Chlorpromazine Elixir BP 25 mg/5 ml Oral Solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

CHLORPROMAZINE HYDROCHLORIDE

Tilgængelig fra:

Pinewood Laboratories Ltd

ATC-kode:

N05AA; N05AA01

INN (International Name):

CHLORPROMAZINE HYDROCHLORIDE

Dosering:

25 mg/5ml

Lægemiddelform:

Oral solution

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Phenothiazines with aliphatic side-chain; chlorpromazine

Autorisation status:

Not marketed

Autorisation dato:

1983-06-23

Indlægsseddel

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.
- 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. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Chlorpromazine Elixir is and what it is used for
2. What you need to know before you take Chlorpromazine Elixir
3. How to take Chlorpromazine Elixir
4. Possible side effects
5. How to store Chlorpromazine Elixir
6. Contents of the pack and other information
1. WHAT CHLORPROMAZINE ELIXIR IS AND WHAT IT IS USED FOR
Chlorpromazine Elixir 25 mg/5 ml Oral Solution belongs to a group of
medicines known as antipsychotics, which have a tranquillising effect,
reducing anxiety and tension, stabilising mood swings and controlling
aggression.
Chlorpromazine Elixir is used for:
• Management of anxiety, agitation, depression, behavioural
disturbances, senile irritability
• Schizophrenia and other psychoses (loss of contact with reality)
including mania (very high or very low moods)
• Terminal illness
• Uncontrollable hiccups
• Eclampsia and pre-eclampsia (in pregnancy)
• Pre and post-anaesthesia
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORPROMAZINE ELIXIR
Do NOT take Chlorpromazine Elixir:
• if you are allergic to chlorpromazine or any of the other
ingredients of this medicine (listed in section 6)
• if you have a low number of blood cells (bone marrow depression)
• if you have increased pressure in the eye (glaucoma)
• if you are taking dopaminergic antiparkinson drugs
• if you are breast-feeding
• if you are taking citalopram or escitalopram
• if you have a history of a low white blood cell count
• if you have urine retention due to a prostate disorder
•

Produktets egenskaber

Health Products Regulatory Authority
08 November 2021
CRN00CMNR
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorpromazine Elixir BP 25 mg/5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 25 mg chlorpromazine hydrochloride.
Excipients with known effect: Each 5ml also contains 3.75g Sucrose,
6mg Parahydroxybenzoates [sodium methyl
parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215),
sodium propyl parahydroxybenzoate (E217)],
Amaranth (E123) and Tartrazine (E102).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Amber-brown coloured oral solution with spearmint odour and flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(i) In the management of anxiety and tension states, agitation,
depression, behavioural disturbances and
subnormality.
(ii) In the management of schizophrenia and other psychoses including
mania and hypomania, and psychopathy,
and in the control of the central effects of such drugs as LSD.
(iii) In the management of terminal illness, senile irritability,
intractable hiccup, eclampsia and pre-eclampsia.
(iv) As a pre- and post- anaesthetic medication and adjunct to
facilitation of anaesthesia, and induction
of hypothermia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Oral administration should be used whenever possible; patients who are
unwilling to swallow tablets should be treated with
elixir. Dosages should be low to begin with and gradually increase
under close supervision until the optimum dosage within
the recommended range is reached. Individuals vary considerably and
the optimum dose may be affected by the formulation
used. Parenteral formulations may be used in emergencies.
Posology
Table 1: Dosage of chlorpromazine in schizophrenia, other psychoses,
anxiety and agitation etc.
Adults
Children under 1 year
Children 1-5 years
Children 6-12 years
Elderly or debilitated
patients
Initially 25 mg t.d.s. or 75
mg at bedtime increasing
by daily amou