PROCHLORPERAZINE 5MG TABLETS

Active substance: PROCHLORPERAZINE MALEATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package Leaflet: Information for the User

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.

In this leaflet
1.
2.
3.
4.
5.
6.

What Prochlorperazine tablets are and what they are used for
Before you take Prochlorperazine tablets
How to take Prochlorperazine tablets
Possible side effects
How to store
Further information

1. What Prochlorperazine tablets are and what they are used for
Prochlorperazine tablets belong to a group of drugs known as phenothiazines, which act on the
central nervous system. In adults they are used in the treatment of vertigo (dizziness) and
Meniere's syndrome (falling to one side), the short term treatment of anxiety and to treat
schizophrenia and other mental (psychotic) disorders. The tablets may also be used for the
prevention and treatment of nausea and vomiting in adults and children.

2. Before you take Prochlorperazine tablets
Do not take Prochlorperazine tablets if you have:


a known hypersensitivity to
prochlorperazine, other phenothiazines or
to any other ingredients in the tablets (see
Section 6)




phaeochromocytoma (tumour near the
kidney) or tumours which grow if your
prolactin levels are high
Depression of central nervous system or
coma

Check with your doctor before taking Prochlorperazine tablets if you have:








heart failure or prolonged QT (ECG change
which increases the risk of potentially serious
cardiac arrhythmias)
liver or kidney problems, history of jaundice
epilepsy or have ever had fits (seizures)
Parkinson’s disease
hypothyroidism (reduced activity of the
thyroid gland)
depression, or if you have high risk of stroke
myasthenia gravis (condition causing weak
muscles)










glaucoma (raised eyeball pressure)
an enlarged prostate
or if you are or may be pregnant, or
breast-feeding
history of blood disorders or an
unexplained fever
you are diabetic or have high blood sugar
(hyperglycaemia)
you have a history of alcohol problems
avoid weather extremes if you are over 65
years old
avoid direct sunlight (it can lead to sun
sensitive rash)

Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines including
medicines obtained without a prescription (as they may alter the effects of this medicine)
especially:
 antacids, anti-Parkinson medications (such as  clonidine (for migraine and to lower blood
levodopa), and lithium (may interfere with
pressure)
absorption of Prochlorperazine tablets)
 drugs affecting blood marrow, such as
 sedatives such as barbiturates (sedative effect
carbamazepine, cytotoxics, or certain
is intensified)
antibiotics
 anticholinergic drugs, anticonvulsants, and
 drugs prolonging QT (ECG change which
general anaesthesia
might result in serious cardiac arrhythmias),
such as certain antiarrhythmics,
 antihypertensive drugs such as alpha
antidepressants, and antipsychotics
blockers, such as guanethidine
 ritonavir (for HIV)
 central nervous system stimulants such as
adrenaline, amphetamines
 disopyramide (a cardiac drug)
 hypoglycaemic agents (medicines for
 desferroxamine, used if you have too much
diabetes)
iron in your blood
 neuroleptics, pimozide, atomoxetine,
antidepressants

Alcohol
This medicine will add to the effects of alcohol; therefore alcohol should be avoided during
treatment.

Pregnancy and breast-feeding
Prochlorperazine should not be used in pregnancy, unless your doctor considers it absolutely
necessary. As prochlorperazine is passed into breast milk, breastfeeding should be suspended during
treatment. The following symptoms may occur in newborn babies, of mothers that have used
Prochlorperazine 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

This medicine may cause some people to become drowsy or less alert than usual. If you are
affected, do not drive or operate dangerous machinery.

Sugar intolerance
If a doctor has told you that you have an intolerance to some sugars, check with your doctor before
taking these tablets, as they contain
a type of sugar called lactose.

3. How to take Prochlorperazine tablets
You will be prescribed the lowest dose needed to control your symptoms. You should check with
your doctor or pharmacist if you are unsure. Do not stop taking your medicine or change the
dose unless your doctor tells you to.
The tablets should be swallowed with a glass of water.

Do not crush the tablets or handle them more than you need to because you may develop a
skin reaction.
Dose for nausea and vomiting
Adults: Prevention of nausea and vomiting 510mg two or three times a day. Treatment of
nausea and vomiting:
20mg followed if
necessary by 10mg two hours later.
Children: Prevention and treatment of nausea
and vomiting:
The dose will depend on the child's bodyweight
and will be calculated on the basis of 250
micrograms per kilogram bodyweight two or three
times a day. Prochlorperazine is not recommended
for children weighing less than 10 kilograms or
children less than two years of age.

Dose for anxiety
Adults: Initially 15-20mg daily in divided
doses. This may be increased if necessary to a
maximum of 40 mg daily in divided dose.

Dose for vertigo and Meniere's syndrome:
Adults: 5mg three times daily, increased if needed
to 30mg daily. Dosage may be reduced gradually to
5-10mg daily.

Elderly patients with mental disorders should
be started on a lower dose of Prochlorperazine.
It 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.

Dose for schizophrenia and other psychotic
(mental) disorders:
Adults: The usual dose is 12.5mg twice daily
for 7 days. The dose is then increased by
12.5mg at 4-7 day intervals until it has a
satisfactory effect. After you have been on an
effective dose for some weeks, your doctor
may advise you to try to reduce the dosage.

Elderly:

If you take more than you should
If you accidentally take more tablets or somebody else takes any tablets, contact a doctor or go to
your nearest hospital casualty department at once. Take any remaining tablets with you and the
container or packaging, so they can be identified.

If you forget to take a tablet

If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a
double dose to make up for a forgotten dose.

4. Possible side effects
Like all medicines Prochlorperazine tablets can cause side effects. Do not be alarmed by this list of
side effects. Most people take prochlorperazine without any problems,
Stop taking the tablets and contact a doctor at once if you develop any of the following
effects:
 you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
 a fever or an unusually bad sore throat or bruising. These could be symptoms of a blood
disorder.
 jaundice (yellowing of the skin and whites of the eyes) sometimes preceded by a sudden onset
of fever, 1-3 weeks after start of treatment.
 a combination of high-temperature, pale complexion, muscle stiffness and changes in levels of
alertness. These are signs of a serious condition called ‘neuroleptic malignant syndrome’.
 You have 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
Tell your doctor at once if you notice any of the following side effects or if you have any other
unusual or worrying effects.
- drowsiness, nasal stuffiness, dry mouth,
- swollen breasts and impotence can occasionally
insomnia (sleeplessness), agitation
occur in men, but only after long term use.
- lowering of blood pressure and postural
- unusual breast milk production in women and
hypotension (fall of blood pressure when
absence of menstrual periods can also
moving from lying down) particularly in the
sometimes occur.
elderly
- a greyish discoloration of exposed skin may
- visual disturbances, changes in heart rate
develop, usually in women who have taken
- skin rashes and with high doses increased
Prochlorperazine continuously for long periods
sensitivity to sunlight. Therefore in sunny
(4-8 years).
weather, direct exposure to sunlight should
- passing large amounts of urine, excessive thirst
be avoided.
and having a dry mouth or skin. You may be
- abnormal movement usually in young patients
more likely to get infections, such as thrush.
and an inability to control certain muscles of
This could be due to too much sugar in your
the body such as tongue, mouth, arms and legs
Blood (hyperglycaemia).
can occur at the start of treatment and after
dose increases. These symptoms usually
disappear.
- muscle rigidity, tremors (uncontrolled shaking
of the hands or limbs) in adults and the elderly
may occur.

5. How to store
Do not store above 25°C. Store in a dry place. Keep the container tightly closed. Keep out of the
reach and sight of children.
Do not use after the expiry date printed on the packaging. If your doctor tells you to stop the
treatment, return any unused tablets to your pharmacist for safe disposal.

6. Further information




The active ingredient (which makes these tablets work) is prochlorperazine maleate BP. Each
tablet contains 5mg prochlorperazine maleate BP.
The tablets also contain lactose, maize starch, pre-gelatinised maize starch, sodium starch
glycollate, sucrose and magnesium stearate.
The tablets are uncoated almost white or pale buff coloured, with flat bevelled edges and are
available in containers of 28, 30, 56, 60, 84, 90, 100, 500, 1000 and in blister packs of 28 and 84
tablets.

Marketing authorisation holder and manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK.

Leaflet revision date November 2011

Prochlorperazine 5mg Tablets
PL8553/0091 © Dr. Reddy’s
Laboratories (UK) Limited
Component code

Expand view ⇕

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.

Hide
(web5)