Stemetil 5mg/5ml syrup

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Prochlorperazine mesilate

Available from:

Sanofi

ATC code:

N05AB04

INN (International Name):

Prochlorperazine mesilate

Dosage:

1mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5000283652069

Patient Information leaflet

301953 - 953
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
STEMETIL 5 MG / 5 ML SYRUP
prochlorperazine mesilate
Is this leafl et hard to see or read?
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READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE
• Keep this leafl et. 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. Do not
pass it on to others. It may harm them, even if
their symptoms are the same as yours
• If any of the side eff ects gets serious, or if you
notice any side eff ects not listed in this leafl et,
please tell your doctor or pharmacist
IN THIS LEAFL ET:
1. What Stemetil Syrup is and what it is used for
2. Before you take Stemetil Syrup
3. How to take Stemetil Syrup
4. Possible side eff ects
5. How to store Stemetil Syrup
6. Further information
1. WHAT STEMETIL SYRUP IS AND WHAT IT IS
USED FOR
Stemetil Syrup contains a medicine called
prochlorperazine mesilate. This belongs to a group
of medicines called ‘phenothiazine antipsychotics’.
It works by blocking the eff ects of a chemical in the
brain.
Stemetil Syrup 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. BEFORE YOU TAKE STEMETIL SYRUP
DO NOT TAKE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
✕ You are allergic (hypersensitive) to
prochlorperazine mesilate or any of the other
ingredients of Stemetil Syrup (listed in Section
6). Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
TAKE SPECIAL CARE WITH STEMETIL SYRUP
CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE
TAKING YOUR MEDICINE IF:
▲You are al

Summary of Product characteristics

OBJECT 1
STEMETIL SYRUP
Summary of Product Characteristics Updated 26-Aug-2014 | SANOFI
1. Name of the medicinal product
Stemetil 5mg/5ml Syrup
2. Qualitative and quantitative composition
The active component of the Stemetil syrup is prochlorperazine
mesilate 5 mg per 5 ml.
Also contains 3.4mg of sucrose, 5.0mg of sodium sulphite anhydrous
(E221) and 5.0mg of sodium
metabisulphite (E222).
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Syrup
A dark straw coloured syrup.
4. Clinical particulars
4.1 Therapeutic indications
Vertigo due to Meniere's Syndrome, labyrinthitis and other causes.
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
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 by 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.
CHILDREN
INDICATION
DOSAGE
Prevention and treatment of nausea and
vomiting
If it is considered unavoidable to us