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Metadate CD advertisement Ladies' Home Journal, August 2001, pages 119-120. Introducing METADATE CD Capsules ~ One dose covers his ADHD for the whole school day Designed to work when he needs it most For patients with a confirmed diagnosis of attention-deficit/hyperactivity disorder (ADHD), once-daily METATDATE® CD Capsules provide school-day-long coverage while freeing them from the inconvenience of a midday dose. Metadate CD Capsules also offer the flexibility to choose after-school dosing if needed. This is important because surveys have shown that 89% of patients don't need or want after-school dosing.1 To learn more, asky your doctor or call toll free 1-866-ADHD-INFO. Look for us on the World Wide Web at www.metadate-CD.com. IMPORTANT SAFETY INFORMATION FOR PATIENTS: Tell your child's doctor about all medications that your child is taking or intends to take. Metadate CD Capsules should not be used in children under 6 years age. Metadate CD Capsules should not be used in patients: * Who are overly anxious, tense, or agitated * With glaucoma, tics, or Tourette's Syndrome * Who are taking or who recently took an MAO inhibitor Caution is advised in patients with a history of drug or alcohol dependence, mental illness, seizures, high blood pressure, or heart conditions. The most common side effects are headache, stomachache, decreased appetite, and sleeplessness. CELLTECH ~ Metadate is a registered trademark of Celltech Pharma, Ltd. ~ Please see brief summary of Prescribing Information on next page. Reference: 1. IMS Health NDTI Audit, August 2000. © 2001 Celltech Pharmaceuticals, Inc. Rochester, NY 14623 M24-028 New once-daily METADATE CD, (methylphenidate HC1, USP) Extended-Release Capsules 20 Mg INFORMATION FOR PATIENTS TAKING METADATE® CD OR THEIR PARENTS OR CAREGIVERS This information is for patients or their parents or caregivers taking METADATE (MET-a-date) CD Capsules for the treatment of Attention Deficit Hyperactivity Disorder. Please read this before you start taking METADATE CD. Remember, this information does not take the place of your doctor's instructions. If you have any questions about this information or about METADATE CD, talk to your doctor or pharmacist. What is METADATE CD? METADATE CD is a once-a-day treatment for Attention Deficit Hyperactivity Disorder, or ADHD. METADATE CD contains the drug methylphenidate, a central nervous system stimulant that has been used to treat ADHD for more than 30 years. METADATE CD is taken by mouth, once each day in the morning, before breakfast. What is Attention Deficit Hyperactivity Disorder? ADHD has three main types of symptoms: inattention, hyperactivity, and impulsiveness. Symptoms of inattention include not paying attention, making careless mistakes, not listening, not finishing tasks, not following directions, and being easily distracted. Symptoms of hyperactivity and impulsiveness include fidgeting, talking excessively, running around at inappropriate times, and interrupting others. Some patients have more symptoms of hyperactivity and impulsiveness while others have more symptoms of inattentiveness. Some patients have all three types of symptoms. Many people have symptoms like these from time to time, but patients with ADHD have these symptoms more than others their age. Symptoms must be present for at least 6 months to be certain of the diagnosis. How does METADATE CD work? The METADATE CD capsule dissolves right after you swallow it in the morning, giving you an initial dose of methylphenidate. The remaining drug is slowly released during the day to continue to help lessen the symptoms of ADHD. Methylphenidate, the active ingredient in METADATE CD, helps increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Who should NOT take METADATE CD? You should NOT take METADATE CD if: * You have significant anxiety, tension, or agitation since METADATE CD may make these conditions worse. * You are allergic to methylphenidate or any of the other ingredients in METADATE CD. * You have glaucoma, an eye disease. * You have tics or Tourette's Syndrome, or a family history of Tourette's Syndrome. Talk to your doctor if you believe any of these conditions apply to you. How should I take METADATE CD? Do not chew, crush, or open the capsules. Swallow METADATE CD capsules whole with the help of water or other liquids, such as milk or juice. Take METADATE CD once each day in the morning, before breakfast. Take the dose prescribed by your doctor. Your doctor may adjust the amount of drug you take until it is right for you. From time to time, your doctor may interrupt your treatment to check your symptoms while you are not taking the drug. What are the possible side effects of METADATE CD? In the clinical studies with patients using METADATE CD, the most common side effects were headache, stomach pain, sleeplessness, and decreased appetite. Other side effects seen with methylphenidate, the active ingredient in METADATE CD, include nausea, vomiting, dizziness, nervousness, tics, allergic reactions, increased blood pressure and psychosis (abnormal thinking or hallucinations). This is not a complete list of possible side effects. Ask your doctor about other side effects. If you develop any side effect, talk to your doctor. What must I discuss with my doctor before taking METADATE CD? Talk to your doctor before taking METADATE CD if you: * Are being treated for depression or have symptoms of depression such as feelings of sadness, worthlessness, and hopelessness. * Have motion tics (hard-to-control, repeated twitching of any parts of your body) or verbal ties (hard-to-control repeating of sounds or words). * Have somebody in your family with motion tics, verbal tics, or Tourette's Syndrome. * Have abnormal thoughts or visions, hear abnormal sounds, or have been diagnosed with psychosis. * Have had seizures (convulsions, epilepsy) or abnormal EEGs (electroencephalograms). * Have high blood pressure. Tell your doctor immediately if you develop any of the above conditions or symptoms while taking METADATE CD. Can I take METADATE CD with other medicines? Tell your doctor about all medicines that you are taking or intend to take. Your doctor should decide whether you can take METADATE CD with other medicines. These include: * Other medicines that a doctor has prescribed. * All medicines that you buy yourself without a prescription. * Any herbal remedies that you may be taking. You should not take METADATE CD with monoamine oxidase (MAO) inhibitors. While on METADATE CD, do not start taking a new medicine or herbal remedy before checking with your doctor. METADATE CD may change the way your body reacts to certain medicines. These include medicines used to treat depression, prevent seizures, or prevent blood clots (commonly called "blood thinners"). Your doctor may need to change your dose of these medicines if you are taking them with METADATE CD. Other Important Safety Information: Abuse of methylphenidate can lead to dependence. Tell your doctor if you have ever abused or been dependent on alcohol or drugs, or if you are now abusing or dependent on alcohol or drugs. Before taking METADATE CD, tell your doctor if you are pregnant or plan on becoming pregnant. If you take methylpheniclate, it may be in your breast milk. Tell your doctor if you are nursing a baby. Tell your doctor if you have blurred vision when taking METADATE CD. Slower growth (weight gain and/or height) has been reported with long-term use of methylphenidate in children. Your doctor will be carefully watching your height and weight. If you are not growing or gaining weight as your doctor expects, your doctor may stop your METADATE CD treatment. Call your doctor immediately if you take more than the amount of METADATE CD prescribed by your doctor. What else should I know about METADATE CD? METADATE CD has not been studied in children under 6 years of age. METADATE CD may be a part of your overall treatment for ADHD. Your doctor may also recommend that you have counseling or other therapy. As with all medicines, never share METADATE CD with anyone else and take only the number of METADATE CD Capsules prescribed by your doctor. METADATE CD should be stored in a safe place at room temperature (between 59°F.-86°F). For more information about METADATE CD: METADATE CD Capsules are available by prescription. Only your doctor knows what is right for you. This sheet is only a brief summary. If you have any questions, or want any information, talk with your doctor or pharmacist, or call the number below. Keep out of the reach of children. For more information call 1-888-METADATE (1 -888-638-2328) or visit us on the World Wide Web at www.metadate-cd.com. Marketed by: C E L LT E C H ~ Manufactured by: Eurand America, Inc., Vandalia, Ohio 45377 USA Celltech Pharmaceuticals, Inc., Rochester, NY 14623 USA ~ © Celltech Pharma Limited 2001 © 2001, Celltech Pharmaceuticals, Inc. Rev. 4/01 R549 |