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PROCHLORPERAZINE MALEATE TABLETS BP 25MG

Active substance(s): PROCHLORPERAZINE MALEATE

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PATIENT INFORMATION LEAFLET

Prochlorperazine Tablets BP
5 mg & 25 mg
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL
THE PRESCRIBED COURSE OF PROCHLORPERAZINE
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR
MORE INFORMATION
What is in your medicine?
The name of this medicine is Prochlorperazine.
Each tablet contains either Prochlorperazine Maleate BP 5
mg or Prochlorperazine Maleate BP 25 mg, together with:
Lactose, maize starch, pre-gelatinised maize starch, sodium
starch glycollate, sucrose and magnesium stearate.
Prochlorperazine Tablets BP 5 mg are round, white tablets,
available in containers of 28, 30, 56, 60, 84, 90, 100, 500
and 1,000. The tablets are also available in blister packs of
28 and 84 tablets.
Prochlorperazine Tablets BP 25 mg are round, white tablets
with a score-line on one side, available in packs of 100 and
500 tablets, and in blister packs of 28 and 84 tablets.
The Manufacturer is: Meridian Healthcare (UK) Ltd, 208-214
York Road, London SW11 3SD.
The Product Licence holder is: Chelonia Healthcare Ltd, 11
Boumpoulinas. Nicosia P.C 1060. Cyprus.
How does Prochlorperazine work?
Prochlorperazine belongs to a group of medicines, the
pheno- thiazines that act on the Central Nervous System
(C.N.S.).
Why have you been prescribed Prochlorperazine?
In adults Prochlorperazine is used for the prevention and
treatment of nausea and vomiting. The medicine is also used
for the treatment of vertigo (dizziness) and Meniere's
syndrome (falling to one side).
Prochlorperazine is used as an aid in the short-term
management of anxiety and for the treatment of
schizophrenia and other mental (psychotic) disorders.
In children, Prochlorperazine is used for the prevention and
treatment of nausea and vomiting.
If you are not sure why you have been prescribed
Prochlorperazine, then please ask your doctor.
Check before you take these tablets
Before taking this medicine, tell your doctor if you have ever
had any unusual or allergic reactions to Prochlorperazine, or
any of the other ingredients, or other phenothiazine
medicines. Also tell your doctor or pharmacist if you are
allergic to any other substances such as foods, preservatives
or dyes.
The presence of other medical problems may affect the use
of this medicine. Make sure, therefore, to tell your doctor if

you have any other medical problems, especially:
• Parkinson's disease
• Any liver or kidney problems for which you have or are
receiving treatment.
• Epilepsy
• Reduced function of your thyroid gland.
• Myasthenia gravis (muscle weakness particularly after
exercise).
• Enlargement of the prostate gland.
• Phaeochromocytoma (a tumor of the medulla of the
adrenal gland, leading to elevated blood pressure).
• Glaucoma (raised eyeball pressure).
• You or someone else in your family has a history of blood
clots, as medicines like Prochloperazine have been
associated with formation of blood clots.
Use in pregnancy and breast-feeding
It is important that you tell your doctor if you are pregnant,
likely to become pregnant, or are breast-feeding.
Do not use this medicine during pregnancy, unless your
doctor considers it essential.
The following symptoms may occur in newborn babies, of
mothers that have used prochlorperazine 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.
Because this medicine may pass into the breast milk, its use
should be avoided during breast feeding.
Can you drive while taking Prochlorperazine?
Make sure you know how you react to this medicine before
you drive, use machines, or do anything else that could be
dangerous if you are dizzy or are not alert. Please remember
that alcohol may intensify these effects and should be
avoided during treatment.
Can you take Prochlorperazine with other
medicines?
You can take these tablets with other medicines, but there
are some medicines which can interfere with
Prochlorperazine tablets. It is very important to tell you
doctor or pharmacist about all the medicines which you
are taking, whether prescribed by your doctor or bought
without a prescription from the pharmacy or elsewhere.
This includes medicines such as amphetamines, adrenaline,
clonidine (used to treat migraine and high blood pressure),
antacids (used to reduce stomach acid), lithium and
treatments for raised blood pressure, diabetes (raised blood
sugar) and Parkinson’s disease.
This medicine will add to the effects of alcohol, and other
medicines that tend to cause drowsiness such as antihistamines (medicines for hay-fever and other allergies),
sedatives such as barbiturates (used to treat depression),
tranquillisers (for anxiety), medicines to help you sleep and
pain relieving medicines.
When and how to take Prochlorperazine
Take this medicine by mouth and only in the doses

prescribed by your doctor. Do not take more of it, and do not
take it more often or for a longer time than your doctor has
ordered.
Your doctor will prescribe the lowest dose necessary to
control your symptoms.
Usual dosages stated below:
Adults:
Prevention of nausea and vomiting: 5-10 mg two or three
times a day. Treatment of nausea and vomiting: 20 mg
followed if necessary by 10 mg two hours later.
Vertigo and Meniere's syndrome: 5 mg three times daily,
increased if necessary to 30 mg daily. Dosage may be
reduced gradually to 5-10 mg daily.
Aid in the short-term management of anxiety: Initially 15-20
mg daily in divided doses. This may be increased if
necessary to a maximum of 40 mg daily in divided doses.
Schizophrenia and other psychotic (mental) disorders: The
usual dose is 12.5 mg twice daily for 7 days. The dose is
then increased by 12.5 mg at 4-7 day intervals until it has a
satisfactory effect. After you have been on an effective dose
for some weeks, your doctor may advise you to try to reduce
the dosage.
Children:
For the prevention and treatment of nausea and vomiting; the
dosage will depend on the child's bodyweight and will be
calculated on the basis of 25 micrograms per kilo bodyweight
two or three times a day. Prochlorperazine is not
recommended for children weighing less than 10 kilograms.
Elderly:
Elderly patients with mental disorders should be started on a
lower dose of Prochlorperazine. It should be used with
caution during very hot or very cold weather to reduce the
risk of an extreme rise or fall in body temperature.
What to do if too many tablets are taken at the same
time
If you think you may have taken an overdose of this
medicine, obtain emergency help at once at your nearest
hospital casualty department or doctor. Tell the doctor in
charge, or the nurse or pharmacist, that you are taking this
medicine, and take any remaining tablets in their original
container with you so that they may be identified.
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to
your regular dosage schedule. Do not take two doses at
once.
If you feel that this medicine is not working as well after you
have taken it for a short time (1 week) do not increase the
dose, instead check with your doctor.
What side effects can Prochlorperazine cause?
Along with its needed effects the medicine may cause some
unwanted effects:
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.
Nasal stuffiness, dry mouth, insomnia, agitation, dizziness
when standing from a lying or sitting position, changes in
heart rate, slowing of breathing in certain individuals.
Abnormal movement, tremors and muscle stiffness, and,
usually in young patients, an inability to control certain
muscles of the body such as tongue, mouth, arms and legs.
You may experience extreme restlessness or agitation.
These symptoms usually disappear after treatment with
prochlorperazine is discontinued.
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 breathing.
A combination of high-temperature, pale complexion, muscle
stiffness and changes in levels of alertness are symptoms of
a serious condition called ‘neuroleptic malignant syndrome’.
If these symptoms develop, you should inform your doctor
immediately.
After weeks or months of treatment it is possible that
uncontrolled shaking of the hands or limbs and muscle
stiffness may occur.
Disorders of the blood may occur during prolonged treatment
or with high doses. If you develop a fever or experience an
unusually bad sore throat or bruising, this could be a
symptom of a blood disorder and you should tell your doctor
immediately.
Jaundice (yellowing of the skin and whites of the eyes) may
occur, sometimes preceded a sudden onset of fever, 1-3
weeks after the start of treatment. If you develop jaundice,
stop the treatment and inform your doctor immediately.
In sunny weather the skin may become sensitive to sunlight,
therefore direct exposure to sunlight should be avoided.
Although never reported with prochlorperazine, it is possible
that visual changes and a greyish discoloration of exposed
skin may develop, but only after continuous long term use.
Swollen breasts can occasionally occur in men, but only after
long term use. Impotence can also sometimes occur.
Unusual breast milk production and absence of menstrual
periods can sometimes occur in women.
Do not crush the tablets or handle them more than you need
to because you may develop a skin reaction.
If you experience any of the above reactions or side effects,
or notice anything unusual which you are worried about,
consult your doctor.
Storing your medicine
You must keep the medicine in a safe place where children
cannot get it. Your medicine could harm them.
Keep your medicine in a dry place and store below 25ºC.
Keep the tablets in the container in which they were given to
you. Protect from light.
If your doctor tells you to stop the treatment, return any
remaining tablets to the pharmacist. Only keep the medicine
if the doctor tells you to.
On the label you will find the words "Expiry Date" followed by
numbers indicating the day, month and year. This is the date
when the medicine is no longer fit for use. Do not use the
medicine after this date, but return it to your doctor or

pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as
yours.
This leaflet does not contain the complete information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist who have
access to additional information.
Product Licence no’s:
5 mg - PL 33414/0083
25 mg - PL 33414/0084
This leaflet was revised in November 2011

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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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