Stemetil 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prochlorperazine maleate

Available from:

Sanofi

ATC code:

N05AB04

INN (International Name):

Prochlorperazine maleate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5000283652816 5000283654131

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
STEMETIL 5MG TABLETS
prochlorperazine maleate
Is this leaflet hard to see or read?
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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 Stemetil Tablets are and what they are
used for
2. What you need to know before you take
Stemetil Tablets
3. How to take Stemetil Tablets
4. Possible side effects
5. How to store Stemetil Tablets
6. Contents of the pack and other information
1. WHAT STEMETIL TABLETS ARE AND
WHAT THEY ARE USED FOR
Stemetil 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.
Stemetil 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
STEMETIL TABLETS
DO NOT TAKE STEMETIL TABLETS IF:
 You are allergic (hypersensitive) to prochlor-
perazine, phenothiazine medicines such as
chlorpromazine or any of the other ingredients
o
f Stemetil Tablets (listed in section 6).
Signs of an allergic reaction include: a rash,
swallowing or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Stemetil 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active component of the Stemetil tablets is prochlorperazine
maleate BP 5 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Off-white to pale cream coloured circular tablets for oral use. The
tablets are marked on one
face ‘STEMETIL’ around a centrally impressed ‘5’, reverse face
plain.
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 – 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.
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 _