Metadate CD

• UCB, Inc.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Metadate CD, there are no specific foods that you must exclude from your diet when receiving Metadate CD.

Take the missed dose as soon as you remember. Skip the missed dose if it is later than 6:00 p.m. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;

• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;

• a seizure (convulsions);

• muscle twitches (tics);

• changes in your vision; or

• penis erection that is painful or lasts 4 hours or longer (rare).

Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• mood changes, feeling nervous or irritable, sleep problems (insomnia);

• fast heart rate, increased blood pressure;

• loss of appetite, weight loss;

• nausea, stomach pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

• Tell all of your health care providers that you take Metadate CD. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Heart attacks, strokes, and sudden deaths have happened in adults taking Metadate CD. Sudden deaths have also happened in children with very bad heart problems or heart defects. Call your doctor right away if you have a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, drooping on 1 side of the face, change in eyesight, chest pain or pressure, shortness of breath, or very bad dizziness or passing out.
• You may have some heart tests before starting this medicine. Talk with your doctor.
• If you have seizures, talk with your doctor.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Avoid drinking alcohol while taking Metadate CD.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Metadate CD (methylphenidate long-acting capsules) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Headache.
• Upset stomach or throwing up.
• Weight loss.
• Nervous and excitable.
• Not hungry.
• Not able to sleep.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Signs And Symptoms

Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes, and rhabdomyolysis.

Recommended Treatment

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for Metadate CD overdosage has not been established.

The prolonged release of methylphenidate from Metadate CD should be considered when treating patients with overdose.

Poison Control Center

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.

NDC 53014-579-07

Once Daily

Metadate CD®
(methylphenidate HCl, USP)
Extended-Release Capsules

CII

100 Capsules
10 mg

Rx Only

ucb

A Medication Guide is required
for every prescription dispensed.

Please use accompanying Medication Guide.

NDC 53014-582-07

Once Daily

Metadate CD®
(methylphenidate HCl, USP)
Extended-Release Capsules

CII

100 Capsules
40 mg

Rx Only

A Medication Guide is required
for every prescription dispensed.

Please use accompanying Medication Guide.

ucb