Patient Information Leaflet Trifluoperazine tablets

This leaflet tells you about ‘Trifluoperazine’ Tablets. Please read it before taking your tablets.

If there is anything you do not understand or you want to know more about your tablets, ask your doctor or pharmacist (chemist).

Please keep this leaflet. You may want to read it again.

What is in ‘Trifluoperazine’ Tablets?

These tablets contain the active ingredient trifluoperazine, they are available in two strengths, 1 and 5 milligrammes (mg). Your doctor will have prescribed one strength of tablet for you. The strength will be shown on your tablet pack.

Your tablets also contain inactive ingredients. These are: Starch, lactose, povidone, magnesium stearate, talc, Opaseal, sucrose, titanium dioxide E171 and Opalux blue which contains E132. ‘Trifluoperazine’ Tablets are available in packs of 50, 100, 250, 500, 1000 tablets.

Who makes ‘Trifluoperazine’ Tablets?

The Product Licence holder is Mercury Pharma (Generics) Ltd,

Capital House, 85 King William Street,

London EC4N 7BL,

UK

Manufactured by

Customs Pharmaceuticals Limited,

Tecore house, Conway Street,

Hove, East Sussex BN3 3LW,

UK.

What is ‘Trifluoperazine’ and how does it work?

This medicine belongs to a class of drugs called phenothiazine tranquillisers. You may also hear it 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 dosage ‘Trifluoperazine’ is used to manage anxiety, depression caused by anxiety and agitation. It is used in this way for short periods of time. ‘Trifluoperazine’ may also be used to treat nausea (feeling sick) and vomiting (being sick).

At high doses ‘Trifluoperazine’ is used to treat schizophrenia and related conditions. It can also be used for short periods of time to treat very bad agitation or dangerous behaviour.

Before taking your medicine

If you answer YES to any of the following questions and you have not already discussed these with your doctor, go back to your doctor and ask what to do.

You may need to be given another medicine or the dose may need to be changed.

•    Are you allergic to ‘Trifluoperazine’ or any related drug?

•    Do you have a liver problem, blood disorder, heart disease (such as angina or heart rhythm problems), epilepsy, Parkinson’s disease, myasthenia gravis (extreme muscle fatigue), glaucoma or prostate problems?

•    Are you pregnant, or think you may be?

•    Are you breast-feeding?

•    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.

Before you take these tablets you should tell your doctor if you are taking any other medicines, including those not prescribed for you that you may have bought. This is particularly important if you are taking the following medicines:

•    Medicines to prevent fits (anticonvulsants)

•    Medicines to treat Parkinson’s disease (e.g. levodopa)

•    Sleeping tablets

•    Strong pain killers

•    Medicines for high blood pressure (e.g. guanethidine)

•    Anti-cholinergic medicines (e.g. atropine, procyclidine)

•    Medicines for depression

•    Medicines which reduce white blood cell production

•    Metrizamide (used in radiology for spinal cord and brain examinations)

•    Desferrioxamine (used to treat iron poisoning)

•    Medicines to thin your blood (anticoagulants)

You should also tell your doctor or dentist if you are taking ‘Trifluoperazine’ before being given an anaesthetic.

Medicines such as ‘Trifluoperazine’ may affect the way your body helps to keep you warm (e.g. shivering) or cool (e.g. sweating). Be careful at extremes of temperature.

You should not drink alcohol while you are taking these tablets.

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.

‘Trifluoperazine’ may cause drowsiness, dizziness and blurred vision. Take care if you are driving, operating machinery or doing other activities where you need to be alert. You should not do any of these activities if you experience any of these effects; if you suffer badly tell your doctor.

This medicine will not be given to patients who are in a coma.

Taking your medicine

Swallow your tablets without chewing them, you can drink a glass of water if you wish.

The dose of Trifluoperazine’ which your doctor prescribes will depend on your symptoms.

The usual dose of ‘Trifluoperazine’ is shown in the table below:

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 total dose is 2 mg to 6 mg a day	The usual dose is 10 mg to 15 mg a day. Further increases in your dose may be made at minimum intervals of 3 days.
Elderly (over 65 years of age)	The starting dose of ‘Trifluoperazine’ should be no more than half that of adult patients	The starting dose of ‘Trifluoperazine’ should be no more than half that of adult patients.
Children	For children aged 6-12 years	For children aged under 12

	the dose is no more than 4 mg a	years the starting dose is no
	day	more than 5 mg a day

You will usually need to take your medicine twice or three times a day depending on the dose your doctor has prescribed. Your doctor or pharmacist will tell you when you should take it.

Doctors sometimes prescribe different doses to those given above. If this applies to you discuss it with your doctor if you have not already done so.

The pharmacist’s label on your pack will tell you how much your doctor would like you to take. Please read the label carefully.

Do not take more than your doctor has recommended.

For how long should you take ‘Trifluoperazine’?

It is important to follow your doctor’s instructions. For mood disorders and schizophrenia, it may take several weeks for you to feel the full benefit of this medicine. If you stop your treatment suddenly, your symptoms may come back. Nausea, vomiting, insomnia and involuntary movement disorders have also been reported. To help prevent this, it is best to gradually reduce the treatment.

What if you have taken too much?

You should only take the dose that your doctor or pharmacist has told you. If you take too many tablets, contact your doctor or hospital casualty department straight away. Take your tablet pack with you.

What if you miss a tablet?

Leave out that dose completely. Take your next dose of ‘Trifluoperazine’ at the normal time.

After taking your medicine

What unwanted effects might ‘Trifluoperazine’ have?

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.

Any medicine can cause unwanted effects. Some patients may experience weakness, drowsiness, dizziness, restlessness, difficulty in sleeping, dry mouth, blurred vision, and muscle weakness, loss of appetite, faintness on standing up, skin rashes (including increased sensitivity to the sun), weight gain, water retention or confusion.

Very rarely patients may experience a fast or irregular heartbeat, constipation, difficulty in passing urine or a high temperature. Rarely ‘Trifluoperazine’ may 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). Occasionally some patients have complained of feeling dulled, whilst others of being agitated.

Very occasionally, medicines such as ‘Trifluoperazine’ 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 postitioning of the head), rigid muscles, tremors or restlessness and difficulty in sitting still. Some patients (especially those on high doses of ‘Trifluoperazine’) 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 head, neck or trunk. Uncontrollable movements of the arms and legs have also been reported in these patients.

If these effects occur tell your doctor straight away.

Rarely patients taking ‘Trifluoperazine’ develop an unusual reaction, even though they may have been taking it for some time. Symptoms of this reaction are a high temperature, rigid muscles, drowsiness and occasional loss of consciousness. This is called Neuroleptic Malignant Syndrome and requires emergency admission to hospital for treatment.

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 have angina and your pain becomes worse, tell your doctor straight away.

There have been very rare reports of jaundice (yellowing of the skin and eyes), eye problems, skin colouring (pigmentation), and blood problems. If you get a bad sore throat or high fever or become very tired and pale or you notice bruises and nose bleeds tell your doctor.

Nausea, vomiting, insomnia and involuntary muscle disorders are all possible if treatment is suddenly stopped.

Your doctor should check your progress regularly, if you are on ‘Trifluoperazine’ for a

long time, to make sure no unwanted effects are developing._

Tell your doctor or pharmacist (chemist) if you notice any of the above, unwanted effects or other effects not listed above.

Storing your medicine

•    Your tablets will have an expiry date on the pack. You should not use your tablets after this date.

•    Keep the tablets in a dry place and do not store above 25°C and protect from light by keeping in their original pack.

Remember this medicine has been prescribed just for you. Never offer your tablets to other people they may not be suitable for them, even if their symptoms seem the same as yours.

This leaflet was last revised in December 2013

Trifluoperazine 1mg PL 16201/0021 Trifluoperazine 5mg PL 16201/0022