Medicinal Products

ARIPIPRAZOLE EG 10 mg

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

© tablet
box of 28
All forms

Indication

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

Aripiprazole is indicated for the treatment of moderate-to-severe manic episodes of bipolar I disorder and for the prevention of manic episode recurrence in patients with adult with manic pre-episodes and for whom manic episodes have responded to aripiprazole treatment (see section 5.1 ).

Aripiprazole is indicated for the treatment of moderate-to-severe manic episodes of bipolar I disorder in adolescents aged 13 and over for a duration of up to 12 weeks (see section on Pharmacodynamic properties ).

Dosage ARIPIPRAZOLE EG 10 mg tablet box of 28

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

Aripiprazole is indicated for the treatment of moderate-to-severe manic episodes of bipolar I disorder and for the prevention of manic episode recurrence in patients with adult with manic pre-episodes and for whom manic episodes have responded to aripiprazole treatment (see section 5.1 ).

Aripiprazole is indicated for the treatment of moderate-to-severe manic episodes of bipolar I disorder in adolescents aged 13 and over for a duration of up to 12 weeks (see section on Pharmacodynamic properties ).

Against indications

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

Side effects Aripiprazole Eg

Summary of the security profile

The most common adverse events reported during placebo-controlled clinical trials are akathisia and nausea, each occurring in more than 3% of patients treated with aripiprazole. orally.

List of undesirable effects in tabular form

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

The frequencies below are defined using the following convention: Frequent (≥ 1/100, <1/10) and not very frequent (≥ 1/1000, <1/100).

Endocrine disorders

Not very common: hyperprolactinemia.

Psychiatric disorders

Frequent: agitation, insomnia, anxiety.

Not very common: depression **, hypersexuality.

Unconditional frequency: aggression.

Nervous system disorders

Frequent: extrapyramidal disorders, akathisia, tremor, dizziness, drowsiness, sedation, cephalitis.

Eye disorders

Frequent: blurred vision.

Not very frequent: diplopia.

Heart conditions

Not very common: tachycardia *.

Vascular disorders

Not very common: orthostatic hypotension *.

Gastrointestinal disorders

Frequent: dyspepsia, vomiting, nausea, constipation, hypersecretion salivary.

General disorders and administration site abnormalities

Frequent: tiredness.

Description of selected adverse effects

Extrapyramidal symptoms

Schizophrenia - In a 52-week long-term controlled clinical trial, the incidence of extrapyramidal symptoms, including parkinsonism, akathisia, dystonia, and dyskinesia, was overall lower in patients treated with aripiprazole (25.8%) compared with patients treated with haloperidol (57.3%). In a 26-week, placebo-controlled, long-term clinical study, the incidence of extrapyramidal symptoms was 19% in aripiprazole-treated patients and 13.1% in patients treated with aripiprazole. patients treated with placebo. In another 26-week long-term controlled clinical trial, the incidence of extrapyramidal symptoms was 14.8% in patients treated with aripiprazole and 15.1% in patients treated with aripiprazole. patients treated with olanzapine.

Manic Episodes in Bipolar I Disorder - In a controlled clinical study of 12 weeks, the incidence of extrapyramidal symptoms was 23.5% in patients treated with aripiprazole and 53.3% in patients treated with haloperidol. In another 12-week clinical trial, the incidence of extrapyramidal symptoms was 26.6% in patients treated with aripiprazole and 17.6% in patients treated with lithium. In the long-term placebo-controlled clinical study of 26 weeks of maintenance phase, the incidence of extrapyramidal symptoms was 18.2% in patients treated with aripiprazole and 15.7% in patients treated with placebo.

akathisia

In placebo-controlled clinical studies, 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 a muscle group, may occur in pre-disposed patients during the first days of treatment. The dystonic symptoms include: spasm of the neck muscles, sometimes progressing to oppression of the throat, difficulty in swallowing, difficulty breathing and / or protrusion of the tongue. While these symptoms may occur in low doses, they have been reported more frequently and with greater severity with first-generation antipsychotics of strong power and at higher doses. A high risk of acute dystonia has been observed in men and in younger patients.

Among patients who presented variations of standard and lipid parameters that may be clinically significant (see section on Pharmacodynamic properties ), there was no significant difference between their clinical status between the aripiprazole group and the placebo group.

Increases in generally transient and asymptomatic CPK (creatine phosphokinase) were observed in 3.5% of patients treated with aripiprazole and in 2.0% of patients treated with aripiprazole. patients treated with placebo.

Hyperprolactinà © mie

In clinical studies of the approved indication (s) and after the marketing of the drug, an increase was observed as well a decrease in serum prolactin levels compared to baseline with aripiprazole (see section 5.1 ).

Other results

Adverse effects known to be associated with antipsychotic medications and also reported during aripiprazole treatment include: neuroleptic malignant syndrome, tardive dyskinesia, seizures, corticovascular untoward effects and increased mortality in elderly patients with dementia, hyperglycaemia and diabetes mellitus (see Warnings and Precautions section ).

Pediatric population

Schizophrenia in adolescents aged 15 and over

In a short-term placebo-controlled clinical trial in 302 schizophrenia adolescents (aged 13 to 17 years), the frequency and nature of the adverse effects were similar to those of adults., With the exception of the following reactions, which were reported more frequently in adolescents taking aripiprazole than in adults taking aripiprazole (and more frequently than in placebo): drowsiness / seizures dation and extrapyramidal disorder were very commonly reported (≥1 / 10), and dryness of the mouth, increased appetite and orthostatic hypotension occurred. Frequently reported (≥ 1/100, <1/10). The tolerability profile in an open-label 26-week extension trial was similar to that seen in the short-term placebo-controlled trial.

The pooled analysis of a population of adolescents (aged 13 to 17 years) with schizophrenia, exposed to the product for periods of up to 2 years, has Showed low plasma prolactin incidence in girls (<3 ng / ml) and boys (<2 ng / ml) of 29.5% and 48.3%, respectively. In the adolescent population (aged 13 to 17 years) with schizophrenia, exposed to a dosage ranging from 5 mg to 30 mg aripiprazole for a period of up to At 72 months, the incidence of low serum prolactin in girls (<3 ng / ml) and in boys (<2 ng / ml) was 25.6% and 45%, respectively. 0%.

Manic Episodes in Bipolar I Disorder in Adolescents Aged 13 Years and Over

The frequency and nature of adverse effects in adolescents with bipolar I disorder were similar to those seen in adults, with the following exceptions: very common (≥ 1/10): somnolence (23.0%), extrapyramidal disorders (18.4%), akathisia (16.0%) and fatigue (11.8%); and frequently (≥ 1/100, <1/10) upper abdominal pain, increased heart rate, weight gain, increased appetite, muscle contractions and dyskinesia.

The following adverse effects had a possible dose-effect relationship: extrapyramidal disorders (the incidence was 9.1% at a dosage of 10 mg, 28.8% at a dosage 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 variations 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 with the placebo.

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

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

After the marketing

The following undesirable effects have been reported after the marketing of the medicinal product. The frequency of these effects is considered as indeterminate (can not be estimated based on available data).

Hematologic 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:

Hyperglycemia, diabetes mellitus, acidoctosis diabetes, hyperosmolar diabetic coma.

Metabolism and nutrition disorders:

Weight gain, weight loss, anorexia, hyponatremia.

Psychiatric disorders

Agitation, nervousness, pathological gambling; suicide attempt, suicidal ideation, and completed suicide (see Warnings and Precautions section ).

Nervous system disorders

Impairment disorders, Neuroleptic Malignant Syndrome (SMN), large epileptic disease, serotonergic syndrome.

Heart conditions

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

Vascular disorders

Syncope, hypertension, thromboembolic event (including pulmonary embolism and deep vein thrombosis).

Respiratory, thoracic and mediastinal disorders

Oropharyngeal spasm, laryngeal spasm, deglutition pneumonia.

Gastrointestinal disorders

Pancreatitis, dysphagia, abdomen discomfort, stomach discomfort, diarrhea.

Hereditary conditions

Hepatic insufficiency, jaundice, hepatitis, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased gamma glutamyl transferase (GGT), increased alkaline phosphatase.

Skin and subcutaneous tissue disorders

Eruption, photosensitivity reaction, alopecia, hyperhidrosis.

Musculoskeletal and systemic disorders

Rhabdomyolysis, myalgia, stiffness.

Renal and urinary disorders

Urinary incontinence, urinary retention.

Pregnancy, Puerperal and Perinatal Conditions

Medication withdrawal syndrome neonatal (see section Pregnancy and breastfeeding ).

Disorders of reproductive organs and breast

Priapism.

General disorders and administration site abnormalities

Temperature regulation disorder (eg, hypothermia, pyrexia), chest pain, peripheral edema.

investigations

Increased Creatine Phosphokinase, increased glycemia, change in glycemia, increased glycosylated hemoglobin.

Declaration of suspected untoward effects

The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals disclose any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (ANSM) and network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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