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PROCHLORPERAZINE MALEATE 5 MG TABLETS

Active substance(s): PROCHLORPERAZINE MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Stemetil 5 mg Tablets

Take special care with Stemetil Tablets
Check with your doctor or pharmacist
prochlorperazine maleate
before taking your medicine if:
 You are allergic to phenothiazine medicines
such as chlorpromazine
 You have heart problems or a family history
Is this leaflet hard to see or read?
of heart problems
Phone 0845 372 7101 for help
 You have ever had a stroke
 You have liver or kidney problems
Read all of this leaflet carefully before you
 You have thyroid problems
start taking this medicine
• Keep this leaflet. You may need to read it again  You have an enlarged prostate gland. This
• If you have any further questions, ask your
means you may have problems when
doctor or pharmacist
passing water (urine)
• This medicine has been prescribed for you. Do  You or someone else in your family has a
not pass it on to others. It may harm them,
history of blood clots, as medicines like
even if their symptoms are the same as yours
these have been associated with formation
• If any of the side effects gets serious, or if
of blood clots
you notice any side effects not listed in this
 You have Parkinson’s disease
leaflet, please tell your doctor or pharmacist  You have dementia
In this leaflet:
 You have epilepsy or have ever had fits
1. What Stemetil Tablets are and what they are
(seizures)
used for
 You have depression
2. Before you take Stemetil Tablets
 You have a tumour on your adrenal gland
3. How to take Stemetil Tablets
called ‘phaeochromocytoma’
4. Possible side effects
 You have a type of muscle weakness called
5. How to store Stemetil Tablets
‘myasthenia gravis’
6. Further information
 You have or have ever had glaucoma (signs
include painful eyes with blurred vision)
1. What Stemetil Tablets are and
 You have or have ever had a low number of
what they are used for
white blood cells (agranulocytosis). This
Stemetil Tablets contain a medicine called
would lead you to get infections more easily
prochlorperazine maleate. This belongs to a
than usual
group of medicines called ‘phenothiazine
 You have low blood levels of potassium,
antipsychotics’. It works by blocking the
calcium and magnesium. Your doctor may
effects of a chemical in the brain.
perform blood tests to check on these
Stemetil Tablets can be used to:
• Treat balance problems or dizziness (vertigo).  You are not eating properly or are very
under-weight
This includes problems of the inner ear such
 You have a history of alcohol problems
as ‘Meniere’s Syndrome’ or ‘labyrinthitis’
 You are elderly (65 years of age or older)
• Stop you feeling sick (nausea) or being sick
 The person is a child. This is because
(vomiting). This can be from any cause
children may develop unusual face and
including migraines
body movements (dystonic reactions)
• Treat schizophrenia
• Treat over-active behaviour or thoughts (mania)  You are diabetic or have high levels of sugar
in your blood (hyperglycaemia). Your doctor
• Treat anxiety in the short-term, when used in
addition to other medicines
may want to monitor you more closely.
If you are not sure if any of the above apply to
2. Before you take Stemetil Tablets
you, talk to your doctor or pharmacist before
taking Stemetil Tablets.
Do not take this medicine and tell your
doctor if:
 You are allergic (hypersensitive) to
Taking other medicines
prochlorperazine maleate or any of the
Please tell your doctor or pharmacist if you
other ingredients of Stemetil Tablets (listed
are taking or have recently taken any other
in Section 6 below)
medicines. This includes medicines you
Signs of an allergic reaction include: a rash, buy without a prescription, including
swallowing or breathing problems, swelling herbal medicines.
1
of your lips, face, throat or tongue
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This is because Stemetil Tablets can affect the way
some other medicines work. Also some medicines
can affect the way Stemetil Tablets 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
• 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)
• Medicines for indigestion and heartburn
(antacids)
• 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
Taking Stemetil Tablets with food and drink
Do not drink alcohol while you are taking
Stemetil Tablets. This is because alcohol can
add to the effects of Stemetil Tablets and can
cause serious breathing difficulties.
Pregnancy and breast-feeding
Do not take Stemetil Tablets 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
Tablets 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 any medicine if you are pregnant or
breast-feeding.

Driving and using machines
You may feel sleepy after taking this medicine.
If this happens, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Stemetil Tablets
• Lactose. This medicine contains lactose, a
type of sugar. If you have been told by your
doctor that you can not tolerate some sugars,
talk to your doctor before taking Stemetil
Tablets
3. How to take Stemetil Tablets
Always take Stemetil Tablets exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Do not give to children under 1 year of age
or who weigh less than 10 kg
• You should not let the tablets touch your
skin for very long, as you may get skin
redness, swelling and itching (contact skin
sensitisation)
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
How much to take
Adults:
Treatment of balance problems or
dizziness (Vertigo):
• The usual dose is 5 mg three times each day
• This may be increased to a total daily dose
of 30 mg each day
• After several weeks treatment, your doctor
may decide to gradually lower your daily
dose to 5 to 10 mg each day
Stopping you feeling sick or being sick:
• The usual dose is 5 or 10 mg
• This may be taken two or three times
each day
Treatment of feeling sick or being sick:
• To begin with you will usually take 20 mg
• This may be followed by 10 mg two hours
later
Treatment of schizophrenia and
overactive behaviour or thoughts (mania):
• The starting dose is usually 12.5 mg twice
each day for seven days
• Your doctor may increase your dose up to
a total daily dose of 75 to 100 mg each day
• After several weeks of treatment, your
doctor may then lower your dose to a total
daily dose of 25 to 50 mg each day
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How much to take (continued)
Adults:
Short-term treatment of anxiety:
• The starting dose will be 15 to 20 mg each
day in divided doses
• Your doctor may then increase your dose
to a total daily dose of 40 mg each day
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 (over 1 year of age and weighing
more than 10 kg):
Stopping your child feeling sick or being
sick:
• Your doctor will decide the dose according
your child’s weight
• A dose of 0.25 mg for each kilogram of
your child’s weight is usually given
• This dose may be given two or three times
a day
If you take more Stemetil Tablets than you
should
If you take more Stemetil Tablets than you
should, tell a doctor or go to a hospital casualty
department straight away. Take the medicine
pack with you. This is so the doctor knows
what you have taken. Taking too much
Stemetil Tablets may cause symptoms such as
feeling 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 forget to take Stemetil Tablets
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for
the next dose, skip the missed dose. Do not take
a double dose to make up for a forgotten dose.
If you stop taking Stemetil Tablets
Keep taking Stemetil Tablets until your doctor
tells you to stop. Do not stop taking Stemetil
Tablets just because you feel better. If you stop,
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 Tablets can cause your skin to be more
sensitive to sunlight. You should avoid exposure
to direct sunlight while taking this medicine.
Tests
Your doctor may do regular tests while you are
taking 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 Tablets can cause
side effects, although not everybody gets them.
Stop taking Stemetil Tablets and see a
doctor or go to a hospital 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
taking Stemetil Tablets for a long period of
time
• Problems with your eyesight after taking
Stemetil Tablets for a long period of time
• Feeling dizzy, lightheaded or faint when
you stand or sit up quickly (due to low
blood pressure)
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• 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
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.
United Kingdom
You can also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
You can also report side effects directly via
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Stemetil Tablets
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Stemetil Tablets after the expiry
date which is stated on the blister and carton,
after EXP. The expiry date refers to the last day
of that month.
Store protected 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 Tablets contains
• Each tablet contains 5 mg of the active
substance, prochlorperazine maleate.
• The other ingredients are lactose, maize
starch, aerosil (E551) and magnesium
stearate
What Stemetil Tablets look like and
contents of the pack
Stemetil Tablets are off-white to pale cream
coloured circular tablets. The tablets marked
“STEMETIL” and “5” on one side
Stemetil Tablets are available in blister packs
containing 28 or 84 tablets.
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
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62,
Alcorcón 28923 (Madrid) Spain
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 04/2015
© Sanofi, 1973 - 2015

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Artworks Department. Madrid. Spain
Product Description: Stemetil 5 mg
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22.05.2015
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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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