Prochlorperazine 5mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Prochlorperazine maleate

Disponible depuis:

A A H Pharmaceuticals Ltd

Code ATC:

N05AB04

DCI (Dénomination commune internationale):

Prochlorperazine maleate

Dosage:

5mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04060000; GTIN: 5025903001805 5025903001799

Notice patient

PATIENT INFORMATION LEAFLET
PROCHLORPERAZINE TABLETS BP
5 MG & 25 MG
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL
THE PRESCRIBED COURSE OF PROCHLORPERAZINE
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR
MORE INFORMATION
_WHAT IS IN YOUR _
_ME_
_DIC_
_I_
_NE_
_?_
_ _
The name of this medicine is Prochlorperazine.
Each tablet contains either Prochlorperazine Maleate BP 5
mg
or Prochlorperazine Maleate BP 25 mg, together with:
Lactose, maize starch, pre-gelatinised maize starch, sodium
starch glycollate, sucrose and magnesium stearate.
Prochlorperazine Tablets BP 5 mg are round, white tablets,
available in containers of 28, 30, 56, 60, 84, 90, 100, 500
and 1,000. The tablets are also available in blister packs of
28 and 84 tablets.
Prochlorperazine Tablets BP 25 mg are round, white
tablets
with
a score-line on one side, available in packs of 100 and
500 tablets, and in blister packs of 28 and 84 tablets.
The Manufacturer is: Meridian Healthcare (UK) Ltd, 208-214
York Road, London SW11 3SD.
The Product Licence holder is: Chelonia Healthcare Ltd, 11
Boumpoulinas. Nicosia P.C 1060. Cyprus.
_HOW DOES _
_PROCHLORPERAZINE _
_WORK?_
_ _
Prochlorperazine
belongs
to
a
group
of
medicines,
the
pheno- thiazines that act on the Central Nervous System
(C.N.S.).
_WHY HAVE YOU BEEN _
_PRESCRIBED PRO_
_CH_
_L_
_O_
_R_
_P_
_E_
_RAZIN_
_E_
_?_
_ _
In adults Prochlorperazine is used for the prevention and
treatment of nausea and vomiting. The medicine is also used
for
the
treatment
of
vertigo
(dizziness)
and
Meniere's
syndrome (falling to one side).
Prochlorperazine
is
used
as
an
aid
in
the
short-term
management
of
anxiety
and
for
the
treatment
of
schizophrenia and other mental (psychotic) disorders.
In children, Prochlorperazine is used for the prevention and
treatment of nausea and vomiting.
If
you
are
not
sure
why
you
have
been
prescribed
Prochlorperazine, then please ask your doctor.
_CHECK BEFORE YOU TAKE THESE _
_TAB_
_

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prochlorperazine maleate 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains 5 mg of prochlorperazine maleate
It also contains 103 mg lactose monohydrate.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White to off white coloured, circular shaped biconvex tablets, with
monogram
P5 on one side and plain on the other 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 twice or three times a day.
Treatment of
nausea and
vomiting
20 mg immediately, followed if necessary by
10 mg two hours later.
Vertigo and
5 mg three times a day increasing if necessary
INDICATION
DOSAGE
Meniere's
syndrome
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 reduce this dosage.
Total daily amounts as small as 50 mg or
even 25 mg have sometimes been found to be
effective.
PAEDIATRIC POPULATION
INDICATION
DOSAGE
Prevention and
treatment of nausea
and vomiting
If it i