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MODECATE INJECTION 25MG/ML

Active substance(s): FLUPHENAZINE DECANOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Modecate® 25mg/ml Injection

3905
1041185B0

3905

fluphenazine decanoate

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

3905

3905
Read all of this leaflet carefully before you
start using this medicine
• Keep this leaflet. You may need to read
it again
• If you have any further questions, ask
your doctor, nurse or pharmacist
• If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor,
nurse or pharmacist

Taking other medicines
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines. This includes medicines
you buy without a prescription, including
herbal medicines. This is because
Modecate can affect the way some other
medicines work. Also some medicines can
affect the way Modecate works.
In particular, do not have this medicine
and tell your doctor if you are taking:
• Medicines to control your heartbeat
(such as amiodarone, sotalol,
procainamide, disopyramide or
quinidine)
• Medicines used for depression
• Other medicines used to calm
emotional and mental health
problems such as chlorpromazine,
lithium and pimozide
• Some medicines used for infections
such as sparfloxacin and pentamidine
• Some medicines used for hay fever,
rashes or other allergies called
antihistamines (such as terfenadine)
• Water tablets (diuretics)
• Quinine - used for malaria
The following medicines can increase
the chance of you getting side effects,
when taken with Modecate:
• General anaesthetics - used during
surgery
• Medicines to help you sleep (sedatives,
barbiturates)
• Medicines for severe pain
• Medicines used to prevent blood
clotting (anticoagulants), such as
warfarin. Your doctor may change
your dose and may monitor your
treatment closely
• Digoxin – used for heart problems.
Your doctor may change your dose
and may monitor your treatment
closely
• Anticholinergic medicines - includes
some medicines used for irritable
bowel syndrome, asthma or
incontinence
• Corticosteroids used for inflammation
such as hydrocortisone, betamethasone
or prednisolone
• Medicines used for muscle spasms
such as suxamethonium,
pancuronium and dantrolene
• Medicines for high blood pressure
• Some medicine used for HIV infection
(protease inhibitors) such as
amprenavir and indinavir
• Cimetidine - for stomach ulcers or
excess acid
• Cocaine or Ecstasy (MDMA)
• Phenylpropanolamine - used in colds
and flu medicines
The following medicines can affect the
way Modecate works or Modecate can
affect the way some of these medicines
work:
• Some medicines used for life
threatening allergic reactions or
conditions such as adrenaline,
dobutamine and dopamine
• Medicines for Parkinson’s disease
(such as l-dopa, apomorphine,
pergolide, lisuride, bromocriptine or
cabergoline)
• Medicines used for fits (epilepsy) such
as phenytoin and carbamazepine
• Medicines for diabetes
• Medicines used to raise 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)
Positron Emission Tomography (PET)
Studies
Having Modecate 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 Modecate.
Having Modecate with food and drink
Do not drink alcohol while you are having
Modecate. This is because alcohol can
increase the effects of Modecate and cause
serious breathing problems.
Pregnancy and breast-feeding
Talk to your doctor before taking this
medicine if you are pregnant, might
become pregnant, or think you may be
pregnant. Modecate may cause an
incorrect false negative result on a
pregnancy test.
The following symptoms may occur in
newborn babies, of mothers that have
used Modecate 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.
You should not breast-feed if you are
taking Modecate. This is because small
amounts may pass into mothers’ milk. If
you are breast-feeding or planning to

In this leaflet:
1. What Modecate is and what it is used for
2. Before you are given Modecate
3. How Modecate is given
4. Possible side effects
5. How to store Modecate
6. Further information

i

1. What Modecate is and what it is
used for

The name of your medicine is Modecate
25mg/ml Injection (called Modecate
throughout this leaflet). Modecate contains a
medicine called fluphenazine decanoate. This
belongs to a group of medicines called
‘phenothiazines’. It works by blocking the
effect of a chemical in the brain.
Modecate can be used for:
• Schizophrenia - this illness can make
you feel, see or hear things which do
not exist, have strange and frightening
thoughts, change how you act and make
you feel alone. Sometimes people with
these symptoms may also feel tense,
anxious or depressed
• Paranoid psychoses - this illness may
make you feel very anxious or afraid for
your own well-being.
2. Before you are given Modecate
Do not have this medicine and tell
your doctor if:
You are allergic (hypersensitive) to:
- fluphenazine decanoate
- other phenothiazine medicines
- the other ingredients of Modecate (listed
in Section 6 below)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
You have a tumour on the adrenal gland
called a ‘phaeochromocytoma’
You have ever had a stroke or mini
stroke (otherwise known as a transient
ischaemic attack or TIA)
You have severe heart problems
You have severe liver or kidney
problems
You have severe depression
You have a blood disorder
You have been recently exposed to
organophosphates
Do not have this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or nurse before being
given Modecate.
You should not be given Modecate if you
are in a coma.
Take special care with Modecate
Check with your doctor or nurse
before you have this medicine if:
You have liver or kidney problems
You have an uneven heartbeat 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 problems with your thyroid
gland
You have severe breathing problems
You have epilepsy
You have brain damage
You have Parkinson’s disease
You have had problems with other
medicines for psychotic diseases
You or members of your family have
ever had glaucoma (painful eyes with
blurred vision)
You have suddenly stopped drinking
alcohol and are having signs of
withdrawal. This may happen if you
suddenly stop after drinking large
amounts for a long time, or stop after a
period of very heavy drinking
You have a form of muscle weakness
called ‘myasthenia gravis’
You have an enlarged prostate gland.
This means you may have problems
when passing water (urine)
You are going to be exposed to very hot
weather
You are elderly (65 years of age or older)
particularly if you are in poor health or
during very cold weather
You are going to have an operation soon
If you are not sure if any of the above
apply to you, talk to your doctor or nurse
before having Modecate.

Modecate® 25mg/ml Injection
fluphenazine decanoate
The following information is extracted from the SPC.
Technical information for the administration of
Modecate Injection
1 NAME OF THE MEDICINAL PRODUCT
Modecate Injection 25mg/ml.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 25mg/ml of the active
substance Fluphenazine Decanoate.
Also contains sesame oil (q.s.).
Benzyl alcohol 15mg/ml.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Pale yellow clear, oily liquid.
4.2 Posology and method of administration
Dosage and Administration
Adults
It is recommended that patients be stabilised on
the injection in hospital.
Recommended dosage regimes for all indications:
Patients without previous exposure to a depot
fluphenazine formulation
Initially 0.5ml ie 12.5mg (0.25 ml ie 6.25mg for
patients over 60) by deep intramuscular injection

into the gluteal region.
The onset of action generally appears between 24
and 72 hours after injection and the effects of the
drug on psychotic symptoms become significant
within 48 to 96 hours. Subsequent injections and
the dosage interval are determined in accordance
with the patient's response. When administered as
maintenance therapy, a single injection may be
effective in controlling schizophrenic symptoms for
up to four weeks or longer.
It is desirable to maintain as much flexibility in the
dose as possible to achieve the best therapeutic
response with the least side-effects; most patients
are successfully maintained within the dose range
0.5ml (12.5mg) to 4.0ml (100mg) given at a dose
interval of 2 to 5 weeks.
Patients previously maintained on oral
fluphenazine
It is not possible to predict the equivalent dose of
depot formulation in view of the wide variability of
individual response.
Patients previously maintained on depot
fluphenazine
Patients who have suffered a relapse following
cessation of depot fluphenazine therapy may be
restarted on the same dose, although the
frequency of injections may need to be
increased in the early weeks of
treatment until satisfactory control is
obtained.

CODICE INTERNO GRAFIMED / GRAFIMED Internal Code :
CLIENTE / Customer :

BRISTOL-MYERS SQUIBB

BOZZA DEL / Proof date :

30/10/2013

PRODOTTO / Product :

Modecate 25 mg SAN GB

DESCRIZIONE MATERIALE / Material description :

insert

DESTINAZIONE COMMERCIALE / Presentation :
MERCATO / Market :

SAN GB

CODICE ITEM / Code :

1041185B0

CODICE LAETUS / Laetus code :
SVOLGIMENTO (vedi schema) / Unwinding (see attacched form) :
FORMATO / Size :

148x592 mm (148X38 mm)

CARTA / Paper :
DIAMETRO MAX. EST. / Reel Max Ext. Diam. :

ANIMA / Core :

FORNITORE / Supplier :
FONT - FONT SIZE / Font - Font Size :
COLORI / Colors :

Nero - Reflex blue - Diecut

NOTE / Notes :
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breast-feed, talk to your doctor or
pharmacist before taking any medicine.
Ask your doctor or nurse for advice before
taking any medicine if you are pregnant or
breast-feeding.
Driving and using machines
You may feel sleepy, tired, have blurred
eyesight or your ability to think or respond
may be lowered after having this medicine.
If this happens, do not drive or use any
tools or machines.
Important information about some of the
ingredients of Modecate
Modecate contains
• Sesame oil. This may cause severe
allergic (hypersensitivity) reactions. The
chances of this happening are rare. Tell
a doctor or nurse straight away if you
get a rash, swallowing or breathing
problems and swelling of your lips, face,
throat or tongue.
• Benzyl alcohol. Modecate Injection contains
15 mg/ml of benzyl alcohol.
It must not be given to premature or
newborn babies. Benzyl alcohol may cause
toxic reactions and allergic reactions in
infants and children up to 3 years old.
3. How Modecate is given
Modecate is normally given by a doctor or
nurse. This is because it needs to be given
as a deep injection into a muscle.
How much Modecate is given
If you are not sure why you are being given
Modecate or have any questions about how
much Modecate is being given to you, speak
to your doctor or nurse.
The usual dose is:
Adults Modecate is usually given
every 2 to 5 weeks.
• Your first dose will be
12.5mg
• This may be increased up
to 100mg depending on
your illness
• The usual dose is 12.5 to
100mg
Elderly Your doctor may start you
on a lower dose of 6.25mg
Children
Modecate should not be given to children.
Tests
Before and during treatment your doctor
may want to carry out some tests. These
might include blood tests and an ECG to
check your heart is working properly.
If you have more Modecate than you
should
It is unlikely that your doctor or nurse will
give you too much medicine. Your doctor
and nurse will monitor your progress, and
check the medicine you are given. Ask
them if you are not sure why you are
getting a dose of medicine.
Having too much Modecate may make you
feel drowsy and you may become
unconscious. You may also feel very cold,
have a fast or irregular heartbeat or severe
muscle spasms. If you start getting any of
these symptoms tell your doctor or nurse
straight away. If you are away from the
hospital, return straight away and speak to
your doctor or nurse or go to the casualty
department.
If you miss a dose of Modecate
Your doctor or nurse will have instructions
on when to give you this medicine. It is
unlikely that you will not be given the
medicine as it has been prescribed.
However, if you do think you have missed a
dose, tell your doctor or nurse.
If you stop having Modecate
Keep having Modecate until your doctor
tells you to stop. If you stop having
Modecate, your illness may come back and
you may have other effects after stopping
such as feeling or being sick, sweating and
difficulty sleeping. You may also get tics
(such as muscle spasms in your face,
rolling eyes, jerking muscles) or feel
restless.
4. Possible side effects









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.
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
of this medicine.
5. How to store Modecate
This medicine will be kept by your doctor
or pharmacist in a safe place where
children cannot see or reach it. Store below
25ºC. Do not refrigerate or freeze.
Keep the ampoules in the outer carton in
order to protect from light.
Do not use Modecate after the expiry date,
which is stated on the ampoule and the
carton. The expiry date refers to the last
day of the month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. Further information

Like all medicines, Modecate can cause
side effects, although not everybody gets
them.




muscles that ache, are stiff or do not
work well. 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, anxiety, fevers, night
sweats, stomach pain, chest pain and
shortness of breath. This could also be
due to changes to your immune system
or an immune condition called Systemic
Lupus Erythematosus (SLE)
• Fits
• An uneven or fast heartbeat
• 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.
Tell a nurse or doctor as soon as possible if
you have any of the following side effects:
• Rigid or stiff muscles, trembling or
shaking, difficulty moving
• Feeling dizzy, light-headed or faint (due
to low blood pressure)
• Changes in skin or eye colour after
having Modecate for a long time
• Swelling of the feet and legs (oedema)
Talk to your doctor or nurse if any of the
following side effects gets serious or lasts
longer than a few days:
• Feeling drowsy or tired
• Abnormal production of breast milk in
men and women
• Breast enlargement in men
• Infrequent, light or loss of menstrual
periods
• Sexual problems
• Difficulty sleeping (insomnia)
• Feeling excited, agitated
• Headache, stuffy nose, being sick
(vomiting)
• Difficulty passing water (urine) or lack of
control over passing water
• Blurred eyesight, dry mouth
• Less ability to perform mental tasks or
having poor judgement
• Skin rashes
• Constipation
Tests
• Modecate can change the levels of liver
enzymes or body fats such as cholesterol
shown up on blood test
• Blood tests may show changes to your
immune system
As with other phenothiazine medicines,
there have been very rare reports of
sudden death with Modecate. These are
possibly caused by heart problems.

Tell a nurse or doctor straight away
if you have;
• An allergic reaction. The signs
may include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
Yellowing of the skin or eyes (jaundice)
A sudden high temperature or an
infection due to low numbers of white
blood cells. These could be signs of a
problem called ‘leucopenia’
High temperature, sweating, stiff
muscles, fast heartbeat, fast breathing
and feel confused, drowsy or agitated.
These could be signs of a serious side
effect called ‘neuroleptic malignant
syndrome’
Low temperature, unusually pale skin
complexion, cold skin, uncontrollable
shivering, slow breathing and slow heart
beat. You may have low body
temperature (hypothermia)
Bruise more easily than usual. This
could be because of a blood disorder
(thrombocytopenia)
Movements that you cannot control of
the tongue, mouth, eyes, jaw, arms and
legs
Feel tired, weak, confused and have

Elderly
Elderly patients may be particularly susceptible to
extrapyramidal reactions, sedative and hypotensive
effects. In order to avoid this, a reduced
maintenance dosage may be required and a
smaller initial dose (see above).
Children
Not recommended for children.
Where a smaller volume of injection is desirable,
patients may be transferred directly to the
equivalent dose of Modecate Concentrate injection
on the basis that 1ml Modecate Concentrate
injection is equivalent to 4ml Modecate injection.
Note
The dosage should not be increased without close
supervision and it should be noted that there is a
variability in individual response.
The response to antipsychotic drug treatment may
be delayed. If drugs are withdrawn, recurrence of
symptoms may not become apparent for several
weeks or months.
Route of administration
Intramuscular.

What Modecate contains
• Each 1ml of the injection contains 25mg
of the active substance, fluphenazine
decanoate
• The other ingredients are sesame oil
and benzyl alcohol
What Modecate looks like and contents of
the pack
Modecate® 25 mg/ml Injection is a pale
yellow clear liquid supplied in 0.5ml, 1ml
and 2ml colourless glass ampoules with an
OPC (one point cut) break system.
Not all sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Bristol-Myers Squibb S.r.l., Contrada
Fontana del Ceraso, 03012 Anagni (FR), Italy.
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in 11/2013
© Sanofi, 1996– 2013

6.3 Shelf life
18 months.
The in use shelf life for the 10ml vial is 28 days.
6.4 Special precautions for storage
Store below 25°C. Do not refrigerate or freeze.
Keep the ampoules in the outer carton in order to protect
from light.
6.5 Nature and contents of container
Type I colourless glass ampoule containing 0.5, 1 or 2ml
with an OPC (one point cut) break system.
Type I Glass cartridge syringes with Helvoet Pharma
rubber plungers and stoppers containing 1 and
2ml.
Type I Glass vials with pharma-gummi rubber
stoppers containing 10ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF
THE AUTHORISATION
Date of first authorisation: 21 March 1996
Date of latest renewal: 23 September 2002
10 DATE OF REVISION OF THE TEXT
January 2013

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl alcohol and sesame oil.
6.2 Incompatibilities
None.

1041185B0

CODICE INTERNO GRAFIMED / GRAFIMED Internal Code :
CLIENTE / Customer :

BRISTOL-MYERS SQUIBB

BOZZA DEL / Proof date :

30/10/2013

PRODOTTO / Product :

Modecate 25 mg SAN GB

DESCRIZIONE MATERIALE / Material description :

insert

DESTINAZIONE COMMERCIALE / Presentation :
MERCATO / Market :

SAN GB

CODICE ITEM / Code :

1041185B0

CODICE LAETUS / Laetus code :
SVOLGIMENTO (vedi schema) / Unwinding (see attacched form) :
FORMATO / Size :

148x592 mm (148X38 mm)

CARTA / Paper :
DIAMETRO MAX. EST. / Reel Max Ext. Diam. :

ANIMA / Core :

FORNITORE / Supplier :
FONT - FONT SIZE / Font - Font Size :
COLORI / Colors :

Nero - Reflex blue - Diecut

NOTE / Notes :
BARCODE TYPE 2/5:
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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