Prochlorperazine 5mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Prochlorperazine maleate

可用日期:

Bristol Laboratories Ltd

ATC代码:

N05AB04

INN（国际名称）:

Prochlorperazine maleate

剂量:

5mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04060000; GTIN: 5060013942358 5060013942365

资料单张

Prochlorperazine Tablets
SAME SIZE ARTWORK
560 x 180mm
Front
30 mm
IXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROCHLORPERAZINE 5 MG TABLETS
(PROCHLORPERAZINE MALEATE)
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 Prochlorperazine Tablets are and what they are used for
2.What you need to know before you take Prochlorperazine Tablets
3.How to take Prochlorperazine Tablets
4.Possible side effects
5.How to store Prochlorperazine Tablets
6. Contents of the pack and other information
1. WHAT PROCHLORPERAZINE TABLETS ARE AND WHAT THEY ARE USED FOR
Prochlorperazine Tablets contain a medicine called Prochlorperazine
maleate. This belongs to a group of medicines called ‘phenothiazine
antipsychotics’. It works by blocking the effects of a chemical in
the brain. Prochlorperazine Tablets can be used to:
• Treat balance problems or dizziness (vertigo). This includes
problems of the inner ear such as ‘Meniere’s Syndrome’or
‘labyrinthitis’
• Stop you feeling sick (nausea) or being sick (vomiting). This can
be from any cause including migraines
• Treat schizophrenia
• Treat over-active behaviour or thoughts (mania)
• Treat anxiety in the short-term, when used in addition to other
medicines
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCHLORPERAZINE TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
• You are allergic (hypersensitive) to prochlorperazine,
phenothiazine medicines such as chlorpromazine or any of the other
ingredients
of Prochlorperazine Tablets (listed in S

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prochlorperazine 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Prochlorperazine Maleate 5 mg
Excipient with known effect: Also contains lactose monohydrate 70.0 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off white, circular, uncoated tablets with ‘5’ debossed
on one side. 4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vertigo due to Meniere's Syndrome, labyrinthis and other causes, and
for nausea
and vomiting from whatever cause including that associated with
migraine. It may
also be used for schizophrenia (particularly in the chronic stage),
acute mania and
as an adjunct to the short-term management of anxiety.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS:
INDICATION
DOSAGE
Prevention of nausea and
vomiting
5 to 10 mg b.d. or t.d.s.
Treatment of nausea and
vomiting
20 mg stat, followed if necessary by 10
mg two hours later.
Vertigo and Meniere's
syndrome
5 mg t.d.s. increasing if necessary to a
total of 30 mg daily. After several weeks
dosage may be reduced gradually to 5-10
mg daily.
Adjunct in the short term
management of anxiety
15-20 mg daily in divided doses initially
but this may be increased if necessary to a
maximum of 40 mg daily in divided doses.
Schizophrenia and other
psychotic disorders
Usual effective daily oral dosage is in the
order of 75-100 mg daily. Patients vary
widely in response. The following
schedule is suggested: Initially 12.5 mg
twice daily for 7 days, the daily amount
being subsequently increased 12.5 mg at 4
to 7 days interval until a satisfactory
response is obtained. After some weeks at
the effective dosage, an attempt should be
made to reduce this dosage. Total daily
amounts as small as 50 mg or even 25 mg
have sometimes been found to be
effective.
PAEDIATRIC POPULATION:
E
L
D
E
R
L
Y
: A lower dose is recommended (see section 4.4).
METHOD OF ADMINISTRATION:
Oral administration
The tablets should be swallowed whole w