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PROCHLORPERAZINE MALEATE 3MG BUCCAL TABLETS

Active substance(s): PROCHLORPERAZINE MALEATE

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PC - 2798

blood pressure (hypertension). Prochlorperazine Maleate 3
mg Buccal Tablets may interact with these types of
medicines.
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including those
obtained without a prescription.

PATIENT INFORMATION LEAFLET

Prochlorperazine Maleate 3 mg
Buccal Tablets
INFORMATION FOR THE USER
PLEASE READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TO TAKE THIS MEDICINE.

Taking with food and drink
Prochlorperazine Maleate 3 mg Buccal Tablets are best
taken after food.
Do not drink alcohol when taking the tablets as it may
interact with medicines like Prochlorperazine Maleate 3 mg
Buccal Tablets.

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 gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Pregnancy and breast feeding
If you are pregnant or thinking of becoming pregnant, you
should only take Prochlorperazine Maleate 3 mg Buccal
Tablets on your doctor's instructions.

In this leaflet:

The following symptoms may occur in newborn babies, of
mothers that have used Prochlorperazine Maleate 3 mg
Buccal 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.

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

Experience with Prochlorperazine Maleate 3 mg Buccal
Tablets is limited. You should therefore not take the tablets if
you are breast-feeding..
Ask your doctor or pharmacist for advice before taking any
medicine.

1. What is this medicine and what is it used for?
Prochlorperazine Maleate 3 mg Buccal Tablets are effective
in treating nausea (feeling sick) and vomiting (being sick)
from whatever cause. They are also used to treat migraine
and dizziness due to ear problems and other causes.

Driving and using machines
Prochlorperazine Maleate 3 mg Buccal Tablets can make
you feel drowsy. Therefore you should avoid driving or using
dangerous machines until you know how the tablets affect
you.

Prochlorperazine Maleate 3 mg Buccal Tablets contain
prochlorperazine maleate. Prochlorperazine belongs to a
large group of drugs known as phenothiazines, which have
a variety of effects.

Important information about some of the ingredients of
Prochlorperazine Maleate 3 mg Buccal Tablets
This product contains 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.

2. Before taking Prochlorperazine Maleate 3 mg Buccal
Tablets
You should only take Prochlorperazine Maleate 3 mg Buccal
Tablets when your doctor prescribes them for you.

3. How to use Prochlorperazine Maleate 3 mg Buccal
Tablets
You must follow the instructions that your doctor has given
you about how much and when to take Prochlorperazine
Maleate 3 mg Buccal Tablets.

Do not take Prochlorperazine Maleate 3 mg Buccal Tablets
if you:
• are allergic (hypersensitive) to Prochlorperazine Maleate
or any of the other ingredients
• have problems with your liver
• have blood problems
• suffer from epilepsy, Parkinson’s Disease or glaucoma
• have problems with your prostate gland.

The usual dosage is one or two tablets twice a day for
adults and children over 12 years of age.
Prochlorperazine Maleate 3 mg Buccal Tablets are not
recommended for children under 12 years of age.

You should ask your doctor before taking
Prochlorperazine Maleate 3 mg Buccal Tablets if you:

INSTRUCTIONS FOR USE

• are elderly
• are pregnant, thinking of becoming pregnant or breast
feeding
• have risk factors for a blood clot 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.

Please read carefully before taking the tablet.

Taking with other medicines
You should tell your doctor if you are already taking
sedatives or tranquilisers, or you are being treated for high
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PC - 2798

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

• Place the tablet high up along your top gum, under the
upper lip either side of your mouth as indicated above.
The tablet must not be swallowed whole or chewed.
• The tablet will soften and adhere to the gum. Allow it to
dissolve slowly and completely - this may take between
1 and 2 hours. Most people 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.

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.

The tablet(s) is best taken after meals.

5. How to store
Keep all medicines out of reach and sight of children.
Keep the blisters in the outer carton in order to protect from
light.
This medicinal product does not require any special
temperature storage condition.
Do not use after the expiry date (EXP month/year) shown on
the outer carton and blister.
The expiry date refers to the last day of that month.

If you take more Prochlorperazine Maleate 3 mg Buccal
Tablets than you should or if you accidentally take too
many tablets you must seek medical attention immediately.
If you forget to take Prochlorperazine Maleate 3 mg
Buccal Tablets
If you forget to take a dose do not double the dose next time.
Just carry on taking the medicine as the doctor has told you.
4. Possible side effects
Like all medicines, Prochlorperazine Maleate 3 mg Buccal
Tablets can cause side effects, although not everybody gets
them.
If you have a high temperature, pale complexion, muscle
stiffness and changes in levels of alertness, you may have
developed a serious condition called neuroleptic malignant
syndrome. If you have these symptoms while taking the
tablets, you should immediately inform your doctor.

6. Further information
What Prochlorperazine Maleate 3 mg Buccal Tablets
contain
Each tablet contains 3mg of the active ingredient
prochlorperazine maleate.
The other ingredients are Sucrose, Povidone (K-30),
Riboflavin Sodium Phosphate, Xantham gum (FF), Talc and
Magnesium stearate.

Other side effects include:
• drowsiness
• dizziness
• dry mouth
• inability to sleep (insomnia)
• agitation
• mild skin reactions
• 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).
• 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.
• 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 Maleate
3 mg Buccal Tablets compared with those not taking
these medicines.

What Prochlorperazine Maleate 3 mg Buccal Tablets
look like and contents of the pack
Prochlorperazine Maleate 3mg Buccal Tablets are Pale
yellow to yellow, circular, biconvex uncoated tablets
debossed with “P3” on one side and plain on the other side.
Prochlorperazine Maleate 3mg Buccal Tablets are available
in blister packs containing 14, 15, 30, 50 and 60 tablets.
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
PL 21880/0122
This leaflet was last revised in 02/2014
POM

Occasional
• local irritation to the gum and mouth may occur.
Rare
• jaundice (yellowing of the skin and/or the whites of the
eyes)
• blood problems.
Very rare
• breast swelling (in men as well as in women)
• abnormal movements, tremors and muscle rigidity, and
unusual movements of the face and tongue.
These reactions are unlikely to happen with the low dose of
prochlorperazine in this medicine.
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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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