PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0781-2364-01 Rx only
Methylphenidate HCl Extended-Release Capsules 

40 mg

100 capsules

Dispense with Medication
Guide attached or provided
separately.

SANDOZ

RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Boxed Warning 10/2023

Dosage and Administration (2.1) 10/2023

Warnings and Precautions (5.1, 5.2, 5.8, 5.9, 5.10) 10/2023

DESCRIPTION SECTION

11 DESCRIPTION

Methylphenidate hydrochloride extended-release capsules are CNS stimulant.

Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric- coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate.

The active substance in methylphenidate hydrochloride extended-release capsules is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is


Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. 

Inactive ingredients: ammonio methacrylate copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only), sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10, 30, and 40 mg capsules only).

INDICATIONS & USAGE SECTION

Highlight: Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age (1).

1 INDICATIONS AND USAGE

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].

DOSAGE & ADMINISTRATION SECTION

Highlight: •

Administer orally once daily in the morning (2.2). 

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Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce (2.2).

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Should not be crushed, chewed, or divided (2.2).

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Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended (2.3).

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For patients currently using methylphenidate hydrochloride tablets: Dosage is based on current dose regimen (2.4).

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If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended release capsules (2.4).

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to treating patients with methylphenidate hydrochloride extended-release capsules, assess:

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 for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

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 the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating methylphenidate hydrochloride extended-release capsules [see Warnings and Precautions (5.10)].

2.2 General Dosing Information

The recommended starting dose for methylphenidate hydrochloride extended- release capsules is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.

Administer methylphenidate hydrochloride extended-release capsules orally once daily in the morning. Methylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided.

The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.

2.3 Patients Currently Using Methylphenidate Hydrochloride Tablets

The recommended dose of methylphenidate hydrochloride extended-release capsules for patients currently taking methylphenidate hydrochloride tablets twice daily is provided below in Table 1.

2.4 Switching from Other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with methylphenidate hydrochloride extended-release capsules using the titration schedule.

Do not substitute for other methylphenidate products on a milligram-per- milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11), Clinical Pharmacology (12.3)].

Clinical judgment should be used when selecting the starting dose. Daily dosage above 60 mg is not recommended.

2.5 Dosage Reduction and Discontinuation

If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride extended-release capsules. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Extended-release capsules: 10 mg, 20 mg, 30 mg, and 40 mg (3).

3 DOSAGE FORMS AND STRENGTHS

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10 mg extended-release capsules white/light brown, (imprinted "NVR R10")

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20 mg extended-release capsules white, (imprinted "NVR R20")

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30 mg extended-release capsules yellow, (imprinted "NVR R30")

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40 mg extended-release capsules light brown, (imprinted "NVR R40")

CONTRAINDICATIONS SECTION

Highlight: •

Known hypersensitivity to methylphenidate or product components (4).

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Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days (4).

4 CONTRAINDICATIONS

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Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)]. 

•

Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)]. 

Boxed Warning section

WARNING: ABUSE, MISUSE, AND ADDICTION

See full prescribing information for complete boxed warning.

Methylphenidate hydrochloride extended-release capsules****have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release capsules, can result in overdose and death (5.1,9.2,10).

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**Before prescribing methylphenidate hydrochloride extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction.**

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**Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.**

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**Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.**

DRUG INTERACTIONS SECTION

Highlight: •

 Antihypertensive Drugs: Monitor blood pressure and heart. Adjust dosage of antihypertensive drug as needed (7.1). 

7 DRUG INTERACTIONS

7.1 Clinically Important Drug Interactions with Methylphenidate

Hydrochloride Extended-Release Capsules

Table 3 presents clinically important drug interactions with methylphenidate hydrochloride extended-release capsules.

USE IN SPECIFIC POPULATIONS SECTION

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/.

Risk Summary

Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations).

No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

CNS stimulants, such as methylphenidate hydrochloride extended-release capsules, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth-weight-infants have been reported in amphetamine- dependent mothers.

Data

Animal Data

In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a mg/m2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo- fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and post-natal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adolescents on a mg/m2 basis).

8.2 Lactation

Risk Summary

Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride extended- release capsules and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release capsules or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

8.4 Pediatric Use

The safety and effectiveness of methylphenidate hydrochloride extended-release capsules for the treatment of ADHD have been established in pediatric patients aged 6 to 12 years.

The safety and effectiveness of methylphenidate hydrochloride extended-release capsules in pediatric patients aged less than 6 years have not been established.

The long-term efficacy of methylphenidate hydrochloride extended-release capsules in pediatric patients has not been established.

Long-Term Suppression of Growth

Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended-release capsules. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7)].

Juvenile Animal Toxicity Data

Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m2 basis.

In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the MRHD given to children on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

8.5 Geriatric Use

Methylphenidate hydrochloride extended-release capsules have not been studied in the geriatric population.

ADVERSE REACTIONS SECTION

Highlight: Most common adverse reactions (greater than 5% during incidence) were headache, insomnia, upper abdominal pain, decreased appetite, and anorexia (6).

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

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Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)]

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Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride extended-release capsules [see Contraindications (4)]

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Hypertensive crisis when used concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4), Drug Interactions (7.1)]

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Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2)]

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Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3)]

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Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)]

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Priapism [see Warnings and Precautions (5.5)]

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Peripheral Vasculopathy, Including Raynaud’s Phenomenon [see Warnings and Precautions (5.6)]

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Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7)]

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 Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8)]

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Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9)]

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Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.10)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical program for methylphenidate hydrochloride extended-release capsules consisted of 6 studies: 2 controlled clinical studies conducted in children with ADHD aged 6 to 12 years and 4 clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received methylphenidate hydrochloride extended-release capsules in doses of 10 to 40 mg per day. Safety of methylphenidate hydrochloride extended-release capsules was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight. A placebo-controlled, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of methylphenidate hydrochloride extended-release capsules in children with ADHD aged 6 to 12 years. All subjects received methylphenidate hydrochloride extended-release capsules for up to 4 weeks, and had their dose optimally adjusted, prior to entering the double-blind phase of the trial. In the 2-week double-blind treatment phase of this study, patients received either placebo or methylphenidate hydrochloride extended-release capsules at their individually-titrated dose (range, 10 mg to 40 mg).

Adverse reactions with an incidence greater than 5% during the initial 4-week single-blind methylphenidate hydrochloride extended-release capsules titration period of this study were headache, insomnia, upper abdominal pain, appetite decreased, and anorexia.

Adverse reactions with an incidence greater than 2% among methylphenidate hydrochloride extended-release capsules-treated subjects, during the 2-week double-blind phase of the clinical study, are shown in Table 2.

Adverse Reactions Associated with Discontinuation of Treatment

In the 2-week double-blind treatment phase of a placebo-controlled parallel- group study in children with ADHD, one methylphenidate hydrochloride extended- release capsules-treated subject (1/65, 1.5%) discontinued due to an adverse event (depressed mood).

In the single-blind titration period of this study, subjects received methylphenidate hydrochloride extended-release capsules for up to 4 weeks. During this period a total of 6 subjects (6/161, 3.7%) discontinued due to adverse events. The adverse events leading to discontinuation were anger (2 patients), hypomania, anxiety, depressed mood, fatigue, migraine, and lethargy.

6.2 Postmarketing Experience

The following adverse reactions have been identified during the post approval use of methylphenidate products. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Adverse Reactions Reported with Methylphenidate Hydrochloride Tablets and Methylphenidate Hydrochloride Extended-Release Capsules

Infections and Infestations: nasopharyngitis

Blood and the Lymphatic System Disorders: leukopenia, thrombocytopenia, anemia

Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis

Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in children

Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, depression

Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs

Eye Disorders: blurred vision, difficulties in visual accommodation

Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris

Respiratory, Thoracic, and Mediastinal Disorders: cough

Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia

Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury

Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura

Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis, trismus

Investigations: weight loss (adult ADHD patients)

Vascular Disorders: peripheral coldness, Raynaud's phenomenon

Adverse Reactions Reported with Other Methylphenidate-Containing Products

The list below shows adverse reactions not listed with methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-release capsules formulations that have been reported with other methylphenidate- containing products.

Blood and Lymphatic Disorders: pancytopenia

Immune System Disorders: hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas

Psychiatric Disorders: affect lability, mania, disorientation, libido changes

Nervous System Disorders: migraine, motor and verbal tics

Eye Disorders: diplopia, increased intraocular pressure, mydriasis

Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole

Respiratory, Thoracic, and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea

Gastrointestinal Disorders: diarrhea, constipation

Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption

Musculoskeletal, Connective Tissue, and Bone Disorders: myalgia, muscle twitching

Renal and Urinary Disorders: hematuria

Reproductive System and Breast Disorders: gynecomastia

General Disorders: fatigue, hyperpyrexia

Urogenital Disorders: priapism

OVERDOSAGE SECTION

10 OVERDOSAGE

Clinical Effects of Overdose

Overdose of CNS stimulants is characterized by the following sympathomimetic effects:

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Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial

infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.

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CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures,

cerebral vascular accidents, and coma may occur.

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Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.

Overdose Management

Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of methylphenidate hydrochloride extended-release capsules should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

SPL MEDGUIDE SECTION

**Abuse, misuse, and addiction.**Methylphenidate hydrochloride extended-release capsuleshave 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.

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

**Increased blood pressure and heart rate.**

**Mental (psychiatric) problems:**

are 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.

are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).

heart problems, heart disease, heart defects, or high blood pressure

mental problems, including psychosis, mania, bipolar illness, or depression

circulation problems in fingers or 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.

if you are pregnant or plan to become pregnant. It is not known if methylphenidate hydrochloride extended-release capsules will harm your unborn baby.

There is a pregnancy registry for females who are exposed to ADHD medications, including 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 of ADHD medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd- medications/.

if you are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride extended-release capsules.

anti-depression medicines, including MAOIs

blood pressure medicines (anti-hypertensive)

risperidone

You should not take methylphenidate hydrochloride extended-release capsules 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.

Take methylphenidate hydrochloride extended-release capsules exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child.

Take methylphenidate hydrochloride extended-release capsules once a day in the morning. Methylphenidate hydrochloride extended-release capsule is an extended-release capsule.

**Do not chew or crush methylphenidate hydrochloride extended-release capsules or the medicine inside the capsule.**Swallow methylphenidate hydrochloride extended-release capsules whole with water or other liquids.

If you cannot swallow the capsule whole, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid.

You should avoid drinking alcohol during treatment with methylphenidate hydrochloride extended-release capsules. This may cause a faster release of methylphenidate hydrochloride extended-release capsules.

see “**What is the most important information I should know about methylphenidate hydrochloride extended-release capsules?**” for information on reported heart and mental problems.

**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.

**circulation problems in fingers and toes** (peripheral vasculopathy, including Raynaud’s phenomenon):

fingers or toes may feel numb, cool, painful

fingers or toes may change color from pale, to blue, to red

**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. Treatment with methylphenidate hydrochloride extended-release capsules 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.

Common side effects include:

fast heartbeat

abnormal heartbeat (palpitations)

trouble sleeping

nervousness

sweating a lot

decreased appetite

nausea

stomach pain

Store methylphenidate hydrochloride extended-release capsules in a safe place and in a tightly closed container at room temperature, 68°F to 77°F (20°C to 25°C).

Protect from 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.**

HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

•

10 mg extended-release capsules (NDC 0781-2361-01) white/light brown, (imprinted “NVR R10”) supplied in bottles of 100

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20 mg extended-release capsules (NDC 0781-2362-01) white, (imprinted “NVR R20”) supplied in bottles of 100

•

30 mg extended-release capsules (NDC 0781-2363-01) yellow, (imprinted “NVR R30”) supplied in bottles of 100

•

40 mg extended-release capsules (NDC 0781-2364-01) light brown, (imprinted “NVR R40”) supplied in bottles of 100

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP controlled room temperature].

Dispense in tight container (USP).