Clonactil 25 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-11-2019
Summary of Product characteristics
(SPC)
25-11-2019
Active ingredient:
CHLORPROMAZINE HYDROCHLORIDE
Available from:
Clonmel Healthcare Ltd
ATC code:
N05AA; N05AA01
INN (International Name):
CHLORPROMAZINE HYDROCHLORIDE
Dosage:
25 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic group:
Phenothiazines with alipathic side-chains
Therapeutic area:
Phenothiazines with aliphatic side-chain; chlorpromazine
Therapeutic indications:
Chlorpromazine belongs to a group of drugs known as antipsychotics, which act on the central nervous system. Clonactil 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.
Authorization status:
Marketed
Authorization date:
1987-04-08
Patient Information leaflet
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLONACTIL 25MG FILM-COATED TABLETS
CLONACTIL 50MG FILM-COATED TABLETS
CLONACTIL 100MG 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 further questions, please 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Clonactil is and what it is used for
2. What you need to know before you take Clonactil Tablets
3. How to take Clonactil Tablets
4. Possible side effects
5. How to store Clonactil Tablets
6. Contents of the pack and other information
1. WHAT CLONACTIL IS AND WHAT IT IS USED FOR
Clonactil tablets contain the active substance chlorpromazine.
Chlorpromazine belongs to a group of
drugs known as antipsychotics, which act on the central nervous
system.
CLONACTIL 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLONACTIL TABLETS
DO NOT TAKE CLONACTIL TABLETS
–
if you are allergic to chlorpromazine or any of the other ingredients
of this medicine (listed in
section 6)
if you have a low blood cell count (bone marrow depression)
if you have prostate trouble
if you have glaucoma (painful eyes with blurred vision)
if you are breast-feeding
if you are in or have ever previously been in a comatose state while
taking barbiturates (medicines
to treat fits, e.g., p
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
24 November 2019
CRN00969X
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonactil 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg Chlorpromazine Hydrochloride.
Excipient with known effect:
Lactose monohydrate: 71.5mg
_For full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film coated tablets (Tablets).
White, circular, biconvex film-coated tablet engraved with 'CZ1' on
one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(i) In the management of anxiety and tension states, agitation,
depression and behavioural disturbances.
(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 and intractable hiccup.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended Dosage
There is a large inter and intra-individual variation in the kinetics
of chlorpromazine, dosage must be on an individual basis.
Initial dosage should be low and gradually increased under close
supervision to the optimum level.
ANXIETY, AGITATION & PSYCHOSES, BEHAVIOURAL DISTURBANCE
Adults
The recommended total daily dosage is 75 to 300 mg in divided doses,
but in the management of psychoses, dosage may be
as high as l g daily.
Paediatric population
6-12 years of age
1
/
3
to ½the adult dose to a maximum recommended dose of 75 mg/day.
1-5 years
0.5 mg/kg every 4-6 hours to a maximum recommended dose of 40 mg/day.
Health Products Regulatory Authority
24 November 2019
CRN00969X
Page 2 of 10
Older people
10-25 mg once or twice daily is usually adequate in the control of
agitated states. For other conditions,
1
/
3
to ½ the usual
adult dose with a gradual titration upwards.
INTRACTABLE HICCUP
Adults
10-25 mg 6 to 8 hourly, increasing to 25-50 mg, 6-8 hourly if
necessary.
TERMINAL ILLNESS
Adults
10-25 mg, 4-6 hourly
Paediatric population
1-5 years: 0.5 mg/kg 4-6
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