Chlorpromazine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorpromazine hydrochloride

Available from:

Teva UK 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; GTIN: 5017007112327

Patient Information leaflet

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORPROMAZINE 25 MG TABLETS
CHLORPROMAZINE 50 MG TABLETS
CHLORPROMAZINE 100 MG TABLETS
Active substance: Chlorpromazine Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Chlorpromazine is and what it is used for
2.
Before you take Chlorpromazine tablets
3.
How to take Chlorpromazine tablets
4.
Possible side effects
5.
How to store Chlorpromazine tablets
6.
Further information
1.
WHAT CHLORPROMAZINE IS AND WHAT IT IS USED FOR
Chlorpromazine belongs to a group of drugs known as antipsychotics,
which act on the central
nervous system.
CHLORPROMAZINE TABLETS ARE USED FOR:
-
The treatment of behavioural disturbances, including schizophrenia,
mania and hypomania
-
The short-term treatment of anxiety, agitation and violent or
impulsive behaviour
-
The treatment of persistent hiccup and nausea and vomiting associated
with terminal illness.
2.
BEFORE YOU TAKE CHLORPROMAZINE TABLETS
_ _
DO NOT TAKE CHLORPROMAZINE TABLETS IF YOU:
-
Are allergic (hypersensitive) to
- Chlorpromazine
- Any of the other ingredients Chlorpromazine tablets (see section 6
“Further information”)
-
Have a low blood cell count (bone marrow depression)
CHECK WITH YOUR DOCTOR BEFORE TAKING CHLORPROMAZINE TABLETS IF YOU:
-
Suffer from liver or kindey problems
-
Suffer from epilepsy (fits)
-
Have had, or any member of your family has had, any disease that has
affected the heart or blood
circulation.
-
Or someone else in your family has a history of blood clots, as
medicines like this have been
assoicated with formation of b

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