Trifluoperazine 1 mg Tablet

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 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.

The product is known by the name above but will be referred to as Trifluoperazine Tablets throughout the rest of this leaflet.

What is in this leaflet:

1. What Trifluoperazine Tablets are and what they are used for
2. What you need to know before you take Trifluoperazine Tablets
3. How to take Trifluoperazine Tablets
4. Possible side effects
5. How to store Trifluoperazine Tablets
6. Contents of the pack and other information

• if you are allergic to trifluoperazine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you are suffering from liver problems, blood disorders, inability of the heart to maintain adequate circulation causing breathlessness and swelling of the ankles.
• if 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.
• if 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).
• if you suffer from any abnormality of the cells of blood or are taking medicines which can reduce blood cells.

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 heart beats.
• if you are suffering from a brain disorder causing tremors, rigidity and slowing of movement (Parkinson’s disease).
• if you are suffering from fits (epilepsy).
• if you are 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.
• if you are exposed to extremes in temperature as this medicine can affect body temperature control.
• if you are an elderly person.
• if you are suffering 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.
• if you previously suffered from neuroleptic malignant syndrome (high fever, sweating, unstable blood pressure, muscle rigidity, dazed, drowsy state).
• if 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.

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)

You should not drink alcohol whilst you are taking this medicine.

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.

It is particularly important not to take Trifluoperazine Tablets during the first three months of pregnancy.

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 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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 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.

• 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.

• Signs of an allergic reaction including a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• 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.

Tell your doctor straight away if you notice any of the following serious side effects:

Rare: may affect up to 1 in 1,000 people

• 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.
• 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).
• Abnormal heart rhythms including a life-threatening irregular heart beat called torsades de pointes or abnormal ECG heart tracing or heart stopping (cardiac arrest) and unexplained death.

Very rare: may affect up to 1 in 10,000 people

• Patients may experience a fast or irregular heartbeat, constipation, difficulty or inability to pass urine or a high temperature.
• Jaundice (yellowing of skin and whites of eyes), eye problems, skin colouring (pigmentation) and blood problems.
• 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.

Not known: frequency cannot be estimated from the available data

• 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).
• 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.
• Occasionally, some patients have complained of feeling slowed down, whilst others of being agitated.
• If you have chest pain (angina) and your pain is getting worse.
• 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, skin rashes (including increased sensitivity to the sun), weight gain, water retention causing swelling or confusion.
• In newborn babies, of mothers that have used Trifluoperazine in the last trimester (last three months of their pregnancy) symptoms such as shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding, may occur.
  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.

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. Website: 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.

• The active substance is trifluoperazine hydrochloride. Trifluoperazine Tablets are available in two strengths, containing trifluroperazine hydrochloride equivalent to 1mg or 5mg of trifluoperazine.
• The other excipients are sucrose, calcium sulfate dihydrate, maize starch, gelatin, talc, stearic acid, carnauba wax (E903) and opadry OY-4492 blue.

Trifluoperazine 1mg Tablets are blue, aqueous film coated tablets marked “FW231”.

Trifluoperazine 5mg Tablets are blue, aqueous film coated tablets marked “FW241”.

They are packed in opaque PVC/aluminium foil blister packs of 28, 56, 100 and 112 tablets . Not all pack sizes may be marketed.