Details for: APO-METHYLPHENIDATE

The following have been reported with use of methylphenidate hydrochloride and other medicines used to treat ADHD:

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 with drugs used for ADHD treatment in children/adolescents with structural heart abnormalities or other serious heart problems. Although some serious heart problems alone can carry an increased risk of sudden death, APOMETHYLPHENIDATE and APO-METHYLPHENIDATE SR generally should not be used in children, adolescents or adults with known structural heart abnormalities or other serious heart disease or conditions.

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.
Your doctor may wish to check your or your child’s blood pressure and heart rate regularly during treatment with APOMETHYLPHENIDATE.

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 APOMETHYLPHENIDATE

2. Mental (Psychiatric) problems:

These new or worse mental problems 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-METHYLPHANIDATE. 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, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Tell your doctor immediately if you experience abnormally sustained or frequent and painful erections of the penis on APO-METHYLPHENIDATE treatment or after treatment discontinuation. This can occur in any age group and may need urgent medical treatment.

If you experience a combination of the following symptoms: restlessness, tremor, sudden muscle contractions, abnormal high temperature and nausea and vomiting while taking methylphenidate with medicines that raise the level of serotonin in the body (serotonergic medicines, for example those used to treat depression like sertraline and venlafaxine), stop treatment with methylphenidate and medicines that raise the level of serotonin in the body and tell your doctor immediately.

BEFORE you or your child uses APO-METHYLPHENIDATE talk to your doctor or pharmacist if you or your child:

• Have structural heart abnormalities.
• Have a family history of sudden death or death related to heart problems.
• Have any other current or previous heart problems
• Do strenuous exercise.
• Take other stimulant drugs.
• Have a history of drug or alcohol abuse
• Have motion tics or if any other family members suffer from tics. Signs of tics that are hard to control, repeated twitching of any parts of the body or repeating sounds and words.
• Have someone in your family with Tourette’s syndrome.
• Have had fits (convulsions, epilepsy, seizures) or abnormal EEGs (electroencephalograms).
• Have mild high blood pressure.
• Have an abnormal heart rate or rhythm.
• Have or have had any disorder of the blood vessels in the brain, e.g. weakening of blood vessels (aneurysm), stroke, inflammation of blood vessels (vasculitis).
• Have aggressive behaviour.
• Have any suicidal thoughts or behaviour.
• Have mental problems or family history of mental problems, including psychosis, mania, bipolar illness, depression or suicide.
• 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 develop any of the above conditions or symptoms while taking APO-METHYLPHENIDATE. The doctor will decide if you can start or continue taking APOMETHYLPHENIDATE.

Before taking APO-METHYLPHENIDATE, tell your doctor if you are pregnant or plan for pregnancy (women and men).

If you take APO-METHYLPHENIDATE, it can be in your breast milk. Do not breast-feed during your treatment with APOMETHYLPHENIDATE. Tell your doctor if you are nursing a baby.

APO-METHYLPHENIDATE may cause dizziness, drowsiness, blurred vision, hallucination or other central nervous system side effects, which can affect concentration. If you experience such symptoms, do not drive or use machines, or do other activities that need quick reactions until you know how this medication affects you.

Monitoring during treatment with APOMETHYLPHENIDATE

To see if APO-METHYLPHENIDATE is having any unwanted effects, the doctor will check from time to time the patient’s health conditions (e.g. blood pressure, heart rate) and will also monitor the growth of children taking APO-METHYLPHENIDATE. Blood tests will be carried out to monitor the amount of blood cells (white blood cells, red blood cells and platelets) if a patient takes APOMETHYLPHENIDATE for a long time.

APO-METHYLPHENIDATE should not be used in children under 6 years of age.