Medicinal Products

ARIPIPRAZOLE FOCUS 15 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Aripiprazole
laboratory: Focus Care Pharma

Compressed
box of 28
All forms

Indication

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

Dosage ARIPIPRAZOLE FOCUS 15 mg tablet box of 28

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

Against indications

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

Adverse effects Aripiprazole Focus

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 uncommon (≥ 1/1000 to <1/100).

Psychiatric disorders

Frequent : agitation, insomnia, anxiety

Uncommon : depression *

Nervous system disorders

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

Eye disorders

Common : blurred vision

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.

Another indication - in a 12-week controlled clinical study, the incidence of extrapyramidal symptoms was 23.5% in aripiprazole-treated patients and 53.3% in 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 patients with other psychiatric disorders 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 Serum prolactin levels in girls (<3 ng / ml) and in boys (<2 ng / ml) were 25.6% and 45.0%, respectively.

Another indication for adolescents aged 13 and over

The frequency and nature of adverse events in adolescents in another indication 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).

The mean changes in weight for adolescents in another indication 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 with placebo respectively. .

In the pediatric population, somnolence and fatigue were observed more frequently in patients in another indication than in those with schizophrenia.

In the pediatric population in another indication (patients aged 10 to 17 years) exposed to the product for 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).

Hematological 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 Warnings and Precautions section ).

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 breastfeeding )

Disorders of the reproductive organs and the breast:

priapism

General disorders and administration site defects:

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 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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