PROCHLORPERAZINE MALEATE 5MG TABLETS

Active substance: PROCHLORPERAZINE MALEATE

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C631 LEAFLET Stemetil 20131206

PACKAGE LEAFLET: INFORMATION FOR THE USER

STEMETIL 5mg TABLETS
PROCHLORPERAZINE MALEATE 5mg TABLETS
(prochlorperazine maleate)
Your medicine is known as the above names but will be referred to
as Stemetil Tablets throughout the following 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

 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

In this leaflet:



Medicines for fits (epilepsy) such as carbamazepine

1. What Stemetil Tablets are and what they are used for



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

5. How to store Stemetil Tablets



Medicines used for diabetes

6. Further information



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



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

2. Before you take Stemetil Tablets
3. How to take Stemetil Tablets
4. Possible side effects

1. WHAT IS 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

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

2. BEFORE YOU TAKE STEMETIL TABLETS



You are breast-feeding or planning to breast-feed

Do not take this medicine and tell your doctor if:

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.

 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

Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

Check with your doctor or pharmacist before taking your
medicine if:

Driving and using machines

 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 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


 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

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)

 You have or have ever had glaucoma (signs include painful
eyes with blurred vision)



If you feel the effect of your medicine is too weak or too strong,
do not change the dose yourself, but ask your doctor

 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

How much to take

 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 low blood levels of potassium, calcium and
magnesium. Your doctor may perform blood tests to check on
these

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

 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)

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

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

Treatment of schizophrenia and overactive behaviour or
thoughts (mania):





Feeling dizzy, lightheaded or faint when you stand or sit up
quickly (due to low blood pressure)

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

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)



After several weeks of treatment, your doctor may then
lower your dose to a total daily dose of 25 to 50 mg 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



Abnormal production of breast milk in men and women



Breast enlargement in men

The starting dose will be 15 to 20 mg each day in divided
doses



Loss of menstrual periods

Your doctor may then increase your dose to a total daily
dose of 40 mg each day



Difficulty in getting or maintaining an erection (impotence)



Difficulty sleeping (insomnia)

Short-term treatment of anxiety:



Tell your doctor or pharmacist if any of the following side
effects get serious or lasts longer than a few days



Feeling restless or agitated

Your doctor may prescribe a lower dose



Dry mouth

You should be careful during very hot or very cold weather
to make sure that you do not get too hot or too cold.



Your skin being more sensitive to the sun than usual



Stuffy nose

Children (over 1 year of age and weighing more than 10 kg):



Skin rashes

Stopping your child feeling sick or being sick:



Skin redness, swelling and itching from touching the medicine



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

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.



This dose may be given two or three times a day

Elderly:



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.

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.

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.

5. HOW TO STORE STEMETIL TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

If you stop taking Stemetil Tablets



Do not store above 25°C. Store in the original package.

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.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.

Exposure to sunlight



If the medicine becomes discoloured or shows 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 that are no longer required. These measures will help
to protect the environment.

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.

6. FURTHER INFORMATION
What Stemetil Tablets contain


Each tablet contains 5mg of the active ingredient,
prochlorperazine (as the maleate).

Like all medicines, Stemetil Tablets can cause side effects,
although not everybody gets them.



Stemetil 5mg Tablets also contain the following: lactose, maize
starch, magnesium stearate and anhydrous colloidal silica.

Stop taking Stemetil Tablets and see a doctor or go to a
hospital straight away if:

What Stemetil Tablets look like and contents of the pack

4. POSSIBLE SIDE EFFECTS







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



Stemetil tablets are round white tablet marked ‘STEMETIL 5’ on
one side.



Stemetil 5mg Tablets are available as blister packs of 100
tablets.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Famar Healthcare Services
Madrid, S.A.U., Alcorcón, Spain.
POM

PL No. 08747/0631

Leaflet revision date: 06 December 2013
Stemetil is a registered trade mark of May & Baker Ltd, UK.S739
C631 LEAFLET Stemetil 20131206

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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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