QuilliChew ER

Common side effects include:

• decreased appetite 
• indigestion 
• dizziness 
• increased blood pressure  
• trouble sleeping  
• stomach pain 
• irritability 
• nausea 
• weight loss  
• mood swings  
• vomiting 
• anxiety  
• fast heart beat

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

QuilliChew ER is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep QuilliChew ER in a safe place to prevent misuse and abuse. Selling or giving away QuilliChew ER may harm others and is against the law.

Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.

The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.

Heart-related problems:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting QuilliChew ER. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with QuilliChew ER. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking QuilliChew ER.

Mental (Psychiatric) problems:

• new or worse behavior and thought problems
• new or worse bipolar illness
• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking QuilliChew ER, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

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

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking QuilliChew ER.

QuilliChew ER should not be taken if you or your child:

• are allergic to methylphenidate hydrochloride, or any of the ingredients in QuilliChew ER.
• are taking or have taken within the past 14 days a type of antidepression medicine referred to as a monoamine oxidase inhibitor or MAOI.

QuilliChew ER is not intended for children less than 6 years of age.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if QuilliChew ER will harm your unborn baby.

This medication may be given to a pregnant woman if it is determined that the benefits to the pregnant woman outweigh any possible risks to her unborn baby.

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

Avoid drinking alcohol, especially if you take extended-release methylphenidate. Alcohol may cause the medicine to be released into the bloodstream too fast.

Methylphenidate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

In the U.S.

• Aptensio XR
• Concerta
• Cotempla XR-ODT
• Metadate CD
• Metadate ER
• Methylin
• Methylin ER
• QuilliChew ER
• Quillivant XR
• Ritalin
• Ritalin LA
• Ritalin-SR

Available Dosage Forms:

• Tablet, Extended Release, Disintegrating
• Capsule, Extended Release
• Tablet, Extended Release, Chewable
• Tablet, Extended Release
• Powder for Suspension, Extended Release
• Solution
• Tablet, Chewable
• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Your doctor should check your or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

You or your child should not use this medicine if you have used a drug for depression, called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child has chest pain, shortness of breath, fainting, or a fast, irregular heartbeat while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of his height and weight to make sure that he is growing properly.

Methylphenidate may cause a condition called Raynaud phenomenon. Check with your doctor right away if you or your child has tingling or pain in the fingers or toes when exposed to cold temperatures, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.

Make sure any doctor or dentist who treats you knows that you are using Metadate CD®. You may need to stop using this medicine before you have surgery.

Avoid drinking alcohol while taking the Aptensio XR™, Cotempla XR-ODT™ extended release disintegrating tablets, Metadate CD®, Quillichew ER™ tablets, or Ritalin LA® extended-release capsules.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Hypersensitivity to Methylphenidate or other Components of Quillichew ER

Quillichew ER is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of Quillichew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6.2)].

Monoamine Oxidase Inhibitors

Quillichew ER is contraindicated during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI), because of the risk of hypertensive crisis [see Drug Interactions (7.1)].

Potential for Abuse and Dependence

CNS stimulants, including Quillichew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Drug Abuse and Dependence (9.2, 9.3)].

Serious Cardiovascular Reactions

Stroke and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in children and adolescents with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillichew ER.

Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Psychiatric Adverse Reactions

Exacerbation of Pre-Existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Quillichew ER. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in placebo-treated patients.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud's Phenomenon

CNS stimulants, including Quillichew ER, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in postmarketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation of digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Long-Term Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or nonmedication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and nonmedication-treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including Quillichew ER. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Risks in Patients with Phenylketonuria

Phenylalanine can be harmful to patients with phenylketonuria (PKU). Quillichew ER extended-release chewable tablets contain phenylalanine, a component of aspartame. Each 20 mg, 30 mg, and 40 mg extended-release chewable tablet contains 3 mg, 4.5 mg, and 6 mg phenylalanine, respectively. Before prescribing Quillichew ER in patients with PKU, consider the combined daily amount of phenylalanine from all sources, including Quillichew ER.

Applies to methylphenidate: oral capsule extended release, oral powder for suspension extended release, oral solution, oral tablet, oral tablet chewable, oral tablet extended release, oral tablet extended release chewable

Other dosage forms:

• transdermal patch extended release

Along with its needed effects, methylphenidate (the active ingredient contained in QuilliChew ER) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methylphenidate:

• Fast heartbeat

• Chest pain
• fever
• joint pain
• skin rash or hives

• Black, tarry stools
• blood in the urine or stools
• blurred vision or other changes in vision
• crusting, dryness, or flaking of the skin
• muscle cramps
• pinpoint red spots on the skin
• scaling, severe redness, soreness, or swelling of the skin
• seizures
• uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
• unusual bleeding or bruising

• Confusion
• depression
• feeling like surroundings are not real
• numbness of the hands
• painful or difficult urination
• pale skin
• paleness or cold feeling in the fingertips and toes
• red, irritated eyes
• red, swollen, or scaly skin
• seeing, hearing, or feeling things that are not there
• severe or sudden headache
• sores, ulcers, or white spots on the lips or in the mouth
• sudden loss of coordination
• sudden slurring of speech
• tingling or pain in the fingers or toes when exposed to cold
• unusual behavior
• unusual tiredness or weakness
• weight loss
• yellow skin or eyes

Get emergency help immediately if any of the following symptoms of overdose occur while taking methylphenidate:

• Agitation
• anxiety
• bigger, dilated, or enlarged pupils of the eyes
• confusion as to time, place, or person
• dark-colored urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry eyes, mouth, nose, or throat
• false or unusual sense of well-being
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• holding false beliefs that cannot be changed by fact
• increased sensitivity of the eyes to light
• loss of consciousness
• muscle pain or stiffness
• muscle twitching
• nervousness
• overactive reflexes
• pounding in the ears
• rapid, shallow breathing
• sweating
• tremors
• unusual excitement, nervousness, or restlessness

Some side effects of methylphenidate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• loss of appetite
• nervousness
• stomach pain
• stuffy nose
• trouble sleeping
• unusually warm skin

• Anger
• decreased appetite
• dizziness
• drowsiness
• fear
• irritability
• muscle aches
• nausea
• runny nose
• scalp hair loss
• talking, feeling, and acting with excitement
• vomiting