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PROCHLORPERAZINE MALEATE 3MG BUCCAL TABLETS

Active substance(s): PROCHLORPERAZINE MALEATE / PROCHLORPERAZINE MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Prochlorperazine Maleate
3mg Buccal Tablets
Prochlorperazine maleate
Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
you.
Always take this medicine exactly as
described in this leaflet or as your doctor
or pharmacist has told you.
- Keep this leaflet. You may need to read
it again.
- Ask your pharmacist if you need more
information or advice.
- 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.
- You must talk to a doctor if you do not
feel better or if you feel worse after 2 days.
- The full name of this medicine is
Prochlorperazine maleate 3mg
Buccal Tablets, but it will be called
Prochlorperazine Tablets in this leaflet.
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 information
1. What Prochlorperazine Tablets
are and what they are used for
Prochlorperazine Tablets are effective
in treating nausea (feeling sick) and
vomiting (being sick) associated with
migraine. Prochlorperazine Tablets
contain prochlorperazine maleate.
Prochlorperazine belongs to a large
group of drugs known as phenothiazines,
which have a variety of effects.
2. What you need to know before
you take Prochlorperazine Tablets
You should only take this medicine if
migraine has previously been diagnosed
by your doctor.
Do not take Prochlorperazine Tablets
if you:
- are allergic to prochlorperazine maleate
or any of the other ingredients of this
medicine (listed in section 6),
- are pregnant, or you think you might be
pregnant or breast-feeding,
- have problems with your liver,
- have blood problems,
- suffer from epilepsy, Parkinson’s
disease, or glaucoma (high pressure in
the eyeball),
- have problems with your prostate gland,
- are under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Prochlorperazine Tablets if you:
- are elderly,
- have risk factors for a blood clot or
stroke such as high blood pressure,
high cholesterol levels, diabetes or
smoking,
- or someone else in your family has a
history of blood clots, as medicines
like these have been associated with
formation of blood clots,
- have a condition called myasthenia
gravis, which causes muscle weakness,
- have AIDS.
Prochlorperazine Tablets may cause
you to be more sensitive to sunlight.
When taking Prochlorperazine Tablets it
is particularly important that you should
avoid exposure to direct sunlight and use
sunscreen.
Children and adolescents
This medicine should not be taken by
children under 18 years of age.

Other medicines and
Prochlorperazine Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including those
obtained without a prescription.
In particular, tell your doctor or
pharmacist if you are taking:
- sedatives or tranquilisers, used to help
you sleep (such as diazepam and
temazepam),
- antihypertensive medicines, used to
treat high blood pressure (such as
atenolol, propranolol or clonidine),
- anticholinergic medicines, used for
conditions such as depression (such
as amitriptyline and imipramine),
- anticonvulsant medicines used
to prevent or treat fits such as
carbamazepine and lamotrigine),
- lithium (used to treat mania and
depression),
- desferrioxamine (used to treat high
levels of iron in your body),
- oral anticoagulants, to help prevent
blood clots (such as warfarin),
- levodopa (used to treat Parkinson’s
disease).
Prochlorperazine Tablets may interact
with these types of medicines.
Prochlorperazine Tablets with food
and alcohol
Prochlorperazine Tablets are best taken
after food.
Do not drink alcohol when taking
Prochlorperazine Tablets as it may
interact with medicines like
prochlorperazine.
Pregnancy and breast-feeding
If you are pregnant or thinking of
becoming pregnant, you should not take
Prochlorperazine Tablets. Experience
with Prochlorperazine Tablets is limited.
You should therefore not take
Prochlorperazine Tablets if you are
breast-feeding.
Driving and using machines
Prochlorperazine Tablets may make you
feel drowsy. Therefore you should avoid
driving or using dangerous machines
until you know how Prochlorperazine
Tablets affect you.
Prochlorperazine Tablets contain
sucrose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.
3. How to take Prochlorperazine
Tablets
Always use this medicine exactly as
described in this leaflet or as your doctor
or pharmacist has told you. Check with
your doctor or pharmacist if you are not
sure.
The recommended dose is one or two
tablets twice a day for a maximum of
2 days, for adults aged 18 years or over.
Instructions for Use: Please read very
carefully before taking the tablet(s)

 Place the tablet high up along your
top gum, under the upper lip either
side of your mouth as shown above.
The tablet must not be swallowed
whole or chewed.
 The tablet will soften and stick to the
gum. Allow it to dissolve slowly and
completely – this may take between

1 and 2 hours. Most people will find
that after a few minutes they no
longer notice the tablet.
 The tablet should not be moved about
the mouth with the tongue as this will
cause it to dissolve too quickly.
 If you wear dentures, the tablet
may be placed in any comfortable
position between your lip and gum.
Prochlorperazine Tablets are best taken
after meals.
Use in children and adolescents
Prochlorperazine Tablets should not be
used in children and adolescents aged
less than 18 years.
If you take more Prochlorperazine
Tablets than you should
If you accidentally take too many tablets
you must seek medical attention
immediately.
If you forget to take Prochlorperazine
Tablets
If you forget to take Prochlorperazine
Tablets, take it as soon as you remember.
However, if it is nearly time for your next
dose, in that case, miss the forgotten
dose and take it next time as instructed
by the doctor or pharmacist.
Do not take a double dose to make up
for a forgotten dose.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Serious side effects
If you experience any of the following
side effects, you should stop taking
Prochlorperazine Tablets and contact
your doctor immediately:
- Symptoms of an allergic reaction
such as rash and swelling of the face,
tongue or throat.
- A high temperature, pale complexion,
muscle stiffness, and changes in
your level of alertness, you may have
developed a serious condition called
neuroleptic malignant syndrome.
- Convulsions (fits).
- Signs of infection such as shivering,
headache, sweating, high temperature,
flushing, a sore throat or mouth and
swollen glands.
- Blood clots in the veins especially in
the legs (symptoms include swelling,
pain and redness in the leg), which
may travel through the blood vessels
to the lungs causing chest pain and
difficulty in breathing.
- Symptoms of decreased sodium
concentration in the blood, such as
nausea and vomiting, headache,
confusion, loss of energy, restlessness,
muscle weakness, spasms or cramps,
seizures and coma.
In elderly people with dementia,
a small increase in the number of
deaths has been reported for patients
taking medicines of the same type as
Prochlorperazine Tablets compared with
those not taking these medicines.
Other side effects include:
 Drowsiness,
 Dizziness,
 Dry mouth,
 Inability to sleep (insomnia),
 Agitation,
 Skin reactions,
 Increased sensitivity to sunlight,
 Low blood pressure (this makes you
feel dizzy or faint, particularly when
you stand up), particularly in elderly
or volume depleted patients (those
who have lost both water and salts
from the body),
 High blood sugar level, which can
cause increased thirst, a dry mouth,
needing to urinate frequently,
tiredness and recurrent infections
such as thrush,
 A condition known as cholestasis
where bile cannot flow properly in
the body, and can cause itchiness,

jaundice (yellowing of the skin and/or
the whites of the eyes), pale stools
and dark urine,
 Abnormal movements, tremors
and muscle rigidity, and unusual
movements of the face and tongue,
 Impotence, ejaculation problems and
persistent/ painful erections,
 Local irritation to the gum and
mouth.
Rare: may affect up to 1 in 1,000 people
 Yellowing of the skin and/or the
whites of the eyes (jaundice),
 Blood problems.
Very rare: may affect up to 1 in
10,000 people
 Breast swelling (in both men and
women),
 Milk secretion from the breasts which
is not due to breast-feeding,
 Absence of menstrual periods,
 A feeling of restlessness or anxiety
that can range from mild to severe.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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 Prochlorperazine
Tablets
This medicinal product does not require
any special storage condition.
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and
on the blister after EXP. 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 throw away 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 substance is prochlorperazine
maleate; each tablet contains 3 mg.
- The other ingredients are locust bean
gum (E 410), xanthan gum (E 415),
compressible sugar, riboflavine-5-sodium
phosphate (E 101), povidone K 30
(E 1201), purified talc (E 553b) and
magnesium stearate (E 470b).
What Prochlorperazine Tablets look
like and contents of the pack
The buccal tablets are off white to pale
yellow circular, biconvex uncoated
tablets, debossed with “3” on one side
and plain on the other side.
Prochlorperazine Tablets are packed in
blisters of white opaque PVC/PVDC with
aluminium foil. Pack containing 8 buccal
tablets is available.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road, Leicester, LE3 0PA,
United Kingdom
Manufacturer
Morningside Pharmaceuticals Ltd
Unit L & S, Castle Business Park,
Loughborough, LE11 5GW,
United Kingdom
This leaflet was last revised in
December 2016.
M0263LAMUKNAS-001

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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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