Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Pipamperone
Box of 20
Short-term treatment of states of agitation and aggression in acute and chronic psychotic states (schizophrenia, chronic non-schizophrenic delusions: paranoid delusions, chronic hallucinatory psychoses).
Dosage DIPIPERON 40 mg Breakable tablet Box of 20
Reserved for adults.
The prescription will preferably be made in one or two evening doses, for example, at dinner and at bedtime.
The daily dosage is:
1 to 3 tablets
In the elderly:
The tablet form is not suitable for treating elderly subjects.
In the elderly, the oral solution form in drops is the only one adapted.
This medicine is CONTRA-INDICATED in the following cases:
· Known hypersensitivity to pipametone or any of the components of the product,
· Comatose state, central nervous system depression,
· Combination with dopaminergic drugs other than Parkinson's (cabergoline, quinagolide) (see section 4.5). See also Interactions with other medicinal products and other forms of interaction .
Adverse effects Dipiperon
Based on safety data from clinical trials, the most commonly reported adverse events (incidence in%) were: Nervous system disorders: somnolence (22.5%), toothed wheel phenomenon (11.3%) %).
Adverse reactions reported during the use of DIPIPERON in clinical trials (including the effects mentioned above) and after marketing are summarized in the table below. The frequencies are presented according to the following convention:
Very common (≥ 1/10) frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000); indeterminate frequency (can not be estimated based on available data).
Classes of organ system
Frequencies of appearance
Blood and lymphatic system disorders
Immune system disorders
Hyperprolactinemia, hyponatremia, SIADH (inappropriate secretion of antidiuretic hormone).
Indifference, anxious reactions, change of mood.
Nervous system disorders
Drowsiness; gear wheel (Phenomenon of).
hypertension; akathisia; oculogyric crises; opisthotonos; dyskinesia, spasmodic torticollis, trismus.
Convulsions (including seizures and status of Grand Epilepticus); Neuroleptic malignant syndrome; parkinsonism; syncope; tardive dyskinesia; tremors.
Ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, cardiac arrest.
Skin and subcutaneous tissue disorders
Rash, erythematous rashes, bullous eruptions including Lyell syndrome (toxic epidermal necrolysis).
Musculoskeletal and systemic disorders
Disorders of reproductive organs and breasts
galactorrhoea; gynecomastia (including gynecomastia and breast hypertrophy); oligomenorrhea; sexual disorders including priapism.
General events and anomalies at the administration site
Walking disorder; asthenia.
Tired; edema (including edema of the face and peripheral edema); hypothermia, hyperthermia
Increased liver enzymes, prolongation of the QT interval.
Pregnancy, puerperium and perinatal conditions
neonatal withdrawal syndrome
In addition, isolated cases of sudden cardiac death and unexplained sudden death have been reported in patients treated with phenothiazine, butyrophenone or benzamide-based antipsychotics.
Cases of venous thromboembolism, including cases of pulmonary embolism and deep vein thrombosis have been reported with antipsychotics (frequency unknown).
Cases of hyperglycemia or glucose intolerance and the occurrence or exacerbation of diabetes have been reported in patients treated with antipsychotics.