Methylphenidate Extended-Release Tablets

What is this medication?

METHYLPHENIDATE (meth il FEN i date) treats attention-deficit hyperactivity disorder (ADHD). It works by improving focus and reducing impulsive behavior. It may also be used to treat narcolepsy. It works by promoting wakefulness. It belongs to a group of medications called stimulants.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Concerta, Metadate ER, Methylin, RELEXXII, Ritalin SR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anxiety or panic attacks
• Circulation problems in fingers and toes
• Difficulty swallowing, problems with the esophagus, or a history of blockage of the stomach or intestines
• Glaucoma
• Hardening or blockages of the arteries or heart blood vessels
• Heart disease or a heart defect
• High blood pressure
• History of a drug or alcohol abuse problem
• History of stroke
• Liver disease
• Mental illness
• Motor tics, family history or diagnosis of Tourette's syndrome
• Seizures
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• Thyroid disease
• An unusual or allergic reaction to methylphenidate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not crush, cut, or chew the tablet. You may take this medication with food. Take your medication at regular intervals. Do not take it more often than directed. If you take your medication more than once a day, try to take your last dose at least 8 hours before bedtime. This well help prevent the medication from interfering with your sleep.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team regarding the use of this medication in children. While this medication may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Lithium
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Other stimulant medications for attention disorders, weight loss, or to stay awake
• Procarbazine

This medication may also interact with the following:

• Atomoxetine
• Caffeine
• Certain medications for blood pressure, heart disease, irregular heart beat
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin
• Cold or allergy medications
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. This prescription requires that you follow special procedures with your care team and pharmacy. You will need to have a new written prescription from your care team every time you need a refill.

This medication may affect your concentration, or hide signs of tiredness. Until you know how this medication affects you, do not drive, ride a bicycle, use machinery, or do anything that needs mental alertness.

Tell your care team if this medication loses its effects, or if you feel you need to take more than the prescribed amount. Do not change the dosage without talking to your care team.

For males, contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

Decreased appetite is a common side effect when starting this medication. Eating small, frequent meals or snacks can help. Talk to your care team if you continue to have poor eating habits. Height and weight growth of a child taking this medication will be monitored closely.

Do not take this medication close to bedtime. It may prevent you from sleeping.

The tablet shell for some brands of this medication does not dissolve. This is normal. The tablet shell may appear whole in the stool. This is not a cause for concern.

If you are going to need surgery, a MRI, CT scan, or other procedure, tell your care team that you are taking this medication. You may need to stop taking this medication before the procedure.

Tell your care team right away if you notice unexplained wounds on your fingers and toes while taking this medication. You should also tell your care team if you experience numbness or pain, changes in the skin color, or sensitivity to temperature in your fingers or toes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Prolonged or painful erection
• Raynaud's—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red
• Stroke in adults—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Anxiety, nervousness
• Blurry vision
• Headache
• Loss of appetite
• Nausea
• Trouble sleeping
• Weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Keep container tightly closed.

This medication may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medication with a substance like cat litter or coffee grounds. Then throw the medication away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.