Aripiprazole Mylan Pharma

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 

Aripiprazole Mylan Pharma 5 mg tablets 

Aripiprazole Mylan Pharma 10 mg tablets 

Aripiprazole Mylan Pharma 15 mg tablets 

Aripiprazole Mylan Pharma 30 mg tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Aripiprazole Mylan Pharma 5 mg tablets 

 

Each tablet contains 5 mg of aripiprazole. 

 

Excipient with known effect 

 

28 mg of maltose per tablet 

 

Aripiprazole Mylan Pharma 10 mg tablets 

 

Each tablet contains 10 mg of aripiprazole. 

 

Excipient with known effect 

 

56 mg of maltose per tablet 

 

Aripiprazole Mylan Pharma 15 mg tablets 

 

Each tablet contains 15 mg of aripiprazole. 

 

Excipient with known effect 

 

84 mg of maltose per tablet 

 

Aripiprazole Mylan Pharma 30 mg tablets 

 

Each tablet contains 30 mg of aripiprazole. 

 

Excipient with known effect 

 

168 mg of maltose per tablet 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Tablet 

 

Aripiprazole Mylan Pharma 5 mg tablets 

 

Blue round and biconvex tablets of 6.1 mm in diameter, engraved with “5” on one side  

 

Aripiprazole Mylan Pharma 10 mg tablets 

 

Pink, round and biconvex tablets of 8.1 mm in diameter, engraved with “10” on one side  

 



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Aripiprazole Mylan Pharma 15 mg tablets 

 

Yellow, round and biconvex tablets of 10.1 mm in diameter, engraved with “15” on one side  

 

Aripiprazole Mylan Pharma 30 mg tablets 

 

Pink, oval and biconvex tablets of 17.1 mm in length, 8.1 mm in width, engraved with “30” on one 

side 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents 

aged 15 years and older. 

 

Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in 

Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced 

predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see 

section 5.1). 

 

Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic 

episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1). 

 

4.2 Posology and method of administration 
 

Posology 

 

Adults 

 

Schizophrenia: the recommended starting dose for aripiprazole is 10 mg/day or 15 mg/day with a 

maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals. 

Aripiprazole is effective in a dose range of 10 mg/day to 30 mg/day. Enhanced efficacy at doses 

higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit 

from a higher dose. The maximum daily dose should not exceed 30 mg. 

 

Manic episodes in Bipolar I Disorder: the recommended starting dose for aripiprazole is 15 mg 

administered on a once-a-day schedule without regard to meals as monotherapy or combination 

therapy (see section 5.1). Some patients may benefit from a higher dose. The maximum daily dose 

should not exceed 30 mg. 

 

Recurrence prevention of manic episodes in Bipolar I Disorder: for preventing recurrence of manic 

episodes in patients, who have been receiving aripiprazole as monotherapy or combination therapy, 

continue therapy at the same dose. Adjustments of daily dosage, including dose reduction should be 

considered on the basis of clinical status. 

 

Paediatric population 

 

Schizophrenia in adolescents aged 15 years and older: the recommended dose for aripiprazole is 

10 mg/day administered on a once-a-day schedule without regard to meals. Treatment should be 

initiated at 2 mg (using an appropriate aripiprazole containing medicinal product) for 2 days, titrated to 

5 mg for 2 additional days to reach the recommended daily dose of 10 mg. When appropriate, 

subsequent dose increases should be administered in 5 mg increments without exceeding the 

maximum daily dose of 30 mg (see section 5.1). Aripiprazole is effective in a dose range of 10 mg/day 

to 30 mg/day. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated 

although individual patients may benefit from a higher dose. 



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Aripiprazole is not recommended for use in patients with schizophrenia below 15 years of age due to 

insufficient data on safety and efficacy (see sections 4.8 and 5.1). 

 

Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose 

for aripiprazole is 10 mg/day administered on a once-a-day schedule without regard to meals. 

Treatment should be initiated at 2 mg (using an appropriate aripiprazole containing medicinal product) 

for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. The 

treatment duration should be the minimum necessary for symptom control and must not exceed 

12 weeks. Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, 

and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse 

reactions including EPS related events, somnolence, fatigue and weight gain (see section 4.8). Doses 

higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical 

monitoring (see sections 4.4, 4.8 and 5.1). 

Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. 

Therefore, aripiprazole is not recommended for use in patients below 13 years of age (see sections 

4.8 and 5.1). 

 

Irritability associated with autistic disorder: the safety and efficacy of aripiprazole in children and 

adolescents aged below 18 years have not yet been established. Currently available data are described 

in section 5.1 but no recommendation on a posology can be made. 

 

Tics associated with Tourette’s disorder: the safety and efficacy of aripiprazole in children and 

adolescents 6 to 18 years of age have not yet been established. Currently available data are described 

in section 5.1 but no recommendation on a posology can be made. 

 

Special populations 

 

Elderly 

The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I 

Disorder in patients aged 65 years and older has not been established. Owing to the greater sensitivity 

of this population, a lower starting dose should be considered when clinical factors warrant (see 

section 4.4). 

 

Hepatic impairment 

Νο dosage adjustment is required for patients with mild to moderate hepatic impairment. In patients 

with severe hepatic impairment, the data available are insufficient to establish recommendations. In 

these patients dosing should be managed cautiously. However, the maximum daily dose of 30 mg 

should be used with caution in patients with severe hepatic impairment (see section 5.2). 

 

Renal impairment 

Νο dosage adjustment is required in patients with renal impairment. 

 

Gender  

No dosage adjustment is required for female patients as compared to male patients (see section 5.2). 

 

Smoking status  

According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see 

section 4.5). 

 

Dose adjustments due to interactions 

When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, 

the aripiprazole dose should be reduced. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from 

the combination therapy, aripiprazole dose should then be increased (see section 4.5). 

When concomitant administration of strong CYP3A4 inducers with aripiprazole occurs, the 

aripiprazole dose should be increased. When the CYP3A4 inducer is withdrawn from the combination 

therapy, the aripiprazole dose should then be reduced to the recommended dose (see section 4.5). 

 



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Method of administration 

 

Aripiprazole Mylan Pharma is for oral use. 

 

Orodispersible tablets or oral solution may be used as an alternative to Aripiprazole Mylan Pharma 

tablets for patients who have difficulty swallowing Aripiprazole Mylan Pharma tablets (see 

section 5.2). 

 

4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

 

4.4 Special warnings and precautions for use 
 

During antipsychotic treatment, improvement in the patient's clinical condition may take several days 

to some weeks. Patients should be closely monitored throughout this period. 

 

Suicidality 

 

The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in 

some cases has been reported early after initiation or switch of antipsychotic treatment, including 

treatment with aripiprazole (see section 4.8). Close supervision of high-risk patients should 

accompany antipsychotic treatment.  

 

Cardiovascular disorders  

 

Aripiprazole should be used with caution in patients with known cardiovascular disease (history of 

myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), 

cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, 

hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including 

accelerated or malignant. Cases of venous thromboembolism (VTE) have been reported with 

antipsychotic medicinal products. Since patients treated with antipsychotics often present with 

acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during 

treatment with aripiprazole and preventive measures undertaken. 

 

QT prolongation 

 

In clinical trials of aripiprazole, the incidence of QT prolongation was comparable to placebo. 

Aripiprazole should be used with caution in patients with a family history of QT prolongation (see 

section 4.8). 

 

Tardive dyskinesia  

 

In clinical trials of one year or less duration, there were uncommon reports of treatment emergent 

dyskinesia during treatment with aripiprazole. If signs and symptoms of tardive dyskinesia appear in a 

patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8). These 

symptoms can temporally deteriorate or can even arise after discontinuation of treatment. 

 

Other extrapyramidal symptoms  

 

In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed. If signs and 

symptoms of other EPS appear in a patient taking aripiprazole, dose reduction and close clinical 

monitoring should be considered. 

 

Neuroleptic Malignant Syndrome (NMS)  

 



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NMS is a potentially fatal symptom complex associated with antipsychotics. In clinical trials, rare 

cases of NMS were reported during treatment with aripiprazole. Clinical manifestations of NMS are 

hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular 

pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may 

include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 

However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with 

NMS, have also been reported. If a patient develops signs and symptoms indicative of NMS, or 

presents with unexplained high fever without additional clinical manifestations of NMS, all 

antipsychotics, including aripiprazole, must be discontinued. 

 

Seizure  

 

In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole. 

Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder 

or have conditions associated with seizures (see section 4.8). 

 

Elderly patients with dementia-related psychosis 

 

Increased mortality 

In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56 to 99 years) of aripiprazole 

in elderly patients with psychosis associated with Alzheimer's disease, patients treated with 

aripiprazole were at increased risk of death compared to placebo. The rate of death in aripiprazole-

treated patients was 3.5 % compared to 1.7 % in the placebo group. Although the causes of deaths 

were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) 

or infectious (e.g. pneumonia) in nature (see section 4.8). 

 

Cerebrovascular adverse reactions  

In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including 

fatalities, were reported in patients (mean age: 84 years; range: 78 to 88 years). Overall, 1.3 % of 

aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of 

placebo-treated patients in these trials. This difference was not statistically significant. However, in 

one of these trials, a fixed-dose trial, there was a significant dose response relationship for 

cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).  

 

Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis. 

 

Hyperglycaemia and diabetes mellitus 

 

Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or 

death, has been reported in patients treated with atypical antipsychotics, including aripiprazole. Risk 

factors that may predispose patients to severe complications include obesity and family history of 

diabetes. In clinical trials with aripiprazole, there were no significant differences in the incidence rates 

of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory 

values compared to placebo. Precise risk estimates for hyperglycaemia-related adverse reactions in 

patients treated with aripiprazole and with other atypical antipsychotics are not available to allow 

direct comparisons. Patients treated with any antipsychotic, including aripiprazole, should be observed 

for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) 

and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored 

regularly for worsening of glucose control (see section 4.8). 

 

Hypersensitivity  

 

Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see 

section 4.8). 

 

Weight gain  

 



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Weight gain is commonly seen in schizophrenic and bipolar mania patients due to co-morbidities, use 

of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe 

complications. Weight gain has been reported post-marketing among patients prescribed aripiprazole. 

When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid 

disorder or pituitary adenoma. In clinical trials aripiprazole has not been shown to induce clinically 

relevant weight gain in adults (see section 5.1). In clinical trials of adolescent patients with bipolar 

mania, aripiprazole has been shown to be associated with weight gain after 4 weeks of treatment. 

Weight gain should be monitored in adolescent patients with bipolar mania. If weight gain is clinically 

significant, dose reduction should be considered (see section 4.8). 

 

Dysphagia 

 

Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including 

aripiprazole. Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia. 

 

Pathological gambling and other impulse control disorders 

 

Patients can experience increased urges, particularly for gambling, and the inability to control these 

urges while taking aripiprazole. Other urges, reported, include: increased sexual urges, compulsive 

shopping, binge or compulsive eating, and other impulsive and compulsive behaviours. It is important 

for prescribers to ask patients or their caregivers specifically about the development of new or 

increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other 

urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be 

associated with the underlying disorder; however, in some cases, urges were reported to have stopped 

when the dose was reduced or the medication was discontinued. Impulse control disorders may result 

in harm to the patient and others if not recognised. Consider dose reduction or stopping the medication 

if a patient develops such urges while taking aripiprazole (see section 4.8). 

 

Patients with attention deficit hyperactivity disorder (ADHD) comorbidity  

 

Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are 

available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be 

taken when these medicinal products are co-administered. 

 

Falls 

 

Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may 

lead to falls. Caution should be taken when treating patients at higher risk and a lower starting dose 

should be considered (e.g. elderly or debilitated patients; see section 4.2). 

 

Excipients 

 

Aripiprazole Mylan Pharma tablets contain maltose. Patients with rare glucose-galactose 

malabsorption should not take this medicine. 

 

Aripiprazole Mylan Pharma tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say 

essentially ‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of 

certain antihypertensive medicinal products. 

 

Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is 

administered in combination with alcohol or other CNS medicinal products with overlapping adverse 

reactions such as sedation (see section 4.8). 

 



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If aripiprazole is administered concomitantly with medicinal products known to cause QT 

prolongation or electrolyte imbalance, caution should be used. 

 

Potential for other medicinal products to affect aripiprazole  

 

A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this 

effect is deemed not clinically relevant. Aripiprazole is metabolised by multiple pathways involving 

the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes. Thus, no dosage adjustment is required 

for smokers. 

 

Quinidine and other CYP2D6 inhibitors  

In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole 

AUC by 107 %, while Cmax was unchanged. The AUC and Cmax of dehydro-aripiprazole, the active 

metabolite, decreased by 32 % and 47 %, respectively. Aripiprazole dose should be reduced to 

approximately one-half of its prescribed dose when concomitant administration of aripiprazole with 

quinidine occurs. Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be 

expected to have similar effects and similar dose reductions should therefore be applied. 

 

Ketoconazole and other CYP3A4 inhibitors 

In a clinical trial in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased 

aripiprazole AUC and Cmax by 63 % and 37 %, respectively. The AUC and Cmax of dehydro-

aripiprazole increased by 77 % and 43 %, respectively. In CYP2D6 poor metabolisers, concomitant 

use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole 

compared to that in CYP2D6 extensive metabolizers. When considering concomitant administration of 

ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh 

the potential risks to the patient. When concomitant administration of ketoconazole with aripiprazole 

occurs, aripiprazole dose should be reduced to approximately one-half of its prescribed dose. Other 

strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to 

have similar effects and similar dose reductions should therefore be applied (see section 4.2). Upon 

discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should be increased 

to the level prior to the initiation of the concomitant therapy. When weak inhibitors of CYP3A4 (e.g. 

diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases 

in plasma aripiprazole concentrations may be expected. 

 

Carbamazepine and other CYP3A4 inducers  

Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral 

aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax 

and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when aripiprazole 

(30 mg) was administered alone. Similarly, for dehydro-aripiprazole the geometric means of Cmax 

and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those 

following treatment with aripiprazole alone. Aripiprazole dose should be doubled when concomitant 

administration of aripiprazole occurs with carbamazepine. Concomitant administration of aripiprazole 

and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, 

efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects and similar dose 

increases should therefore be applied. Upon discontinuation of strong CYP3A4 inducers, the dosage of 

aripiprazole should be reduced to the recommended dose. 

 

Valproate and lithium  

When either valproate or lithium was administered concomitantly with aripiprazole, there was no 

clinically significant change in aripiprazole concentrations and therefore no dose adjustment is 

necessary when either valproate or lithium is administered with aripiprazole. 

 

Potential for aripiprazole to affect other medicinal products 

 

In clinical studies, 10 mg/day to 30 mg/day doses of aripiprazole had no significant effect on the 

metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), 

CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan). Additionally, 



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aripiprazole and dehydro-aripiprazole did not show potential for altering CYP1A2-mediated 

metabolism in vitro. Thus, aripiprazole is unlikely to cause clinically important medicinal product 

interactions mediated by these enzymes. 

 

When aripiprazole was administered concomitantly with either valproate, lithium or lamotrigine, there 

was no clinically important change in valproate, lithium or lamotrigine concentrations. 

 

Serotonin syndrome 

Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and 

symptoms for this condition can occur especially in cases of concomitant use with other serotonergic 

medicinal products, such as selective serotonin reuptake inhibitor/selective serotonin noradrenalin 

reuptake inhibitor (SSRI/SNRI), or with medicinal products that are known to increase aripiprazole 

concentrations (see section 4.8). 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

 

There are no adequate and well-controlled trials of aripiprazole in pregnant women. Congenital 

anomalies have been reported; however, causal relationship with aripiprazole could not be established. 

Animal studies could not exclude potential developmental toxicity (see section 5.3). Patients must be 

advised to notify their physician if they become pregnant or intend to become pregnant during 

treatment with aripiprazole. Due to insufficient safety information in humans and concerns raised by 

animal reproductive studies, this medicinal product should not be used in pregnancy unless the 

expected benefit clearly justifies the potential risk to the foetus. 

 

Newborn infants exposed to antipsychotics (including aripiprazole) during the third trimester of 

pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that 

may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, 

hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborn 

infants should be monitored carefully (see section 4.8). 

 

Breast-feeding 

 

Aripiprazole/metabolites are excreted in human milk. A decision must be made whether to discontinue 

breast-feeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of 

breast-feeding for the child and the benefit of therapy for the woman. 

 

Fertility 

 

Aripiprazole did not impair fertility based on data from reproductive toxicity studies. 

 

4.7 Effects on ability to drive and use machines 
 

Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential 

nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see 

section 4.8).  

 

4.8 Undesirable effects 
 

Summary of the safety profile 

 

The most commonly reported adverse reactions in placebo-controlled trials were akathisia and nausea 

each occurring in more than 3 % of patients treated with oral aripiprazole. 

 

Tabulated list of adverse reactions 

 



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The incidences of the Adverse Drug Reactions (ADRs) associated with aripiprazole therapy are 

tabulated below. The table is based on adverse events reported during clinical trials and/or post-

marketing use.  

 

All ADRs are listed by system organ class and frequency; very common (≥ 1 /10), common (≥ 1/100 

to< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) 

and not known (cannot be estimated from the available data). Within each frequency grouping, 

adverse reactions are presented in order of decreasing seriousness. 

 

The frequency of adverse reactions reported during post-marketing use cannot be determined as they 

are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified 

as "not known”. 

 

 Common Uncommon Not known 

Blood and lymphatic 

system 

disorders 

  Leukopenia 

Neutropenia 

Thrombocytopenia 

Immune system 

disorders 

  Allergic reaction (e.g. anaphylactic 

reaction, angioedema including 

swollen tongue, tongue oedema, 

face oedema, pruritus allergic, or 

urticaria) 

Endocrine 

disorders 

 Hyperprolactinaemia Diabetic hyperosmolar coma 

Diabetic ketoacidosis 

 

Metabolism and 

nutrition disorders 

Diabetes 

mellitus 

Hyperglycaemia Hyponatremia 

Anorexia 

 

Psychiatric 

disorders 

Insomnia 

Anxiety 

Restlessness 

Depression, 

Hypersexuality 

Suicide attempt, suicidal ideation 

and completed suicide (see 

section 4.4) 

Pathological gambling 

Impulse-control disorders 

Binge eating 

Compulsive shopping 

Poriomania 

Aggression 

Agitation 

Nervousness 

Nervous system 

disorders 

Akathisia 

Extrapyramidal 

disorder 

Tremor 

Headache  

Sedation 

Somnolence 

Dizziness 

Tardive dyskinesia 

Dystonia 

Neuroleptic Malignant Syndrome 

Grand mal convulsion 

Serotonin syndrome 

Speech disorder 

Eye disorders Vision blurred Diplopia 

Photophobia 

Oculogyric crisis 



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Cardiac disorders  Tachycardia Sudden death unexplained 

Torsades de pointes 

Ventricular arrhythmias  

Cardiac arrest  

Bradycardia 

Vascular disorders  Orthostatic 

hypotension 

Venous thromboembolism 

(including pulmonary embolism 

and deep vein thrombosis) 

Hypertension 

Syncope 

Respiratory, 

thoracic and 

mediastinal disorders 

 Hiccups Aspiration pneumonia 

Laryngospasm 

Oropharyngeal spasm 

Gastrointestinal 

disorders 

Constipation 

Dyspepsia 

Nausea  

Salivary 

hypersecretion 

Vomiting 

 Pancreatitis 

Dysphagia 

Diarrhoea 

Abdominal discomfort 

Stomach discomfort 

Hepatobiliary 

disorders 

  Hepatic failure 

Hepatitis 

Jaundice 

 

Skin and subcutaneous 

tissue 

disorders 

  Rash 

Photosensitivity reaction 

Alopecia 

Hyperhidrosis 

Musculoskeletal and 

connective tissue 

disorders 

  Rhabdomyolysis 

Myalgia 

Stiffness 

Renal and urinary 

disorders 

  Urinary incontinence 

Urinary retention 

Pregnancy, 

puerperium and 

perinatal conditions 

  Drug withdrawal syndrome 

neonatal (see section 4.6) 

Reproductive 

system and breast 

disorders 

  Priapism 

General disorders and 

administration site  

conditions 

Fatigue  Temperature regulation disorder 

(e.g. hypothermia, pyrexia) 

Chest pain 

Peripheral oedema 



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Investigations   Weight decreased 

Weight gain 

Alanine Aminotransferase increased 

Aspartate Aminotransferase increased 

Gamma-glutamyltransferase 

increased 

Alkaline phosphatase increased 

QT prolonged 

Blood glucose increased 

Glycosylated haemoglobin increased 

Blood glucose fluctuation 

Creatine phosphokinase increased 

 

Description of selected adverse reactions 

 

Adults 

 

Extrapyramidal symptoms (EPS) Schizophrenia: in a long-term 52-week controlled trial, aripiprazole-

treated patients had an overall-lower incidence (25.8 %) of EPS including Parkinsonism, akathisia, 

dystonia and dyskinesia compared with those treated with haloperidol (57.3 %). In a long-term 

26-week placebo-controlled trial, the incidence of EPS was 19 % for aripiprazole-treated patients and 

13.1 % for placebo-treated patients. In another long-term 26-week controlled trial, the incidence of 

EPS was 14.8 % for aripiprazole-treated patients and 15.1 % for olanzapine-treated patients.  

 

Manic episodes in Bipolar I Disorder: in a 12-week controlled trial, the incidence of EPS was 23.5 % 

for aripiprazole-treated patients and 53.3 % for haloperidol-treated patients. In another 12-week trial, 

the incidence of EPS was 26.6 % for patients treated with aripiprazole and 17.6 % for those treated 

with lithium. In the long-term 26-week maintenance phase of a placebo-controlled trial, the incidence 

of EPS was 18.2 % for aripiprazole-treated patients and 15.7 % for placebo-treated patients. 

 

Akathisia  

In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1 % with aripiprazole 

and 3.2 % with placebo. In schizophrenia patients the incidence of akathisia was 6.2 % with 

aripiprazole and 3.0 % with placebo. 

 

Dystonia 

Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in 

susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of 

the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty 

breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur 

more frequently and with greater severity with high potency and at higher doses of first generation 

antipsychotic medicinal products. An elevated risk of acute dystonia is observed in males and younger 

age groups. 

 

Prolactin 

In clinical trials for the approved indications and post-marketing, both increase and decrease in serum 

prolactin as compared to baseline was observed with aripiprazole (section 5.1). 

 

Laboratory parameters 

Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially 

clinically significant changes in routine laboratory and lipid parameters (see section 5.1) revealed no 

medically important differences. Elevations of CPK (Creatine Phosphokinase), generally transient and 

asymptomatic, were observed in 3.5 % of aripiprazole treated patients as compared to 2.0 % of 

patients who received placebo. 

 

Paediatric population 

 



13 

 

Schizophrenia in adolescents aged 15 years and older 

In a short-term placebo-controlled clinical trial involving 302 adolescents (13 to 17 years) with 

schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for 

the following reactions that were reported more frequently in adolescents receiving aripiprazole than 

in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and 

extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, 

and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10). The safety profile in a 

26-week open-label extension trial was similar to that observed in the short-term, placebo-controlled 

trial. 

The safety profile of a long-term, double-blind, placebo-controlled trial was also similar except for the 

following reactions that were reported more frequently than paediatric patients taking placebo: weight 

decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100, 

< 1/10). 

 

In the pooled adolescent schizophrenia population (13 to 17 years) with exposure up to 2 years, 

incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 29.5 % 

and 48.3 %, respectively. In the adolescent (13 to 17 years) schizophrenia population with aripiprazole 

exposure of 5 mg to 30 mg up to 72 months, incidence of low serum prolactin levels in females 

(< 3 ng/mL) and males (< 2 ng/mL) was 25.6 % and 45.0 %, respectively. 

In two long-term trials with adolescent (13 to 17 years) schizophrenia and bipolar patients treated with 

aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) 

was 37.0 % and 59.4 %, respectively. 

 

Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older 

The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to 

those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), 

extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, 

< 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle 

twitching, and dyskinesia. 

 

The following adverse reactions had a possible dose response relationship; extrapyramidal disorder 

(incidences were 10 mg, 9.1 %; 30 mg, 28.8 %; placebo, 1.7 %); and akathisia (incidences were 

10 mg, 12.1 %; 30 mg, 20.3 %; placebo, 1.7 %). 

 

Mean changes in body weight in adolescents with Bipolar I Disorder at 12 and 30 weeks for 

aripiprazole were 2.4 kg and 5.8 kg, and for placebo 0.2 kg and 2.3 kg, respectively. 

 

In the paediatric population somnolence and fatigue were observed more frequently in patients with 

bipolar disorder compared to patients with schizophrenia. 

 

In the paediatric bipolar population (10 to 17 years) with exposure up to 30 weeks, incidence of low 

serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 28.0 % and 53.3 %, 

respectively. 

 

Pathological gambling and other impulse control disorders 

Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can 

occur in patients treated with aripiprazole (see section 4.4). 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 
 

Signs and symptoms 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


14 

 

 

In clinical trials and post-marketing experience, accidental or intentional acute overdose of 

aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with 

no fatalities. The potentially medically important signs and symptoms observed included lethargy, 

increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea. In addition, 

reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have been received 

with no fatalities. The potentially medically serious signs and symptoms reported included 

somnolence, transient loss of consciousness and extrapyramidal symptoms. 

 

Management of overdose  

 

Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, 

oxygenation and ventilation, and management of symptoms. The possibility of multiple medicinal 

product involvement should be considered. Therefore, cardiovascular monitoring should be started 

immediately and should include continuous electrocardiographic monitoring to detect possible 

arrhythmias. Following any confirmed or suspected overdose with aripiprazole, close medical 

supervision and monitoring should continue until the patient recovers. 

 

Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by 

about 41 % and AUC by about 51 %, suggesting that charcoal may be effective in the treatment of 

overdose. 

 

Haemodialysis 

 

Although there is no information on the effect of haemodialysis in treating an overdose with 

aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole is 

highly bound to plasma proteins. 

 

 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12 

 

Mechanism of action 

 

It has been proposed that aripiprazole’s efficacy in schizophrenia and Bipolar I Disorder is mediated 

through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and 

antagonism of serotonin 5-HT2A receptors. Aripiprazole exhibited antagonist properties in animal 

models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic 

hypoactivity. Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 

5-HT1A and 5-HT2A receptors and moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, 

alpha-1 adrenergic and histamine H1 receptors. Aripiprazole also exhibited moderate binding affinity 

for the serotonin reuptake site and no appreciable affinity for muscarinic receptors. Interaction with 

receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of 

aripiprazole. 

 

Aripiprazole doses ranging from 0.5 mg to 30 mg administered once a day to healthy subjects for 

2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor 

ligand, to the caudate and putamen detected by positron emission tomography. 

 

Clinical efficacy and safety 

 

Adults 

 

Schizophrenia 



15 

 

In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult 

patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically 

significantly greater improvements in psychotic symptoms compared to placebo. 

 

Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult 

patients who have shown an initial treatment response. In a haloperidol-controlled trial, the proportion 

of responder patients maintaining response to medicinal product at 52-weeks was similar in both 

groups (aripiprazole 77 % and haloperidol 73 %). The overall completion rate was significantly higher 

for patients on aripiprazole (43 %) than for haloperidol (30 %). Actual scores in rating scales used as 

secondary endpoints, including PANSS and the Montgomery-Åsberg Depression Rating Scale 

(MADRS) showed a significant improvement over haloperidol. 

 

In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, 

aripiprazole had significantly greater reduction in relapse rate, 34 % in aripiprazole group and 57 % in 

placebo. 

 

Weight gain 

In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain. In a 

26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 

314 adult patients and where the primary endpoint was weight gain, significantly less patients had at 

least 7 % weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight 

of~80.5 kg) on aripiprazole (n = 18, or 13 % of evaluable patients), compared to olanzapine (n = 45, or 

33 % of evaluable patients). 

 

Lipid parameters 

In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole 

has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, 

High Density Lipoprotein (HDL) and Low Density Lipoproten (LDL). 

 

Prolactin 

Prolactin levels were evaluated in all trials of all doses of aripiprazole (n = 28,242). The incidence of 

hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3 %) was 

similar to that of placebo (0.2 %). For patients receiving aripiprazole, the median time to onset was 

42 days and median duration was 34 days. 

 

The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole 

was 0.4 %, compared with 0.02 % for patients treated with placebo. For patients receiving 

aripiprazole, the median time to onset was 30 days and median duration was 194 days. 

 

Manic episodes in Bipolar I Disorder 

In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or 

mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in 

reduction of manic symptoms over 3 weeks. These trials included patients with or without psychotic 

features and with or without a rapid-cycling course. 

 

In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic or 

mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo. 

 

In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed 

episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior 

efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at 

week 12. Aripiprazole also demonstrated a comparable proportion of patients in symptomatic 

remission from mania as lithium or haloperidol at week 12. 

 

In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I 

Disorder, with or without psychotic features, who were partially non-responsive to lithium or 

valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole as 



16 

 

adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium or 

valproate monotherapy. 

 

In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who 

achieved remission on aripiprazole during a stabilization phase prior to randomisation, aripiprazole 

demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing 

recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into 

depression. 

 

In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I 

Disorder who achieved sustained remission (Youn Mania Rating Scale [YMRS] and MADRS with 

total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 

12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46 % 

decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65 % decreased risk 

(hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to 

demonstrate superiority over placebo in preventing recurrence into depression. Adjunctive aripiprazole 

demonstrated superiority over placebo on the secondary outcome measure in Clinical Global 

Impression Bipolar version(CGI-BP) Severity of Illness (SOI; mania) scores. In this trial, patients 

were assigned by investigators with either open-label lithium or valproate monotherapy to determine 

partial non-response. Patients were stabilised for at least 12 consecutive weeks with the combination 

of aripiprazole and the same mood stabilizer. Stabilized patients were then randomised to continue the 

same mood stabilizer with double-blind aripiprazole or placebo. Four mood stabilizer subgroups were 

assessed in the randomised phase: aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; 

placebo + valproate. The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive 

treatment arm were 16 % in aripiprazole + lithium and 18 % in aripiprazole + valproate compared to 

45 % in placebo + lithium and 19 % in placebo + valproate. 

 

Paediatric population 

 

Schizophrenia in adolescents 

In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 to 17 years), 

presenting with positive or negative symptoms, aripiprazole was associated with statistically 

significantly greater improvements in psychotic symptoms compared to placebo. In a sub-analysis of 

the adolescent patients between the ages of 15 to 17 years, representing 74 % of the total enrolled 

population, maintenance of effect was observed over the 26-week open-label extension trial. 

 

In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects 

(n = 146; ages 13 to 17 years) with schizophrenia, there was a statistically significant difference in the 

rate of relapse of psychotic symptoms between the aripiprazole (19.39 %) and placebo (37.50 %) 

groups. The point estimate of the hazard ratio (HR) was 0.461 (95 % confidence interval, 0.242 to 

0.879) in the full population. In sub-group analyses the point estimate of the HR was 0.495 for 

subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age. However, the 

estimation of the HR for the younger (13 to 14 years) group was not precise, reflecting the smaller 

number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for 

this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of 

a treatment effect. In contrast the 95 % confidence interval for the HR in the older subgroup 

(aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be 

concluded in the older patients. 

 

Manic episodes in Bipolar I Disorder in children and adolescents 

Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents 

(10 to 17 years), who met DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders) 

for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a 

YMRS score ≥ 20 at baseline. Among the patients included in the primary efficacy analysis, 

139 patients had a current co-morbid diagnosis of ADHD. 

 



17 

 

Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS 

total score. In a post-hoc analysis, the improvement over placebo was more pronounced in the patients 

with associated co-morbidity of ADHD compared to the group without ADHD, where there was no 

difference from placebo. Recurrence prevention was not established. 

 

The most common treatment-emergent adverse events among patients receiving 30 mg were 

extrapyramidal disorder (28.3 %), somnolence (27.3 %), headache (23.2 %), and nausea (14.1 %). 

Mean weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients 

treated with placebo. 

 

Irritability associated with autistic disorder in paediatric patients (see section 4.2) 

Aripiprazole was studied in patients aged 6 to 17 years in two 8-week, placebo-controlled trials [one 

flexible-dose (2 mg/day to 15 mg/day) and one fixed-dose (5 mg/day, 10 mg/day, or 15 mg/day)] and 

in one 52-week open-label trial. Dosing in these trials was initiated at 2 mg/day, increased to 5 mg/day 

after one week, and increased by 5 mg/day in weekly increments to the target dose. Over 75% of 

patients were less than 13 years of age. Aripiprazole demonstrated statistically superior efficacy 

compared to placebo on the Aberrant Behaviour Checklist Irritability subscale. However, the clinical 

relevance of this finding has not been established. The safety profile included weight gain and changes 

in prolactin levels. The duration of the long-term safety study was limited to 52 weeks. In the pooled 

trials, the incidence of low serum prolactin levels in females (<3 ng/mL) and males (<2 ng/mL) in 

aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively. In the placebo-

controlled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole. 

 

Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial. After a 13 to 26 

week stabilisation on aripiprazole (2 mg/day to 15 mg/day) patients with a stable response were either 

maintained on aripiprazole or substituted to placebo for further 16 weeks. Kaplan-Meier relapse rates 

at week 16 were 35% for aripiprazole and 52% for placebo; the hazard ratio for relapse within 16 

weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference). The mean weight gain 

over the stabilisation phase (up to 26 weeks) on aripiprazole was 3.2 kg, and a further mean increase 

of 2.2 kg for aripiprazole as compared to 0.6 kg for placebo was observed in the second phase (16 

weeks) of the trial. Extrapyramidal symptoms were mainly reported during the stabilisation phase in 

17% of patients, with tremor accounting for 6.5%. 

 

Tics associated with Tourette’s disorder in paediatric patients (see section 4.2)  

The efficacy of aripiprazole was studied in paediatric subjects with Tourette’s disorder (aripiprazole: 

n = 99, placebo: n = 44) in a randomised, double-blind, placebo-controlled, 8 week study using a fixed 

dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting 

dose of 2 mg. Patients were 7 to 17 years of age and presented an average score of 30 on Total Tic 

Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline. Aripiprazole showed an 

improvement on TTS-YGTSS change from baseline to week 8 of 13.35, for the low dose group (5 mg 

or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 

7.09 in the placebo group.  

 

The efficacy of aripiprazole in paediatric subjects with Tourette’s syndrome (aripiprazole: n = 32, 

placebo: n = 29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting 

dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in South-

Korea. Patients were 6 to 18 years and presented an average score of 29 on TTS-YGTSS at baseline. 

Aripiprazole group showed an improvement of 14.97 on TTS-YGTSS change from baseline to 

week 10 as compared with an improvement of 9.62 in the placebo group. 

 

In both of these short-term trials, the clinical relevance of the efficacy findings has not been 

established, considering the magnitude of treatment effect compared to the large placebo effect and the 

unclear effects regarding psycho-social functioning. No long-term data are available with regard to the 

efficacy and the safety of aripiprazole in this fluctuating disorder. 

 



18 

 

The European Medicines Agency has deferred the obligation to submit the results of studies with 

aripiprazole in one or more subsets of the paediatric population in the treatment of schizophrenia and 

in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 
 

Absorption 

 

Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 to 5 hours after 

dosing. Aripiprazole undergoes minimal pre-systemic metabolism. The absolute oral bioavailability of 

the tablet formulation is 87 %. There is no effect of a high fat meal on the pharmacokinetics of 

aripiprazole. 

 

Distribution 

 

Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 

4.9 L/kg, indicating extensive extravascular distribution. At therapeutic concentrations, aripiprazole 

and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin. 

 

Biotransformation 

 

Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: 

dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 and CYP2D6 

enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is 

catalysed by CYP3A4. Aripiprazole is the predominant medicinal product moiety in systemic 

circulation. At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of 

aripiprazole AUC in plasma. 

 

Elimination 

 

The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers 

of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6. 

 

The total body clearance of aripiprazole is 0.7 mL/min/kg, which is primarily hepatic. 

 

Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered 

radioactivity was recovered in the urine and approximately 60 % in the faeces. Less than 1 % of 

unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in 

the faeces. 

 

Paediatric population 

 

The pharmacokinetics of aripiprazole and dehydro-aripiprazole in paediatric patients 10 to 17 years of 

age were similar to those in adults after correcting for the differences in body weights. 

 

Pharmacokinetics in special patient groups 

 

Elderly 

There are no differences in the pharmacokinetics of aripiprazole between healthy elderly and younger 

adult subjects, nor is there any detectable effect of age in a population pharmacokinetic analysis in 

schizophrenic patients. 

 

Gender 

There are no differences in the pharmacokinetics of aripiprazole between healthy male and female 

subjects nor is there any detectable effect of gender in a population pharmacokinetic analysis in 

schizophrenic patients. 

 



19 

 

Smoking  

Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from 

smoking on the pharmacokinetics of aripiprazole. 

 

Race 

Population pharmacokinetic evaluation showed no evidence of race-related differences on the 

pharmacokinetics of aripiprazole. 

 

Renal impairment 

The pharmacokinetic characteristics of aripiprazole and dehydro-aripiprazole were found to be similar 

in patients with severe renal disease compared to young healthy subjects. 

 

Hepatic impairment 

A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, 

and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of 

aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver 

cirrhosis, which is insufficient to draw conclusions on their metabolic capacity. 

 

5.3 Preclinical safety data 
 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction 

and development. 

 

Toxicologically significant effects were observed only at doses or exposures that were sufficiently in 

excess of the maximum human dose or exposure, indicating that these effects were limited or of no 

relevance to clinical use. These included: dose-dependent adrenocortical toxicity (lipofuscin pigment 

accumulation and/or parenchymal cell loss) in rats after 104 weeks at 20 mg/kg/day to 60 mg/kg/day 

(3 to 10 times the mean steady-state AUC at the maximum recommended human dose) and increased 

adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at 

60 mg/kg/day (10 times the mean steady-state AUC at the maximum recommended human dose). The 

highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended 

dose. 

 

An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of 

hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 mg/kg/day 

to 125 mg/kg/day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical 

dose or 16 to 81 times the maximum recommended human dose based on mg/m2). However, the 

concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose 

proposed, 30 mg per day, were no more than 6 % of the bile concentrations found in the monkeys in 

the 39-week study and are well below (6 %) their limits of in vitro solubility. 

 

In repeat-dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable to 

that observed in adult animals, and there was no evidence of neurotoxicity or adverse reactions on 

development. 

 

Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non-

genotoxic. Aripiprazole did not impair fertility in reproductive toxicity studies. Developmental 

toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were 

observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses 

resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended 

clinical dose. Maternal toxicity occurred at doses similar to those eliciting developmental toxicity. 

 

 

6. PHARMACEUTICAL PARTICULARS 
 

6.1 List of excipients 



20 

 

 

Tablet core 

 

Crystalline Maltose 

Microcrystalline cellulose 

Pregelatinised starch 

Croscarmellose Sodium 

Magnesium stearate 

 

Tablet coat 

 

Aripiprazole Mylan Pharma 5 mg tablets 

Indigo carmine (E132) 

 

Aripiprazole Mylan Pharma 10 mg tablets 

Iron Oxide Red (E172) 

 

Aripiprazole Mylan Pharma 15 mg tablets 

Iron Oxide Yellow (E172) 

 

Aripiprazole Mylan Pharma 30 mg tablets 

Iron Oxide Red (E172) 

 

6.2 Incompatibilities 
 

Not applicable. 

 

6.3 Shelf life 
 

3 years 

 

6.4 Special precautions for storage 
 

Store in the original package in order to protect from moisture. 

 

6.5 Nature and contents of container 
 

PA/Alu/PVC- Aluminium foil perforated blisters (alu-alu blister) in cartons of 14, 28, 56 and 98 

tablets and 28 x 1 tablets (unit dose). 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 
 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Mylan S.A.S, 

117, Allée des Parcs, 

69800 Saint-Priest, 

France 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 



21 

 

 

Aripiprazole Mylan Pharma 5 mg tablets 

 

EU/1/15/1005/001 

EU/1/15/1005/002 

EU/1/15/1005/003 

EU/1/15/1005/013 

EU/1/15/1005/014  

 

Aripiprazole Mylan Pharma 10 mg tablets 

 

EU/1/15/1005/004 

EU/1/15/1005/005  

EU/1/15/1005/006 

EU/1/15/1005/015 

EU/1/15/1005/016  

 

Aripiprazole Mylan Pharma 15 mg tablets 

 

EU/1/15/1005/007 

EU/1/15/1005/008 

EU/1/15/1005/009 

EU/1/15/1005/017 

EU/1/15/1005/018  

 

Aripiprazole Mylan Pharma 30 mg tablets 

 

EU/1/15/1005/010 

EU/1/15/1005/011 

EU/1/15/1005/012 

EU/1/15/1005/019 

EU/1/15/1005/020  

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 30 June 2015 

Date of latest renewal: 25 February 2020 

 

 

10. DATE OF REVISION OF THE TEXT 
 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


22 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

 USE 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE 

 MARKETING AUTHORISATION 

 

D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

 SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 



23 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturers responsible for batch release 

 

Pharmathen S.A. 

6, Dervenakion  

Pallini 15351 

Attiki, 

Greece 

 

or 

 

Pharmathen International S.A 

Industrial Park Sapes,  

Rodopi Prefecture, Block No 5,  

Rodopi 69300,  

Greece 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription. 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic safety update reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   

 

• Risk management plan (RMP) 
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 

and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 

and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result of an important 

(pharmacovigilance or risk minimisation) milestone being reached. 

 

 

 

  



24 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



25 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



26 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 5 mg tablets 

aripiprazole 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each tablet contains 5 mg of aripiprazole. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains maltose. See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Tablet 

 

14 tablets 

28 tablets 

56 tablets 

98 tablets 

28 x 1 tablets  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE 
STORED OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 



27 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL 
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL 

PRODUCTS, IF APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S, 

117, Allée des Parcs, 

69800 Saint-Priest, 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/15/1005/001 

EU/1/15/1005/002 

EU/1/15/1005/003 

EU/1/15/1005/013 

EU/1/15/1005/014 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Aripiprazole Mylan Pharma 5 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 

 

 



28 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 5 mg tablets 

aripiprazole 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



29 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 10 mg tablets 

aripiprazole 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each tablet contains 10 mg of aripiprazole. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains maltose. See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Tablet 

 

14 tablets 

28 tablets 

56 tablets 

98 tablets 

28 x 1 tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE 
STORED OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 



30 

 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL 
PRODUCTSOR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL 

PRODUCTS, IFAPPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S, 

117, Allée des Parcs, 

69800 Saint-Priest, 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/15/1005/004 

EU/1/15/1005/005 

EU/1/15/1005/006 

EU/1/15/1005/015 

EU/1/15/1005/016 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Aripiprazole Mylan Pharma 10 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 

 

 



31 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 10 mg tablets 

aripiprazole 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



32 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 15 mg tablets 

aripiprazole 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each tablet contains 15 mg of aripiprazole. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains maltose. See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Tablet 

 

14 tablets 

28 tablets 

56 tablets 

98 tablets 

28 x 1 tablets  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE 
STORED OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 



33 

 

Store in the original package in order to protect from moisture. 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL 
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL 

PRODUCTS, IF APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S, 

117, Allée des Parcs, 

69800 Saint-Priest, 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/15/1005/007 

EU/1/15/1005/008 

EU/1/15/1005/009 

EU/1/15/1005/017 

EU/1/15/1005/018 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Aripiprazole Mylan Pharma 15 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 

 

 

 



34 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 15 mg tablets 

aripiprazole 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



35 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 30 mg tablets 

aripiprazole 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each tablet contains 30 mg of aripiprazole. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains maltose. See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Tablet 

 

14 tablets 

28 tablets 

56 tablets 

98 tablets 

28 x 1 tablets  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE 
STORED OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 



36 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL 
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL 

PRODUCTS, IF APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S, 

117, Allée des Parcs, 

69800 Saint-Priest, 

France 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/15/1005/010 

EU/1/15/1005/011 

EU/1/15/1005/012 

EU/1/15/1005/019 

EU/1/15/1005/020 

 

 

13. BATCH NUMBER 

 

Lot 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Aripiprazole Mylan Pharma 30 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 

 

 

 

 

 



37 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aripiprazole Mylan Pharma 30 mg tablets 

aripiprazole 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



38 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 

  



39 

 

Package leaflet: Information for the user 

 

Aripiprazole Mylan Pharma 5 mg tablets 

Aripiprazole Mylan Pharma 10 mg tablets 

Aripiprazole Mylan Pharma 15 mg tablets 

Aripiprazole Mylan Pharma 30 mg tablets 

aripiprazole 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

• Keep this leaflet. You may need to read it again. 

• If you have any further questions, ask your doctor or pharmacist. 

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 
even if their signs of illness are the same as yours. 

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What Aripiprazole Mylan Pharma is and what it is used for 

2. What you need to know before you take Aripiprazole Mylan Pharma  

3. How to take Aripiprazole Mylan Pharma  

4. Possible side effects 

5. How to store Aripiprazole Mylan Pharma 

6. Contents of the pack and other information  

 

 

1. What Aripiprazole Mylan Pharma is and what it is used for 
 

Aripiprazole Mylan Pharma contains the active substance aripiprazole and belong to a group of 

medicines called antipsychotics. 

It is used to treat adults and adolescents aged 15 years and older who suffer from a disease 

characterised by symptoms such as hearing, seeing or sensing things which are not there, 

suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with 

this condition may also feel depressed, guilty, anxious or tense. 

 

Aripiprazole Mylan Pharma is used to treat adults and adolescents aged 13 years and older who suffer 

from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing 

much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In 

adults it also prevents this condition from returning in patients who have responded to the treatment 

with Aripiprazole Mylan Pharma. 

 

 

2. What you need to know before you take Aripiprazole Mylan Pharma 
 

Do not take Aripiprazole Mylan Pharma 

• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in 
section 6). 

 

Warnings and precautions 

Talk to your doctor before taking Aripiprazole Mylan Pharma 

 

Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor 

immediately if you are having any thoughts or feelings about hurting yourself. 

 

Before treatment with Aripiprazole Mylan Pharma tell your doctor if you suffer from 

• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts 

of urine, increase in appetite and feeling weak) or family history of diabetes 



40 

 

• fits (seizures) since your doctor may want to monitor you more closely 

• involuntary, irregular muscle movements, especially in the face 

• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular 

disease, stroke or "mini" stroke, abnormal blood pressure 

• blood clots, or family history of blood clots, as antipsychotics have been associated with 

formation of blood clots 

• past experience with excessive gambling 

  

If you notice you are gaining weight, develop unusual movements, experience somnolence that 

interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell 

your doctor. 

 

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you 

or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke. 

 

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. 

Suicidal thoughts and behaviours have been reported during aripiprazole treatment. 

 

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, 

sweating, altered mental status, or very rapid or irregular heart beat. 

 

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to 

behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry 

out certain activities that could harm yourself or others. These are called impulse control disorders and 

can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high 

sex drive or preoccupation with an increase in sexual thoughts or feelings. 

Your doctor may need to adjust or stop your dose. 

 

Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in 

your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you 

are an elderly patient or have some debility. 

 

Children and adolescents 

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe 

and effective in these patients. 

 

Other medicines and Aripiprazole Mylan Pharma  

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines, including medicines obtained without a prescription. 

 

Blood pressure-lowering medicines: Aripiprazole Mylan Pharma may increase the effect of medicines 

used to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood 

pressure under control. 

 

Taking Aripiprazole Mylan Pharma with some medicines may mean the doctor will need to change 

your dose of Aripiprazole Mylan Pharma or the other medicines. It is especially important to mention 

the following to your doctor: 

 

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)  

• antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, 

paroxetine, venlafaxine, St. John's Wort) 

• antifungal medicines (such as ketoconazole, itraconazole) 

• certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors 

e.g. indinavir, ritonavir) 

• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) 

• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin) 

 



41 

 

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Mylan 

Pharma; if you get any unusual symptom taking any of these medicines together with Aripiprazole 

Mylan Pharma you should see your doctor. 

 

Medicines that increase the level of serotonin are typically used in conditions including depression, 

generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as 

migraine and pain: 

 

• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety 

disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain 

• selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for 

depression, OCD, panic and anxiety 

• other anti-depressants (such as venlafaxine and tryptophan) used in major depression 

• tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness 

• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression 

• pain killers (such as tramadol and pethidine) used for pain relief 

• triptans (such as sumatriptan and zolmitripitan) used for treating migraine 

 

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of 

these medicines together with Aripiprazole Mylan Pharma, you should see your doctor. 

 

Aripiprazole Mylan Pharma with food, drink and alcohol 

This medicine can be taken regardless of meals. 

Alcohol should be avoided. 

 

Pregnancy, breast-feeding and fertility 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor for advice before taking this medicine. 

 

The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole Mylan 

Pharma tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness 

and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby 

develops any of these symptoms you may need to contact your doctor. 

 

If you are taking, Aripiprazole Mylan Pharma your doctor will discuss with you whether you should 

breast-feed considering the benefit to you of your therapy and the benefit to your baby of 

breast-feeding. You should not do both. Talk to your doctor about the best way to feed your baby if 

you are taking this medicine. 

 

Driving and using machines 

Dizziness and vision problems may occur during treatment with this medicine (see section 4).  

This should be considered in cases where full alertness is required, e.g. when driving a car or handling 

machines. 

 

Aripiprazole Mylan Pharma contains maltose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 

before taking this medicine. 

 

Sodium content 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-

free’. 

 

 

3. How to take Aripiprazole Mylan Pharma 
 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

http://en.wikipedia.org/wiki/Major_depressive_disorder
http://en.wikipedia.org/wiki/Generalized_anxiety_disorder
http://en.wikipedia.org/wiki/Social_anxiety_disorder


42 

 

 

The recommended dose for adults is 15 mg once a day. However, your doctor may prescribe a 

lower or higher dose to a maximum of 30 mg once a day. 

 

Use in children and adolescents 

This medicinal product may be started at a low dose with the oral solution (liquid) form. The dose may 

be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, 

your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day. 

 

If you have the impression that the effect of Aripiprazole Mylan Pharma is too strong or too weak, talk 

to your doctor or pharmacist. 

 

Try to take Aripiprazole Mylan Pharma at the same time each day. It does not matter whether you 

take it with or without food. Always take the tablet with water and swallow it whole. 

 

Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Mylan Pharma 

without first consulting your doctor. 

 

If you take more Aripiprazole Mylan Pharma than you should 

If you realise you have taken more Aripiprazole Mylan Pharma than your doctor has recommended (or 

if someone else has taken some of your Aripiprazole Mylan Pharma), contact your doctor right away. 

If you cannot reach your doctor, go to the nearest hospital and take the pack with you. 

 

Patients who have taken too much aripiprazole have experienced the following symptoms: 

• rapid heartbeat, agitation/aggressiveness, problems with speech. 

• unusual movements (especially of the face or tongue) and reduced level of consciousness. 

 

Other symptoms may include: 

• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, 

• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood 

pressure, abnormal rhythms of the heart. 

 

Contact your doctor or hospital immediately if you experience any of the above. 

 

If you forget to take your Aripiprazole Mylan Pharma  

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one 

day. 

 

If you stop taking Aripiprazole Mylan Pharma  

Do not stop your treatment just because you feel better. It is important that you carry on taking 

Aripiprazole Mylan Pharma for as long as your doctor has told you to. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Common side effects (may affect up to 1 in 10 people):  

• diabetes mellitus, 

• difficulty sleeping, 

• feeling anxious, 

• feeling restless and unable to keep still, difficulty sitting still, 

• uncontrollable twitching, jerking or writhing movements, restless legs, 

• trembling, 

• headache, 



43 

 

• tiredness, 

• sleepiness, 

• light-headedness, 

• shaking and blurred vision, 

• decreased number of or difficulty making bowel movements, 

• indigestion, 

• feeling sick, 

• more saliva in mouth than normal, 

• vomiting,  

• feeling tired. 
 

Uncommon side effects (may affect up to 1 in 100 people):  

• increased blood levels of the hormone prolactin, 

• too much sugar in the blood, 

• depression, 

• altered or increased sexual interest; 

• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), 

• muscle disorder causing twisting movements (dystonia), 

• double vision, 

• eye sensitivity to light, 

• fast heartbeat, 

• a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting, 

• hiccups. 
 

The following side effects have been reported since the marketing of oral aripiprazole but the 

frequency for them to occur is not known: 

 

• low levels of white blood cells, 

• low levels of blood platelets, 

• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),  

• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, 

• high blood sugar, 

• not enough sodium in the blood, 

• loss of appetite (anorexia),  

• weight loss, 

• weight gain, 

• thoughts of suicide, suicide attempt and suicide,  

• feeling aggressive, 

• agitation, 

• nervousness, 

• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and 
sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome), 

• seizure,  

• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, 
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),  

• speech disorder,  

• fixation of the eyeballs in one position, 

• sudden unexplained death, 

• life-threatening irregular heartbeat, 

• heart attack, 

• slower heartbeat,  

• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in 
the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty 

in breathing (if you notice any of these symptoms, seek medical advice immediately), 



44 

 

• high blood pressure, 

• fainting, 

• accidental inhalation of food with risk of pneumonia (lung infection),  

• spasm of the muscles around the voice box, 

• inflammation of the pancreas,  

• difficulty swallowing,  

• diarrhoea, 

• abdominal discomfort, 

• stomach discomfort,  

• liver failure,  

• inflammation of the liver, 

• yellowing of the skin and white part of eyes, 

• reports of abnormal liver test values,  

• skin rash,  

• skin sensitivity to light, 

• baldness, 

• excessive sweating, 

• abnormal muscle breakdown which can lead to kidney problems, 

• muscle pain,  

• stiffness, 

• involuntary loss of urine (incontinence),  

• difficulty in passing urine, 

• withdrawal symptoms in newborn babies in case of exposure during pregnancy,  

• prolonged and/or painful erection,  

• difficulty controlling core body temperature or overheating,  

• chest pain,  

• swelling of hands, ankles or feet, 

• in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin. 

• Inability to resist the impulse, drive or temptation to perform an action that could be harmful 
to you or others, which may include: 

- strong impulse to gamble excessively despite serious personal or family consequences 

- altered or increased sexual interest and behaviour of significant concern to you or to others, for 

example, an increased sexual drive 

- uncontrollable excessive shopping 

- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating 

more food than normal and more than is needed to satisfy your hunger) 

- a tendency to wander away. 

Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing 

or reducing the symptoms. 

 

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In 

addition, cases of stroke or "mini" stroke have been reported. 

 

Additional side effects in children and adolescents 

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type 

to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, 

and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, 

increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the 

limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common 

(greater than 1 in 100 patients). 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 



45 

 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store Aripiprazole Mylan Pharma  
 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the blister and on the carton after 

EXP. The expiry date refers to the last day of that month. 

 

Store in the original package in order to protect from moisture. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 
 

What Aripiprazole Mylan Pharma contains 

• The active substance is aripiprazole. Each tablet of 5, 10, 15, 30 mg containing 5, 10, 15, 30 mg of 
aripiprazole respectively. 

• The other ingredients for 5 mg are crystalline maltose, microcrystalline cellulose, pregelatinised 
starch, croscarmellose sodium, indigo carmine (E132) and magnesium stearate. 

• The other ingredients for 10, 30 mg are crystalline maltose, microcrystalline cellulose, 
pregelatinised starch, croscarmellose sodium, iron oxide red (E172) and magnesium stearate. 

• The other ingredients for 15 mg are crystalline maltose, microcrystalline cellulose, pregelatinised 
starch, croscarmellose sodium, iron oxide yellow (E172) and magnesium stearate. 

 

What Aripiprazole Mylan Pharma look like and contents of the pack 

Aripiprazole Mylan Pharma 5 mg tablets are blue, round and biconvex of 6.1 mm in diameter, 

engraved with ‘5’ on one side.  

Aripiprazole Mylan Pharma 10 mg tablets are pink, round and biconvex of 8.1 mm in diameter, 

engraved with ‘10’ on one side.  

Aripiprazole Mylan Pharma 15 mg tablets are yellow, round and biconvex of 10.1 mm in diameter, 

engraved with ‘15’ on one side.  

Aripiprazole Mylan Pharma 30 mg tablets are pink, oval and biconvex of 17.1mm in length, 8.1 mm in 

width, engraved with ‘30’ on one side.  

 

They are supplied in PA/Alu/PVC-Aluminium foil perforated blisters packed in cardboard box 

containing 14, 28, 56 or 98 tablets and 28 x 1 tablets (unit dose).  

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Mylan S.A.S, 117, Allée des Parcs, 69800 Saint-Priest, France 

 

Manufacturer 

Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, 

Greece 

or 

Pharmathen S.A., 6, Dervenakion, Pallini 15351, Attiki, Greece 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


46 

 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

 

Lietuva 

BGP Products UAB  

Tel: +370 5 205 1288 

 

България 

Майлан ЕООД 

Тел: +359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: + 32 (0)2 658 61 00 

(Belgique/Belgien) 

 

Česká republika 

Mylan Healthcare CZ s.r.o. 

Tel: +420 222 004 400 

 

Magyarország 

Mylan EPD Kft 

Tel: + 36 1 465 2100  

Danmark 

Mylan Denmark ApS 

Tel: +45 28 11 69 32 

 

Malta 

V.J. Salomone Pharma Ltd 

Tel: + 356 21 22 01 74 

 

Deutschland 

Mylan Healthcare GmbH  

Tel: +49 (0) 800 0700 800 

 

Nederland 

Mylan BV 

Tel: +31 (0)20 426 3300  

Eesti 

BGP Products Switzerland GmbH Eesti filiaal  

Tel: + 372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

 

Ελλάδα  

Generics Pharma Hellas ΕΠΕ  

Τηλ:  +30 210 993 6410  

 

Österreich 

Arcana Arzneimittel GmbH 

Tel: +43 1 416 2418 

 

España 

Mylan Pharmaceuticals, S.L 

Tel: + 34 900 102 712 

 

Polska 

Mylan Healthcare Sp. z.o.o. 

Tel: + 48 22 546 64 00 

 

France 

Mylan S.A.S 

Tel: +33 4 37 25 75 00 

 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 56 

 

Hrvatska 

Mylan Hrvatska d.o.o.   

Tel: +385 1 23 50 599  

România 

BGP Products SRL 

Tel: +40 372 579 000 

 

Ireland 

Mylan Ireland Limited 

Tel: +353 (0) 87 1694982   

Slovenija 

Mylan Healthcare d.o.o 

Tel: + 386 1 23 63 180 

 

Ísland 

Icepharma hf 

Tel: +354 540 8000 

 

Slovenská republika 

Mylan s.r.o. 

Tel: +421 2 32 199 100  

Italia 

Mylan Italia S.r.l 

Tel: + 39 02 612 46921 

 

Suomi/Finland 

Mylan Finland OY 

Puh/Tel: +358 20 720 9555 

 

Κύπρος 

Varnavas Hadjipanayis Ltd  

Τηλ: +357 2220 7700 

Sverige 

Mylan AB  

Tel: + 46 855 522 750 

 



47 

 

Latvija 

Mylan Healthcare SIA 

Tel: +371 676 055 80 

 

 

United Kingdom 

Generics [UK] Ltd 

Tel: +44 1707 853000 

This leaflet was last revised in MM/YYYY. 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency (EMA) web 

site: http://www.ema.europa.eu. 

 

 

 

 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET