nogen Pharma

3. HOW TO TAKE TRIFLUOPERAZINE TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Trifluoperazine Tablets 1mg and 5mg

[trifluoperazine]

Read all of this leaflet carefully before you start

taking this medicine because it contains

important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. WHAT TRIFLUOPERAZINE TABLETS ARE AND WHAT THEY ARE USED FOR

Trifluoperazine Tablets in low dosage are useful

for:-

•    Short term treatment of anxiety states, depression associated with anxiety and agitation usually in combination with other treatments

•    Treatmentofnauseaandvomiting.

Trifluoperazine Tablets in high dosage are useful

for:

•    Treatment and prevention of recurrence in schizophrenia and other psychiatric illnesses although not usually in depression

•    Part of the treatment of severe agitation and impulsive behaviour.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIFLUOPERAZINE TABLETS

Do not take Trifluoperazine Tablets ifyou:

•    Are hypersensitive (allergic) to trifluoperazine or any of the other ingredients of Trifluoperazine Tablets (listed in section 6)

•    Have been told you have abnormalities in your blood count

•    Have liver disease

•    Suffer from a condition where the heart is unable to maintain adequate circulation causing breathlessness and swelling of the ankles.

These tablets should not be used in patients who

are in a coma.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before

taking Trifluoperazine Tablets ifyou:

•    Are elderly as your dose may be reduced

•    Have angina

•    Have heart disease, abnormal heartbeat or a family history of a condition that effects the normal heart rate)

•    Are already on neuroleptics e.g clozapine, amisulpride used to treat schizophrenia or bipolar disorder

•    Have Parkinson's disease (a neurological disorder that causes muscle tremor, stiffness and weakness)

•    Have epilepsy

•    Have been diagnosed as having narrow angle glaucoma or if you are aware of some visual loss and/or fogginess of vision and/or dull aching pain in and above the eye

•    Have been diagnosed as having myasthenia gravis (your muscles, particularly the eyelids, face, throat and limbs are weak and tire easily)

•    Suffer from an enlarged prostate gland with difficulties in passing urine

•    Have ever had a stroke, or are considered to have risk factors associated with a stroke

•    Are about to undergo surgery

•    Suffer from loss of cognitive (memory, language, intelligence) ability

•    Have dementia

•    Have or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

•    Are exposed to extremes in temperature as this medicine can affect body temperature control.

Other medicines and Trifluoperazine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor if you are taking any of the following:

•    Medicines which result in lowering of blood pressure (e.g. guanethidine)

•    Medicines for Parkinson's disease (e.g. levodopa)

•    Antacids used to treat indigestion

•    Medicines such as metrizamide used in certain X-ray procedures

•    Anaesthetics used prior to surgery

•    Medicines for fits (anticonvulsants)

•    Medicines used to treat iron poisoning (desferrioxamine)

•    Sleeping tablets

•    Strong pain killers (e.g. codeine)

•    Antidepressants (e.g. other phenothiazines, lithium)

•    Alcohol

•    Medicines such as ritonavir used in the treatment of AIDS patients

•    Medicines for irregular heart rhythms

•    Blood thinning medicines (anticoagulants such as warfarin)

•    Anticholinergic medicines used to reduce saliva and lung secretions (e.g. atropine, procyclidine).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant or are breastfeeding. Please check with your doctor if you are taking these tablets and want to breastfeed your baby.

The following symptoms may occur in newborn babies, of mothers that have used Trifluoperazine Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. Ifyour baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

These tablets can cause some people to feel dizzy or drowsy. Ifyou are affected do not drive or operate machinery as your alertness may be impaired.

Trifluoperazine Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

Always take Trifluoperazine Tablets exactly as your doctor has told you. The pharmacist's label on your pack will tell you how much and how often you should take your medicine. Please read the label carefully. You should check with your doctor or pharmacist if you are not sure. Do not take more than your doctor has recommended.

Adults:

Low dosage: The normal dose for anxiety or vomiting is 2-4mg daily. This is given in divided doses. This dose may be increased to 6mg daily if necessary.

This medicine may also cause:

•    Changes in your blood cells which would be measured by a blood test with symptoms of easy bruising, unusual tendency to bleed from the gums or elsewhere, feeling unexpectedly tired and looking pale.

•    Heart problems with changes in heart beat including rapid heart beat, and in rare cases cardiac arrest

•    At higher dose levels and after prolonged treatment there may be appearance of uncontrolled movements (jerking of the limbs and writhing of the face muscles). Elderly patients and those with a pre existing brain disease may also experience these side effects.

High Dose: The normal starting dose for schizophrenia is 5mg twice daily. This may be increased if necessary to 15mg daily, after the first week of treatment.

This dose can be increased by 5mg every 3 days until satisfactory control has been achieved.

Maintenance: Once your doctor is satisfied that your condition is under control, your dosage may be gradually reduced until an effective maintenance dose is achieved. Yourdoctorwill tell you what dose to take when necessary.

During treatment your doctor should regularly check you for physical side effects, changes in your blood counts or liver function, and any heart problems, especially if you taking this medicine for a long time or are also taking other medicines.

Children:

This product is not recommended for use in children under the age of 12 years.

Ifyou take more Trifluoperazine Tablets than you should

This medicine is to be taken at regular intervals, as determined by the physician. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

Ifyou stop taking Trifluoperazine Tablets

Do not stop taking Trifluoperazine Tablets without consulting your doctor as your condition may deteriorate

If you forget to take Trifluoperazine Tablets

If you have forgotten to take a dose, leave out that dose completely. Take your next dose at the normal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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. Ifyou notice any of these symptoms seek medical advice immediately.

Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling ofthe face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularlywhen standing up. Ifany ofthese occur STOP taking the medicine and contact a doctor immediately.

Ifyou sufferfrom the following side effects inform your doctor:

•    Jaundice with symptoms of yellowing of the skin or the whites of the eyes

•    Neuroleptic malignant syndrome characterized by extremely high body temperature, stiffness, altered consciousness, blood pressure changes, constipation, diarrhoea, incontinence, dizziness and sweating

•    The development of certain types of breast cancers or breast enlargement in men or inappropriate milk production or altered menstrual cycle (e.g. periods stop).

Other side effects seen include:

•    Tiredness, drowsiness, dizziness, convulsions, transient restlessness and difficulty sleeping

•    Dry mouth, constipation, upset stomach

•    Muscle weakness, loss ofappetite, fits, falls in blood pressure especially when you stand up

•    Difficulty in passing water and blurred vision have also been reported

•    Weightgain

•    Skin reactions sometimes worse when exposed to strong sunlight, pigmentation

•    Water retention

•    Even at low doses you may feel dull or agitated

•    High temperature.

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.

Many of the above mentioned side effects should disappearwhen treatment is stopped.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 By reporting side effects you can help provide more information on the safety ofthis medicine.

5. HOW TO STORE TRIFLUOPERAZINE TABLETS

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Store in a cool dry place, protect from light.

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Trifluoperazine Tablets contain:

Each Trifluoperazine 1mg Tablet contains trifluoperine hydrochloride equivalent to 1mg of trifluoperazine.

Each Trifluoperazine 5mg Tablet contains trifluoperine hydrochloride equivalent to 5mg of trifluoperazine.

The other ingredients are: Corn starch, lactose, polyvinylpyrrolidone, magnesium stearate, talc, Opadry II Blue and Purfied water.

What Trifluoperazine Tablets look like and contents of the pack

Trifluoperazine 1mg and 5mg Tablets are blue film coated tablets, plain on both side.

Trifluoperazine 1mg and 5mg Tablets are supplied in packs of 50, 100, 112, 500 or 1000.

Not all pack sizes may be marketed.

Manufacturer and Marketing Authorisation Holder

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in January 2015.