Medicinal Products

ARIPIPRAZOLE TEVA 15 mg tablet box of 28 precut platelets of 1

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

Tablet breackable
All forms

Indication

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

Dosage ARIPIPRAZOLE TEVA 15 mg tablet box of 28 platelets precut of 1

ARIPIPRAZOLE TEVA 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 Teva

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 undesirable effects

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 *.

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

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

General disorders and administration site conditions

Frequent: 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.

akathisia

In placebo-controlled clinical studies, the incidence of akathisia in schizophrenia patients 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.

Post-Market Adverse Reactions

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

Hematologic 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, 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, suicide accomplished (see Warnings and Precautions section ).

Nervous system disorders: slurred speech, Neuroleptic Malignant Syndrome (NMS), large epilepticus, serotonin syndrome.

Cardiac disorders : 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, swallowing pneumonia.

Gastrointestinal disorders : pancreatitis, dysphagia, discomfort in the abdomen, discomfort in the stomach, diarrhea.

Hepatobiliary disorders : 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 : 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 Medication Withdrawal Syndrome (see section Pregnancy and breastfeeding ).

Disorders of the reproductive organs and the breast : priapism.

General disorders and administration site conditions : temperature regulation disorder (eg hypothermia, fever), chest pain, peripheral edema.

Investigations : increased creatinine 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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