Stemetil 12.5mg/1ml solution for injection ampoules

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:

12.5mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5000283652434

Patient Information leaflet

_I_
IF YOU MISS A DOSE OF STEMETIL INJECTION
Your doctor or nurse will have instructions on when to
give you this medicine. It is unlikely that you will not
be given the medicine as it has been prescribed.
However, if you do think you have missed a dose, tell
your doctor or nurse.
IF YOU STOP HAVING STEMETIL INJECTION
Keep having Stemetil Injection until your doctor tells
you to stop. If you stop having Stemetil Injection, your
illness may come back and you may have other effects
such as feeling or being sick or difficulty sleeping. Your
doctor will gradually stop your medicine to prevent
these effects happening.
EXPOSURE TO SUNLIGHT
Stemetil Injection can cause your skin to be more
sensitive to sunlight. You should avoid exposure to
direct sunlight while having this medicine.
TESTS
Your doctor may do regular tests while you are having
this medicine. These might include blood tests and an
ECG to check your heart is working properly.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Stemetil Injection can cause side
effects, although not everybody gets them.
TELL A DOCTOR OR NURSE STRAIGHT AWAY IF:
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
HOW MUCH STEMETIL INJECTION IS GIVEN
If you are not sure why you are being given Stemetil
Injection or have any questions about how much
Stemetil Injection is being given to you, speak to your
doctor or nurse. The usual doses are:
SCHIZOPHRENIA AND OVERACTIVE BEHAVIOUR OR
THOUGHTS (MANIA)
Adults:
12.5 - 25 mg two or three times a day.
You will be given injections until you are
able to take Stemetil Tablets or syrup
STOPPING YOU FEELING SICK OR BEING SICK:
Adults:
To begin with 12.5 mg by injection. This
may be followed by oral medication
6 hours later if necessary
Elderly:
Your doctor may prescribe a lower dose.
You should be careful during very hot or
very cold weather to make sure that yo

Summary of Product characteristics

OBJECT 1
STEMETIL INJECTION
Summary of Product Characteristics Updated 27-Jul-2016 | SANOFI
1. Name of the medicinal product
Stemetil 12.5mg/ml Injection
2. Qualitative and quantitative composition
Each 1 ml of Stemetil injection contains 12.5 mg prochlorperazine
mesilate.
Excipients:
Each 1 ml of Stemetil injection contains 1 mg of sodium sulphite, 0.75
mg of sodium metabisulphite and
6 mg of sodium chloride.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Colourless sterile solution.
4. Clinical particulars
4.1 Therapeutic indications
Stemetil is a potent phenothiazine neuroleptic.
Uses: The treatment of nausea and vomiting and in schizophrenia
(particularly the chronic stage) and
acute mania.
4.2 Posology and method of administration
ADULTS
For deep intramuscular injection.
INDICATION
DOSAGE
Treatment of nausea and vomiting
12.5 mg by deep i.m. injection followed by oral
medication 6 hours later if necessary.
Schizophrenia and other psychotic disorders
12.5 mg to 25 mg b.i.d. or t.d.s. by deep i.m.
injection until oral treatment becomes possible.
CHILDREN
Intramuscular Stemetil should not be given to children.
ELDERLY
A lower dose is recommended (see section 4.4).
4.3 Contraindications
Known hypersensitivity to prochlorperazine or to any of the other
ingredients. The use of Stemetil
injection is contraindicated in children as it has been associated
with dystonic reactions after the
cumulative dose of 0.5 mg/kg.
4.4 Special warnings and precautions for use
Stemetil should be avoided in patients with liver or renal
dysfunction, Parkinson's disease,
hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis,
prostate hypertrophy. It should
be avoided in patients known to be hypersensitive to phenothiazines or
with a history of narrow angle
glaucoma or agranulocytosis.
Close monitoring is required in patients with epilepsy or a history of
seizures, as phenothiazines may
lower the seizure threshold.
As agranulocytosis has been reported, regular monitoring of the
complete blood coun