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PROCHLORPERAZINE MALEATE BP 5MG TABLETS

Active substance(s): PROCHLORPERAZINE MALEATE

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Stemetil® 5mg Tablets
Prochlorperazine maleate BP 5mg Tablets
(prochlorperazine maleate)
Your medicine is known by one of the above names, but will be referred to
as Stemetil Tablets throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Stemetil Tablets are and what they are used for
2) Before you take Stemetil Tablets
3) How to take Stemetil Tablets
4) Possible side effects
5) How to store Stemetil Tablets
6) Further 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 ‘phenothiazene 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) Before you take Stemetil Tablets
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to prochlorperazine maleate or any of
the other ingredients of Stemetil Tablets (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
Take special care with Stemetil Tablets
Check with your doctor or pharmacist before taking Stemetil Tablets
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 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 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 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 under-weight
You have a history of alcohol problems
You are elderly (65 years of age or older)
The person is a child. This is because children may develop unusual
face and body movements (dystonic reactions)
 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 taking Stemetil Tablets.
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 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
 Desferroxamine - 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 cannot 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 10kg
 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
Adults
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

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.

 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
Talk to your doctor or pharmacist if any of the side effects gets serious or
lasts longer than a few days, or if you notice any side effects not listed in
this leaflet.
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
By reporting side effects you can help provide more information on the
safety of this medicine.

5) How to store Stemetil Tablets
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 a 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)
 Rigid or stiff muscles, trembling or shaking, difficulty moving, or loss of
muscle power

Keep all medicines out of the sight and reach of children.
 Do use Stemetil Tablets after the expiry date printed on the carton, label
or blister strip. The expiry date refers to the last day of that month.
 Your tablets should be stored in the pack in which you were given them,
and away from light.
 If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
 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:
The active ingredient in Stemetil Tablets is prochlorperazine maleate.
Each Stemetil tablet contains 5mg of prochlorperazine maleate.
Stemetil Tablets also contain the following inactive ingredients: lactose,
maize starch, magnesium stearate, and colloidal silicone dioxide.
What Stemetil Tablets looks like and contents of the pack
Stemetil Tablets are off white, circular, biconvex tablets, marked,
‘STEMETIL’ around a centrally impressed number ‘5,’ on one face and
plain on the other face.
Stemetil Tablets are available in blister packs of 100 tablets.
PL 10383/1628

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Aventis Pharma, Dagenham, Essex,
RM10 7XS, UK. Procured from within the EU and repackaged by Product
Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue
Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 12.11.2013
Stemetil Tablets® is a registered trademark of Sanofi-aventis UK.

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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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