- Abilifin® tablets can not be used, If the patient is allergic to aripiprazole. Reactions
   have ranged from pruritus /urticaria to anaphylaxis
 

- Using strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong
  CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) concomitantly with
  Abilifin® will increase the exposure of aripiprazole compared to use Abilifin® alone.
  Consequently, reducing the Abilifin® dosage is clinically recommended.
- Using strong CYP3A4 Inducers (e.g., carbamazepine, rifampin), concomitantly with
  Abilifin® will decreased the exposure of aripiprazole compared to use Abilifin® 
  alone. Therefore, increasing the Abilifin® dosage is clinically recommended. 
- Antihypertensive Drugs: Abilifin® has the potential to enhance the effect of certain
  antihypertensive agents due to its alpha adrenergic antagonism so monitoring blood
  pressure and adjust dose accordingly is clinically recommended.
- Benzodiazepines (e.g., lorazepam), intensity of sedation and orthostatic hypotension
  for using Abilifin® and lorzepam together were greater than using each one alone so
  monitoring sedation and blood pressure and Adjust dose accordinglyis clinically
  recommended.
 

- Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with
third trimester exposure 
- lactation: There are reports of poor weight gain in breastfed infants exposed to
  aripiprazole and reports of inadequate milk supply in lactating women taking

 Commonly observed adverse reactions (incidence ≥5% and at least
  twice that for placebo) were
- Adult patients with schizophrenia: akathisia.
- Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder,
  somnolence, and tremor.
- Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, 
  tremor, and extrapyramidal disorder.
- Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania:
  akathisia, insomnia, and extrapyramidal disorder
- Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal
  disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and 
  dizziness
- Adult patients with major depressive disorder (adjunctive treatment to antidepressant
   therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision
- Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting,
  somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion,
  extrapyramidal disorder, and lethargy.
- Pediatric patients (6 to 18 years) with Tourette’s disorder: sedation, somnolence,
  nausea, headache, nasopharyngitis, fatigue, increased appetite.
- Adult patients with agitation associated with schizophrenia or bipolar mania: nausea. 
- This include any possible side effects not listed in this leaflet. you can report side
  effect directly via the: http\\www.modernpharmaye.com\adrs.pdf. and send to
  uson: adrs@modernpharmaye.com
 

- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia- Related
  Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke,
  transient ischemic attack) 
- Neuroleptic Malignant Syndrome: manage with immediate discontinuation and close
   monitoring. 
- Tardive Dyskinesia: discontinue if clinically appropriate. 
- Pathological Gambling and other Compulsive behaviors: consideration the reduction
  of dose or discontinuation. 
- Metabolic Changes: Atypical antipsychotic drugs have been associated with
  metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and 
  body weight gain 
- Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at 
  risk for diabetes 
- Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients
  treated with atypical antipsychotics 
- Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor
  weight 
- Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients
  with known cardiovascular or cerebrovascular disease, and risk of dehydration or
  syncope. 
- Leukopenia, Neutropenia, and Agranulocytosis: have been reported with
  antipsychotics including Abilifin®. Patients with a history of a clinically significant low
  white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have
  their complete blood count (CBC) monitored frequently during the first few months of 
  therapy and discontinuation of Abilifin® should be considered at the first sign of a
  clinically significant decline in WBC in the absence of other causative factors 
- Seizures/Convulsions: Use cautiously in patients with a history of seizures or with
  conditions that lower the seizure threshold. 
- Potential for Cognitive and Motor Impairment: Use caution when operating
  machinery. 
- Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar
  disorder. Closely supervise high-risk patients.
 

- Abilifin® 5Tablets (Blister of 10  Tablets, Pack of 3 blister)

- Abilifin® 10 Tablets (Blister of 10  Tablets, Pack of 3 blister)
- Abilifin® 15 Tablets (Blister of 10  Tablets, Pack of 3 blister)
- Abilifin® 20 Tablets (Blister of 10  Tablets, Pack of 3 blister)

- Abilifin® 30Tablets (Blister of 10  Tablets, Pack of 3 blister)

- Store in a dry place at a temperature  not exceeding 25 ºC.