PERICYAZINE Tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Pericyazine 2.5mg Tablets.
Qualitative and quantitative composition
Each tablet contains 2.5mg pericyazine. For the full list of excipients, see section 6.1.
Pharmaceutical form
Pericyazine 2.5mg Tablets: Circular, very pale lime-yellow tablet, with one face impressed S171 just inside the perimeter. Break-line on reverse.
Therapeutic indications
a) In adults with schizophrenia or other psychoses, for the treatment of symptoms or prevention of relapse. b) In anxiety, psychomotor agitation, violent or dangerously impulsive behaviour. Pericyazine ...
Posology and method of administration
Posology Severe conditions Indication (a) Adults: Initially 75 mg per day in divided doses. Dosage should be increased by 25 mg per day at weekly intervals until the optimum effect is achieved. Maintenance ...
Contraindications
See use in pregnancy below. Known hypersensitivity to pericyazine or to any of the other excipients listed in section 6.1.
Special warnings and precautions for use
Neuroleptics should be avoided in patients with liver or renal dysfunction, Parkinsons disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostrate hypertrophy. It should be ...
Interaction with other medicinal products and other forms of interaction
Interactions of phenothiazine neuroleptics The CNS depressant actions of neuroleptic agents may be intensified (additively) by alcohol, barbiturates and other sedatives. Respiratory depression may occur. ...
Pregnancy and lactation
Pregnancy Available data from studies in animals have shown no evidence of a teratogenic effect. Available human data are insufficient to exclude a risk of congenital malformation in children exposed in ...
Effects on ability to drive and use machines
Patients should be warned about drowsiness during early days of treatment, and advised not to drive or operate machinery. The elderly are particularly susceptible to postural hypotension.
Undesirable effects
Liver function: jaundice, occurs in a very small percentage of patients taking neuroleptics. A premonitory sign may be a sudden onset of fever after one to three weeks of treatment followed by the development ...
Overdose
Toxicity and treatment of overdosage Symptoms of neuroleptic overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe ...
Pharmacodynamic properties
Pericyazine is a neuroleptic with cardiovascular and antihistamine effects similar to those of chlorpromazine, but it has a stronger antiserotonin effect and a powerful central sedative effect.
Pharmacokinetic properties
Kinetics There is little information about plasma concentrations, distribution and excretion in humans. The rate of metabolism and excretion of phenothiazines decreases in old age.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Lactose, anhydrous Cellulose, microcrystalline (E460) Sodium starch glycolate Magnesium stearate Silica, colloidal anhydrous (E551) Methyl parahydroxybenzoate (E218)
Incompatibilities
None known.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Store below 30°C. Store in the original package in order to protect from light.
Nature and contents of container
Securitainer or HDPE bottle containing 500 tablets. PVDC coated UPVC aluminium foil blister containing 84 tablets.
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Marketing authorization number(s)
PL 17780/0458
Date of first authorization / renewal of the authorization
17 July 2009
Date of revision of the text
09 July 2020
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