Medicinal Products

DIPIPERON 40 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Pipamperone
laboratory: Eumedica

Tablet breackable
Box of 20
All forms

Indication

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:

Age

Average dosage

Initial dose

Daily progress

Adult

1 to 3 tablets

1/2 tablet

1/2 tablet

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.

Against indications

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).

Side effects

Classes of organ system

Frequencies of appearance

Very common
(≥ 1/10)

Frequent
(≥ 1/100, <1/10)

indeterminate

Blood and lymphatic system disorders

Leukopenia, thrombocytopenia.

Immune system disorders

Hypersensitivity.

Endocrine disorders

Hyperprolactinemia, hyponatremia, SIADH (inappropriate secretion of antidiuretic hormone).

Psychiatric disorders

Depression.

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.

Heart conditions

Tachycardia.

Ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, cardiac arrest.

Vascular disorders

Orthostatic hypotension.

Hypotension.

Gastrointestinal disorders

Vomiting.

Skin and subcutaneous tissue disorders

Urticaria.

Rash, erythematous rashes, bullous eruptions including Lyell syndrome (toxic epidermal necrolysis).

Musculoskeletal and systemic disorders

Muscular spasticity.

Disorders of reproductive organs and breasts

Amenorrhea.

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

investigations

Increased liver enzymes, prolongation of the QT interval.
Weight gain.

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.

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