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IMPORTANT SAFETY INFORMATION
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\r\n JORNAY PM is a federally controlled substance (CII) because it contains\r\n methylphenidate and has a high chance of abuse and misuse and\r\n may lead to substance use problems, including addiction. Misuse and abuse of JORNAY PM can lead to overdose and death, which is increased\r\n with higher doses of JORNAY PM or if it is used in ways that are not approved, such\r\n as snorting or injection. Your healthcare provider (HCP)\r\n should check for signs of abuse, misuse, and addiction before starting and during treatment with JORNAY PM. JORNAY PM may lead to physical\r\n dependence after prolonged use, even if taken as directed by your HCP. Tell your HCP if you or your child have\r\n ever abused or been dependent\r\n on alcohol, prescription medicines, or street drugs.\r\n
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\r\n JORNAY PM can be a target for people who abuse prescription medicines or\r\n street\r\n drugs. Keep JORNAY PM in a safe place to protect it from\r\n theft. Never give your JORNAY PM to anyone else, because it may cause death or harm\r\n them. Selling or giving away JORNAY PM may harm others\r\n and is against the law.\r\n\r\n
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\r\n JORNAY PM should not be taken if you or your child is allergic to\r\n methylphenidate or any of the ingredients in JORNAY PM or is taking or has\r\n taken an antidepressant called a monoamine oxidase inhibitor (MAOI) within the last 14 days.\r\n
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\r\n JORNAY PM may other cause serious side effects, including:\r\n
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\r\n - \r\n Risks for people with serious heart disease. Sudden death has happened in people who have\r\n heart\r\n defects or other serious heart disease.\r\n Your HCP should check carefully for heart problems before starting JORNAY PM. Tell your HCP about any heart\r\n problems, heart disease, or\r\n heart defects. Call your HCP or go to the nearest hospital emergency room right away if there are any\r\n signs of heart problems, such as\r\n chest pain, shortness of breath, or fainting during treatment.\r\n
\r\n - Increased blood pressure and heart rate. Blood pressure and heart rate should be checked\r\n regularly during treatment.
\r\n - \r\n Mental (psychiatric) problems, including new or worse behavior and thought problems; new or\r\n worse bipolar illness; new psychotic symptoms\r\n (such as hearing voices or seeing or believing things that are not real) or new manic symptoms. Tell your HCP\r\n about any mental problems, or\r\n about a family history of suicide, bipolar illness, or depression. Call your HCP right away if there\r\n are\r\n any new or worsening mental\r\n symptoms or problems during treatment.\r\n
\r\n - Painful and prolonged erections (priapism) in males. If painful and prolonged erections\r\n happen, get medical help right away.
\r\n\r\n - Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s\r\n phenomenon). Signs and symptoms may include\r\n fingers or toes feeling numb, cool, painful, sensitive to temperature, and/or changing color from pale, to\r\n blue,\r\n to red. Tell your HCP about\r\n any circulation problems in fingers or toes. Call your HCP right away if any signs of\r\n unexplained wounds appear on fingers or toes.
\r\n\r\n - Slowing of growth (height and weight) in children. Children should have their height and\r\n weight checked often while taking JORNAY PM.
\r\n - Eye problems (increased pressure in the eye and glaucoma). Tell your HCP about any eye\r\n problems. Call your HCP right away if changes in\r\n vision or eye pain, swelling, or redness occurs.
\r\n - New or worsening tics or worsening Tourette’s syndrome. Tell your HCP if any new or\r\n worsening\r\n tics or worsening Tourette’s syndrome occurs.
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\r\n Before taking JORNAY PM, tell your HCP if you or your child:\r\n
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\r\n - \r\n are pregnant or plan to become pregnant. It is not known if JORNAY PM will harm\r\n an\r\n unborn baby.\r\n
\r\n - are breastfeeding or plan to breastfeed. JORNAY PM passes into the breast milk.\r\n\r\n
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Tell your HCP about all of the medicines that you or your child takes, including prescription and\r\n over-the-counter medicines, vitamins, and herbal supplements. JORNAY PM and some medicines may interact with\r\n each\r\n other and cause serious side effects.\r\n Especially tell your HCP if you or your child takes medicine to treat depression, including MAOIs.
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\r\n Avoid drinking alcohol during treatment with JORNAY PM. This may cause a faster release of the medicine in\r\n JORNAY\r\n PM.\r\n
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\r\n The most common side effects of methylphenidate include decreased appetite, stomach pain,\r\n irritability, trouble sleeping, weight loss, mood\r\n swings (affect lability), nausea, anxiety, increased heart rate, vomiting, dizziness, increased blood pressure,\r\n and indigestion.\r\n
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\r\n The most common side effects of JORNAY PM in clinical studies in children\r\n ages 6 to 12 with ADHD\r\n include trouble sleeping, nausea,\r\n decreased appetite, mood swings, restlessness (psychomotor hyperactivity), vomiting, and headache. These are not\r\n all the possible side effects\r\n of JORNAY PM.\r\n
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\r\n \r\n You are encouraged to report negative side effects of prescription\r\n drugs to the FDA. Visit\r\n www.fda.gov/medwatch, or call\r\n 1-800-FDA-1088.\r\n \r\n
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What is JORNAY PM?
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\r\n JORNAY PM is a central nervous system (CNS) stimulant prescription medicine used\r\n for\r\n the treatment of Attention Deficit Hyperactivity Disorder\r\n (ADHD) in people 6 years of age and older. JORNAY PM may help increase attention\r\n and\r\n decrease impulsiveness and hyperactivity in people 6\r\n years of age and older with ADHD. It is not known if JORNAY PM is safe and\r\n effective\r\n in children under 6 years of age.\r\n
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\r\n Please see\r\n Medication Guide, including Boxed Warning.\r\n
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Ⓒ Ironshore Pharmaceuticals Inc.
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All rights reserved. IP001358 12/22
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