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TERRAZINE / TRIFLUOPERAZINE 1MG

Active substance(s): TRIFLUOPERAZINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

TERRA-ZINE / Trifluoperazine
Hydrochloride 1 & 5 mg
tablets
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL
THE PRESCRIBED COURSE OF TERRA-ZINE.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR
MORE INFORMATION.
What is in Terra-zine tablets?
The active ingredient of Terra-zine is trifluoperazine
hydrochloride BP.
Terra-zine 1 mg tablets contain trifluoperazine hydrochloride
BP 1.18 mg.
Terra-zine 5 mg tablets contain trifluoperazine hydrochloride
BP 5.90 mg.
Terra-zine 1 mg and 5 mg are both dark green sugar coated
tablets
The tablets contain the following inactive ingredients; lactose,
starch, pregelatinised maize starch, magnesium stearate,
shellac, talc, titanium dioxide (E171), sucrose, povidone,
opalux (trade name) as F-5922, beeswax, carnauba wax.
Both strengths of Terra-zine are available in containers of 28,
30, 50, 56, 60, 84, 100, 250, 500, & 1000 tablets.
The name and address of the Product Licence holder is:
Chelonia Healthcare Ltd, 11 Boumpoulinas. Nicosia
P.C.1060. Cyprus.
The Manufacturer of Terra-zine is:
DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road,
London SW11 3SE.
The active ingredient in Terra-zine tablets, trifluoperazine,
belongs to a group of drugs known as phenothiazines.
Why have you been prescribed Terra-zine?
Used to help in the control of short-term anxiety, agitation,
excitement, impulsive/violent behaviour, and uncontrolled
bodily shaking.
Also used in the management of the symptoms of
schizophrenia, and other more serious psychological
disorders (paranoia, mania, hypomania).
If you are not sure why you have been prescribed Terrazine, then please ask your doctor.
Before taking your medicine.
Before taking this medicine, tell your doctor if any of the
following apply:
• If you have experienced unusual or allergic reactions in
the past to other drugs belonging to the same
















phenothiazine group as this medicine.
If you have ever had liver, heart, kidney, or respiratory
disease.
If you have Parkinson’s disease.
If you have epilepsy.
If you have diabetes.
If you suffer from depression.
If there is a history of glaucoma (increased eyeball
pressure) in your family.
If you are suffering from alcohol withdrawal.
If you are allergic to any foods, preservatives or dyes.
If you suffer from hypothyroidism which is a condition of
the thyroid gland.
If you suffer from myasthenia gravis which is a weakness
of certain muscles.
If you suffer from phaeochromocytoma which causes an
increase in blood pressure.
If you suffer from prostatic hypertrophy which is
enlargement of the prostate gland.
If you have any blood disorders.
If you or someone else in your family has a history of
blood clots, as medicines like Terra-Zine have been
associated with formation of blood clots.

Use in pregnancy and while breast-feeding.
Tell your doctor if you are pregnant or planning a pregnancy
and if you are breast-feeding, as Terra-zine should not be
used in pregnancy or while breast-feeding.
The following symptoms may occur in newborn babies, of
mothers that have used trifluoperazine 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.
Can you drive when taking Terra-zine?
Because of the risk of impaired alertness it is advisable
not to drive or operate machinery.
Can you take Terra-zine with other medicines?
It is very important to tell your doctor or pharmacist about
all the medicines that you are taking, whether or not any
medicines were prescribed by your doctor or bought without
a prescription from the pharmacy or elsewhere. Your doctor
will be able to identify medicines you should not take with
Terra-zine.
If you are taking other medicines. Some medicines will affect
the actions of Terra-zine e.g. central nervous system
depressant drugs such as alcohol, sedatives, barbiturates,
sleeping pills. Other medicines which interfere with the
actions of Terra-zine, or which are interfered with by the use
of Terra-zine include:
• Guanethidine and clonidine (for high blood pressure).
• Anti-Parkinsonian drugs such as levadopa and
benzhexol, and other anticholinergic drugs (e.g.
orphenadrine, benztropine).
• Anti-diabetic drugs (meformin, chlorpropamide).
• Anticoagulant drugs (blood thinning medicines such as

warfarin)
• Medicines used to treat heart conditions and high blood
pressure (e.g. quinidine, corticosteroids, digoxin,
diazoxide).
• Lithium, used for psychological disorders.
• Sympathomimetic agents, which increase heart rate and
contraction of heart muscle.
• Anti-depressants, which are used to treat depression.
• Antacids, used to treat increased stomach acidity.
Tea and coffee can affect the absorption of Terra-zine.
Antacids will also affect the absorption of Terra-zine.
If you go to a doctor, dentist or hospital for any reason, tell
them you are taking Terra-zine.
When and how to take Terra-zine.
This medicine is to be taken by mouth and only in the doses
prescribed by your doctor. Do not take more and do not take
more often.
You will be prescribed the lowest dose necessary to control
your symptoms. Do not stop taking your medicine or change
the dose unless your doctor tells you to, and for the shortest
possible time excepting under certain conditions where your
doctor believes that long-term treatment is required.
Do not stop taking your medicine or change the dose unless
your doctor tells you to.
Usual dosages are stated below:
ADULTS:
The recommended dosage when Terra-zine is used together
with other medicines for the short-term management of
anxiety, agitation, excitement, and impulsive behaviour is: 2-4 mg a day in divided doses. This dosage may be
increased to a maximum of 6 mg per day in divided doses.
When Terra-zine is used together with other medicines for
the short-term management of anxiety or severe agitation,
and excitement, violent or dangerous impulsive behaviour
the recommended dose is 2-4mg a day in divided doses,
which may be increased to a maximum of 6mg per day in
divided doses.
In the treatment of the symptoms of schizophrenia, and
psychological disorders, the recommended starting dose is 5
mg twice a day for physically fit adults. This dose may be
increased after one week if necessary to 15 mg a day.
Further increases may be made of 5 mg at 3 day intervals;
this is the minimum time that should be allowed to elapse
between dosage increases.
After satisfactory control has been achieved the dosage may
be gradually reduced until an affective dosage maintenance
level is arrived at.
After commencing treatment it may take several weeks for
improvement to be felt. It is always necessary that
withdrawal from treatment should be gradual to avoid a
relapse of the condition if stopping treatment is sudden.
ELDERLY:
A quarter or half the normal starting dose may be sufficient
for therapeutic response in the elderly.

CHILDREN:
Not recommended for use in children.
GENERAL:
Terra-zine should always be used for the minimum possible
time at the minimal effective dosage level excepting where it
is established that long-term administration for conditions
such as schizophrenia is required.
What to do if too many tablets are taken at the same
time.
If you accidentally take more tablets than recommended
contact your nearest doctor or hospital casualty department
at once. Take any remaining tablets with you and keep in the
original container or packaging so that they can be identified.
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to
your regular dosage schedule. Do not take two doses at
once. If you feel that this medicine is not working as well
after you have taken it for a short time (3-4 days) do not
increase the dose, instead check with your doctor.
What side effects can Terra-zine have?
Common side effects noticed particularly at the start of
treatment and with high dosages include drowsiness,
sedation, dry mouth and nasal stuffiness.
Terra-zine may affect concentration and alertness,
particularly at the start of treatment. These effects will be
increased by the consumption of alcohol.
In very hot weather or very cold weather, and particularly
with the elderly, there is a risk of heat stroke or hypothermia.
The elderly also have increased risk of low blood pressure
which can be caused by moderate to high doses of
trifluoperazine.
In elderly people with dementia, a small increase in the
number of deaths has been reported for patients taking
antipsychotics compared with those not receiving
antipsychotics.
Other dose-related side effects include blurring of vision,
alterations of heart beat, constipation and difficulty passing
urine.
Some reactions are common and can occur at low dosages,
though are more common at moderate to high dosage.
These include muscle rigidity (stiffness), tremor (fine shaking
of the hands), jerky body movements and the inability to
control movements of the hand and body. There is a risk of
sustained fixed movement of the eyes and head (oculogyric
crises) though this is more common in Parkinson patients.
Anti-Parkinson medicines (such as levadopa) used together
with trifluoperazine may aggravate these conditions and
therefore should be avoided. These side effects may present
themselves immediately or shortly after you stop taking this
medicine. Abrupt drug withdrawal can increase the risk of
these side effects.
Random repetitive unintentional movements (known as
tardive dyskinesia) is a symptom which can occur when
taking Terra- zine. It is characterised by grimacing, lip
smacking, and sticking your tongue out without wishing to. It
is more common in the elderly, but is also common among

patients taking high doses of Terra-zine over a long time.
Taking Anti-Parkinson medicines with Terra-zine can also
cause it.
A combination of high temperature, pale complexion, muscle
stiffness and changes in levels of alertness are symptoms of
a serious condition called ‘neuroleptic malignant syndrome’.
If these symptoms develop, you should inform your doctor
immediately.
In low doses, Terra-zine can cause the following side effects,
which will disappear on their own, or once the medicine is
stopped. These side effects are: feelings of being mentally
slowed down or dulled, sickness, dizziness, headache,
excitement, agitation, and sleeplessness. Confusion and
epileptic fits (seizures) can also occur. Stopping the
medication suddenly can lead to sickness, difficulty in
sleeping and vomiting.
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 breathing.
Various types of blood disorders may occur. Be sure to tell
your doctor if you are suffering from bruising or an unusually
bad sore throat, or fever.
Rarely Terra-zine may cause problems with your liver. If you
notice a yellowing of your skin or eyeballs tell your doctor.
You may have to stop taking your medicine.
Trifluoperazine rarely causes sunburn with exposure to
sunlight, and can cause skin rashes and sensitivity. With
long- term use trifluoperazine can change skin pigmentation
(colour). Very rarely, and only with excessively high doses,
vision may become impaired due to pigment deposits in the
eye. Terra-zine can also cause thickening of the skin.
The use of trifluoperazine can lead to hormonal changes:
enlargement of the breasts, production of breast milk,
reduction or stopping of monthly periods. The use of Terrazine can also affect sexual function. Weight gain is common.
Water retention and increased levels in the blood of
cholesterol and sugar have been reported as side effects of
trifluoperazine.
After withdrawal of Terra-zine the following may occur:
writhing movements, smacking of the lips, protrusion of the
tongue, chewing movements and facial grimaces. Repetitive
movements of the neck or trunk may occur. These
withdrawal symptoms are not likely to occur with low doses
used as recommended. Because withdrawal symptoms may
be related to length of treatment as well as daily dose, Terrazine should always be given in the smallest effective dose for
the shortest possible time.
If you notice any of the above reactions or side effects, or if
you notice other unusual or worrying changes contact
your doctor.
Storing your medicine
You must keep this medicine in a safe place where children
cannot get at it. Your medicine could harm them.
Keep your medicine in a dry place, below 25°C. Protect from
light. Keep the tablets in the container in which they were
given to you.
If your doctor tells you to stop the treatment, return any
remaining tablets/capsules to the pharmacist.

On the container, you will find the words “expiry date”
followed by numbers indicating the day, month and year.
This is the date after which the medicine is no longer fit for
use. Do not use the medicine after this date but return it to
your doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as
yours.
This leaflet does not contain the complete information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist who have
access to additional information.
PL Nos.: 33414/0115, and 33414/0116
This leaflet was revised in November 2011

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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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