Patient leaflet - Trifluoperazine 2 mg tablets
1. What trifluoperazine tablets are and what they are used for
Trifluoperazine tablets contain the active ingredient trifluoperazine, which belongs to a class of drugs called phenothiazine tranquilisers. 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 and 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.
2. What you need to know before you take trifluoperazine tablets
DO NOT take trifluoperazine tablets if:
- you are allergic to trifluoperazine or any of the other ingredients of this medicine (listed in section 6).
- you are having a liver problem, blood disorders, heart disease (such as angina or heart rhythm problems).
This medicine will not be given to patients who are in a coma.
Warning and precautions
Talk to your doctor or pharmacist before taking trifluoperazine tablets 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.
- are an elderly person.
- suffer from loss of cognitive (memory, language, intelligence) ability - dementia.
- or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
- previously suffered from neuroleptic malignant syndrome (high fever, sweating, unstable blood pressure, muscle rigidity, dazed, drowsy state).
- have had a stroke, or you have any of the following that can increase your risk of having a stroke.
- have a heart attack.
- have a TIA (transient ischaemic attack). This is a type of stroke where symptoms last less than 24 hours.
- have an artificial heart valve.
- have uncontrolled high blood pressure.
- have diabetes.
- have high cholesterol.
- have a family history of strokes.
- smoke.
- drink excess alcohol (this tends to weaken blood vessels and can raise blood pressure). PACKAGE LEAFLET: INFORMATION FOR THE USER
Trifluoperazine 1 mg, 2 mg and 5 mg Tablets
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).
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.
Even though some of the above may appear obvious, it is important that your doctor is aware if any of them apply to you.
Other medicines and trifluoperazine tablets
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines. 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)
anticholinergic medicines
(e.g. atropine, procyclidine)
- medicines for depression (e.g. other phenothiazines (e.g. prochlorperazine), lithium)
- 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.
Trifluoperazine tablets with food, drink and alcohol
You should not drink alcohol whilst you are taking these tablets.
Pregnancy, breast-feeding and fertility
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.
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 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.
Trifluoperazine tablets contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Trifluoperazine tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’
3. How to take trifluoperazine tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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 recommended dose is:
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.
Patient
Type
Low dosage
For the
treatment of anxiety or nausea and
vomiting
High dosage
For the control of schizophrenia and related conditions
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 the dose
is no more than
4 mg a day
For children aged under 12 years the starting dose is no 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.
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 take more trifluoperazine tablets than you should
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.
If you forget to take your trifluoperazine tablets
Leave out that dose completely. Take your next dose of trifluoperazine at the normal time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking trifluoperazine tablets
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any below serious side effects, stop taking trifluoperazine tablets immediately and contact your doctor straight away.
- Blood clots in the veins especially in the legs (symptoms include swelling, pain 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.
- Signs of serious abnormal or irregular heart rhythms or abnormal ECG heart tracing.
- Skin rashes (including increased sensitivity to the sun).
- 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.
Other side effects are:
Rare: may affect up to 1 in 1,000 people
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 positioning of the head), rigid muscles, tremors or restlessness and difficulty in sitting still.
Very rare: may affect up to 1 in 10,000 people
- Fast heartbeat
- Constipation
- Difficulty in passing urine
- High temperature
- Jaundice (yellowing of the skin and eyes)
- Eye problems
- Skin colouring (pigmentation)
- 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.
Not known: frequency cannot be estimated from the available data
‘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) MPL17833 - P1.1
- Physical or mental tiredness or lack of energy
- Loss of appetite
- Weight gain
- Drowsiness,
- Dizziness
- Restlessness
- Difficulty in sleeping
- Blurred vision
- Faintness on standing up
- Dry mouth
- Muscle weakness
- Water retention
- Confusion
- Occasionally some patients have complained of feeling dulled, whilst others of being agitated
- 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.
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.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store trifluoperazine tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package and protect from light.
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.
6. Contents of the pack and other information
What trifluoperazine tablets contain
The active substance in trifluoperazine tablets is trifluoperazine hydrochloride.
Trifluoperazine tablets are available in three strengths, containing trifluoperazine hydrochloride equivalent to 1 mg, 2 mg or 5 mg of trifluoperazine.
The other ingredients are:
- Core Tablet: Calcium sulphate dihydrate, Sucrose, Maize starch, Sodium starch glycollate and Magnesium stearate (E470b).
- Film-coating: Opadry blue-OY-4492, Opadry white 02B180002 and Propylene glycol 400 (E1520).
What trifluoperazine tablets look like and contents of the pack
Trifluoperazine 1 mg tablets are blue coloured, round biconvex film-coated tablet debossed with ‘S1’ on one side and plain on other side. Diameter 5.60mm.
Trifluoperazine 2 mg tablets are white coloured, round biconvex film-coated tablet debossed with ‘S2’ on one side and plain on other side. Diameter 5.60mm.
Trifluoperazine 5 mg tablets are blue coloured, round biconvex film-coated tablet debossed with ‘S5’ on one side and plain on other side. Diameter 7.60mm.
The tablets are packaged in PVC/PVdC-Alu blister packs of 4, 7, 10, 14, 20, 24, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way, Leicester, LE19 1WP, UK
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Loughborough, LE11 5GW, UK Morningside Pharmaceuticals Ltd.
& Aspire Pharma Ltd.
Second Floor, Boss Court, 7 Barton Close Grove Park, Leicester, LE19 1SJ, UK Aspire Pharma Ltd.
Unit 4, Rotherbrook Court, Bedford Road Petersfield, Hampshire, GU32 3QG, UK