Consumer Important Safety Information

Most Important Information About COTEMPLA XR-ODT:

Abuse, misuse, and addiction. COTEMPLA XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of COTEMPLA XR-ODT, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of COTEMPLA XR-ODT or when it is used in ways that are not approved, such as snorting or injection.

Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check your child carefully for heart problems before starting COTEMPLA XR-ODT. Tell your healthcare provider if your child has any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking COTEMPLA XR-ODT.
Increased blood pressure and heart rate. Your healthcare provider should check your child’s blood pressure and heart rate regularly during treatment with COTEMPLA XR-ODT.
Mental (Psychiatric) problems: Tell your healthcare provider about any mental problems your child has, or about a family history of suicide, bipolar illness, depression, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real), or new manic symptoms. Call your healthcare provider right away if your child has any new or worsening mental symptoms or problems while taking COTEMPLA XR-ODT, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is COTEMPLA XR-ODT: COTEMPLA XR-ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children under 6 to 17 years of age. COTEMPLA XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in children 6 to 17 years of age with ADHD. It is not known if COTEMPLA XR-ODT is safe and effective in children under 6 years of age.

You should avoid drinking alcohol during treatment with COTEMPLA XR-ODT.

COTEMPLA XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep COTEMPLA XR-ODT in a safe place to protect it from theft. Never give your COTEMPLA XR-ODT to anyone else because it may cause death or harm them. Selling or giving away COTEMPLA XR-ODT may harm others and is against the law.

Do Not Give COTEMPLA XR-ODT to Your Child if They are: COTEMPLA XR-ODT should not be taken if you or your child:

Are allergic to methylphenidate or any of the ingredients in COTEMPLA XR-ODT
Are taking or have taken within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor MAOI

Before Taking COTEMPLA XR-ODT Tell Your Child’s Healthcare Provider About All Medical Conditions, Including if Your Child:

Has heart problems, heart disease, heart defects, or high blood pressure
Has mental problems including psychosis, mania, bipolar illness, or depression
Has circulation problems in fingers or toes
Have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
Have, or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
Is pregnant or plans to become pregnant. It is not known if COTEMPLA XR-ODT will harm the unborn baby.
Is breastfeeding or plans to breastfeed. COTEMPLA XR-ODT passes into breast milk. You and your healthcare provider should decide if your child will take COTEMPLA XR-ODT or breastfeed.

Tell your healthcare provider about all of the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. COTEMPLA XR-ODT and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with COTEMPLA XR-ODT. Your healthcare provider will decide whether COTEMPLA XR-ODT can be taken with other medicines. Especially tell your healthcare provider if your child takes anti-depression medicines including MAOIs.

Do not start any new medicine during treatment with COTEMPLA XR-ODT without talking to your healthcare provider first.

The most common side effects of COTEMPLA XR-ODT include decreased appetite and problems sleeping. COTEMPLA XR-ODT can cause serious side effects, including:

Painful or prolonged erections (priapism). If your child develops priapism, get medical help right away.
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon): fingers and toes may feel numb, cool, painful and/or change from pale to blue or red. Tell your healthcare provider if your child has numbness, pain, skin color change, sensitivity to temperature in their fingers or toes, or any signs of unexplained wounds appearing on fingers or toes during treatment with COTEMPLA XR-ODT.
Slowing of growth (height and weight in children). Children should have their height and weight checked often during treatment with COTEMPLA XR-ODT. COTEMPLA XR-ODT treatment may be stopped if your child is not gaining weight or height.
Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if your child develops changes in their vision or eye pain, swelling, or redness.
New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if your child gets any new or worsening tics or worsening Tourette’s syndrome during treatment with COTEMPLA XR-ODT.
The most common side effects of methylphenidate products include: decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, increased blood pressure.

These are not all the possible side effects of COTEMPLA XR-ODT.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please click here for Full Medication Guide.