Core Safety Profile
Active substance: Niaprazine Pharmaceutical form(s)/strength: Syrup 200 g – bottle and 30 mg coated tablets P - RMS: IT/H/PSUR/0013/001 Date of FAR: 20.01.2010
4.1 Therapeutic indications
Coated tablets: sleep disorders. Syrup: in paediatrics, to support the induction of sleep subjects with psychomotor agitation.
4.2 Posology and method of administration
Coated tablets Adults: Usual posology is 1 or 2 30-mg-coated tablets in the evening, 30 minutes before going to bed.
Syrup Children: With the provided dispenser follow the mean indicative posologic scheme here reported: - from 6 months to 1 year: from 1.5 to 3 ml - from 1 year to 3 years: from 3 to 4.5 ml - from 3 years to 6 years:from 4.5 to 6 ml - from 6 years to 10 years:from 6 to 10.5 ml - children over 10 years: from 10.5 to 13.5 ml to be taken in the evening, 30 minutes before going to bed. The advised posology is 1 mg per kg of body weight (1 ml of /…/ = 3 mg of niaprazine). It is advisable to use half a dose for the first administration, in order to keep into account the individual sensitivity, and to reduce the dose in case of side effects occurrence. In the treatment of elderly patients the posology should be carefully established by the physician, who will evaluate a possible reduction of the above mentioned dosages. Follow the medical prescription, scrupulously respecting the posology.
4.3 Contraindications
Do not use under the 6th month of age. Do not use under the 3 years of age Ascertained hypersensitivity to the components.
4.4 Special warnings and precautions for use
We draw attention on the risk of sleepiness caused by this drug. The syrup preparation contains saccharose; keep in mind in case of diabetes or hypocaloric diets. Keep out of reach of children.
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4.5 Interactions with other drugs and other forms of interactions
Being unpredictable the individual reactions it is advisable to avoid the concomitant intake of alcoholic beverages.
Alcohol: alcohol increases the sedative effect of the H1 antihistamine. Impaired alertness can make dangerous driving and operating machinery. Avoid making alcoholic drinks and medicines containing alcohol.
Atropine and other substances atropine: (tricyclic antidepressants, antiparkinsonian Anticholinergic, antispasmodic atropine, disopyramide, neuroleptics phenothiazines): addition of atropine to side effects such as urinary retention,constipation, dry mouth.
Other depressants, central nervous system: opioid derivatives (analgesics, cough and substitution treatment); benzodiazepine anxiolytic other than benzodiazepines (carbamates, Captodiame, ETIFOXINE); hypnotics, sedatives, antidepressants; neuroleptics; central antihypertensive; baclofen; thalidomide: increase the central depression. Impairment of alertness can make driving dangerous vehicles and operating machinery.
The association with psychoactive drugs requires particular caution and vigilance by the physician in order to avoid unexpected interaction-induced undesirable effects.
4.6 Pregnancy and lactation
In lab animals (mouse, rat, rabbit) the drug showed to lack undesirable activity on fecundation and gestation. However, although literature does not report conclusive data on the use of substances with antihistamine activity during pregnancy, since the safety of its utilization was not established it is advised not to use the drug in pregnancy and during lactation.
4.7 Effects on the ability of driving and using machines
Because of its short half-life of elimination, the drug usually allows a lucid and prompt awakening, without residual phenomena. Nevertheless, base on the type of drug, risks of sleepiness cannot be excluded in particularly sensitive subjects and therefore it is needed to warn the patients to avoid activities requiring the integrity of the vigilance state (driving motor-vehicles, manoeuvres of potentially dangerous machines, etc.).
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4.8 Undesirable effects
We draw attention on the risks of day sleepiness caused by this drug. Cases of malaise have been reported sometimes coupled with hypotonia or hypertonia and dizzy symptoms, prevalently at the moment of the first intake, coinciding with a high posology. Dry mouth, disorders of accommodation, constipation, retention urinary, convulsions, agitation, very rare tardive dyskinesia, apnea. have been reported
A possible overdose may exceptionally cause a paradox excitement, in addition to day sleepiness. In both conditions it is sufficient a symptomatic surveillance.
4.9 Overdose
A specific antidote does not exist. In case of accidental intake of high amounts of the drug the predominant symptom is sleepiness or sleep. Also after the intake of an entire bottle of syrup in 2- and 3-year-old children no serious effects on vital functions were observed. The symptomatology resolved within some hours, without having recourse to particular therapeutic interventions. A possible overdose may exceptionally cause a paradox excitement.
The clinical picture may include: excitation with agitation, hallucinations, ataxia, incoordination, athetosis, seizures, balance disorders, drowsiness, coma and respiratory depression. Treatment is symptomatic in a specialized environment.
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