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PROCHLORPERAZINE MALEATE 3 MG BUCCAL TABLETS

Active substance(s): PROCHLORPERAZINE MALEATE

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PC No.: 3205

5. HOW TO STORE PROCHLORPERAZINE MALEATE 3 MG
BUCCAL TABLETS
Keep out of the reach and sight of children
Do not store above 25ºC. Store in the original package
Do not remove the medicine form the blister until you are ready to take the
medicine
Do not use the tablets after the expiry date stated on the blister and carton,
after EXP. The expiry refers to the last day of the month
Medicines should not be disposed of via waste water or house hold waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help protect environment.
6. FURTHER INFORMATION
What Prochlorperazine Maleate 3 mg Buccal Tablets contains
Each tablet contains 3 mg of the active substance, Prochlorperazine Maleate.
The other ingredients are Sucrose, Povidone (K-30), Riboflavin Sodium
Phosphate, Xantham gum (FF), Talc and Magnesium stearate
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 8 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and company responsible for manufacture:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk
Prochlorperazine Maleate 3mg Buccal Tablets. PL No: 21880/0126
This leaflet was last revised in 06/2013

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prochlorperazine Maleate 3 mg Buccal
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 get serious, or if you notice any side effects not listed in this
leaflet, tell your doctor or pharmacist.
In this leaflet:
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. Storing Prochlorperazine Maleate 3 mg Buccal Tablets
6. Further information
1. WHAT PROCHLORPERAZINE MALEATE 3 MG BUCCAL TABLETS ARE
AND WHAT THEY ARE USED FOR
Prochlorperazine maleate belongs to a group of medicines called ‘Phenothiazines’. It
works by blocking the effects of a chemical in the brain.
Prochlorperazine can be used to:
treat nausea and vomiting in cases of previously diagnosed migraine.
2. BEFORE YOU TAKE PROCHLORPERAZINE MALEATE 3 MG BUCCAL
TABLETS
You should only use this medicine if migraine has previously been diagnosed by your
doctor.
Do not take Prochlorperazine Maleate 3 mg Buccal Tablets and tell your
doctor if you:
• are allergic (hypersensitive) to Prochlorperazine maleate or any of the other
ingredients of this medicine. Signs of an allergic reaction include a rash, swallowing or
breathing problems, and swelling of your lips, face, throat or tongue.
• have liver problems
• have blood problems such as low red or white blood cell counts
• have Parkinson’s disease
• have an enlarged prostate gland. This means you may have problems passing urine
• have narrow angle glaucoma (signs include painful eyes with blurred vision)
• have epilepsy
• are pregnant or you think you might be pregnant or breast feeding
• are under 18 years of age
Take special care and tell your doctor before taking the tablets if you:
• are elderly
• have high 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.

P

The tablets may mask the signs of other illnesses you may get as they stop you from
feeling sick and being sick. Look out for other signs of illness and tell your doctor if you
are worried.
Taking other medicines
You should tell your doctor if you are already taking sedatives or tranquilisers, or you are
being treated for high blood pressure (hypertension). Prochlorperazine Maleate 3mg
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.

This section is continued overleaf →
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If you are pregnant or thinking of becoming pregnant, you should not take Prochlorperazine
Maleate 3mg Buccal Tablets.

If you take more Prochlorperazine Maleate 3 mg Buccal tablets than you
should
If you take too many tablets or a child swallows some, see your doctor immediately or
contact the accident and emergency department of the nearest hospital. Take the
medicine pack with you so the doctor knows what you have taken. Taking too many
tablets may cause symptoms such as feeling sleepy or dizzy, increased or rapid heartbeat,
feeling very cold and confused, writhing movements, feeling restless, stiffness or shaking.
You may lose consciousness.

Experience with Prochlorperazine Maleate 3mg Tablets is limited. You should therefore
not take the tablets if you are breast-feeding.

If you forget to take Prochlorperazine Maleate 3 mg Buccal Tablets

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

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

If you forget to take a dose do not double the dose next time. Just carry on taking the
medicine as the doctor, pharmacist or nurse has told you.
4. POSSIBLE SIDE EFFECTS

Ask your doctor or pharmacist for advice before taking any medicine.

Like all medicines, Prochlorperazine Maleate 3 mg Buccal Tablets can cause side effects,
although not everybody gets them.

Driving and using machines
Prochlorperazine Maleate 3 mg Buccal Tablets can cause side effects such as drowsiness,
dizziness, light-headedness and movement problems. Do not drive or use machines if
affected.

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.

Important information about some of the ingredients of Prochlorperazine
Maleate 3mg Buccal Tablets
• Sucrose: This medicine contains Sucrose, a type of sugar. If you have been told by your
doctor that you cannot tolerate some sugars, talk to your doctor before having this
medicine.

Other side effects include:

3. HOW TO TAKE PROCHLORPERAZINE MALEATE 3 MG BUCCAL
TABLETS

• agitation

Do not swallow or chew the tablet.

• 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).

Dosage
You must follow the instructions that your doctor has given you about how much and
when to take Prochlorperazine Maleate 3 mg Buccal Tablets.
The usual dosage is one or two tablets twice a day for a maximum of 2 days,
for adults aged 18 years or over.
These tablets are not recommended for children under 18 years of age.
Maximum dose is 4 tablets in any 24 hour period.
The tablet(s) is best taken after meals.

• drowsiness
• dizziness
• dry mouth
• inability to sleep (insomnia)
• mild skin reactions

• 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.
Occasional

How to use
Place the tablet high up along your top
gum, under your upper lip, on either side
of your mouth as indicated in the
pictures opposite.

• local irritation to the gum and mouth may occur.
Rare
• jaundice (yellowing of the skin and/or the whites of the eyes)
• blood problems

The tablet will soften and stick to your
gum, and will take between about 1 and
2 hours to dissolve completely. Allow it
to dissolve slowly and completely.

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.

Most people find that after a few
minutes they no longer notice the tablet.

These reactions are unlikely to happen with the low dose of prochlorperazine in this
medicine.

Do not move the tablet around your
mouth with your tongue as this will
cause it to dissolve more quickly.

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.

The tablet(s) is best taken after meals.
If you wear dentures, the tablet(s) may
be placed in any comfortable position
between your lip and gum.

More information is provided overleaf →
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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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