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TRIFLUOPERAZINE 5MG/5ML ORAL SOLUTION

Active substance(s): TRIFLUOPERAZINE HYDROCHLORIDE

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low blood pressure. You may feel dizzy when standing up
yellowing of the skin and whites of your eyes (jaundice)
unusual movements, often of the mouth, lips, eyes and tongue. These movements can also include trembling
and shaking of the hands and feet, twisting of the body, shuffling walk and stiffness of the arms and legs
and unable to sit still
n blurred vision, eye changes such as clouding of the lens or purple colouring of the skin
n repeated infections. Your doctor may want to perform some tests
n symptoms coming back if you have breast cancer.
Tell your doctor if you get any of these side effects:
n feeling tired, drowsy or dizzy
n unable to sleep, feeling restless
n dry mouth
n fever
n skin rashes, skin reaction to direct sunlight
n swelling of the breasts (particularly in men) and breast milk
production
n light periods or absence of periods
n weight gain, loss of appetite
n muscle weakness
n water retention, difficulty in passing water (urine)
n constipation
n changes in your level of alertness
n sleep walking, particularly if you are taking lithium at the same time as 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/Yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Trifluoperazine Solution
Keep this medicine out of the sight and reach of children
Store below 25°C. Protect from light
Take back any remaining solution to the pharmacy 1 month after you first open it
Do not use this medicine after the expiry date which is stated on the label and carton (exp: month, year)
The expiry date refers to the last day of that month
Do not use this medicine if you notice that the appearance or smell of your medicine has changed. Talk to
your pharmacist
n Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
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6. Contents of the pack and other information
What Trifluoperazine Solution contains
n The active ingredient is trifluoperazine hydrochloride
n The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol
(E1520), sorbitol solution 70% (E420), liquid maltitol (E965), ascorbic acid (E330), lime flavour, aniseed flavour,
caramel E150 and purified water.
What Trifluoperazine Solution looks like and contents of the pack
A pale brown syrup with an odour of aniseed and lime.
It comes in a brown glass bottle holding 150ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last revised in 11/2015

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Package leaflet: Information for the user
Trifluoperazine 5mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine
- because it contains important information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or
your pharmacist.
n This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
n If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Trifluoperazine Solution is and what it is used for
2. What you need to know before you take Trifluoperazine Solution
3. How to take Trifluoperazine Solution
4. Possible side effects
5. How to store Trifluoperazine Solution
6. Contents of the pack and other information


1. What Trifluoperazine Solution is and what it is used for

The name of your medicine is Trifluoperazine 5mg/5ml Oral Solution (referred to as Trifluoperazine Solution in this
leaflet). It contains trifluoperazine hydrochloride. This belongs to a group of medicines called phenothiazines.
Trifluoperazine can be used to treat:
n schizophrenia
n behavioural problems
n feeling and being sick
n or to calm your emotions particularly if you feel anxious, agitated, paranoid depressed.

2. What you need to know before you take Trifluoperazine Solution
Do not take Trifluoperazine Solution if:
n you are allergic (hypersensitive) to trifluoperazine (or medicines like trifluoperazine) or any other ingredients in
this liquid (listed in section 6). The signs of allergic reaction can include a rash, itching or shortness of breath
n you are pregnant or breast-feeding
n you have a history of or currently have blood problems
n you have liver problems
n you have heart failure.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist
before taking Trifluoperazine Solution.
Warnings and precautions
Talk to your doctor or pharmacist before taking Trifluoperazine Solution, if:
n you have heart problems including unusual heart beats, heart disease or heart failure or angina
n you have Parkinson’s Disease
n you have epilepsy
n you have or have had in the past narrow angle glaucoma (this is abnormal pressure in the eye accompanied by
pain and blurred vision)
n you have a condition that causes muscle weakness with tiredness, called myasthenia gravis
n you have an enlarged prostate gland
n 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
n you have had a stroke or you have any of the following that can increase your risk of having a stroke
- a heart attack
- a TIA (transient ischaemic attack). This is a type of stroke where symptoms last less than 24 hours

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- an artificial heart valve
- uncontrolled high blood pressure
- diabetes
- high cholesterol
- a family history of strokes
- you smoke
- you drink excess alcohol (this tends to weaken blood vessels and can raise blood pressure).
Trifluoperazine may affect the way your body helps to keep you warm (shivering) or cool (sweating). Be careful at
extremes of temperature.
Other important information to take into account before you

take this medicine:
n if you or members of your family have heart problems

(including heart failure, heart attack or uneven heart beats) or
you have low potassium or magnesium in your blood, your
doctor may do some tests on your heart and blood before
giving you this medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Trifluoperazine
Solution.
Other medicines and Trifluoperazine Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes
medicines you buy without a prescription, including herbal medicines. This is because trifluoperazine can affect the
way some other medicines work. Also some medicines can affect the way trifluoperazine works.
Tell your doctor if you are taking any of these medicines:
n medicines that help you sleep such as temazepam
n anaesthetics used prior to surgery
n strong painkillers such as codeine
n medicines to treat high blood pressure such as guanethidine
n anticholinergic medicines used to reduce saliva and lung secretions such as atropine, procyclidine
n heart medicines such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, bretylium
n desferrioxamine, used to treat some types of anaemia, a type of blood problem
n medicines that affect electrolytes such as diuretics (water tablets)
n levodopa, used to treat Parkinson's disease
n metrizamide, used when you are having scans at the hospital (radiography)
n medicines to treat mental illness and depression such as other phenothiazines, lithium
n medicines to thin your blood (anticoagulants) such as warfarin
n medicines to treat heartburn or indigestion
n medicines for psychiatric conditions such as neuroleptics.
Trifluoperazine Solution with food, drink and alcohol
You must not drink alcohol whilst taking this medicine. This is because this medicine may make you feel drowsy and
drinking alcohol will make you even more drowsy. Drinking alcohol may also affect the condition you are suffering
from.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. You should not use this medicine if you are pregnant or breastfeeding unless your doctor feels it is absolutely necessary.
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 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 you have
any doubts, talk to your doctor before you drive or use machines.
Important information about what is in this medicine:
Trifluoperazine Solution contains:
n methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some
time after starting the medicine
n sorbitol and liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see
your doctor before taking this medicine.
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3. How to take Trifluoperazine Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if
you are not sure.
Taking this medicine
n this medicine contains 5mg of trifluoperazine in each 5ml
n take this medicine by mouth
n if you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but
talk to your doctor or pharmacist.

Adults
n The usual dose ranges from 2mg to 15mg daily in divided
doses
n You will start treatment on a low dose and will be increased
as necessary by your doctor
n Older people will need to start on a lower dose as you may be
more sensitive to the effects of the medicine. Your doctor will gradually increase this dose.
Children
Low Dose
n Children aged 3 to 5 years: up to 1mg a day. You should split this dose over the day
n Children aged 6 to 12 years: up to 4mg a day. You should split this dose over the day
High dose
n Children under 12 years of age: up to 5mg a day. You should split this dose over the day. Your doctor may
increase this dose.
If you take more Trifluoperazine Solution than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you
have taken. Signs of an overdose may include difficulty with movement and low blood pressure which may make
you feel dizzy when standing up.
If you forget to take Trifluoperazine Solution
n Do not take a double dose (two doses at the same time) to make up for forgotten doses.
n Skip the missed dose then go on as before.
If you stop taking Trifluoperazine Solution
Keep taking Trifluoperazine solution until your doctor tells you to stop. The doctor will lower your dose gradually.
If you stop taking the medicine suddenly you may get withdrawal symptoms. Signs include:
n feeling or being sick, sweating and difficulty in sleeping (insomnia)
n your original symptoms becoming worse
n movements that you can’t control.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects

Like all medicines, trifluoperazine can cause side effects, although not everybody gets them.
Stop taking the medicine straight away and see your doctor if:
n you have an allergic reaction to trifluoperazine solution
An allergic reaction may include any kind of skin rash, flaking skin, boils or sore lips and mouth, sudden
wheezing, fluttering or tightness of the chest or collapse.
n you have any of the following symptoms:
- unusually fast heart beat, unstable blood pressure (feeling dizzy, light-headed or faint) and sweating.

These are early warning signs of a disorder caused by the type of medicine you are taking
- very high body temperature, muscle stiffness or a change in consciousness leading to coma.
If you get any of the following side effects, see your doctor as soon as possible:
n 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
n feeling agitated, confused or over-excited
n blood problems. You may notice signs such as high temperature or chills, sore throat, ulcers in
your mouth or throat and unusual tiredness
n heart changes including fast heart beats, unusual heart beats, heart attack. Symptoms of a heart attack
are chest pain which may spread to the shoulders, neck or arms and shortness of breath. If you get these
see a doctor straight away. Unexplained deaths have been reported but it is not proven that they were
caused by trifluoperazine
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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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