Chlorpromazine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorpromazine hydrochloride

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

N05AA01

INN (International Name):

Chlorpromazine hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORPROMAZINE 25MG, 50MG, 100MGTABLETS
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 Chlorpromazine Tablets are and what they are used for
2.
What you need to know before you take Chlorpromazine Tablets
3.
How to take Chlorpromazine Tablets
4.
Possible side effects
5.
How to store Chlorpromazine Tablets
6.
Contents of the pack and other information
1. WHAT CHLORPROMAZINE TABLETS ARE AND WHAT THEY ARE USED FOR
Chlorpromazine tablets belong to a group of drugs known as
phenothiazines, which act on the central nervous system. They are used
to treat the
following conditions: SCHIZOPHRENIA and OTHER PSYCHOSES particularly
PARANOIA (delusions and feelings of persecution), MANIA (overactive
behaviour and HYPOMANIA (elated moods and excitability), ANXIETY,
AGITATION and VIOLENT OR DANGEROUSLY IMPULSIVE behaviour.
Chlorpromazine is also used for prolonged periods of HICCUPS, FEELING
OR BEING SICK (when other drugs have failed), to LOWER BODY
TEMPERATURE
and for CHILDHOOD SCHIZOPHRENIA and AUTISM (learning and communication
difficulties).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORPROMAZINE TABLETS
DO NOT TAKE CHLORPROMAZINE TABLETS AND TELL YOUR DOCTOR if you:
are ALLERGIC (hypersensitive) to Chlorpromazine, other
phenothiazines or to any of the other ingredients in the
tablets (see Section 6). Signs of an allergic reaction
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
have a low number of blood cells (bone

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlorpromazine 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorpromazine Hydrochloride 50.00 mg
See 6.1 for excipients
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, white, film-coated tablets marked ‘CPZ50’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Schizophrenia
and
other
psychoses
(especially
where
paranoia
is
a
predominant
symptom),
mania
and
hypomania.
In
anxiety,
psychomotor
agitation,
excitement,
violent
or
dangerously
impulsive
behaviour.
Chlorpromazine may be used as an adjunct in the short-term management
of
these conditions.
Intractable hiccup.
Nausea and vomiting in terminal illness (where other drugs have failed
or are
not available).
Induction of hypothermia is facilitated by Chlorpromazine Tablets
which
prevents shivering and causes vasodilatation.
Childhood schizophrenia and autism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosages should be low to begin with and gradually increased under
close
supervision until the optimum dosage for the individual is reached.
Individuals
vary considerably and the optimum dose may be affected by the
formulation
used.
Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety
and
agitation etc.
Adult:
Initially 25 mg t.d.s. or 75 mg at bedtime increasing by daily amounts
of 25
mg to an effective maintenance dose. This is usually in the range 75
to 300 mg
daily but some patients may require up to 1 g daily.
Children under 1 year:
Do not use unless the risk-benefit ratio has been assessed.
Children 1-5 years:
0.5 mg/kg body weight every 4-6 hours to a maximum recommended dose of
40 mg daily.
Children 6-12 years:
1
/
3
-½ adult dose to a maximum recommended dose of 75 mg daily.
Elderly or debilitated patients:
Start with
1
/
3
-½ usual adult dose with a more gradual increase in dosage.
Hiccups
Adult:
25-50 mg t.d.s. or q.d.s.
Children under 1 year:
No information available.
Children 1-5 years:
No information available.
Children 6-12 years:
No information available