Details for: APO-METHYLPHENIDATE ER

1. Heart-related problems:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. Apo-Methylphenidate ER generally should not be used in children, adolescents or adults with known structural heart abnormalities.

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor may wish to check you or your child carefully for heart problems before starting APOMETHYLPHENIDATE ER.

Your doctor may wish to check you or your child’s blood pressure and heart rate regularly during treatment with APO-METHYLPHENIDATE ER.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking APO-METHYLPHENIDATE ER

2. Mental (Psychiatric) problems:

• New or worse thoughts or feelings related to suicide (thinking about or feeling like killing oneself) and suicide actions (including suicide attempt, suicidal ideation and completed suicide)
• new or worse symptoms of bipolar illness,characterized by extreme mood swings, with periods of mania (unusually excited, overactive or uninhibited) alternating with periods of depression (feelings of sadness, worthlessness or hopelessness)
• new or worse aggressive behaviour or hostility
• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

These new or worse mental symptoms may be more likely to occur if you/your child have mental disorders that you may or may not know about. Tell your doctor about any mental problems or about any personal or family history of suicide, bipolar illness, or depression you or your child have.

A small number of patients taking ADHD drugs may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of suicide, self-harm or harm to others. Those suicidal thoughts or behaviors may occur at any time during treatment, particularly at the start or during dose changes, and also after stopping APO-METHYLPHENIDATE ER. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Apo-Methylphenidate ER, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

BEFORE you or your child uses ApoMethylphenidate ER, talk to your doctor or pharmacist if you / your child:

• have structural heart abnormalities;
• have tics (movements or sounds that you cannot control) or Tourette’s syndrome, or if someone in your family has tics or Tourette’s syndrome;
• have eye problems, such as:
• increased pressure in the eye
• far-sightedness (difficulty seeing near objects)
• have mental problems or family history of mental problems, including psychosis, mania, bipolar illness, depression or suicide;
• become aggressive, anxious or agitated, or feel more aggressive, anxious or agitated than usual;
• have mild high blood pressure;
• take blood pressure medications;
• take cold, allergy or other drugs that can affect blood pressure;
• have a narrowing or blockage of your gastrointestinal tract (your esophagus, stomach, or small or large intestine);
• have a family history of sudden death or death related to heart problems;
• do strenuous exercise;
• take other drugs for ADHD;
• have or have had any disorder of the blood vessels in the brain (e.g., aneurysm, stroke, vasculitis), or
• have circulation problems in fingers and toes, including numbness; feeling cold or pain. (This is also known as Raynaud’s).

Tell your doctor immediately if you / your child develop any of the above conditions or symptoms while taking Apo-Methylphenidate ER. He/she will decide if you can start/continue taking ApoMethylphenidate ER.

BEFORE taking Apo-Methylphenidate ER, tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are nursing a baby. Methylphenidate passes into breast milk. If you take APO-METHYLPHENIDATE ER, it can be in your breast milk. You should consult with your doctor to determine whether you should stop breast-feeding or discontinue APO-METHYLPHENIDATE ER.

Your doctor will monitor your progress with APOMETHYLPHENIDATE ER and may require you to do occasional tests to ensure your health and safety