Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about MODECATE. It does not contain all the available information. Some of the information contained in this leaflet may not apply to you.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking MODECATE against the benefits they expect it will have for you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What MODECATE is used for
MODECATE is a trade name (manufacturer's name) for the medicine fluphenazine (FLOO-fen-A-zeen) decanoate. MODECATE belongs to a group of medicines called phenothiazines (FEE-no-THI-a-ZEENS). It helps to correct chemical imbalances in the brain, which may cause mental illness.
MODECATE is used for the treatment of mental illnesses such as schizophrenia. These mental illnesses may cause disturbances in thinking, feelings and behaviour.
Your doctor may have prescribed MODECATE for another reason. Ask your doctor if you have any questions about why MODECATE has been prescribed for you.
There is no evidence that MODECATE is addictive.
This medicine is available only with a doctor's prescription.
MODECATE is not recommended for use in children under the age of 12, as safety and effectiveness have not been established in this age group.
Before you are given MODECATE
When you must not be given it
You should not be given MODECATE if you have an allergy to:
related medications (for example, other phenothiazine medicines)
any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction to MODECATE may include:
rash, itching or hives on the skin
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
yellow discolouration of the skin/eyes
MODECATE must not be given to anyone who is unconscious or in a coma.
You should not be given MODECATE if you have or have had any of the following:
brain damage or suspected brain damage
liver disease or yellowing of the eyes/skin (jaundice)
severe circulatory problems
disease of the blood with a reduced number of red or white blood cells, or platelets
alcohol or drug intoxication
any condition requiring large doses of medicine to calm you or to help you sleep
Do not use MODECATE after the expiry date printed on the pack. If you take this medicine after this date has passed it may not work as well.
Do not use MODECATE if the packaging is torn or shows signs of tampering. If this is the case, return it to your pharmacist.
Do not use MODECATE if the injection is not the usual colour or does not look right.
MODECATE should not be given to a child under 12 years, unless directed by the child's doctor. MODECATE is not recommended for children under 12 years.
If you are not sure whether you should be having MODECATE, talk to your doctor or pharmacist.
Before you are given it
Tell your doctor or pharmacist if you have allergies to:
any other medicines
any other substances such as foods, preservatives or dyes
Tell your doctor if you are pregnant or intend to become pregnant. Like most phenothiazines, MODECATE is not recommended for use during pregnancy. If you need to be given MODECATE during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is recommended that you do not breast-feed while taking MODECATE, as it may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.
Tell your doctor if you have or have had any medical conditions especially the following:
neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature, sweating, fast heart beat, muscle stiffness and fluctuating blood pressure, which may lead to coma
tardive dyskinesia, a reaction to some medicines with worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks or jaw which may progress to the arms and legs
fast or irregular heart beat
heart problems or blood vessel problems
low blood pressure
tumour of the pituitary gland, a small gland at the base of the brain
brain tumour, or other brain disorder
kidney problems or difficulty passing urine
liver disease. If you have this condition, higher blood levels of drug may occur, increasing the chance of side effects
disease of the blood with a reduced number of red/white blood cells/platelets
epilepsy, seizures or fits
yellowing of the skin or eyes (jaundice), skin rashes or other allergic reactions to other products related to phenothiazine (ingredients similar to fluphenazine decanoate, the active ingredient of MODECATE)
glaucoma, a condition in which there is a build-up of fluid in the eye, or other eye problems
breathing difficulties or lung disease
alcohol abuse/addiction. Certain side effects such as heat stroke may be more likely to occur.
Pheochromocytoma, a rare tumour of the adrenal glands which sit near the kidneys
Muscular disorders such as Parkinson's disease or Myasthenia gravis
Small bowel not working properly (severe pain in the stomach with bloating, gut cramps and vomiting)
Tell your doctor if you will be in a hot environment or do a lot of vigorous exercise. MODECATE may make you sweat less, causing your body to overheat.
Tell your doctor if you are exposed to pesticides which contain phosphorous. The risk of you experiencing a side effect may be increased.
Tell your doctor if you drink alcohol. Your doctor may advise you to avoid alcohol as it can magnify the side effects of this medicine.
If you have not told your doctor or pharmacist about any of the above, tell them before you are given MODECATE.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and MODECATE may interfere with each other. These include:
non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain, swelling and other signs of inflammation
benzodiazepines and other medicines used to treat anxiety or to help you sleep/for sedation
antihistamines, medicines used to treat allergies such as hayfever
anticoagulant medicines used to prevent blood clotting (for example warfarin)
anticonvulsants, medicines used to control epilepsy or seizures
medicines used to control depression (antidepressants) or mood swings
antipsychotic medicines which are used to treat mental illness including lithium or lithium-containing preparations
medicines used to treat high blood pressure (including guanethidine and clonidine), such as ACE inhibitors and/or diuretics
beta-blockers, medicines used to treat angina, migraine and glaucoma
medicines used to treat Parkinson's Disease, a disease of the brain affecting movement
medicines used to treat symptoms of movement disorders (for example benserazide)
adrenaline, a medicine used in emergency situations
stimulants such as amphetamines
medicines used to control diabetes
over the counter medicines for colds
anticholinergic medicines which are used to relieve stomach cramps, spasms and travel-sickness
These medicines may be affected by MODECATE, or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases your doctor may want to change the dosage or other precautions may be necessary.
Use in people over 60 years of age:
If you are over 60 years of age you should be especially careful while taking MODECATE. Report any side effects promptly to your doctor. As people grow older, they are more likely to get side effects from medicines.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking MODECATE.
How MODECATE is given
How much is given
Your doctor will decide what dose you will receive and how frequently you should have an injection of MODECATE. Your dose depends on your condition and other factors such as your age or weight.
How it is given
MODECATE is given as a deep injection into a large muscle (intramuscular). It may also be given as an injection under the skin (subcutaneous) injection. MODECATE should only be given by a doctor, nurse or other trained person.
MODECATE should not be injected intravenously.
How often it is given
Usually MODECATE is given every four to six weeks. Your doctor will determine how often you need to be given MODECATE.
How many injections you will need
MODECATE helps to control your condition but does not cure it. Therefore you will need regular injections. Do not miss any injections, even if you feel better.
If you are given too much (overdose)
As MODECATE is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects, after being given MODECATE, tell your doctor immediately or go to Accident and Emergency at your nearest hospital. You may need urgent medical attention.
While you are being given MODECATE
Things you must do
Tell your doctor immediately if you notice any worm-like movements of the tongue or other uncontrolled movements of the face, mouth or jaw, which may progress to the arms and legs. These are symptoms of a condition called tardive dyskinesia which may develop in people taking phenothiazine medicines, including MODECATE.
This condition is more likely to occur during long-term treatment with MODECATE, especially in elderly women. It is very important that you see your doctor immediately as soon as any fine, worm-like movements of the tongue or twitches in the face start to occur.
Tell your doctor immediately if you notice any abnormal movement of the limbs, rotation of the eyes, body spasms of the back muscle, stiff limbs, drooling, mask-like stare, shuffling gait and mouth tremor. These symptoms are similar to those experienced by Parkinson disease sufferers and may occur in patients being given MODECATE. These effects are usually reversible, and you should tell your doctor as soon as possible so that you can be treated quickly.
Tell any other doctors, dentists or pharmacists who are treating you that you are taking MODECATE.
If you are about to be started on any new medicine, tell your doctor, dentist and pharmacist that you are taking MODECATE.
If you plan to have any kind of surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking MODECATE.
If you become pregnant while taking MODECATE, tell your doctor immediately.
If you need to have any medical tests, tell your doctor that you are taking MODECATE. MODECATE may interfere with the result of pregnancy tests.
Be sure to keep all of your doctor's appointments so that your progress can be checked. Your doctor will check your progress and may want to take some blood/eye/skin tests from time to time. This helps to prevent unwanted side effects.
Things you must not do
Do not give MODECATE to anyone else, even if their symptoms seem similar, or they have the same condition as you.
Do not use MODECATE to treat any other complaints unless your doctor tells you to.
Do not stop MODECATE, or lower the dosage without checking with your doctor, even if you feel better. If you stop MODECATE suddenly, your condition may worsen or your chance of getting an unwanted side effect (such as gastritis, nausea, vomiting, dizziness and trembling) may increase. To prevent this, your doctor may gradually reduce the amount of MODECATE you are given before stopping completely.
Do not take any medicines that cause drowsiness while you are using MODECATE, unless recommended by your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how MODECATE affects you. MODECATE may cause some people to become drowsy or less alert than they are normally or cause light-headedness, dizziness or tiredness.
Make sure you know how you react to MODECATE before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.
If you drink alcohol, dizziness or light-headedness may be worse.
If MODECATE makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position. Getting up slowly might help.
Be careful when drinking alcohol while taking MODECATE. Combining MODECATE and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are being treated with MODECATE.
If outdoors, wear protective clothing and use at least a 15+ sunscreen. MODECATE may cause your skin to be much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If your skin does appear to be burning, tell your doctor.
Do not use a sunlamp or tanning booth.
MODECATE may cause your eyes to be more sensitive to sunlight than they are normally. Exposure to sunlight over a period of time (several months to years) may cause blurred vision, change in colour vision or difficulty in seeing at night. When you do go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light. Ordinary sunglasses may not protect your eyes.
MODECATE may also make you more sensitive to cold temperatures. Dress warmly during cold weather. Be careful during prolonged exposure to cold, such as in winter sports or swimming in cold water.
Use extra care not to become overheated during exercise in hot weather while you are taking MODECATE. MODECATE may make you sweat less, causing your body temperature to increase. Overheating yourself may cause heat stroke. Also hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.
You may also get mouth dryness while taking MODECATE. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease and fungus infections.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MODECATE. MODECATE helps most people with mental illness, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Children, adolescents or the elderly may have an increased chance of getting side effects. Ask your doctor or pharmacist to answer any questions you may have.
If any of the following happen, immediately tell your doctor or go to the Accident and Emergency Centre at your nearest hospital:
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, asthma, wheezing, difficulty breathing or swallowing
build up of fluid in the lungs, difficulty in breathing, wheezing or breathlessness, which may be very severe and usually worsens on lying down. Soreness of the mouth, gums or throat together with a cold or lung infection
convulsions or fits
loss of blood sugar control
changing consciousness, widening of pupils in the eye and gradual loss of consciousness
unusual weakness, fatigue or intense headache (cerebral oedema)
sudden increase in body temperature with fever, sweating, fast heartbeat, irregular pulse or heart problems, high or low blood pressure, muscle stiffness or muscle spasm, especially of the face, neck and back (neuroleptic malignant syndrome)
yellowing of the skin or eyes (jaundice)
These are serious side effects. You may need urgent medical attention or hospitalisation. Also see your doctor immediately or go to the nearest hospital with an Accident and Emergency Centre if you experience:
sudden onset of uncontrollable muscle spasms affecting eyes, head, neck or body. These effects are usually reversible and you should tell your doctor as soon as possible so that you can be treated.
If any of the following happen, tell your doctor immediately:
worm-like movements of the tongue or other uncontrolled movements of the mouth, cheeks and jaws which can progress to the arms and legs
itching, flaking skin
blurred vision, change in colour vision or difficulty in seeing at night
difficulty in speaking or swallowing
inability to move eyes
loss of balance control, fainting
restlessness or need to keep moving
shuffling walk, stiffness of arms or legs, twitching movements, trembling and shaking of hands and fingers
weakness of arms and legs
difficulty passing urine or loss of bladder control (incontinence)
symptoms of sunburn (such as redness, itching, swelling or bleeding of the skin) that happens more quickly than normal or after minimum exposure to sunlight
abdominal or stomach pains
aching muscles or joints
fever and chills
hot, dry skin or lack of sweating
skin discolouration (tan or blue-grey), severe skin itching
unusual bleeding or bruising.
These may be serious side effects. You may need urgent medical attention.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
redness and pain at injection site
dizziness, drowsiness, blurred vision
changes in menstrual periods
impaired sexual function in men
breast enlargement in men
swelling or pain in breasts, unusual secretion of milk
unusual weight changes
restlessness, excitement or bizarre dreams
fluid retention, swelling of hands, feet or ankles
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell. You may notice some side effects after you stop taking MODECATE. The effects of MODECATE may last a few days after it has been stopped.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using MODECATE
Keep your MODECATE injections in the pack until it is time to be given an injection. If you take the injections out of the pack they may not keep well.
Keep your injections in a cool place, protected from light, where the temperature stays below 30°C.
Do not store MODECATE or any other medicine in the bathroom or near a sink. Do not leave it in a car or on windowsills. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Alternatively MODECATE may be stored in the pharmacy, on the ward or in the clinic.
If your doctor tells you to stop having MODECATE injections, or the medicine has passed its expiry date, your doctor, pharmacist or health care professional will dispose of any left over MODECATE.
What it looks like
MODECATE Injection is supplied in ampoules containing an oily liquid.
Each ampoule contains:
Active ingredient:fluphenazine decanoate 25 mg/mL Other ingredients:sesame seed oil, benzyl alcohol Presentation
MODECATE is supplied in the following ampoule sizes in packs of five ampoules:
0.5 mL ampoule AUST R 19263
1 mL ampoule AUST R 47023
2 mL ampoule AUST R 47024
This product is manufactured in Italy and distributed in Australia by:
Bristol-Myers, Squibb Australia Pty Ltd,
ACN 004 333 322
556 Princes Highway,
® MODECATE is a registered trademark of a Bristol-Myers Squibb Company.
Date of preparation: