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Trifluoperazine Tablets Bp 1mg

Document: leaflet MAH GENERIC_PL 11311-0383 change

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Trifluoperazine 1mg and 5mg Tablets

(Trifluoperazine Hydrochloride)

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.

■    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.

What is in this leaflet:

J What Trifluoperazine is and what it is used for    M    Possible side effects

2    What you need to know before you take Trifluoperazine Q How to store Trifluoperazine

3    How to take Trifluoperazine    Q    Contents of the pack and other information


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

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:

o If you have had a mini stroke where

symptoms last less than 24 hours (Transient Ischaemic Attack 'TIA')

o If you have uncontrolled high blood pressure o If you have diabetes, high cholesterol o If you are a smoker o If you drink excessive amounts of alcohol o 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.

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.

continued....

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