Prochlorperazine 5mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Prochlorperazine maleate

Disponible depuis:

DE Pharmaceuticals

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

Notice patient

Prochlorperazine Tablets
SAME SIZE ARTWORK
430 x 140 mm
Front
50 mm
430 mm
140 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 maleate or any
of the other ingredients of Prochlorperazine
Tablets (listed in Section 6) Signs of a

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prochlorperazine tablets BP 5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg Prochlorperazine Maleate PhEur.
Excipients with known effect: Each 5mg tablet contains 61.00mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white, uncoated tablets.
White to off-white, circular, flat bevelled-edge uncoated tablets
impressed “C”
on one face and the identifying letters “Z and P” on either side
of a central
division line on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prochlorperazine is a potent phenothiazine neuroleptic.
1.
It is indicated in vertigo due to Meniere's syndrome, labyrinthitis
and other
causes, and for nausea and vomiting from any cause including that
associated with migraine.
2.
It may also be used for schizophrenia (especially 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 – 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 – 7 days interval until a satisfactory response is
obtained.
After some weeks at the effective dosage, an
attempt should be made reduce this dosage.
T