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TRIFLUOPERAZINE 1MG/5ML SYRUP

Active substance(s): TRIFLUOPERAZINE / TRIFLUOPERAZINE HYDROCHLORIDE

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Var (02: Add/Amend) To correct an error in section 4 of the PIL.
By BasherH at 2:46 pm, Oct 10, 2013

PACKAGE LEAFLET: INFORMATION FOR THE USER

Stelazine® 1mg/5ml Syrup
(trifluoperazine hydrochloride)

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

In this leaflet:

1.
2.
3.
4.
5.
6.

What Stelazine 1mg/5ml Syrup is and what it is used for
Before you take Stelazine 1mg/5ml Syrup
How to take Stelazine 1mg/5ml Syrup
Possible side effects
How to store Stelazine 1mg/5ml Syrup
Further information

1. What Stelazine 1mg/5ml Syrup is and
what it is used for
Stelazine 1mg/5ml Syrup contains the active ingredient
trifluoperazine hydrochloride, which belongs to a class of drugs
called phenothiazine tranquilisers, also referred to as a neuroleptic
drug. It influences the activity of certain brain cells by decreasing
the effect of dopamine, a natural chemical in the brain.
ƒ
At a low dose, Stelazine 1mg/5ml Syrup is used to manage
anxiety and depression. It is used in this way for short
periods of time. Stelazine 1mg/5ml Syrup may also be used
to treat nausea (feeling sick) and vomiting (being sick).
ƒ
At high doses, Stelazine 1mg/5ml Syrup is used to treat and
prevent relapses of schizophrenia (a serious mental illness).
It can also be used for short periods of time to treat bad
agitation or dangerous behaviour.

2. Before you take Stelazine 1mg/5ml Syrup
DO NOT take Stelazine 1mg/5ml Syrup if:
ƒ

ƒ

ƒ

You know that you are allergic to trifluoperazine
hydrochloride or any of the other ingredients of
Stelazine 1mg/5ml Syrup (see section 6 of this leaflet).
You are suffering from liver problems, blood disease,
inability of the heart to maintain adequate circulation
causing breathlessness and swelling of the ankles.
If you have previously had to stop taking other medicines for
psychiatric problems like Stelazine 1mg/5ml Syrup (known
as phenothiazines) because they have affected your blood
cells or caused jaundice (yellowing of the skin or eyes). Ask
your doctor about this.

Take special care with Stelazine 1mg/5ml Syrup
and tell your doctor if you are:

suffering from any disease involving the heart and blood
vessels (cardiovascular disease) including chest pain
(angina) and irregular heart beats
ƒ
suffering from a brain disorder causing tremors, rigidity and
slowing of movement (Parkinson’s disease)
ƒ
suffering from fits (epilepsy)
ƒ
suffering from an eye disease called narrow angle glaucoma
which causes increased pressure inside the eye,
ƒ
suffering from abnormal muscle weakness (Myasthenia
gravis)
ƒ
suffering from an enlargement of prostate gland
ƒ
exposed to extremes in temperature as this medicine can
affect body temperature control
ƒ
an elderly person
ƒ
if you suffer from loss of cognitive (memory, language,
intelligence) ability - dementia.
ƒ
if you or someone else in your family has a history of blood
clots, as medicines like these have been associated with
formation of blood clots.
ƒ
If you have had a stroke or have any of the following that
can increase your risk of having a stroke (e.g. heart attack,
uncontrolled high blood pressure, diabetes, family history of
strokes, you smoke or drink excess alcohol).
Even though some of the above may appear obvious, it is
important that your doctor is aware if any of them apply to you.

ƒ

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
The effects of these medicines may change, especially if you are
taking:
ƒ
sleeping tablets,
ƒ
strong pain killers (e.g. codeine)
ƒ
medicines which result in lowering of blood pressure (e.g.
guanethidine)
ƒ
anticholinergic medicines used to reduce saliva and lung
secretions (e.g. atropine, procyclidine)
ƒ
antidepressants (e.g. other phenothiazines, lithium)
ƒ
medicines for fits (anticonvulsants)
ƒ
medicines for Parkinson’s disease (e.g. levodopa)
ƒ
blood thinning medicines (anticoagulants such as warfarin)
ƒ
medicines used to treat iron poisoning (desferrioxamine)
ƒ
antacids used to treat indigestion.
ƒ
medicines for psychiatric conditions (neuroleptics)
ƒ
heart medicines which prolong the QT interval (e.g
quinidine, disopyramide, procainamide, amiodarone, sotalol)
ƒ
drugs causing electrolyte imbalances (e.g. diuretics)
You should tell your doctor or dentist that you are taking Stelazine
1mg/5ml Syrup before being given an anaesthetic.

Taking Stelazine 1mg/5ml Syrup with food and
drink

You should not drink alcohol whilst you are taking this medicine.
Stelazine 1mg/5ml Syrup can be taken with or without food.

Page 1 of 2

ASSESSED AGAINST THE UK PIL DATED MARCH 2012
Pregnancy and breast-feeding

Do not take Stelazine 1mg/5ml Syrup if you are pregnant, think
you may be pregnant or are planning to become pregnant, or
while breast-feeding, unless your doctor decides that treatment is
essential. It is particularly important not to take Stelazine
1mg/5ml Syrup during the first three months of pregnancy.
Ask your doctor or pharmacist for advice before taking any
medicine.
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.

Driving and using machines

Stelazine 1mg/5ml Syrup may make you feel drowsy or dizzy or
give you blurred vision. You should not drive or use machines
when you first start to take this medicine until you are certain that
you are not getting these side effects. If in any doubt, speak to
your doctor before you drive or use machines.

Important information about some of the
ingredients of Stelazine 1mg/5ml Syrup

This medicine also contains:
Sorbitol (E420), which is a sugar. If you have been told by your
doctor that you are intolerant to some sugars, contact your doctor
before taking this medicine. Sorbitol can also cause stomach upset
and diarrhoea in some patients.
Sunset yellow (E110) which may cause allergic reactions.
Sodium benzoate which may increase the risk of jaundice in
newborn babies.
This medicinal product contains 55.22mmol sodium per dose. To
be taken into consideration for patients on a controlled sodium
diet.

3. How to take Stelazine 1mg/5ml Syrup
Always take Stelazine 1mg/5ml Syrup exactly as your doctor has
told you. The pharmacist’s label on your pack will tell you how
much and how often you should take your Syrup. Please read the
label carefully. You should check with your doctor or pharmacist if
you are not sure. Do not take more than your doctor has
recommended.
Your doctor will decide on a suitable dose depending on your
condition. The usual dose is shown in the table below. You will
usually need to take your medicine twice or three times a day,
depending on the dose your doctor has chosen for you.

Var (02: Add/Amend) To correct an error in section 4 of the PIL.
Remember each 5ml spoonful of syrup contains 1mg of
“Trifluoperazine”
Patient Type

Adults

Elderly
(over 65 years
of age)
Children

Low dosage
For the treatment
of
anxiety or nausea
and vomiting

High dosage
For the control of
schizophrenia and
related conditions

The usual dose is
2mg to 6mg a day

High dose in adults is
5-25mg a day in
divided doses

The starting dose of
syrup should be no
more than half that of
adult patients

The starting dose of
syrup should be no
more than half that
of adult patients

For children aged
3-5 years, the dose is
no more than 1mg a
day. For children aged
6-12 years the dose is
no more than 4mg a
day.

High dose in children
(aged 6-12 years) is
5mg in divided doses.

During treatment your doctor should regularly check you for
physical side effects, changes in your blood counts or liver
function, and any heart problem, especially if you taking this
medicine for a long time or are also taking other medicines.

If you stop taking Stelazine 1mg/5ml Syrup

Continue to take Stelazine 1mg/5ml Syrup even if you no longer
feel ill. Do not stop taking this medicine without talking with your
doctor first, especially if you have taken large doses for a long
time. When the time comes to stop your doctor will probably
decrease your dose gradually as stopping the Syrup suddenly may
cause ill-effects such as nausea (feeling sick), vomiting (being
sick), sweating and difficulty in sleeping.
For mood disorders and schizophrenia, it may take several weeks
for you to feel the full benefit of this medicine. If you stop taking
this medicine suddenly, your symptoms may come back.

If you take more Stelazine 1mg/5ml Syrup than you
should:
If you think that you, or any other person, have taken too much
Syrup, contact your doctor or hospital casualty department
immediately. Take this leaflet and any remaining Syrup with you
so that the medical staff know exactly what you have taken.

If you forget to take your Stelazine 1mg/5ml Syrup:
If you miss a dose, wait until your next dose. Do not take the
dose you have missed. You can then carry on as before. Do not
take more than one dose at a time.

4. Possible side effects
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.
Like all medicines, Stelazine 1mg/5ml Syrup can sometimes cause
side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following:
ƒ
Very rarely, patients may experience a fast or irregular
heartbeat, constipation, difficulty or inability to pass urine or
a high temperature.
ƒ
Rarely, Stelazine 1mg/5ml Syrup can affect certain types of
breast cancers or lead to breast enlargement in men or to
inappropriate milk production or altered menstrual cycle
(e.g. periods stop).
ƒ
Rarely patients may develop Neuroleptic Malignant
Syndrome. This causes a high temperature, rigid muscles,
drowsiness, occasional loss of consciousness, and requires
emergency admission to hospital for treatment.
ƒ
If you have chest pain (angina) and your pain is getting
worse.
ƒ
Very occasionally, medicines such as Stelazine 1mg/5ml
Syrup can have effects on muscle control. If this happens,
symptoms can include slurred speech, odd movements of
the face, particularly of the tongue, eyes, head or neck
(such as twisting of the neck which causes an unnatural
positioning of the head, rigid muscles, tremors or
restlessness and difficulty in sitting still). Some patients
(especially on high doses of this medicine) experience
problems with muscle control which may continue for years.
Such patients may experience constant chewing or tongue
movements or other gentle movements of the neck, head or
trunk. Uncontrollable movements of the arms and legs have
also been reported in these patients.
ƒ
Occasionally, some patients have complained of feeling
slowed down, whilst others of being agitated
ƒ
Rarely, jaundice (yellowing of skin and whites of eyes), eye
problems, skin colouring (pigmentation) and blood
problems.
ƒ
if you suffer from a sore throat, high fever, feel very tired,
become pale, develop bruises and nose bleeds. These may
indicate blood problems developing as a result of using this
medicine.
ƒ
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.
Some patients may also experience weakness, drowsiness,
dizziness, restlessness, difficulty in sleeping, dry mouth, blurred
vision, muscle weakness, loss of appetite, faintness on standing
up, skin rashes (including increased sensitivity to the sun), weight
gain, water retention causing swelling or confusion.
Your doctor should check your progress regularly if you are on
Stelazine 1mg/5ml Syrup to make sure no unwanted effects are
developing.
Page 2 of 2

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

5. How to store Stelazine 1mg/5ml Syrup
ƒ
ƒ

ƒ
ƒ

ƒ

ƒ

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Stelazine 1mg/5ml Syrup after the expiry date
which is stated on the carton and bottle. The expiry date
refers to the last day of that month. If your Syrup is out of
date, take it to your pharmacist who will get rid of it safely.
Do not store above 25°C. Keep the bottle in the outer carton
in order to protect from light.
If your doctor decides to stop the treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears discoloured or shows any other
signs of deterioration, take it to your pharmacist who will
advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further information
What Stelazine 1mg/5ml Syrup contains

The active substance in Stelazine 1mg/5ml Syrup is
trifluoperazine hydrochloride. Each 5ml syrup contains 1mg
trifluoperazine (as hydrochloride).
Also contains: sodium saccharin, sodium benzoate (E211),
anhydrous citric acid (E330), sodium citrate,
sorbitol liquid (non-crystallising) (E420), quinoline yellow (E104),
sunset yellow (E110), peach flavour and purified water.

What Stelazine 1mg/5ml Syrup looks like and
contents of the pack

Stelazine 1mg/5ml Syrup is a clear, pale yellow, peach flavoured
syrup available in amber glass bottles containing 200ml syrup.

Manufacturer

Stelazine 1mg/5ml Syrup is manufactured by: Universal Products
(Lytham) Manufacturing Ltd., Fairfield, Bradshaw Lane,
Greenhalgh, Kirkham, Preston, Lancashire, United Kingdom.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0554

POM

Leaflet revision and issue date (Ref): 10.10.13
Stelazine® is a registered trademark of Mercury Pharma
Group Ltd.

Var (02: Add/Amend) To correct an error in section 4 of the PIL.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Trifluoperazine 1mg/5ml Syrup
(trifluoperazine hydrochloride)

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

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

What Trifluoperazine 1mg/5ml Syrup is and what it is used
for
Before you take Trifluoperazine 1mg/5ml Syrup
How to take Trifluoperazine 1mg/5ml Syrup
Possible side effects
How to store Trifluoperazine 1mg/5ml Syrup
Further information

1. What Trifluoperazine 1mg/5ml Syrup is
and what it is used for
Trifluoperazine 1mg/5ml Syrup contains the active ingredient
trifluoperazine hydrochloride, which belongs to a class of drugs
called phenothiazine tranquilisers, also referred to as a neuroleptic
drug. It influences the activity of certain brain cells by decreasing
the effect of dopamine, a natural chemical in the brain.
ƒ
At a low dose, Trifluoperazine 1mg/5ml Syrup is used to
manage anxiety and depression. It is used in this way for
short periods of time. Trifluoperazine 1mg/5ml Syrup may
also be used to treat nausea (feeling sick) and vomiting
(being sick).
ƒ
At high doses, Trifluoperazine 1mg/5ml Syrup is used to
treat and prevent relapses of schizophrenia (a serious
mental illness). It can also be used for short periods of time
to treat bad agitation or dangerous behaviour.

2. Before you take Trifluoperazine 1mg/5ml
Syrup
DO NOT take Trifluoperazine 1mg/5ml Syrup if:
ƒ

ƒ

ƒ

You know that you are allergic to trifluoperazine
hydrochloride or any of the other ingredients of
Trifluoperazine 1mg/5ml Syrup (see section 6 of this leaflet).
You are suffering from liver problems, blood disease,
inability of the heart to maintain adequate circulation
causing breathlessness and swelling of the ankles.
If you have previously had to stop taking other medicines for
psychiatric problems like Trifluoperazine 1mg/5ml Syrup
(known as phenothiazines) because they have affected your
blood cells or caused jaundice (yellowing of the skin or
eyes). Ask your doctor about this.

Take special care with Trifluoperazine 1mg/5ml
Syrup and tell your doctor if you are:

suffering from any disease involving the heart and blood
vessels (cardiovascular disease) including chest pain
(angina) and irregular heart beats
ƒ
suffering from a brain disorder causing tremors, rigidity and
slowing of movement (Parkinson’s disease)
ƒ
suffering from fits (epilepsy)
ƒ
suffering from an eye disease called narrow angle glaucoma
which causes increased pressure inside the eye,
ƒ
suffering from abnormal muscle weakness (Myasthenia
gravis)
ƒ
suffering from an enlargement of prostate gland
ƒ
exposed to extremes in temperature as this medicine can
affect body temperature control
ƒ
an elderly person
ƒ
if you suffer from loss of cognitive (memory, language,
intelligence) ability - dementia.
ƒ
if you or someone else in your family has a history of blood
clots, as medicines like these have been associated with
formation of blood clots.
ƒ
If you have had a stroke or have any of the following that
can increase your risk of having a stroke (e.g. heart attack,
uncontrolled high blood pressure, diabetes, family history of
strokes, you smoke or drink excess alcohol).
Even though some of the above may appear obvious, it is
important that your doctor is aware if any of them apply to you.

ƒ

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
The effects of these medicines may change, especially if you are
taking:
ƒ
sleeping tablets,
ƒ
strong pain killers (e.g. codeine)
ƒ
medicines which result in lowering of blood pressure (e.g.
guanethidine)
ƒ
anticholinergic medicines used to reduce saliva and lung
secretions (e.g. atropine, procyclidine)
ƒ
antidepressants (e.g. other phenothiazines, lithium)
ƒ
medicines for fits (anticonvulsants)
ƒ
medicines for Parkinson’s disease (e.g. levodopa)
ƒ
blood thinning medicines (anticoagulants such as warfarin)
ƒ
medicines used to treat iron poisoning (desferrioxamine)
ƒ
antacids used to treat indigestion.
ƒ
medicines for psychiatric conditions (neuroleptics)
ƒ
heart medicines which prolong the QT interval (e.g
quinidine, disopyramide, procainamide, amiodarone, sotalol)
ƒ
drugs causing electrolyte imbalances (e.g. diuretics)
You should tell your doctor or dentist that you are taking
Trifluoperazine 1mg/5ml Syrup before being given an anaesthetic.

Taking Trifluoperazine 1mg/5ml Syrup with food
and drink

You should not drink alcohol whilst you are taking this medicine.
Trifluoperazine 1mg/5ml Syrup can be taken with or without food.

Page 1 of 2

Pregnancy and breast-feeding

Do not take Trifluoperazine 1mg/5ml Syrup if you are pregnant,
think you may be pregnant or are planning to become pregnant,
or while breast-feeding, unless your doctor decides that treatment
is essential. It is particularly important not to take Trifluoperazine
1mg/5ml Syrup during the first three months of pregnancy.
Ask your doctor or pharmacist for advice before taking any
medicine.
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.

Driving and using machines

Trifluoperazine 1mg/5ml Syrup may make you feel drowsy or
dizzy or give you blurred vision. You should not drive or use
machines when you first start to take this medicine until you are
certain that you are not getting these side effects. If in any doubt,
speak to your doctor before you drive or use machines.

Important information about some of the
ingredients of Trifluoperazine 1mg/5ml Syrup

This medicine also contains:
Sorbitol (E420), which is a sugar. If you have been told by your
doctor that you are intolerant to some sugars, contact your doctor
before taking this medicine. Sorbitol can also cause stomach upset
and diarrhoea in some patients.
Sunset yellow (E110) which may cause allergic reactions.
Sodium benzoate which may increase the risk of jaundice in
newborn babies.
This medicinal product contains 55.22mmol sodium per dose. To
be taken into consideration for patients on a controlled sodium
diet.

3. How to take Trifluoperazine 1mg/5ml
Syrup
Always take Trifluoperazine 1mg/5ml Syrup exactly as your doctor
has told you. The pharmacist’s label on your pack will tell you how
much and how often you should take your Syrup. Please read the
label carefully. You should check with your doctor or pharmacist if
you are not sure. Do not take more than your doctor has
recommended.
Your doctor will decide on a suitable dose depending on your
condition. The usual dose is shown in the table below. You will
usually need to take your medicine twice or three times a day,
depending on the dose your doctor has chosen for you.

Var (02: Add/Amend) To correct an error in section 4 of the PIL.
Remember each 5ml spoonful of syrup contains 1mg of
“Trifluoperazine”
Patient Type

Low dosage
For the treatment
of
anxiety or nausea
and vomiting

High dosage
For the control of
schizophrenia and
related conditions

Adults

The usual dose is
2mg to 6mg a day

High dose in adults is
5-25mg a day in
divided doses

Elderly
(over 65 years
of age)

The starting dose of
syrup should be no
more than half that of
adult patients

The starting dose of
syrup should be no
more than half that
of adult patients

Children

For children aged
3-5 years, the dose is
no more than 1mg a
day. For children aged
6-12 years the dose is
no more than 4mg a
day.

High dose in children
(aged 6-12 years) is
5mg in divided doses.

During treatment your doctor should regularly check you for
physical side effects, changes in your blood counts or liver
function, and any heart problem, especially if you taking this
medicine for a long time or are also taking other medicines.

If you stop taking Trifluoperazine 1mg/5ml Syrup

Continue to take Trifluoperazine 1mg/5ml Syrup even if you no
longer feel ill. Do not stop taking this medicine without talking
with your doctor first, especially if you have taken large doses for
a long time. When the time comes to stop your doctor will
probably decrease your dose gradually as stopping the Syrup
suddenly may cause ill-effects such as nausea (feeling sick),
vomiting (being sick), sweating and difficulty in sleeping.
For mood disorders and schizophrenia, it may take several weeks
for you to feel the full benefit of this medicine. If you stop taking
this medicine suddenly, your symptoms may come back.

If you take more Trifluoperazine 1mg/5ml Syrup
than you should:

If you think that you, or any other person, have taken too much
Syrup, contact your doctor or hospital casualty department
immediately. Take this leaflet and any remaining Syrup with you
so that the medical staff know exactly what you have taken.

If you forget to take your Trifluoperazine 1mg/5ml
Syrup:
If you miss a dose, wait until your next dose. Do not take the
dose you have missed. You can then carry on as before. Do not
take more than one dose at a time.

4. Possible side effects
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.
Like all medicines, Trifluoperazine 1mg/5ml Syrup can sometimes
cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following:
ƒ
Very rarely, patients may experience a fast or irregular
heartbeat, constipation, difficulty or inability to pass urine or
a high temperature.
ƒ
Rarely, Trifluoperazine 1mg/5ml Syrup can affect certain
types of breast cancers or lead to breast enlargement in
men or to inappropriate milk production or altered menstrual
cycle (e.g. periods stop).
ƒ
Rarely patients may develop Neuroleptic Malignant
Syndrome. This causes a high temperature, rigid muscles,
drowsiness, occasional loss of consciousness, and requires
emergency admission to hospital for treatment.
ƒ
If you have chest pain (angina) and your pain is getting
worse.
ƒ
Very occasionally, medicines such as Trifluoperazine
1mg/5ml Syrup can have effects on muscle control. If this
happens, symptoms can include slurred speech, odd
movements of the face, particularly of the tongue, eyes,
head or neck (such as twisting of the neck which causes an
unnatural positioning of the head, rigid muscles, tremors or
restlessness and difficulty in sitting still). Some patients
(especially on high doses of this medicine) experience
problems with muscle control which may continue for years.
Such patients may experience constant chewing or tongue
movements or other gentle movements of the neck, head or
trunk. Uncontrollable movements of the arms and legs have
also been reported in these patients.
ƒ
Occasionally, some patients have complained of feeling
slowed down, whilst others of being agitated
ƒ
Rarely, jaundice (yellowing of skin and whites of eyes), eye
problems, skin colouring (pigmentation) and blood
problems.
ƒ
if you suffer from a sore throat, high fever, feel very tired,
become pale, develop bruises and nose bleeds. These may
indicate blood problems developing as a result of using this
medicine.
ƒ
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.
Some patients may also experience weakness, drowsiness,
dizziness, restlessness, difficulty in sleeping, dry mouth, blurred
vision, muscle weakness, loss of appetite, faintness on standing
up, skin rashes (including increased sensitivity to the sun), weight
gain, water retention causing swelling or confusion.
Your doctor should check your progress regularly if you are on
Trifluoperazine 1mg/5ml Syrup to make sure no unwanted effects
are developing.
Page 2 of 2

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

5. How to store Trifluoperazine 1mg/5ml
Syrup
ƒ
ƒ

ƒ
ƒ

ƒ

ƒ

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Trifluoperazine 1mg/5ml Syrup after the expiry
date which is stated on the carton and bottle. The expiry
date refers to the last day of that month. If your Syrup is
out of date, take it to your pharmacist who will get rid of it
safely.
Do not store above 25°C. Keep the bottle in the outer carton
in order to protect from light.
If your doctor decides to stop the treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears discoloured or shows any other
signs of deterioration, take it to your pharmacist who will
advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further information
What Trifluoperazine 1mg/5ml Syrup contains

The active substance in Trifluoperazine 1mg/5ml Syrup is
trifluoperazine hydrochloride. Each 5ml syrup contains 1mg
trifluoperazine (as hydrochloride).
Also contains: sodium saccharin, sodium benzoate (E211),
anhydrous citric acid (E330), sodium citrate,
sorbitol liquid (non-crystallising) (E420), quinoline yellow (E104),
sunset yellow (E110), peach flavour and purified water.

What Trifluoperazine 1mg/5ml Syrup looks like and
contents of the pack
Trifluoperazine 1mg/5ml Syrup is a clear, pale yellow, peach
flavoured syrup available in amber glass bottles containing 200ml
syrup.

Manufacturer

Trifluoperazine 1mg/5ml Syrup is manufactured by:
Universal Products (Lytham) Manufacturing Ltd., Fairfield,
Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire,
United Kingdom.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0554

POM

Leaflet revision and issue date (Ref): 10.10.13

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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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