Fluphenazine Decanoate Injection should not be used:

• if you have had a hypersensitivity reaction (allergy) to fluphenazine decanoate or sesame oil
• if you have severe depression
• if you have a disease causing narrowing of the blood vessels around your brain (cerebral atherosclerosis)
• if you have serious liver, kidney or heart problems
• if you have existing severe blood disorders (you may have had an unexplained fever or repeated infections, e.g. sore throat or chest infection)
• in children under 12 years of age
• in patients in a coma
• if you have a phaechromocytoma (a tumour, usually of the adrenal gland, that causes high blood pressure)
• if you have jaundice (yellowing of the skin or the whites of the eyes)

Tell your doctor if:

• you are pregnant or planning to become pregnant
• you are breast-feeding
• you have had an allergic reaction to another medicine of the phenothiazine group e.g. chlorpromazine, haloperidol, thioridazine
• you drink alcohol
• you have not been eating very much
• you have lung, liver or heart disease
• you have thyroid problems
• you have epilepsy or have ever had fits
• you have Parkinson’s disease
• you have diabetes
• you have an enlarged prostate or difficulty passing urine
• you or your blood relatives have ever had raised pressure in the eye
• you have a disease of the muscles called myasthenia gravis
• you are going to have surgery
• you have or have had subarachnoid haemorrhage (a bleed into the brain)
• you are taking or have recently taken any medicines, including ones you have bought yourself, including:
  • sleeping tablets or strong painkillers (other than aspirin or paracetamol)
  • medicines used to treat Parkinson’s disease
  • anticonvulsants - used to treat epilepsy, fits and convulsions
  • lithium and medicines used to treat depression
  • anticoagulant therapy - used to thin the blood (e.g. warfarin and heparin)
  • medicines used to treat diabetes
  • steroids
  • medicines used to treat heart rhythm disorders (e.g. quinidine and digoxin)
  • clonidine and guanethidine - used to treat high blood pressure, migraines and menopausal flushing
  • adrenaline - may be used in allergic emergencies

Special care will be taken by the doctor if you have low levels of calcium, potassium or magnesium in your blood. Your doctor may do blood tests to check for these problems.

Fluphenazine may cause problems with the way your body responds to heat and cold. You may be more prone to overheating in hot weather or after exercise. If the weather is cold, you may be more prone to hypothermia, especially if you are elderly.

If you are taking this medicine, you should carry a treatment card indicating the dosage received.

Before driving or using machines

This medicine may impair mental and physical abilities. Do not drive or use machines if you experience these effects.

If any of the following happen, tell the doctor immediately:

• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing) and you may feel you are going to faint
• neuroleptic malignant syndrome (NMS) - this has the symptoms of high temperature, stiff muscles, rapid heart rate, confusion, variable blood pressure, sweating, stupor or coma, reduced ability to move your muscles, an increase in certain enzymes and white cells in your blood, abnormalities in your liver function and acute kidney failure
• acute dystonic reactions - these are abnormal body movements which may consist of abnormal, uncontrollable movements of the eyes and severe muscular spasm where the head and heels are bent backwards and the body bowed forward (may be worse in the elderly)
• quivering of your tongue (this may be an early sign of a condition called tardive dyskinesia (see below)

You may need urgent medical attention.

If you experience any of the following, tell your doctor as soon as possible:

• muscular quivering and restlessness, inability to sit still (may be worse in the elderly)
• drowsiness or lethargy (may be worse in the elderly)
• blurred vision
• dryness of the mouth
• constipation
• difficulty with passing urine or incontinence
• lowered blood pressure which may make you feel faint
• unexplained fever or repeated infections – this may be due to alterations in your blood count
• impairment of judgement and mental skills
• epilepsy or fits
• jaundice (yellowing of the skin or the whites of the eye)
• transient abnormalities of liver function tests
• transient rise in serum cholesterol
• sweating
• changes in heart beat - this may be detected by your doctor taking an ECG trace
• alterations in menstruation
• sexual function may be impaired
• fluid retention, which may result in swelling, particularly round the ankles
• breast enlargement in men (gynaecomastia)
• milk expressed from the breasts (galactorrhoea)
• a disease called Systematic Lupus Erythematosis (SLE), which may cause joint or muscle pains, skin rash (particularly on the face), fever and kidney, lung and heart problems

Some reactions may occur after long term use:

• abnormal skin pigmentation may occur with long-term treatment
• clouding of the lens of the eye may occur with long-term treatment
• tardive dyskinesia, this involves: rhythmical uncontrollable movements of the tongue, face, mouth or jaw (e.g. protrusion of tongue, puffing of cheeks, puckering of the mouth, chewing movements), which may be accompanied by involuntary movements of the extremities. Tardive dyskinesia is more likely to occur in the elderly and/or after high dose, long term therapy. This may also occur after drug therapy has been discontinued.

Transient abnormalities of liver function tests and sudden unexpected and unexplained death may also occur.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

During treatment, routine blood tests may be needed as fluphenazine may alter blood counts, liver and kidney function and cholesterol level. Eye and heart tests may be performed to monitor for possible side effects.