What are the possible side effects of 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.
• Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before treatment with COTEMPLA XR-ODT and will monitor your child during treatment.
• COTEMPLA XR-ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
• Do not give COTEMPLA XR-ODT to anyone else

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 during treatment with COTEMPLA XR-ODT.

Mental (psychiatric) problems, including:

• New or worse behavior and thought problems
• New or worse bipolar illness
• New psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms

Tell your healthcare provider about any mental problems your child has, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with COTEMPLA XR-ODT, especially hearing voices, seeing or believing things that are not real, or new manic symptoms

Painful and prolonged erections (priapism).

• Priapism has happened in males who take products that contain methylphenidate. If your child develops priapism, get medical help right away.

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon).

• Signs and symptoms may include:
  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red
• Tell your healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in their fingers or toes.

Call your healthcare provider right away if your child has 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 you or your child develop changes in your vision or eye pain, swelling, or redness.

New or worsening tics or worsening Tourette’s syndrome.

Other Medications

• Tell your healthcare provider about all of the medicines that 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
• Know the medicines that your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist.

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