Active substance: TRIFLUOPERAZINE

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• 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.
• If you have chest pain (angina) and your pain is getting worse.
• 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.
• Occasionally, some patients have complained of feeling slowed down, whilst
• Rarely, jaundice (yellowing of skin and whites of eyes), eye problems,
skin colouring (pigmentation) and blood problems.
• 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.
• 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.
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.

Keep this medicine out of the sight and reach of children.
Do not use Stelazine 1mg/5ml Syrup after the expiry date which is stated on
the box. 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out of date, take it to your pharmacist who will get rid of it safely.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. Store in the original package.

The active substance in Stelazine 1mg/5ml Syrup is trifluoperazine
hydrochloride. Each 5ml spoonful of Stelazine 1mg/5ml Syrup contains 1mg
trifluoperazine present as hydrochloride.
Stelazine 1mg/5ml Syrup also contains sodium saccharin, sodium benzoate
(E211), anhydrous citric acid (E330), sodium citrate, sorbitol (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 and
comes in amber glass bottles, containing 200ml syrup.

Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd.,
No.1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Universal Products (Lytham) Manufacturing Ltd.,
Fairfield, Bradshaw Lane, Greenhalgh, Preston, Lancashire, PR4 3JA
This leaflet was last revised in March 2012
Stelazine is a registered trade mark of Mercury Pharma Group Limited.




Stelazine® 1mg/5ml Syrup

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:

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

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.
• 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).
• 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.

DO NOT take Stelazine 1mg/5ml Syrup if:
• 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 (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
• suffering from a brain disorder causing tremors, rigidity and slowing of
movement (Parkinson’s disease)
• suffering from fits (epilepsy)
• suffering from an eye disease called narrow angle glaucoma which
causes increased pressure inside the eye,
• suffering from abnormal muscle weakness (Myasthenia gravis)
• suffering from an enlargement of prostate gland
• exposed to extremes in temperature as this medicine can affect body
temperature control

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• an elderly person
• if you suffer from loss of cognitive (memory, language, intelligence) ability
- dementia.
• 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.
• 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.

Remember each 5ml spoonful of syrup contains 1mg of “Trifluoperazine”

Patient Type

Low dosage
For the treatment of
anxiety or nausea
and vomiting


The usual dose is 2 mg to High dose in adults is
6mg a day
5-25mg a day in
divided doses

(over 65 years of age)

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


For children aged 3-5 High dose in children
years, the dose is no
(aged 6-12 years) is
more than 1mg a day. 5mg in divided doses.
For children aged 6-12
years the dose is no
more than 4mg a day.

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:
• sleeping tablets,
• strong pain killers (e.g. codeine)
• medicines which result in lowering of blood pressure (e.g. guanethidine)
• anticholinergic medicines used to reduce saliva and lung secretions (e.g.
atropine, procyclidine)
• antidepressants (e.g. other phenothiazines, lithium)
• medicines for fits (anticonvulsants)
• medicines for Parkinson’s disease (e.g. levodopa)
• blood thinning medicines (anticoagulants such as warfarin)
• medicines used to treat iron poisoning (desferrioxamine)
• antacids used to treat indigestion.
• medicines for psychiatric conditions (neuroleptics)
• heart medicines which prolong the QT interval (e.g quinidine,
disopyramide, procainamide, amiodarone, sotalol)
• drugs causing electrolyte imbalances (e.g diuretics)
You should tell your doctor or dentist that you are taking Stelazine 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.

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 55.22 mmol sodium per dose. To be taken
into consideration for patients on a controlled sodium diet.

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.

High dosage
For the control of
schizophrenia and
related conditions

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

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.

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:
• Very rarely, patients may experience a fast or irregular heartbeat,
constipation, difficulty or inability to pass urine or a high temperature.
• 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).


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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.