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|Daytrana System

Daytrana System

Daytrana System is used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Daytrana System is a central nervous system stimulant. Exactly how it works to treat ADHD is not known.

Do NOT use Daytrana System if:

• you are allergic to any ingredient in this medicine
• you have severe anxiety, agitation, or tension
• you have glaucoma
• you have motor tics, Tourette syndrome, or a family history of Tourette syndrome
• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Daytrana System:

Some medical conditions may interact with Daytrana System. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have skin inflammation, a cut, or a skin wound; skin problems (eg, eczema, psoriasis); or an allergy or sensitivity to soap, lotion, cosmetics, or adhesives
• if you have a history of high blood pressure or heart problems (eg, problems with the heart structure or muscle, heart failure, fast or irregular heartbeat), or you have had a recent heart attack
• if you have a history of seizures or abnormal electroencephalograms (EEGs)
• if you have a history of an overactive thyroid, chronic fatigue, cystic fibrosis, or stomach or bowel problems (eg, blockage, inflammation, or narrowing)
• if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a member of your family has had any of these problems

Some MEDICINES MAY INTERACT with Daytrana System. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because severe high blood pressure may occur
• Clonidine because serious side effects may occur
• Pressor agents (eg, norepinephrine) because the risk of high blood pressure may be increased
• Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Daytrana System
• Guanethidine or other medicines for high blood pressure because their effectiveness may be decreased by Daytrana System

This may not be a complete list of all interactions that may occur. Ask your health care provider if Daytrana System may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Daytrana System:

Use Daytrana System as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Daytrana System comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Daytrana System refilled.
• Do not remove the patch from the pouch until you are ready to apply it.
• Do NOT use the patch if the pouch seal is open or damaged or if the patch is cut or damaged in any way.
• Do NOT apply the patch to skin that is oily, damaged, or irritated, or skin that has lotion or powder on it. Do NOT apply to an open wound or cut skin.
• Do NOT apply the patch to the waistline or anywhere that tight clothing may rub it or cause it to fall off.
• Apply the patch 2 hours before the effect is needed, unless your doctor tells you otherwise.
• Gently wash and completely dry the application area before you apply the patch. Open the pouch. Remove the protective liner from the patch. Apply the patch to a clean, dry area on the hip. Hold it in place for 30 seconds. Be sure the edges are firmly attached to the skin. Choose a new area on the opposite hip each day when you apply the patch.
• Wash your hands immediately after handling Daytrana System.
• Remove the patch 9 hours after it is applied, unless otherwise directed by your doctor.
• After removing the used patch, fold it in half with the sticky sides together. Flush the patch down the toilet or discard it as directed by your doctor.
• If the patch falls off during the day, be sure you know when and how the patch came off. Choose a different site on the same hip and apply a new patch. Remove the patch at the regularly scheduled time.
• Do not wear the patch any longer than 9 hours in a 24-hour period.
• Use the administration chart that comes with Daytrana System to monitor the date and time that you apply and remove the patch. Also record how you dispose of it.
• If you miss a dose of Daytrana System, apply the missed patch if you remember that day. Then remove the patch at the regularly scheduled time. If it is close to the time that you would regularly remove the patch, or if you do not remember until the next day, skip the missed dose. Go back to your regular dosing schedule the next day. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Daytrana System.

Important safety information:

• Daytrana System may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Daytrana System with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Daytrana System should not be used to treat depression or to prevent or treat normal fatigue.
• Tell your doctor or dentist that you take Daytrana System before you receive any medical or dental care, emergency care, or surgery.
• Check with your doctor if Daytrana System causes persistent loss of appetite or persistent sleeping problems. You may need to remove the patch earlier in the day, or you may need a different dose. Do not change your dose or stop using Daytrana System without checking with your doctor.
• Contact your doctor if you develop redness, swelling, or blisters that do not improve within 24 hours after the patch is removed or that spread beyond the patch site.
• If you develop an allergic reaction to Daytrana System, talk to your doctor before taking any other form of Daytrana System (eg, tablets). You may also be allergic to the other forms of Daytrana System.
• Do not expose the patch site to heating pads, electric blankets, hot water beds, or any other external heat source. It may increase the amount of medicine released from the patch, which may increase your risk of side effects.
• The patch should not come off during swimming, bathing, or showering if it has been applied properly. If the patch does come off during the day, apply a new patch as directed.
• Daytrana System may cause harm if it is chewed on or swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Lab tests, including complete blood cell counts and platelet counts, may be performed while you use Daytrana System. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• It is not known if Daytrana System may affect growth rate in CHILDREN and teenagers. They may need regular growth checks while they use Daytrana System.
• Caution is advised when using Daytrana System in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
• Daytrana System should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Daytrana System while you are pregnant. It is not known if Daytrana System is found in breast milk. If you are or will be breast-feeding while you use Daytrana System, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Daytrana System may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Daytrana System stops working well. Do not take more than prescribed.

Some people who use Daytrana System for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Daytrana System. If you stop taking Daytrana System suddenly, you may have WITHDRAWAL symptoms. These may include depression or other mental problems.

Possible side effects of Daytrana System:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; loss of appetite; mild sore throat; nausea; nervousness; redness, mild itching, or small bumps on the skin at the application site; stuffy nose; trouble sleeping; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes (eg, aggression, hostility); chest pain; confusion; fainting; fast or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, agitation, anxiety, depression, irritability, persistent crying, unusual sadness); purple or brownish red spots on the skin; seizures; severe or persistent dizziness or headache; swelling or blisters at the application site; uncontrolled muscle movements; vision problems or blurred vision.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include agitation; coma; confusion; dilated pupils; exaggerated reflexes; excessive sweating; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; mental or mood changes; muscle twitching; seizures; severe vomiting; tremors.

Store Daytrana System at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store the patch in its sealed pouch in the tray provided. Do not store the patches outside the pouch. Throw away any unused patches within 2 months of opening the tray. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Daytrana System out of the reach of children and away from pets.

General information:

• If you have any questions about Daytrana System, please talk with your doctor, pharmacist, or other health care provider.
• Daytrana System is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Daytrana System. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.