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PROCHLORPERAZINE TABLETS 5MG

Active substance(s): PROCHLORPERAZINE MALEATE / PROCHLORPERAZINE MALEATE / 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
Genethics Europe Limited,
41 – 43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
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 04/2016

GE0009/O/PIL/GE1

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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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