STEMETIL 12.5MG/ML INJECTION

Active substance: PROCHLORPERAZINE MESILATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Stemetil 12.5 mg/ml Injection
prochlorperazine mesilate

In this leaflet:
1. What Stemetil Injection is and what it is used for
2. Before you have Stemetil Injection
3. How Stemetil Injection is given
4. Possible side effects
5. How to store Stemetil Injection
6. Further information

1. What Stemetil Injection is and
what it is used for

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for help
Read all of this leaflet carefully before you start
having this medicine
• 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. 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 effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist

i

Stemetil Injection contains a medicine called
prochlorperazine mesilate. This belongs to a group of
medicines called ‘phenothiazine antipsychotics’. It
works by blocking the effects of a chemical in the brain.
Stemetil Injection can be used to:
• Stop you feeling sick (nausea) or being sick
(vomiting)
• Treat schizophrenia
• Treat overactive behaviour or thoughts (mania)

2. Before you have Stemetil Injection
Do not have this medicine and tell your
doctor if:
X You are allergic (hypersensitive) to prochlorperazine
mesilate or any of the other ingredients of Stemetil
Injection (listed in Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue

X The person is a child. This is because children may
develop unusual face and body movements
(dystonic reactions)
Take special care with Stemetil Injection
Check with your doctor or pharmacist
before having your medicine if:
▲ You are allergic to phenothiazine medicines such as
chlorpromazine
▲ You have heart problems or a family history of heart
problems
▲ You have ever had a stroke
▲ You have liver or kidney problems
▲ You have thyroid problems
▲ You have an enlarged prostate gland. This means
you may have problems when passing water (urine)
▲ You have Parkinson’s disease
▲ You have dementia
▲ You have epilepsy or have ever had fits (seizures)
▲ You have depression
▲ You have a tumour on your adrenal gland called
‘phaeochromocytoma’
▲ You have a type of muscle weakness called
‘myasthenia gravis’
▲ You have or have ever had glaucoma (signs include
painful eyes with blurred vision)
▲ You have or have ever had a low number of white
blood cells (agranulocytosis). This would lead you to
get infections more easily than usual
▲ You or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots

▲ You have low blood levels of potassium, calcium
and magnesium. Your doctor may perform blood
tests to check on these
▲ You are not eating properly or are very underweight
▲ You have a history of alcohol problems
▲ You are elderly (65 years of age or older)
▲ You are diabetic or have high levels of sugar in your
blood (hyperglycaemia). Your doctor may want to
monitor you more closely
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before having Stemetil
Injection.

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines. This is because Stemetil
Injection can affect the way some other medicines
work. Also some medicines can affect the way Stemetil
Injection works.
In particular, tell your doctor if you are taking any of
the following:
• Medicines to help you sleep (sedatives, barbiturates)
• Other medicines used to calm emotional and
mental conditions
• Medicines used for depression
• Medicines used for Parkinson’s disease such as
levodopa
• Medicines for fits (epilepsy) such as carbamazepine
• Medicines used to control your heartbeat such as
amiodarone, disopyramide, propanolol or quinidine

G. Tartini,
15 8 - M I L A N O
e-mail:
Tel.
CROMinFOTO s.n.c. Via 02.375787 • 2 2 0crominfoto@tiscali.it
-

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

89027710
(int. version 2)

TYPE OF MATERIAL: DESCRIPTION:

LEAFLET

STEMETIL 12.5 mg/1 ml

MIN. FONT SIZE: CODE:

8.5 pt.

89027710

VERSION: OLD CODE :

2 a

89026654

28 APR 2014

COUNTRY:

UK
DIMENSIONS mm:

420 x 125

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

LOGO VERSION:

//

COLOUR 2:

XXXXXXXXX

• Medicines for high blood pressure such as
doxazosin, terazosin, guanethidine or clonidine
• Medicines used for diabetes
• Medicines used for cancer (cytotoxics)
• Medicines used for infections (antibiotics)
• Anticholinergic medicines - includes some
medicines used for irritable bowel syndrome,
asthma or incontinence
• Amphetamines - used for Attention Deficit
Hyperactivity Disorder (ADHD)
• Adrenaline - used for life threatening allergic
reactions
• Desferrioxamine - used when you have too much
iron in your blood
• Lithium - used for some types of mental illness
Having Stemetil Injection with food and drink
Do not drink alcohol while you are having Stemetil
Injection. This is because alcohol can add to the effects
of Stemetil Injection and can cause serious breathing
difficulties.
Pregnancy and breast-feeding
Do not have Stemetil Injection if:
• You are pregnant, might become pregnant or think
you might be pregnant
• You are breast-feeding or planning to breast-feed
The following symptoms may occur in newborn babies,
of mothers that have used Stemetil Injection in the last
trimester (last three months of their pregnancy):
shaking, muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems, and difficulty in feeding.

If your baby develops any of these symptoms you may
need to contact your doctor.
Ask your doctor or pharmacist for advice before taking
or having any medicine if you are pregnant or
breast-feeding.

Driving and using machines
You may feel sleepy after having this medicine. If this
happens, do not drive or use any tools or machines.
Important information about some of the
ingredients of Stemetil Injection
• Sodium: This medicine contains 2.91mg of sodium
per injection. This should be taken into
consideration by people on a controlled sodium diet
• Sulphites: This medicine contains small amounts of
sulphites. These may cause severe allergic
(hypersensitivity) reactions and difficulty in
breathing (bronchospasm). This is more likely to
happen if you have a history of asthma or allergies.
The chances of this happening are rare. Stop having
the medicine if you get a rash, swallowing or
breathing problems or swelling of your lips, face,
throat or tongue

3. How Stemetil Injection is given
Stemetil Injection is normally given by a doctor or
nurse. This is because it needs to be given as a deep
injection into a muscle.

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 you
do not get too hot or too cold.
Children: Stemetil Injection is not given to
children
If you have more Stemetil Injection than you should
It is unlikely that your doctor or nurse will give you too
much medicine. Your doctor and nurse will monitor
your progress, and check the medicine you are given.
Always ask if you are not sure why you are getting a
dose of medicine.
Having too much Stemetil may make you feel sleepy or
dizzy, increased or rapid heartbeat, feeling very cold
and confused, writhing movements, feeling restless,
stiffness or shaking. You may lose consciousness.

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

• You have an unusually pale complexion, sweating,
high temperature, fast heartbeat, stiff muscles, fast
breathing and feel confused, drowsy or agitated.
These could be signs of a serious side effect called
‘neuroleptic malignant syndrome’
• You have frequent infections such as fever, sore
throat or mouth ulcers. These could be signs of a
blood problem called leucopenia
• You may get infections more easily than usual. This
could be because of a blood disorder
(agranulocytosis)
• You have yellowing of your skin or eyes (jaundice).
These could be signs of liver problems
• You have very fast, uneven or forceful heartbeats
(palpitations) and experience breathing problems
such as wheezing, shortness of breath, tightness in
the chest and chest pain
• You have blood clots in the veins especially in the
legs (symptoms include swelling, pain and redness
in the leg), which may travel through blood vessels
to the lungs causing chest pain and difficulty in
breathing. If you notice any of these symptoms seek
medical advice immediately
• You have rigid or stiff muscles, trembling or shaking,
unusual eye movements (including rolling of the
eyes), difficulty moving, or loss of muscle power
Tell your doctor as soon as possible if you have any
of the following side effects:
• Breathing problems
• Changes in your skin or eye colour after having
Stemetil Injection for a long period of time
• Problems with your eyesight after having Stemetil
Injection for a long period of time

• Feeling dizzy, lightheaded or faint when you stand
or sit up quickly (due to low blood pressure)
• You have fits (convulsions)
• Feeling tired,weak,confused and have muscles that
ache, are stiff or do not work well. This may be due
to low sodium levels in your blood (hyponatraemia)
• Feeling unwell, confused and/or weak, feeling sick
(nausea), loss of appetite, feeling irritable. This
could be something called a syndrome of
inappropriate anti-diuretic hormone secretion
(SIADH)
• Passing large amounts of urine, excessive thirst and
having a dry mouth or skin. You may be more likely
to get infections, such as thrush. This could be due
to too much sugar in your blood (hyperglycaemia)
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer
than a few days
• Abnormal production of breast milk in men and
women
• Breast enlargement in men
• Loss of menstrual periods
• Difficulty in getting or maintaining an erection
(impotence)
• Difficulty sleeping (insomnia)
• Feeling restless or agitated
• Dry mouth
• Your skin being more sensitive to the sun than usual
• Stuffy nose
• Skin rashes
• Skin redness, swelling and itching from touching the
medicine

G. Tartini,
15 8 - M I L A N O
e-mail:
Tel.
CROMinFOTO s.n.c. Via 02.375787 • 2 2 0crominfoto@tiscali.it
-

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

89027710
(int. version 2)

TYPE OF MATERIAL: DESCRIPTION:

LEAFLET

STEMETIL 12.5 mg/1 ml

MIN. FONT SIZE: CODE:

8.5 pt.

89027710

VERSION: OLD CODE :

2 a

89026654

28 APR 2014

COUNTRY:

UK
DIMENSIONS mm:

420 x 125

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

LOGO VERSION:

//

COLOUR 2:

XXXXXXXXX

As with other phenothiazine medicines, there have
been very rare reports of sudden death with Stemetil
Injection. These are possibly caused by heart problems.
In elderly people with dementia, a small increase in
the number of deaths has been reported for patients
taking antipsychotics compared with those not
receiving antipsychotics.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Stemetil Injection
This medicine will be kept by your doctor or
pharmacist in a safe place where children cannot see
or reach it.
Do not use Stemetil Injection after the expiry date
which is stated on the label and carton. The expiry
date refers to the last day of that month.
Keep the ampoules in the outer carton, in order to
protect from light.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6. Further information
What Stemetil Injection contains
• Each 1 ml of Stemetil Injection contains 12.5 mg of
the active substance, prochlorperazine mesilate.
• The other ingredients are sodium sulphite
anhydrous (E221), sodium metabisulphite powder
(E223), sodium chloride, ethanolamine and water
for injection
What Stemetil Injection looks like and contents of
the pack
Stemetil Injection is a colourless sterile solution.
Stemetil Injection is available in packs containing 10 x
1 ml ampoules or 10 x 2 ml ampoules. Not all pack
sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
SANOFI-AVENTIS S.P.A
Loc. Valcanello
03012 Anagni (FR)
ITALY
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in April 2014
89027710
© Sanofi, 1973 - 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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