MercuryPharma

PATIENT INFORMATION LEAFLET

Trifluoperazine 1mg and 5mg Tablets

3. How to take Trifluoperazine Tablets

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 nas 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.

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

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 heart beats.

•    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.

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 lor schizophrenia is no more than 5mg a day.

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 casually department immediately. Take this leaflet and any remaining tablets with you so that the medical staff know exactly what you nave taken.

If you forget to take your Trifluoperazine Tablets:

If you miss a dose, wait until your next dose. Do not take Ihe 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 1o 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 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.

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.

5. How to store Trifluoperazine Tablets

Keep this medicine out of the sight and reach of children.

Do not use Trifluoperazine Tablets after the expiry date which is stated on the box. The expiry date refers to the last day of that month. If your tablets are out of date, take them to your pharmacist who will get rid of them safely.

Do not store above 25°C. Store in the original package.

6. Further information

The active substance in Trifluoperazine Tablets is trifluoperazine hydrochloride. Trifluoperazine Tablets are available in two strengths, containing trifluroperazine hydrochloride equivalent to 1 mg or 5mg of trifluoperazine.

Trifluoperazine Tablets also contains sucrose, calcium sulphate dihydrate, maize starch, gelatin, talc, stearic acid, carnauba wax (E903) and opadry OY-4492 blue.

What Trifluoperazine Tablets look like and contents of the pack:

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

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

They are packed in Dlister packs of 28,56,100 or 112 tablets and securitainers of 28,56,100,112,1000 and 5000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mercury Pharmaceuticals Ltd.,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK Manufacturer:

Mercury Pharmaceuticals Ltd.,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK Alternate Manufacturer:

Bristol Laboratories Limited, Laporte way, Luton, Bedfordshire, LU4 8WL, UK

This leaflet was last revised in June 2016.    100190/LF/027/05, 100191/LF/027/05

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