Details for: APO-AMPHETAMINE XR

• 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, APO-AMPHETAMINE XR generally should not be used in children, adolescents or adults with known structural heart abnormalities, disease of the heart muscle, serious heart rhythm abnormalities or other serious heart disease or conditions.

Tell your doctor if you or your child has 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 APOAMPHETAMINE XR. Your doctor may wish to check you or your child’s blood pressure and heart rate regularly during treatment with APO-AMPHETAMINE XR.

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-AMPHETAMINE XR.

2. Mental (Psychiatric) problems:

• New or worse thoughts or feelings related to suicide (thinking about or feeling like killing yourself) and suicide actions (suicide attempt, completed suicide)
• New or worse bipolar illness, characterized by extreme mood swings, with periods of mania (unusually excited, over-active or un-inhibited) alternating with periods of depression (feelings of sadness, worthlessness or hopelessness)
• New or worse aggressive behavior or hostility
• New psychosis (such as hearing voices, believing things that are not true, are suspicious) or new mania (unusually excited, over-active or uninhibited)

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 you or your child have, or about any personal or family history of suicide, bipolar illness, or depression.

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-AMPHETAMINE XR. Should this happen to you, or to those in your care if you are a caregiver or guardian, talk to your doctor immediately. Close observation by a doctor is necessary in this situation.

Call your doctor right away if you or your child has any new or worsening mental symptoms while taking APOAMPHETAMINE XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

BEFORE you/your child uses APO-AMPHETAMINE XR, talk to your doctor, nurse, or pharmacist if you/your child:

• have heart disease or a heart condition, structural heart abnormalities or high blood pressure
• have a family history of sudden death or death related to heart problems
• participate in strenuous exercise or activities
• take other drugs for ADHD
• have mental problems or a family history of mental problems including psychosis, mania, bipolar illness, depression or suicide.
• have motion tics (hard to control, repeat twitching of any parts of the body) or verbal tics (hard to control repeating of sounds or words) or Tourette’s syndrome
• have relatives with motion tics, verbal tics, or Tourette’s syndrome
• have a history of seizures (convulsions, epilepsy) or have had an abnormal brain wave test (EEG)
• are pregnant or plan to become pregnant. Taking APO-AMPHETAMINE XR during pregnancy can cause harm to your baby. If APO-AMPHETAMINE XR is required during pregnancy, the risk to the unborn baby should be weighed against the benefits for the mother. Your doctor can discuss these issues with you
• have symptoms of Raynaud’s phenomenon (fingers and toes feeling numb, tingling and changing colour when cold) or thromboangitis obliterans (causes pain in hands and feet)
• have any kidney related problems as your doctor may reduce the dose.

Drug Abuse and Dependence
Amphetamines have the potential for abuse and misuse. Abuse of amphetamines can lead to dependence and possibly serious heart problems and death. Substance abuse may be less likely in patients with ADHD if they are treated with medication. APO-AMPHETAMINE XR should only be given under close medical supervision to patients whose condition has been properly diagnosed (see Serious Warnings and Precautions above).

Growth in Children
Other stimulants have been reported to temporarily slow growth in children, however there is not sufficient evidence to determine if mixed salts amphetamine extended-release capsules in children may cause slower growth (slowed weight gain and/or height). The doctor will be carefully watching your / your child’s height and weight. If you / your child is not growing or gaining weight as the doctor expects, the doctor may stop APOAMPHETAMINE XR treatment.