Medicinal Products

ARIPIPRAZOLE CRISTERS 10 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Aripiprazole
laboratory: Cristers

Compressed
box of 28
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Indication

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

ARIPIPRAZOLE CRISTERS 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 treatment with aripiprazole (see section 5.1 Pharmacodynamic properties ).

ARIPIPRAZOLE CRISTERS 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 CRISTERS 10 mg tablet box of 28

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

ARIPIPRAZOLE CRISTERS 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 treatment with aripiprazole (see section 5.1 Pharmacodynamic properties ).

ARIPIPRAZOLE CRISTERS 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 Cristers

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 presented in tabular form

All adverse reactions are listed by organ system class and frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to <1 / 100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000), and indeterminate frequency (can not be estimated from the available data). Within each frequency class, adverse effects are presented in order of decreasing severity.

The frequency of adverse reactions reported during post-marketing use can not be determined since they are derived from spontaneous reports. As a result, the frequency of these adverse events is described as "undetermined".

Frequent

Rare

Not known frequency

Blood and lymphatic system disorders

leukopenia

neutropenia

thrombocytopenia

Immune system disorders

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

Endocrine disorders

hyperprolactinemia

Hyperosmolar diabetic coma

Diabetic ketoacidosis

hyperglycemia

Metabolism and nutrition disorders

Diabetes

hyperglycemia

hyponatremia

Anorexia

Weightloss

Weight gain

Psychiatric disorders

Insomnia

Anxiety

impatiences

Depression

hypersexuality

Attempted suicide, suicidal ideation, completed suicide (see Warnings and Precautions for Use section )

Pathological gambling

Aggressiveness

agitation

Nervousness

Nervous system disorders

akathisia

Extrapyramidal disorder

tremor

cephalalgia

Sedation

Drowsiness

Dizzying sensation

Late dyskinesia

dystonia

Neuroleptic malignant syndrome (NMS)

State of great epilepticus

Serotonin syndrome

Language disorder

Eye disorders

Blurry vision

diplopia

Heart conditions

tachycardia

Unexplained sudden death

Torsades de pointes

QT lengthened

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

hiccough

Swallowing pneumonia

laryngospasm

Oropharyngeal spasm

Gastrointestinal disorders

Constipation

Dyspepsia

nausea

ptyalism

Vomiting

pancreatitis

dysphagia

Diarrhea

Abdominal discomfort

Stomach discomfort

Hepatobiliary disorders

Hepatic insufficiency

Hepatitis

icterus

Increased alanine amino transferase (ALAT)

Increase in Aspartate Amino Transferase (ASAT)

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

Negative drug withdrawal syndrome (see section Pregnancy and lactation )

Disorders of reproductive organs and breast

priapism

General disorders and administration site conditions

Tired

Disturbance of thermoregulation (eg hypothermia, fever)

Chest pain

Peripheral edema

investigations

Increased blood sugar

Glycosylated hemoglobin increased

Fluctuation of blood glucose

Increased blood creatine phosphokinase

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.

prolactin

In clinical trials for approved and post-marketing indications, an increase and a decrease in serum prolactin levels were both observed compared to the initial value after treatment with aripiprazole (section Pharmacodynamic properties ).

investigations

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.

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.

The safety profile of a double-blind, placebo-controlled trial was similar, with the exception of the following reactions, which were reported more frequently than pediatric placebo-treated patients: weight loss, increased insulinemia, arrhythmia, and leukopenia have been reported frequently (≥ 1/100, <1/10).

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 Serum prolactin levels in girls (<3 ng / ml) and in boys (<2 ng / ml) were 25.6% and 45.0%, respectively.

In two long-term trials in adolescents (aged 13 to 17 years) with schizophrenia and bipolar patients treated with aripiprazole, the incidence of low prolactin levels in women (<3 ng / ml) and in men (<2 ng / ml) were 37.0% and 59.4%, respectively.

Manic episodes in bipolar I disorder in adolescents aged 13 and over

The frequency and nature of adverse reactions in adolescents with bipolar I disorder were similar to those seen in adults with the exception of the following: 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).

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 declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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