Chlorpromazine 100mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

CHLORPROMAZINE HYDROCHLORIDE

Tilgængelig fra:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC-kode:

N05AA01

INN (International Name):

CHLORPROMAZINE HYDROCHLORIDE 100 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

CHLORPROMAZINE HYDROCHLORIDE 100 mg

Recept type:

POM

Terapeutisk område:

PSYCHOLEPTICS

Autorisation status:

Authorised

Autorisation dato:

2006-11-27

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHLORPROMAZINE 25 MG FILM-COATED TABLETS
CHLORPROMAZINE 100 MG FILM-COATED TABLETS
Chlorpromazine Hydrochloride
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 is and what it is used for
2.
What you need to know before you take Chlorpromazine
3.
How to take Chlorpromazine
4.
Possible side effects
5.
How to store Chlorpromazine
6.
Contents of the pack and other information
1. WHAT CHLORPROMAZINE IS AND WHAT IT IS USED FOR
Chlorpromazine contains the active substance chlorpromazine
hydrochloride.
Chlorpromazine belongs to the group of medicines that are called
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, nausea
and vomiting (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
DO NOT TAKE CHLORPROMAZINE
:
•
if you are allergic (hypersensitive) to chlorpromazine, other
phenothiazines or to any of
the other ingredients in the tablets (listed in section 6). Signs of
an allergic reaction
include: a

Produktets egenskaber

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SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Chlorpromazine 25 mg film-coated tablets
Chlorpromazine 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Chlorpromazine _
_25 mg _
_film-coated _
_tablets:_
Each
film-coated
tablet
contains
25 mg
chlorpromazine hydrochloride.
Excipient(s) with known effect:
This product contains 38 mg lactose.
_Chlorpromazine _
_100 mg _
_film-coated _
_tablets:_
Each
film-coated
tablet
contains
100 mg
chlorpromazine hydrochloride.
Excipient(s) with known effect:
This product contains 151.9 mg lactose.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, film-coated tablets.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Schizophrenia and other psychoses (especially paranoia), mania and
hypomania. In anxiety,
psychomotor
agitation,
excitement,
violent
or
dangerously
impulsive
behaviour.
Chlorpromazine is 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
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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.
Posology
Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety
and agitation etc.
_Adult: _
Initially 25 mg three times a day 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: _
Chlorpromazi