate hydrochloride oral solution treatment for a while to check ADHD symptoms.

If you or your child take too much methylphenidate hydrochloride oral solution, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of methylphenidate hydrochloride oral solution?

Methylphenidate hydrochloride oral solution can cause serious side effects, including:

•  See "What is the most important information I should know about methylphenidate hydrochloride oral solution?"
•  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 methylphenidate hydrochloride oral solution.

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

The most common side effects of methylphenidate hydrochloride oral solution include:

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

These are not all the possible side effects of methylphenidate hydrochloride oral solution.

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 oral solution?

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

Keep methylphenidate hydrochloride oral solution and all medicines out of the reach of children.

General information about the safe and effective use of methylphenidate hydrochloride oral solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride oral solution for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride oral solution 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 oral solution that was written for healthcare professionals.

What are the ingredients in methylphenidate hydrochloride oral solution?

Active Ingredient: methylphenidate hydrochloride, USP        

Inactive Ingredients: PEG 1450, glycerin, phosphoric acid, and purified water

Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873

Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202

SAP Code: 275054

Rev. 11/2023