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PROCHLORPERAZINE TABLETS BP 5MG

Active substance(s): PROCHLORPERAZINE MALEATE

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Prochlorperazine 5mg 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.
Index
What Prochlorperazine tablets are and
1 
what they are used for
Before you take
2 
How to take
3 
Possible side effects
4 
5 
How to store
Further information
6 

1 What Prochlorperazine tablets are and what they
are used for

Prochlorperazine tablets belong to a group of medicines called
phenothiazine tranquillisers. They may be used to treat:
• dizziness due to ear diseases (such as Meniere’s syndrome or
labyrinthitis), or due to other causes
• nausea and vomiting including during a migraine
• mental illnesses (such as schizophrenia and mania)
• anxiety in the short term

2 Before you take

Do not take Prochlorperazine tablets and tell your doctor
if you have:

• are not eating properly
• have low blood concentrations of potassium (hypokalaemia),
calcium (hypocalcaemia) or magnesium (hypomagnesaemia)
• or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood
clots
• suffer with dementia
• have ever had a stroke.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. Especially:
• strong painkillers (eg morphine, codeine phosphate)
• antacids or kaolin preparations
• medicines to treat depression such as lithium or tricyclics (eg
amitriptyline, dosulepin, imipramine)
• terfenadine (to treat allergies)
• medicines to treat diabetes (eg chlorpropamide, gliclazide)
• medicines to treat high blood pressure (eg clonidine, doxazosin,
guanethidine, nifedipine, verapamil),
• medicines to treat Parkinson’s disease and some mental illnesses
such as bromocriptine, cabergoline, levodopa, pramipexole,
ropinirole, apomorphine, lisuride, pergolide
• anticholinergics (eg atropine sulfate, oxybutynin)
• medicines used to treat anxiety and difficulty sleeping (eg
diazepam, chlordiazepoxide)
• sotalol (to prevent and treat some heart conditions)
• desferrioxamine (to treat iron poisoning)
• sibutramine (used for weight loss)
• adrenaline (epinephrine)
• amphetamine
• antipsychotics (e.g. chlorpromazine, trifluoperazine)
• medicines to treat epilepsy (e.g. phenobarbital)
• medicines to treat irregular heart beat (e.g. amiodarone,
flecainide)
• if you are about to undergo surgery or dentistry where an
anaesthetic will be used
• ritonavir (for HIV infection)
• cimetidine (to treat stomach ulcers)

• an allergy (hypersensitivity) to prochlorperazine meleate,
phenothiazines or any of the other ingredients (see section 6)
• high blood pressure due to a tumour near the kidney
(phaeochromocytoma)

Alcohol

Check with your doctor or pharmacist before taking
Prochlorperazine tablets if you:

Pregnancy and breast-feeding

• liver or kidney problems or have ever had jaundice (yellowing
or the skin or whites of the eyes)
• epilepsy
• muscle weakness (myasthenia gravis)
• an underactive thyroid gland
• Parkinson’s disease
• increased pressure in the eye (glaucoma)
• an enlarged prostate gland
• are elderly. Prochlorperazine tablets 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
• have had any heart disease
• have ever abused alcohol
Continued top of next column
AAAG9479 50776894

You are advised not to drink alcohol with this medicine as it may cause
difficulty breathing and increase the chance of other side effects,
including drowsiness.
This medicine is not recommended for women who are pregnant or
breast-feeding.
If you are pregnant, planning to become pregnant or are breastfeeding ask your doctor or pharmacist for advice before taking any
medicine.
The following symptoms may occur in newborn babies, of mothers
that have used prochlorperazine 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.

Driving and using machines

Prochlorperazine tablets may cause drowsiness. Make sure you are not
affected before you drive or operate machinery.
Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Prochlorperazine 5mg, PIL, United Kingdom
item no:

AAAG9479

dimensions: 148 x 210

print proof no:

2

pharmacode:

origination date: 11.6.14
approved for print/date

min pt size:

colours/plates:

Prochlorperazine Tablets 5mg
x 28 & 84’S (UK)

1. black

JDE No.:

2.
3.
4.

7 pt

originated by:

db

revision date:

20.6.14

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

5.
6.
Non Printing Colours
1. profile
2.
3.

50776894

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 5896
Date Sent:
26/02/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your
doctor before taking this medicine, as it contains a type of sugar called
lactose.

3 How to take

Always take Prochlorperazine tablets exactly as your doctor has told you. If
you are not sure, check with your doctor or pharmacist.
Swallow the tablets with water. Do not handle the tablets more than you
need to as you may develop sore, red or blistered skin.
Doses:
Adults
• Dizziness:
5mg three times a day, up to a maximum of 30mg a day. Your doctor may
gradually reduce to 5-10mg a day after several weeks.
• Nausea and vomiting:
Prevention: 5-10mg two or three times a day.
Treatment: 20mg immediately, followed if necessary by 10mg two
hours later.
• To help with the treatment of anxiety:
15-20mg a day (divided throughout the day). Up to a maximum of 40mg
a day (divided throughout the day).
• Mental illness:
75-100mg a day, depending on response.
Start with 12.5mg twice a day for seven days, rising by 12.5mg every four
to seven days.
Elderly: Your doctor may prescribe a lower dose.
Children: Not recommended to children under 12 years of age.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you
think a child may have swallowed any, contact your nearest hospital casualty
department or tell your doctor immediately. Signs of an overdose include
drowsiness, loss of consciousness, low blood pressure, fast or irregular heart
rate, low body temperature.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to
take a dose take it as soon as you remember it and then take the next dose
at the right time.

If you stop taking the tablets

Contact your doctor before stopping Prochlorperazine tablets as you may
develop withdrawal effects such as feeling or being sick, sweating, difficulty
sleeping, or involuntary movements. Your doctor will reduce your dose
gradually to reduce the risk of developing withdrawal effects.

4 Possible side effects

Like all medicines, Prochlorperazine tablets can cause side effects, although
not everybody gets them.
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.

Contact your doctor immediately if you experience the following :
• Blood: this medicine may alter the numbers and types of your blood cells,
you may notice increased bruising, nosebleeds, sore throats or infections.
Your doctor may want to give you a blood test.
• 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.
• Liver: a sudden fever 1-3 weeks after starting the tablets, followed by
jaundice (yellowing of the skin or whites of the eyes) and possibly a rash.
• Neuroleptic Malignant Syndrome: excessive temperature, drowsiness,
rigid muscles, rapid breathing, restlessness and uncontrolled movements.

Tell your doctor if you notice any of the following side effects or notice
any other effects not listed:
• Nervous system:
− Parkinsonian effects (tremor, rigidity, loss of normal muscle movement)
− tardive dyskinesia (lip smacking or puckering; puffing of cheeks, rapid
or worm-like movements of tongue, uncontrolled chewing movements,
uncontrolled movements of arms and legs)
− difficulty in controlling movements and jerky movements and muscle
spasms (more common in children and young adults)
− trouble in sleeping, agitation
• Eye: visual disturbances
• Heart: dizziness and feeling faint especially when you stand up, irregular
or fast heartbeats, heart block (these are more likely if you already
suffer from heart problems, are elderly, have low levels of potassium in
the blood or are taking medicines known as tricyclic antidepressants),
changes in the electrical activity of the heart or heart attack.
• Chest and airways: blocked nose, difficulty breathing
• Stomach and intestines: dry mouth
• Skin and tissues: greyish-mauve discolouration of skin (following
direct contact with the tablets), sensitivity to sunlight (if this occurs you
should avoid sun lamps and direct sunlight, you may be advised to use a
sunscreen), skin rashes
• Reproductive system: raised blood levels of the hormone prolactin
which can cause breast milk production, breast tenderness and swelling
or changes in periods, reduced sexual potency in men

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.

5 How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place, protected from light, and in the original
packaging.
Do not use Prochlorperazine tablets after the expiry date stated on the
label/carton/bottle. 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 tablets contain

• The active substance (the ingredient that makes the tablet
work) is 5mg of prochlorperazine maleate.
• The other ingredients are lactose monohydrate, magnesium
stearate, maize starch, microcrystalline cellulose (E460).

What Prochlorperazine tablets look like and
contents of the pack

Prochlorperazine tablets are white, circular, uncoated tablets
Pack sizes are 28 and 84 tablets
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision April 2014

Continued top of next column
AAAG9479 50776894

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Prochlorperazine 5mg, PIL, United Kingdom
item no:

AAAG9479

dimensions: 148 x 210

print proof no:

2

pharmacode:

origination date: 11.6.14
approved for print/date

min pt size:

colours/plates:

Prochlorperazine Tablets 5mg
x 28 & 84’S (UK)

1. black

JDE No.:

2.
3.
4.

7 pt

originated by:

db

revision date:

20.6.14

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

5.
6.
Non Printing Colours
1. profile
2.
3.

50776894

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 5896
Date Sent:
26/02/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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