PROCHLORPERAZINE 5MG TABLETS

Active substance: PROCHLORPERAZINE MALEATE

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Package Leaflet: Information for the User
Prochlorperazine 5mg tablets
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
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 only. Do not pass it on to others. It may harm
them even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Prochlorperazine tablets are and what they are used for
What you need to know before you take Prochlorperazine tablets
How to take Prochlorperazine tablets
Possible side effects
How to store Prochlorperazine Tablets
Contents of the pack and other information

1. What Prochlorperazine tablets are and what they are used for
Prochlorperazine tablets belong to a group of drugs known as phenothiazines, which act on the
central nervous system. In adults they are used in the treatment of vertigo (dizziness) and
Meniere's syndrome (falling to one side), the short term treatment of anxiety and to treat
schizophrenia and other mental (psychotic) disorders. The tablets may also be used for the
prevention and treatment of nausea and vomiting in adults and children.
2. What you need to know before you take Prochlorperazine tablets
Do not take Prochlorperazine tablets if you:
• are allergic to prochlorperazine, other
phenothiazines or to any other
ingredients in the tablets (listed in section
6). Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue.



have depression of the central nervous
system or coma

Warnings and precautions
Talk to your doctor or pharmacist before taking Prochlorperazine tablets if:














You have heart problems such as heart
failure or prolonged QT (ECG change
which increases the risk of potentially
serious cardiac arrhythmias) or have a
family history of heart problems
You have ever had a stroke
You have liver or kidney problems,
history of jaundice
You have epilepsy or have ever had fits
(seizures)
You have or someone in the family has a
history of blood clots, as medicines like
these have been associated with the
formation of blood clots
You have Parkinson’s disease
You have thyroid problems such as
hypothyroidism (reduced activity of the
thyroid gland)
You have dementia
You have depression
You have myasthenia gravis (condition
causing weak muscles)
You have or ever had glaucoma (raised
eyeball pressure)

• 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 a tumour on your adrenal gland
called ‘phaeochromocytoma’
• You have an enlarged prostate gland.
This means you may have problems when
passing water (urine)
• 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 blood sugar
(hyperglycaemia). Your doctor may want
to monitor you more closely

Other medicines and Prochlorperazine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines including medicines obtained without a prescription (as they may alter the effects of
this medicine) especially:









Medicines to help you sleep (sedatives
such as barbiturates - sedative effect is
intensified)
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 if you have too
much iron in your blood
Lithium – used for some type of mental
illness
Ritonavir (for HIV)

Taking Prochlorperazine Tablets with food and drink
Do not drink alcohol while you are taking Prochlorperazine Tablets. This is because alcohol can
add to the effects for Prochlorperazine Tablets and can cause serious breathing difficulties.
Pregnancy and breast-feeding
Do not take Prochlorperazine 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
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.
Ask your doctor or pharmacist for advice before taking any medicines if you are pregnant or
breast-feeding.
Driving and using machines
This medicine may cause some people to become drowsy or less alert than usual. If you are
affected, do not drive or operate dangerous machinery.
Prochlorperazine Tablets contain lactose
If a doctor has told you that you have an intolerance to some sugars, check with your doctor
before taking these tablets, as they contain a type of sugar called lactose.
3. How to take Prochlorperazine tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
You will be prescribed the lowest dose needed to control your symptoms. Do not stop taking
your medicine or change the dose unless your doctor tells you to.
The tablets should be swallowed with a glass of water.
Do not crush the tablets or handle them more than you need to because you may develop a
skin reaction.
Dose for nausea and vomiting
Adults : Prevention of nausea and vomiting:
5 - 10mg two or three times a day.
Treatment of nausea and vomiting: 20mg
followed if necessary by 10mg two hours later.

Dose for anxiety
Adults: Initially 15 - 20mg daily in divided
doses. This may be increased if necessary to a
maximum of 40mg daily in divided doses.

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

of nausea and vomiting:
The dose will depend on the child's bodyweight
and will be calculated on the basis of 250
micrograms per kilogram bodyweight two or
three times a day.
Prochlorperazine is not recommended for
children weighing less than 10 kilograms or
children less than 1 year of age.
Dose for vertigo and Meniere's syndrome:
Adults: 5mg three times daily, increased if
needed to 30mg daily. Dosage may be reduced
gradually to 5 - 10mg daily.

Dose for schizophrenia and other
psychotic (mental) disorders:
Adults: The usual dose is 12.5mg twice daily
for 7 days. The dose is then increased by
12.5mg 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.

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.

If you take more Prochlorperazine Tablets than you should
If you accidentally take more tablets or somebody else takes any tablets, contact a doctor or go to
your nearest hospital casualty department at once. Take any remaining tablets with you and the
container or packaging, so they can be identified. Taking too many Prochlorperazine 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 Prochorperazine Tablets
If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Prochlorperazine Tablets
Keep taking Prochlorperazine Tablets until your doctor tells you to stop. Do not stop taking
Prochlorperazine 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
Prochlorperazine 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Prochlorperazine Tablets can cause side effects although not everybody gets
them.
Stop taking the tablets and see a doctor at once or go to a hospital straight away if you
develop any of the following 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 a combination of high-temperature, pale complexion, muscle stiffness and feel
confused, drowsy or agitated. These are signs of a serious condition called ‘neuroleptic
malignant syndrome’.
• You have frequent infections such as fever or an unusually bad sore throat, mouth ulcers or
bruising. These could be symptoms of a blood disorder called leucopenia.
• You may get infections more easily than usual. This could be because of a blood disorder
(agranulocytosis).
• You have yellowing of the skin and whites of the eyes (jaundice) sometimes preceded by a
sudden onset of fever, 1-3 weeks after start of treatment. 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 or if you
have any other unusual or worrying effects.
- Breathing problems
- Feeling dizzy, lightheaded or faint when
you stand or sit up quickly (due to low
- Changes in your skin or eye colour after taking
blood pressure)
Prochlorperazine Tablets continuously for
- Passing large amounts of urine, excessive
long periods of time (4 – 8 years)
thirst and having a dry mouth or skin. You
- Problems with your eyesight after taking
may be more likely to get infections, such
Prochlorperazine Tablets for a long period of
as thrush. This could be due to too much
time
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
- Dry mouth
and women
- Your skin being more sensitive to the sun
- Breast enlargement in men
than usual
- Loss of menstrual periods
- Stuffy nose
- Difficulty in getting or maintaining an erection - Skin rashes
(impotence)
- Skin redness, swelling and itching from
touching this medicine.
- Difficulty sleeping (insomnia)
- Feeling restless or agitated
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: http://yellowcard.mhra.gov.uk/
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Prochlorperazine Tablets
Do not store above 25°C. Store in a dry place. Keep the container tightly closed. Keep out of the
sight and reach of children.
Do not use this medicine after the expiry date which is printed on the packaging. The expiry
date refers to the last day of that month. If your doctor tells you to stop the treatment, return any
unused tablets to your pharmacist for safe disposal. Do not throw away any medicines via
wastewater or household waste. Ask your pharmacist how to throw away any medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Prochlorperazine Tablets contain
• The active ingredient (which makes these tablets work) is prochlorperazine maleate BP. Each
tablet contains 5mg prochlorperazine maleate BP.
• The tablets also contain lactose, maize starch, pre-gelatinised maize starch, sodium starch
glycollate, sucrose and magnesium stearate.
What Prochlorperazine Tablets look like and contents of the pack
The tablets are uncoated almost white or pale buff coloured, with flat bevelled edges and are
available in containers of 28, 30, 56, 60, 84, 90, 100, 500, 1000 tablets and in blister packs of 28
and 84 tablets.
Marketing authorisation holder and manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD.
Leaflet revision date May 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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