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TRIFLUOPERAZINE 1MG TABLETS

Active substance(s): TRIFLUOPERAZINE / TRIFLUOPERAZINE HYDROCHLORIDE

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Ref: 1512/260615/1/F

Trifluoperazine 1mg Tablets
(trifluoperazine hydrochloride)
Patient Information Leaflet
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.
Your medicine is called Trifluoperazine 1mg Tablets but will be referred to as
Trifluoperazine Tablets throughout the rest of this leaflet. Please note that
the leaflet also contains information about the other strength of the medicine,
Trifluoperazine 5mg Tablets
In this leaflet:
1

What Trifluoperazine Tablets are and what they are used for

2

Before you take Trifluoperazine Tablets

3

How to take Trifluoperazine Tablets

4

Possible side effects

5

How to store Trifluoperazine Tablets

6

Further information

1

What Trifluoperazine Tablets are and what they are
used for

Trifluoperazine Tablets contain the active ingredient trifluoperazine
hydrochloride, which belongs to a class of drugs called phenothiazine
tranquilisers. It influences the activity of certain brain cells by decreasing the
effect of dopamine, a natural chemical in the brain.
* At a low dose, Trifluoperazine Tablets are used to manage anxiety and
depression. It is used in this way for short periods of time.
* Trifluoperazine tablets may also be used to treat nausea (feeling sick) and
vomiting (being sick).
* At high doses, Trifluoperazine Tablets are used to treat and prevent
relapses of schizophrenia (a serious mental illness) and related conditions.

2

Before you take Trifluoperazine Tablets

DO NOT take Trifluoperazine Tablets if:
* You know that you are allergic to trifluoperazine hydrochloride or any of the
other ingredients of Trifluoperazine Tablets (see section 6 of this leaflet).
* You are suffering from liver problems, blood disorders, inability of the heart
to maintain adequate circulation causing breathlessness and swelling of
the ankles.
* You have previously had to stop taking other medicines for psychiatric
problems like Trifluoperazine (known as phenothiazines) because they
have affected your blood cells or caused jaundice (yellowing of the skin
and eyes). Ask your doctor about this.
* You are having a special X-ray examination of the brain or spinal cord
involving a chemical called metrizamide (your doctor will be able to help
you).
Take special care with Trifluoperazine Tablets and tell your doctor if
you are:
* if you or any member of your family is suffering from any disease involving
the heart and blood vessels (cardiovascular disease) including chest pain
(angina) and irregular heartbeats.
* 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, abnormal muscle weakness
(Myasthenia gravis) or enlargement of prostate gland.
* exposed to extremes in temperature as this medicine can affect body
temperature control.
* 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.
* 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.

-

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).

Even though some of the above may appear obvious, it is important that
your doctor is aware if any of them apply to you.
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.
* anaesthetics used prior to surgery.
* 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)
Taking Trifluoperazine Tablets with food and drink
You should not drink alcohol whilst you are taking this medicine.
Pregnancy and breast feeding
Do not take Trifluoperazine Tablets 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 Tablets 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 Tablets 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
Tablets
This medicine also contains sucrose. If you have been told by your doctor
that you are intolerant to some sugars, contact your doctor before taking this
medicine.

3

How to take Trifluoperazine Tablets

Always take Trifluoperazine Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Swallow the tablets with a glass of water. The tablets can be taken with or
without food. Your doctor will decide on a suitable dose depending on your
condition.
Adults:
* The normal adult dose for anxiety or vomiting is 2-6mg daily, and for
schizophrenia is 10-15mg daily. The dose may be split over two or three
times a day.
Children:

* For children aged 6-12 years the dose for anxiety or nausea and

vomiting is no more than 4mg a day, and for children aged under 12
years the starting dose for schizophrenia is no more than 5mg a day.

Ref: 1512/260615/1/B

Trifluoperazine 1mg Tablets
(trifluoperazine hydrochloride)
Patient Information Leaflet (continued)
The pharmacist’s label on your pack will tell you how much and how often
you should take your tablets. Please read the label carefully. Do not take
more than your doctor has recommended.
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 are also taking other medicines.
If you stop taking Trifluoperazine Tablets:
* Continue to take Trifluoperazine Tablets 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 tablets 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 Tablets than you should:
If you think that you, or any other person, have taken too many tablets,
contact your doctor or hospital casualty department immediately. Take this
leaflet and any remaining tablets with you so that the medical staff know
exactly what you have taken.
If you forget to take your Trifluoperazine Tablets:
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 Tablets can sometimes cause side effects,
although not everybody gets them.
Stop taking Trifluoperazine Tablets immediately and call your doctor if
you experience signs of allergic reaction.
Signs of an allergic reaction include a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
Tell your doctor straight away if you notice any of the following serious side
effects:
* 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.
* Rarely, Trifluoperazine Tablets 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).
* 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.
* Very occasionally, medicines such as Trifluoperazine Tablets 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.
* Very rarely, patients may also experience a fast or irregular heartbeat,
constipation, difficulty or inability to pass urine or a high temperature.
* Occasionally, some patients have complained of feeling slowed down,
whilst others of being agitated.
* If you have angina and your pain is getting worse.
* There have been very rare reports of jaundice (yellowing of skin and
whites of eyes), eye problems, skin colouring (pigmentation) and blood
problems.
* 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 or eye problems,
muscle weakness, loss of appetite, faintness on standing up, weight gain,
water retention causing swelling or confusion.
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 Tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
Do not take Trifluoperazine Tablets after the expiry date stated on blister
label or carton. The expiry date refers to the last day of that month.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
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 Tablets contains:
Each film coated tablet contains 1mg trifluoperazine present as the
hydrochloride.
Other ingredients are calcium sulphate dihydrate, sucrose, maize starch,
gelatin, talc, stearic acid, hypromellose (E464), titanium dioxide (E171),
macrogol 400, indigo carmine (E132) and carnauba wax.
What Trifluoperazine Tablets looks like and contents of the pack
Trifluoperazine 1mg are blue aqueous film coated tablets marked FW231
and plain on the reverse.
Each blister pack contains 112 Film-Coated tablets.
Manufacturer and Licence Holder
Manufactured by Bristol Laboratories Ltd., Laporte Way, Luton Bedfordshire,
LU4 8WL and is procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1512

Trifluoperazine 1mg Tablets

Revision date: 26/06/15

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Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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