Patient leaflet - Trifluoperazine tablets BP 5 mg
1 What Trifluoperazine is and what it is used for
Trifluoperazine belongs to a group of medicines called phenothiazines. They act on the central nervous system and produce a calming effect, relieving anxiety and tension.
Trifluoperazine is used for the following:
Low dose
- For short term treatment of anxiety and agitation
- To treat feeling or being sick (nausea and vomiting)
High dose
- To treat and prevent relapse of mental disorders such as schizophrenia
- To treat severe agitation, or mental disorders where dangerous or impulsive behaviour may be likely
2 What you need to know before you take Trifluoperazine
Do not take Trifluoperazine if:
- You are allergic (hypersensitive) to Trifluoperazine, other phenothiazines or any of the other ingredients of this medicine (listed in Section 6)
- You have loss of consciousness (comatose state)
- You have slower breathing or heartbeat, loss of motor skills, unclear speech, thinking or vision (CNS depression)
- You have an untreated growth on your adrenal gland (phaeochromocytoma)
- You have blood problems
- You have liver problems
- You have uncontrolled heart problems
Warnings and precautions
Talk to your doctor before taking Trifluoperazine if:
- You have or your family has a history of heart problems, including irregular heartbeat and chest pain (angina pectoris)
- You have had bone marrow suppression (condition where bone marrow activity is decreased, resulting in fewer red and white blood cells and platelets) or jaundice (yellowing of the skin or whites of the eyes) when being treated with a phenothiazine
- You have Parkinson’s disease, as the symptoms may become worse
- You have epilepsy
- You are given metrizamide, used during hospital scans (radiography)
- You have increased pressure in the eye (narrow angle glaucoma)
- You have muscle weakness (myasthenia gravis)
- You have an enlarged prostate
- You are elderly as you may be more susceptible to effects such as movement disorders, and low blood pressure. Trifluoperazine is not intended for the treatment of dementia-related behavioural disturbances
You are at risk of having a stroke. Risk factors include:
- If you have had a mini stroke where symptoms last less than 24 hours (Transient Ischaemic Attack ’TIA’)
- If you have uncontrolled high blood pressure
- If you have diabetes, high cholesterol
- If you are a smoker
- If you drink excessive amounts of alcohol
- If you have a history of blood clots
Other medicines and Trifluoperazine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which should not be taken with Trifluoperazine:
- Desferrioxamine, for acute iron poisoning
Medicines which may interact with or be affected by Trifluoperazine:
- Levodopa, used to treat Parkinson’s disease (the effects may be reversed)
- Anaesthetics
- Strong pain relievers, such as morphine and codeine (analgesics)
- Guanethidine, for high blood pressure
- Other medicines for high blood pressure, heart problems or migraine,such as propanolol (beta blockers), captopril (ACE inhibitors) and candesartan (angiotensin −II− antagonists)
- Medicines to prevent motion sickness and used as a pre−medication for anaesthesia (anticholinergics), such as atropine and hyoscine
- Lithium, for mood disorders
- Antidepressants, such as amitriptyline
- Medicines for abnormal heart rhythms such as sotalol
- Metoclopramide and domperidone, for feeling (nausea) or being sick (vomiting)
- Kaolin, for diarrhoea
- Cimetidine and sucralfate, for stomach ulcers and indigestion (antacids)
- Medicines for diabetes, such as glipizide (sulphonylureas)
- Medicines for epilepsy such as carbamazepine, phenytoin, phenobarbital
- Medicines for mental or emotional disorders such as pimozide, thioridazine, haloperidol, sulpride, clozapine, chloropromazine, olanzapine, risperidone quetiapine, zotipine (antipsychotics)
- Sibutramine, for weight loss
- Medicines for treatment of severe allergic reactions, such as adrenaline (sympathomimetics)
- Tetrabenazine, for movement disorders
- Diazepam and buspirone, used to treat anxiety (hypnotics)
- Medicines that cause electrolyte imbalances such as diuretics (medicines used to increase frequency of urination such as furosemide)
- Medicines used to thin the blood such as warfarin (anticoagulants)
Taking Trifluoperazine with alcohol
Trifluoperazine may enhance the effects of alcohol.
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 for advice before taking this medicine.
Pregnancy
Trifluoperazine should not be taken if you are pregnant, especially during the first 3 months, unless your doctor considers it absolutely necessary.
The following symptoms may occur in newborn babies, of mothers that have used Trifluoperazine in the last trimester (last three months of pregnancy): shaking (tremor), muscle stiffness and/or weakness, sleepiness (somnolence), agitation, breathing problems and difficulty in feeding.
Breast-feeding
If you are breast−feeding you should not take this medicine (as it is passed into breast milk), unless told to do so by your doctor.
Driving and using machines
Trifluoperazine may cause drowsiness, dizziness and visual disturbances. Do not drive or use machines when you first start taking this medicine until you are certain that you are not getting these effects.
Trifluoperazine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 How to take Trifluoperazine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- These tablets are to be taken orally
- Swallow whole with a little water
Adults:
Low dose (anxiety, feeling or being sick)
- The usual dose is 2mg to 4mg each day in divided doses.
- The maximum dose is 6mg each day.
High dose (severe agitation, mental disorders)
- The intial dose is 5mg twice a day.
- After a week, your doctor may increase this dose to 15mg a day. If necessary, your doctor may increase the dose every three days by 5mg a day.
- When your doctor is happy that you are responding to your treatment, they may gradually reduce the dose.
Use in children
Low dose (anxiety, feeling or being sick)
- Age 3 − 5 years: syrup form of the medicine is recommended.
- Age 6 − 12 years: the usual dose is up to 4mg a day in divided doses.
High dose (severe agitation, mental disorders)
- Age under 12 years: the intial dose is up to 5mg a day in divided doses. If necessary this dose may be increased, very gradually (not more than every 3 days) and the dose should be adjusted according to the child’s age and weight and response.
Elderly and frail patients
- The starting dose should be at least half the adult dose.
If you take more Trifluoperazine than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately. Remember to take this leaflet or any remaining tablets with you.
Symptoms of overdose include: medicine-induced movement disorders (extrapyramidal symptoms) and low blood pressure (hypotension).
If you forget to take Trifluoperazine
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Trifluoperazine
You may not feel better for several weeks after you start taking your tablets. It is important that you keep taking Trifluoperazine for as long as your doctor has told you to. Your doctor will advise you to lower the dose gradually.
The following withdrawal symptoms can occur after you stop treatment, especially if stopped suddenly: feeling (nausea) or being sick (vomiting), sweating, difficulty sleeping (insomnia), recurrence of original symptoms, movement disorders such as involuntary movements (dyskinesia), feeling restless (akathisia) or being unable to sit still (dystonia).
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.
Seek medical advice immediately if you develop the following symptoms:
- Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness
- Very high temperature (hyperpyrexia)
If you get any of the following side effects, see your doctor as soon as possible:
- Spasms or involuntary muscle contractions/movements. These may include tremor (shakiness), muscle stiffness, shuffling, feeling restless, unable to keep still, distortion of the head or face, tightly closed jaw, tongue protrusion and unusual eye movement (more likely to occur if dose is more than 6mg a day) . These effects are likely to be particularly severe in children.
- Abnormal muscle contraction of the face or limbs has occurred in some patients on long-term high dosage. Symptoms may appear for the first time either during or after a course of treatment; they may become worse when treatment is stopped. The symptoms may continue for several months or years and while they may gradually disappear, they may be permanent. Elderly, female or patients with impaired mental function are more at risk
- Irregular heart rhythm, feeling your heartbeat (palpitations), extreme dizziness, shortness of breath, chest pain. These may be symptoms of serious heart problems including heart attack (cardiac arrest). Unexplained deaths have been reported
- Yellowing of the skin and whites of the eyes (jaundice)
- Blood disorders which may make infections more likely, cause weakness, bruising or increase the risk of bleeding
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
Side effects
- Physical or mental weariness (lassitude)
- Drowsiness
- Constipation
- Difficulty passing urine or unable to pass urine
- Skin colouring (pigmentation)
- Cloudy lenses of the eye
- Abnormally high levels of prolactin in the blood (hyperprolactinaemia)
- Secretion of breast milk not due to breast-feeding (galactorrhoea)
- Lack of menstrual periods (amenorrhoea)
- Enlargement of breasts in men (gynaecomastia)
- Feeling restless
- Feeling indifferent or unemotional (apathy)
- Difficulty sleeping (insomnia)
- Dizziness
- Muscle weakness
- Dry mouth
- Blurred vision
- Feeling dizzy when standing up (postural hypotension)
- Loss of appetite (anorexia)
- Increased sensitivity to sunlight (photosensitivity)
- Weight gain
- Swelling of parts of the body (oedema)
- Confusion
- Faster heartbeat (tachycardia)
- Reduced alertness
- Feeling agitated
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
- Keep this medicine out of the sight and reach of children.
- Do not use Trifluoperazine after the expiry date which is stated on the label after EXP.
- Store in a cool, dry place.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6 Contents of the pack and other information
What Trifluoperazine Tablets contains:
- Each 1mg tablet contains 1.2mg of trifluoperazine hydrochloride equivalent to 1mg of trifluoperazine
- Each 5mg tablet contains 6mg of trifluoperazine hydrochloride equivalent to 5mg of trifluoperazine
The other ingredients are: starch, pregelatinised starch, lactose, sodium starch glycollate, water, colloidal anhydrous silica and magnesium stearate
The sugar coating contains: sugar, povidone, purified talc, titanium dioxide (E171), opalux ASF 5899 (dry basis) quinoline yellow (E104), patent blue (E131) and iron oxide (E172), beeswax, carnauba wax, opagloss.
What Trifluoperazine looks like and the contents of the pack:
Trifluoperazine are pea−green, sugar−coated tablets.
Trifluoperazine is available in:
Trifluoperazine Tablets are available in containers of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250, 500 or 1000 tablets. Trifluoperazine 5mg also comes in a 5000 pack size.
Not all pack sizes may be marketed.
Product Licence Numbers:
- Trifluoperazine 1mg Tablets: PL 20416/1088 PL 51718/0014
- Trifluoperazine 5mg Tablets: PL 20416/1089PL 51718/0015
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Crescent Pharma Limited
Key House, Sarum Hill,
Basingstoke, RG21 8SR
United Kingdom
Manufacturer
Clydesdale Pharma Ltd
Unit 3-4 Campbell Court
Campbell Road
Tadley
United Kingdom
This leaflet was last revised in April 2020April 2025
CP0014-15.LT.V0