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PROCHLORPERAZINE TABLETS 5MG

Active substance(s): PROCHLORPERAZINE MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PROCHLORPERAZINE
5 mg TABLETS
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 become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Prochlorperazine is for
2. Before you take Prochlorperazine
3. How to take Prochlorperazine
4. Possible side effects
5. How to store Prochlorperazine
6. Further information

1. WHAT PROCHLORPERAZINE IS FOR
Prochlorperazine belongs to a group of medicines
called phenothiazines. It can be used for:
 preventing and treating nausea, vomiting and
migraine
 vertigo (dizziness or spinning) due to a variety of
causes including diseases of the inner ear such as
Meniere’s syndrome or labyrinthitis
 short-term relief of severe anxiety
 mental health problems such as schizophrenia or
mania (unusual behaviour due to
over-excitement).
If you are not sure why you have been prescribed
these tablets then please ask your doctor.

2. BEFORE YOU TAKE PROCHLORPERAZINE
Do not take Prochlorperazine if you:
 are allergic to prochlorperazine, any of the other
ingredients in the tablets (listed in section 6 of this
leaflet) or to other phenothiazines
 suffer from depression of the central nervous
system, which may cause problems with your
vision, coordination, breathing or heart rate
 suffer from high blood pressure due to a tumour
near the kidneys (phaeochromocytoma).
Do not give Prochlorperazine to patients in a coma
(a state of unconsciousness).

Take special care with Prochlorperazine
Tell your doctor before you take this medicine if you:
 have any problems with your heart, liver or kidneys
 have severe breathing problems
 have or have had yellowing of the skin or whites of
the eyes (jaundice)
 suffer from epilepsy, Parkinson’s disease,
depression, an eating disorder or alcohol and drug
abuse
 have an underactive thyroid gland, an enlarged
prostate gland, muscle weakness (myasthenia
gravis), increased eyeball pressure (glaucoma) or
sensitivity to sunlight
 are elderly and suffer from a fall in blood pressure
on standing up, which causes dizziness or fainting
or if you suffer from a rise or fall in body
temperature in very hot or very cold weather
 have a blood disorder including a low white blood
cell count. Regular blood tests may be needed
if you have unexplained infections or fever
 have low blood levels of calcium, magnesium or

potassium
 or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots

Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken, any other medicines, even medicines
bought without a prescription.
In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may
affect how Prochlorperazine tablets work:
 medicines to treat depression or mental health
problems such as lithium or pimozide
 medicines to treat anxiety, difficulty sleeping or
daytime sleepiness
 amphetamine or atomoxetine to treat Attention
Deficit Hyperactive Disorder (ADHD)
 memantine to treat Alzheimer’s disease
 medicines to treat Parkinson’s disease such as
amantadine or levodopa
 medicines for epilepsy such as carbamazepine,
ethosuximide or phenytoin
 tetrabenazine to treat movement disorders
 metoclopramide for nausea and vomiting
 medicines to relieve pain such as tramadol or
general anaesthetics
 medicines to treat high blood pressure such as
clonidine, guanethidine or minoxidil
 medicines to treat irregular heartbeat such as
amiodarone, disopyramide or sotalol
 medicines to treat diabetes
 medicines to increase urine production
 medicines to treat cancer
 antibiotics like moxifloxacin to treat bacterial
infections or ritonavir to treat viral infections
 artemether and lumefantrine to treat malaria or
pentamidine isetionate to treat lung infections
 desferrioxamine to treat iron poisoning
 antihistamines to treat hayfever or other allergies
 adrenaline to treat allergic reactions or cardiac
arrest
 medicines to treat bladder or gut problems
 cimetidine to treat stomach ulcers
 antacids to treat indigestion or heartburn
 kaolin to treat diarrhoea
 sibutramine for weight loss
AVOID ALCOHOL when taking this medicine.
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking
Prochlorperazine.

Pregnancy and breast-feeding
Do not take Prochlorperazine tablets if you are
pregnant, planning a pregnancy or breast-feeding,
unless your doctor has advised you to take them.
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.
Driving and using machines
Prochlorperazine tablets can make you feel drowsy or
less alert. If affected do not drive or operate
machinery.
AVOID ALCOHOL as it can increase these effects.
Important information about some of the
ingredients of Prochlorperazine
If you know you have an intolerance to lactose or
other sugars contact your doctor before taking this
medicine.

3. HOW TO TAKE PROCHLORPERAZINE
Always take Prochlorperazine tablets exactly as
your doctor has told you.

Take this medicine by mouth.

Dosage
Your doctor will decide your dose and length of
treatment, as it depends on your condition.
DO NOT STOP taking the tablets until your doctor tells
you to.

Adults:
Prevention of nausea and vomiting: Typical dose is
5-10 mg two or three times a day.
Treatment of nausea and vomiting: Typical dose is
20 mg to start with, followed if necessary by 10 mg two
hours later.
Vertigo and Meniere’s syndrome: Typical dose is 5
mg three times a day, increased if necessary to a
maximum of 30 mg daily. After several weeks the
dosage may be reduced gradually to 5-10 mg a day.
Short-term relief of severe anxiety: Typical dose is
15-20 mg a day in divided doses, increased if
necessary to a maximum of 40 mg in divided doses.
Mental health problems: Typical dose starts with
12.5 mg twice a day for seven days, followed by
gradual increases of 12.5 mg a day at four to seven
day intervals, to a maximum of 75-100 mg a day. After
several weeks the dosage may be reduced gradually
to 25-50 mg a day.

Elderly:
Require smaller doses. Follow your doctor’s advice.
Children over 10 kg:
Prevention and treatment of nausea and vomiting:
Your child will be given a dose depending on their
bodyweight. Typical dose is 0.25 mg/kg two to three
times a day.
Do not give to children weighing less than 10 kg.
If you take more Prochlorperazine than you
should
Contact your doctor or pharmacist immediately. Show
them the package.
If you forget to take Prochlorperazine
Don’t worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for
the one you have missed.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Prochlorperazine can cause side
effects, although not everybody gets them.

STOP TAKING this medicine and see a doctor
straight away if you have:
 a condition called Neuroleptic Malignant
Syndrome, which causes fever, sweating, pale
skin, muscle stiffness, difficulty passing urine, fast
heart beat or changes in alertness or blood
pressure
 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.
Common side effects (these may depend on the
dose, length of treatment or response to the
medicine):
 restlessness, shaking (tremor) or jerky movements
 uncontrollable, repetitive movements of the tongue,
face, jaw, arms, legs or entire body
 a fall in blood pressure on standing up, which
causes dizziness or fainting
 a rise or fall in body temperature in very hot or very
cold weather.

Rare side effects:
 blood disorders causing unexplained bleeding,
bruising, sore throat, general illness or fever.
Very rare side effects:
 high blood pressure, fast or irregular heart beat
 jaundice
 eye problems including glaucoma
 skin sensitivity when the drug is placed in contact
with the skin, rashes, sensitivity to sunlight or a
purple tint to the skin and eyes.
Other side effects:
 drowsiness, dizziness, headache or confusion
 agitation, excitement, lack of interest or emotion
 fits
 difficulty sleeping (insomnia)
 blocked nose
 dry mouth
 blurred vision
 constipation or difficulty passing urine
 stomach or gut problems
 breathing problems
 weight gain
 loss of periods in women, breast milk production,
development of breasts in men or problems
maintaining an erection
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.
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE PROCHLORPERAZINE
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original
package or container and keep the container tightly
closed.
Do not use these tablets after the expiry date, which is
stated on the package or container. The expiry date
refers to the last day of that month.
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 Prochlorperazine contains
The active ingredient in Prochlorperazine 5 mg tablets
is prochlorperazine maleate. The other ingredients are
lactose, maize starch, pregelatinised maize starch,
sodium starch glycollate, sucrose and magnesium
stearate.
What Prochlorperazine looks like and contents
of the pack
Prochlorperazine 5 mg tablets are round white tablets
with the marking MP13 on one side.
The tablets come in blister packs of 28 and 84 tablets
and containers of 28, 30, 56, 60, 84, 90, 100, 500 and
1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
Haupt Pharma Berlin GmbH,
Gradestraße 13, Moosrosenstraße 5 and Britzer
Damm 120, 12347 Berlin, Germany
For more information about this product, please
contact the Marketing Authorisation Holder.

This leaflet was last revised in 04/2012

M0013/O/PIL/G1

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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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