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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 inforamtion for you.
 eep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• T his 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 What Prochlorperazine tablets are and
what they are used for
2 What you need to know before you
take Prochlorperazine tablets
3 How to take Prochlorperazine tablets
4 Possible side effects
5 How to store Prochlorperazine tablets
6 Contents of the pack and other

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:
 izziness due to ear diseases (such as Meniere’s syndrome or
labyrinthitis), or due to other causes
 ausea and vomiting including during a migraine
 ental illnesses (such as schizophrenia and mania)
• a nxiety in the short term

2 What you need to know before you take
Prochlorperazine tablets

Do not take Prochlorperazine tablets and tell your doctor if you
• a n allergy (hypersensitivity) to prochlorperazine meleate,
phenothiazines or any of the other ingredients (see section 6)
 igh blood pressure due to a tumour near the kidney

Warnings and precautions
Talk to your doctor or pharmacist before taking
Prochlorperazine tablets if you:
• liver or kidney problems or have ever had jaundice (yellowing
or the skin or whites of the eyes)
• e pilepsy
 uscle weakness (myasthenia gravis)
• a n underactive thyroid gland
 arkinson’s disease
• increased pressure in the eye (glaucoma)
• a n enlarged prostate gland
• a re 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
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 ave had any heart problems or a family history of heart
 ave ever abused alcohol
• a re not eating properly
 ave low blood concentrations of potassium (hypokalaemia),
calcium (hypocalcaemia) or magnesium (hypomagnesaemia),
neutrophils (agranulocytosis)
 r someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of
blood clots
• s uffer with dementia
 ave ever had a stroke
Other medicines and Prochlorperazine tablets
Tell you doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
• s trong painkillers (eg morphine, codeine phosphate)
• a ntacids or kaolin preparations
 edicines to treat depression such as lithium or tricyclics (eg
amitriptyline, dosulepin, imipramine)
• t erfenadine (to treat allergies)
 edicines to treat diabetes (eg chlorpropamide, gliclazide)
 edicines to treat high blood pressure (eg clonidine,
doxazosin, guanethidine, nifedipine, verapamil)
 edicines to treat Parkinson’s disease and some mental
illnesses such as bromocriptine, cabergoline, levodopa,
pramipexole, ropinirole, apomorphine, lisuride, pergolide
• a nticholinergics (eg atropine sulfate, oxybutynin)
 edicines used to treat anxiety and difficulty sleeping (eg
diazepam, chlordiazepoxide)
• s otalol (to prevent and treat some heart conditions)
 esferrioxamine (to treat iron poisoning)
• s ibutramine (used for weight loss)
• a drenaline (epinephrine)
• a mphetamine
• a ntipsychotics (e.g. chlorpromazine, trifluoperazine)
 edicines to treat epilepsy (e.g. phenobarbital)
 edicines to treat irregular heart beat (e.g. amiodarone,
• if you are about to undergo surgery or dentistry where an
anaesthetic will be used
• r itonavir (for HIV infection)
• c imetidine (to treat stomach ulcers)
 edicines that effect electrolyte imbalance e.g. diuretics
(furosemide or bumetande)
Prochlorperazine tablets with alcohol
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.
Pregnancy and breast-feeding
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.
Continued over page

Driving and using machines
Prochlorperazine tablets may cause drowsiness. Make sure you are not
affected before you drive or operate machinery.
Prochlorperazine tablets contains lactoe
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 Prochlorperazine tablets

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets with water. Do not handle the tablets more than
you need to as you may develop sore, red or blistered skin.
 izziness: the recommended dose is 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.
 ausea and vomiting: Prevention: the recommended dose is
5-10mg two or three times a day.
Treatment: the recommended dose is 20mg immediately, followed if
necessary by 10mg two hours later.
 o help with the treatment of anxiety: the recommended dose is
15-20mg a day (divided throughout the day). Up to a maximum of
40mg a day (divided throughout the day).
 ental illness: the recommended dose is 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.
Use in children and adolescents: Not recommended for children
under 12 years of age.
If you take more Prochlorperazine tablets 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 and jerky movements.
If you forget to take the Prochlorperazine 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 Prochlorperazine 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, this medicine 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 antpsychotics compared
with those not receiving antipsychotics.
Contact your doctor immediately if you experience the following :
 lood: 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.
 lood 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
• L iver: 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

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 euroleptic 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:
 ervous system:
- Parkinsonian effects (tremor, rigidity, loss of normal muscle
- 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 sleeping, agitation
 ye: visual disturbances
 eart: 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, sudden death.
 hest and airways: blocked nose, difficulty breathing
 igestive system: dry mouth
 kin 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
 eproductive 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
 ther: drug withdrawal in newborn infants
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:
By reporting side effects you can help provide more information on the
safety of this medicine.

5 How to store Prochlorperazine tablets

Keep out of the sight and reach of children.
Store below 25°C in a dry place, protected from light, and in
the original packaging.
Do not use this medicine after the expiry date stated on the
label/carton/bottle. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help to
protect the environment.

6 Contents of the pack and other

What Prochlorperazine tablets contain
• T he active substance (the ingredient that makes the
tablet work) is 5mg of prochlorperazine maleate.
• T he 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
Pack sizes are 28 and 84 tablets
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision November 2016

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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.