Pericyazine 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pericyazine

Available from:

Zentiva Pharma UK Ltd

ATC code:

N05AC01

INN (International Name):

Pericyazine

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5000283653707

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
PERICYAZINE 2.5MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your
doctor or pharmacist
 This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
 If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What pericyazine is and what it is used for
2. What you need to know before you take
pericyazine
3. How to take pericyazine
4. Possible side effects
5. How to store pericyazine
6. Contents of the pack and other information
1. WHAT PERICYAZINE IS AND WHAT IT IS USED FOR
The name of your medicine is Pericyazine
2.5mg Tablets (referred to as pericyazine
throughout this leaflet).This belongs to a group
of medicines called ‘phenothiazines’. It works
by blocking the effect of a chemical in the brain.
It can be used for:
 Schizophrenia
 The short term treatment of anxiety, agitation
and violent or dangerously impulsive
behaviour when used with other medicines
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERICYAZINE
DO NOT TAKE THIS MEDICINE AND TELL
YOUR DOCTOR IF:
 You are allergic (hypersensitive) to pericyazine
or any of the other ingredients in this
medicine (listed in Section 6)
 Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue
 You are pregnant, might become pregnant
or think you may be pregnant (see Section
below: ‘Pregnancy and breast-feeding’)
 You have urine retention due to a prostate
disorder
 You are taking a dopaminergic
antiparkinsonism drug
 You have increased pressure in the eye
(glaucoma)
 You have a history of a low white blood
cell count
 It is intended

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pericyazine 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg pericyazine.
Excipients of with known effect:
Methyl hydroxybenzoate: Each 2.5mg tablet contains 0.001 mg benzoate
salt.
Lactose: Each 2.5mg tablet contains 51.1mg lactose.
For the full list of excipients, see section 6.1.
3
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.
4
CLINICAL PARTICULARS
4.1
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 is used as an adjunct to the short-term
management of
these conditions.
4.2
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 therapy would not normally be expected to exceed 300 mg
per
day.
Elderly: _ _Initially 15-30 mg per day in divided doses. If this is
well tolerated
the dosage may be increased if necessary for optimum control of
behaviour.
_Mild or moderate conditions _
_ _
_Indication (b) _
_ _
Adults: Initially 15-30 mg daily, divided into two portions with a
larger dose
being given in the evening.
Elderly: 5-10 mg per day is suggested as a starting dose. It may be
divided so
that a larger portion is given in the evening. Half or quarter the
normal adult
dose may be sufficient for maintenance therapy.
Pericyazine tablets are not recommended for children.
Method of administration
Oral.
Dosage requirement varies with the individual and the severity of the
condition being treated. Initial dosage should be low with progressive
increases until the desired response is obtained, after which dosage
should be
adj