Patient Information Leaflet

FLUPHENAZINE DECANOATE INJECTION BP 25mg per ml and 100mg per ml

This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered. The leaflet contains a summary but not all of the information about Fluphenazine Decanoate Injection BP. If you require any further information or you are unsure about anything, ask your doctor or pharmacist.

WHAT’S IN YOUR MEDICINE

Fluphenazine Decanoate Injection BP is a clear, light-yellow, sterile injection in clear glass ampoules.

Active ingredient: Fluphenazine decanoate.

Inactive ingredient: Sesame oil.

Pack Sizes: Fluphenazine Decanoate Injection BP 25mg per ml is available in the following pack sizes:

10 X 1ml (each 1ml contains 25mg of active ingredient).

10 X 0.5ml (each 0.5ml contains 12.5mg of active ingredient).

Fluphenazine Decanoate Injection BP 100mg per ml is available in the following pack sizes:

10 X 1ml (each 1ml contains 100mg of active ingredient).

10 X 0.5ml (each 0.5ml contains 50mg of active ingredient).

Product Licence Holder: Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. PL 02848/0132 (25mg per ml) and PL 02848/0133 (100mg per ml).

Manufacturer: Antigen Pharmaceuticals Limited, Roscrea, Co. Tipperary, Ireland.

Type of medicine: Fluphenazine decanoate belongs to a group of medicines known as phenothiazine neuroleptics. It is used to improve the symptoms of major mental disorders.

USES

Fluphenazine Decanoate Injection BP is a long-acting preparation. It may be used when prolonged treatment is required to improve the symptoms of major mental disorders such as in schizophrenia or paranoia (paranoia means having a strong but abnormal belief such as false sense of persecution).

BEFORE YOU ARE GIVEN FLUPHENAZINE DECANOATE INJECTION

DO NOT USE Fluphenazine Decanoate injection if:

•    You are allergic to Fluphenazine Decanoate or any of the other ingredients.

•    You have severe heart disease or problems with the blood vessels supplying blood to the brain.

•    You have tumour of the adrenal gland (a condition called as 'phaeochromocytoma’).

•    You are suffering from liver or kidney failure

•    You have severe depression

•    You have a blood disorder

Fluphenazine Decanoate Injection should not be given when the patient is in coma.

Do not have this medicine if any of above apply to you. If you are not sure, talk to your doctor or nurse before being given Fluphenazine Decanoate injection.

Take special care and tell your doctor if:

•    You have liver or kidney problems

•    You have an irregular heart beat or heart disease. If you or a member of your family has ever had heart disease, your doctor may carry out tests on your heart and blood before giving you this medicine.

•    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 abnormal functions of thyroid gland

•    You suffer from damage of optic nerve and disturbances in vision.

•    You suffer from an enlargement of prostate gland

•    You are elderly particularly if you are in poor health or during cold weather.

•    You have severe breathing problems

•    You have a brain disorder causing tremors, rigidity and slowing of movement

•    You suffer from fits or you have a condition that might lead to fits such as brain injury or are having signs of withdrawal (alcohol)

•    You are exposed to extremes of temperature as this medicine can affect body temperature control

•    You have had problems with other medicines used for mental illness

•    You have a form of muscle weakness(myasthenia gravis)

•    You are going to have an operation soon

•    You have lung infection

•    You are exposed to organophosphorus compounds

Even though some of above may be obvious, it is important that your doctor is aware if any of them apply to you.

Taking other medicines:

Do not take this medicine if you are taking:

•    Medicines used to induce the sleep or relive the pain e.g. barbiturate, codeine

•    Medicines like quinidine, disopyramide, procainamide, amiodarone, sotalol used to control your heart beat

•    Medicines used to treat depression like lithium, tricyclic antidepressants (e.g. amitriptyline), tetracyclic anti-depressants (e.g. maprotiline), phenothiazines, pimozide, MAO inhibitors and selective serotonin reuptake inhibitors (SSRIs) like fluoxetine.

•    Medicine used to increase heart rate e.g. adrenaline

•    Medicines used to treat heart failure e.g. digoxin

•    Medicines used to treat hay fever, rashes or other allergies called antihistamines (such as terfenadine)

•    Medicines used to treat infection like sparfloxacin and pentamidine

•    Water tablets (thiazide diuretics)

•    Medicine used to treat malaria e.g. quinine

•    This medicine can increase chance of side effect if you are taking:

•    Medicine used during surgery like general anaesthetics

•    Medicines used to prevent blood clotting like warfarin

• Medicines used to treat irritable bowel syndrome, asthma or muscular spasms Anticholinergic medicines (e.g. Atropine)

• Medicines used for inflammation such as Corticosteroids (e.g. hydrocortisone or prednisolone).

•    Medicines which result in lowering of blood pressure like guanethidine, beta blockers, lisinopril, enalapril, candesartan, amlodipine and clonidine

•    Medicines used to treat stomach ulcers or excess acid e.g. Cimetidine

•    Medicines used in colds and flu medicines e.g. Phenylpropanolamine

•    Medicines for Parkinson’s disease (such as levodopa or methyldopa)

•    Medicines used for fits such as phenytoin and carbamazepine

•    Medicines for diabetes

•    Medicines used to increase blood pressure (adrenergic vasoconstrictors) such as ephedrine and phenylephrine

•    Metrizamide - used to help with tests such as X-ray examinations

•    Amfetamines - used for Attention Deficit Hyperactive Disorder (ADHD)

•    Cocaine or Ecstasy (MDMA)

Positron Emission Tomography (PET) Studies

Having Fluphenazine Decanoate injection may affect the results PET studies carried out using labelled glucose. If you are going to have a PET study, it is important to tell your doctor you are having Fluphenazine Decanoate injection.

Having Fluphenazine Decanoate injection with food and drink

Do not drink alcohol while you are having Fluphenazine Decanoate injection. This is because alcohol can increase the effects of Fluphenazine Decanoate injection and cause serious breathing problems.

Pregnancy and breast-feeding

Tell your doctor before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant or are breast-feeding unless your doctor decides that treatment is essential.

The following symptoms may occur in newborn babies, of mothers that have used Fluphenazine 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.

Fluphenazine may cause an incorrect pregnancy test. You should not breast-feed if you are taking Fluphenazine Decanoate injection. This is because small amounts may pass into mothers’ milk.

Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines

Fluphenazine Decanoate injection could interfere with your ability to drive or to use machines. Do not drive or operate machinery whilst you are taking this medicine. When your Fluphenazine Decanoate injection treatment has stopped, ask your doctor when it will be safe for you to drive or use machines.

HOW THIS MEDICINE IS ADMINISTERED

Fluphenazine Decanoate Injection BP is administered by injection deep into a muscle. At the start of treatment, your doctor may want to bring you into hospital to stabilise your treatment. Usually, it takes one to three days before your medicine starts to act, and two to four days for it to have a significant effect on your symptoms.

Dosage for adults

If you are receiving a long-acting injection form of fluphenazine for the first time, you may be given 12.5mg to start by deep injection into a muscle in your buttock. This dose should be halved (6.25mg) if you are over 60 years of age. After your first injection, your doctor will decide on what further doses you require and how often they should be given. Most patients can be successfully maintained on doses of between 12.5mg and 100mg given every two to five weeks.

If you are resuming treatment with a long-acting injection form of fluphenazine, you may bee given the same dose as the one you were receiving before your treatment was stopped. In this case, your doctor may want you to receive your injections more frequently in the early weeks of treatment until your symptoms are properly controlled.

If you are elderly, your doctor may prescribe smaller maintenance doses to reduce the possibility of your medicine causing unwanted effects.

Dosage for children

This medicine is not recommended for use in children.

What to do if you miss a dose

If you miss a dose, make sure to tell your doctor or nurse. The missed dose can be given as soon as possible afterwards. Then you can continue as before, allowing the usual time interval (which is usually 2-5 weeks) between each dose.

Overdose: If you think that you have been given too much of this medicine, tell your doctor immediately.

POSSIBLE SIDE EFFECTS

Like all medicines, Fluphenazine Decanoate injection can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare.

Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body should be reported to a doctor immediately.

If you are experiencing the following side effects while taking your medicine, you should stop taking your injection and tell your doctor straight away:

•    Rigid or stiff muscles, trembling or shaking, difficulty moving (acute dystonic reaction)

•    Yellowing of the skin or eyes (jaundice)

A sudden high temperature

•    High temperature, excessive sweating, stiff muscles, fast heartbeat, fast breathing and feeling confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’

•    Low temperature (hypothermia) may occur especially in elderly patients or patients having underactive thyroid gland.

•    A sudden high temperature or an infection due to low numbers of white blood cells. These could be signs of a problem called ‘leucopenia’

•    Internal bleeding or bruising more easily than usual. This could be because of a blood disorder (thrombocytopenia)

•    Movements that you cannot control of the tongue, face, mouth, eyes, jaw, arms and legs

•    Feeling tired, weak, confused and having muscles that ache or are stiff. This may be due to low sodium levels in your blood or a condition called Syndrome of Inappropriate Anti-diuretic Hormone Secretion (SIADH)

•    Joint aches and pains, swollen joints, increased sensitivity to sunlight, mouth ulcers, hair loss, fever, chest pain and skin rash over the face This could also be due to an autoimmune condition called Systemic Lupus Erythematosus (SLE)

•    Irregular or fast heartbeats

•    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.

•    brain disorder causing tremors, rigidity and slowing of movement

•    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.

Other possible side effects:

•    Feeling dizzy, light-headed or faint (due to low blood pressure)

•    Swelling of the feet and legs (oedema)

•    Feeling drowsy or tired

•    Sexual problems or false results with pregnancy test

•    Difficulty in sleeping (insomnia)

•    Feeling excited, agitated

•    Headache, stuffy nose, vomiting

•    Eye disorder (disturbances in vision)

•    Low concentration of sodium in blood

•    Difficulty in passing water or lack of control over passing water

•    Blurred eyesight, dry mouth

•    Impairment of judgment and of mental skills

•    Skin rashes

•    Constipation

•    Abnormal skin pigmentation

•    Fits

•    High levels of prolactin in the blood which may cause abnormal production of breast milk in women, Breast enlargement in men and Infrequent, light or loss of menstrual periods

Tests

•    Fluphenazine Decanoate injection can change the levels of liver enzymes or body fats such as cholesterol shown up on blood test

Talk to your doctor or nurse if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

As with other phenothiazine medicines, there have been very rare reports of sudden death with Fluphenazine Decanoate injection. These are possibly caused by heart problems.

STORING YOUR MEDICINE

Do not use this product after the expiry date printed on the ampoule label and carton.

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

Do not refrigerate.

If only part of the contents of an ampoule is used, discard the remaining solution.

Keep out of reach of children.

Marketing Authorisation Holder:

Mercury Pharma International Ltd.,4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

This leaflet was last revised in March 2012.