Medicinal Products

ARIPIPRAZOLE SANDOZ 10 mg

Generic drug of Abilify
Therapeutic Class: Neurology-Psychiatry
active ingredients: Aripiprazole
laboratory: Sandoz

Compressed
box of 28 blister packs of 1
All forms

Indication

Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and adolescents aged 15 years and older.

Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes of bipolar I disorder and for the prevention of recurrence of manic episodes in adults with predominantly manic episodes and for whom manic episodes have responded to a manic episode. treatment with aripiprazole (see section 5.1 Pharmacodynamic properties ).

Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes of bipolar I disorder in adolescents 13 years of age and older for up to 12 weeks (see section 5.1 ).

Dosage ARIPIPRAZOLE SANDOZ 10 mg tablet box of 28 blister packs of 1

Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and adolescents aged 15 years and older.

Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes of bipolar I disorder and for the prevention of recurrence of manic episodes in adults with predominantly manic episodes and for whom manic episodes have responded to a manic episode. treatment with aripiprazole (see section 5.1 Pharmacodynamic properties ).

Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes of bipolar I disorder in adolescents 13 years of age and older for up to 12 weeks (see section 5.1 ).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Adverse effects Aripiprazole Sandoz

Summary of the security profile

The most commonly reported adverse events in placebo-controlled clinical studies were akathisia and nausea, each occurring in more than 3% of patients treated with oral aripiprazole.

List of adverse reactions in tabular form

The following side effects have been reported more frequently (≥ 1/100) than placebo, or have been identified as clinically significant adverse events (*).

The frequencies below are defined using the following convention: frequent (≥ 1/100 to <1/10) and infrequent (≥ 1/1000 to <1/100).

Psychiatric disorders

Frequent: agitation, insomnia, anxiety

Uncommon: depression *, hypersexuality

Nervous system disorders

Common: extrapyramidal disorders, akathisia, tremor, dizziness, somnolence, sedation, headache

Eye disorders

Common: vision disorder

Uncommon: diplopia

Heart conditions

Uncommon: tachycardia *

Vascular disorders

Uncommon: orthostatic hypotension *

Gastrointestinal disorders

Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion

General disorders and administration site conditions

Frequency: tiredness

Description of selected adverse reactions

Extrapyramidal symptoms

Schizophrenia: In a 52-week long-term controlled clinical trial, the incidence of extrapyramidal symptoms, including parkinsonism, akathisia, dystonia, and dyskinesia, was generally lower in aripiprazole-treated patients (25.8%) compared with patients treated with haloperidol (57.3%). In a 26-week long-term, placebo-controlled clinical study, the incidence of extrapyramidal symptoms was 19% in the aripiprazole-treated patients and 13.1% in the placebo-treated patients. In another 26-week long-term controlled clinical study, the incidence of extrapyramidal symptoms was 14.8% in the aripiprazole-treated patients and 15.1% in the olanzapine-treated patients. Manic episodes in bipolar I disorder: In a 12-week controlled clinical trial, the incidence of extrapyramidal symptoms was 23.5% in the aripiprazole-treated patients and 53.3% in the haloperidol-treated patients. In another 12-week clinical study, the incidence of extrapyramidal symptoms was 26.6% in patients treated with aripiprazole and 17.6% in patients treated with lithium. In the 26-week, long-term, placebo-controlled clinical study, the incidence of extrapyramidal symptoms was 18.2% in aripiprazole-treated patients and 15.7% in placebo-treated patients. .

akathisia

In placebo-controlled clinical studies, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo. In schizophrenic 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 a muscle group have been reported in patients predisposed during the first days of treatment. Dystonic symptoms include spasm of the neck muscles, sometimes progressing to oppression of the throat, difficulty swallowing, difficulty breathing, and / or protrusion of the tongue. While these symptoms may occur at low doses, they have been reported more frequently and with greater severity with high-potency and higher-dose first-generation antipsychotics. A high risk of acute dystonia has been observed in groups of men and youth.

Among patients who experienced changes in standard and lipid parameters that could be clinically significant (see section 5.1 ), there was no significant difference in clinical status between the aripiprazole group and the placebo group. Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5% of aripiprazole-treated patients and 2.0% of placebo-treated patients.

Other data

Adverse reactions known to be associated with antipsychotic medications have also been reported during treatment with aripiprazole (neuroleptic malignant syndrome, tardive dyskinesia, convulsions, cerebrovascular adverse events and increased mortality in elderly patients with dementia, hyperglycaemia and diabetes) (see section Warnings and precautions for use ).

Pediatric population

Schizophrenia in adolescents aged 15 and over

In a short-term placebo-controlled clinical trial in 302 schizophrenic adolescents (aged 13 to 17 years), the frequency and nature of adverse events were similar to those of adults, with the exception of the following reactions that were reported more frequently in adolescents taking aripiprazole compared to adults taking aripiprazole (and more frequently than placebo): drowsiness / sedation and extrapyramidal disorder were very common (≥ 1/10), dry mouth, increased appetite and hypotension orthostatic have been reported frequently (≥ 1/100, <1/10). The safety profile in an open-label 26-week extension trial was similar to that seen in the short-term placebo-controlled trial.

Pooled analysis of a population of adolescents (aged 13 to 17 years) with schizophrenia, exposed to the product for up to 2 years, reveals low plasma prolactin incidence in girls (<3 ng / mL) and boys (<2 ng / mL) of 29.5% and 48.3%, respectively.

In a population of adolescents (aged 13 to 17 years) with schizophrenia, exposed to a dosage ranging from 5 mg to 30 mg aripiprazole for up to 72 months, the incidence of low serum prolactin in girls (<3 ng / mL) and in boys (<2 ng / mL)

was respectively 25.6% and 45.0%.

Manic episodes in bipolar I disorder in adolescents aged 13 years and older The frequency and nature of adverse events in adolescents with bipolar I disorder were similar to those seen in adults, except following reactions: very frequently (≥ 1/10) drowsiness (23.0%), extrapyramidal disorders (18.4%), akathisia (16.0%) and fatigue (11.8%); frequently (≥ 1/100, <1/10) upper abdominal pain, increased heart rate, weight gain, increased appetite, muscle contractions and dyskinesia.

The following adverse events had a possible dose-effect relationship: extrapyramidal disorders (the incidence was 9.1% at a dose of 10 mg, 28.8% at a dose of 30 mg and 1.7% for placebo) ; and akathisia (the incidence was 12.1% at a dosage of 10 mg, 20.3% at a dosage of 30 mg and 1.7% for placebo).

Mean weight changes in adolescents with bipolar I disorder after 12 and 30 weeks of treatment were 2.4 kg and 5.8 kg with aripiprazole and 0.2 kg and 2.3 kg, respectively with the placebo.

In the pediatric population, somnolence and fatigue were observed more frequently in patients with bipolar disorder compared to those with schizophrenia.

In the pediatric population with bipolar disorder (patients aged 10 to 17 years), exposed to the product for periods up to 30 weeks, the incidence of low plasma prolactin levels was 28.0% in females ( <3 ng / mL) and 53.3% in boys (<2 ng / mL).

Post-Market Adverse Reactions

The following side effects have been reported after marketing. The frequency of these effects is considered unknown (can not be estimated from the available data).

Blood and lymphatic system disorders

leukopenia, neutropenia, thrombocytopenia

Immune system disorders

allergic reactions (eg anaphylactic reaction, angioedema including swelling of the tongue, edema of the tongue, edema of the face, pruritus or urticaria)

Endocrine disorders

hyperglycemia, diabetes mellitus, ketoacidosis diabetes, hyperosmolar diabetic coma

Metabolism and nutrition disorders

weight gain, weight loss, anorexia, hyponatremia

Psychiatric disorders

agitation, nervousness, pathological gambling; suicide attempt, suicidal ideation, completed suicide (see

section Warnings and precautions for use )

Nervous system disorders

slurred speech, neuroleptic malignant syndrome (NMS), epilepticus, serotonin syndrome

Heart conditions

QT prolongation, ventricular arrhythmia, unexplained sudden death, cardiac arrest, torsades de pointes, bradycardia

Vascular disorders

syncope, hypertension, thromboembolic events (including pulmonary embolism and deep vein thrombosis)

Respiratory, thoracic and mediastinal disorders

oropharyngeal spasm, laryngeal spasm, swallowing pneumonia

Gastrointestinal disorders

pancreatitis, dysphagia, discomfort in the abdomen, discomfort in the stomach, diarrhea

Hepatobiliary disorders

liver failure, jaundice, hepatitis, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased gamma glutamyl transferase (GGT), increased alkaline phosphatase

Skin and subcutaneous tissue disorders

rash, photosensitivity reaction, alopecia, hyperhidrosis

Musculoskeletal and systemic disorders

rhabdomyolysis, myalgia, stiffness

Renal and urinary disorders

urinary incontinence, urinary retention

Pregnancy, puerperium and perinatal disorders

neonatal drug withdrawal syndrome (see section Pregnancy and lactation )

Disorders of reproductive organs and breast

priapism

General disorders and administration site conditions

disorder of temperature regulation (eg hypothermia, fever), chest pain, peripheral edema

investigations

increased creatine phosphokinase, increased blood glucose, change in blood glucose, increased glycosylated hemoglobin

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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