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MODECATE 25MG/ML INJECTION

Active substance(s): FLUPHENAZINE DECANOATE

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Modecate® 25 mg/ml Injection

2273
28.07.15[6]

(fluphenazine decanoate)
PATIENT INFORMATION LEAFLET
This medicine is available using the above name but will be referred to as
Modecate throughout the leaflet
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
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
1. WHAT MODECATE IS AND WHAT IT IS USED FOR
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.
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.

Modecate® 25 mg/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 25mg/ml Injection.
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.

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 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 15mg/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.

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.

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 12.5 mg
- This may be increased up to 100 mg depending on your
illness
- The usual dose is 12.5 to 100 mg
Elderly

Your doctor may start you on a lower dose of 6.25 mg

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

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.
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 between 15º C and 30º C. Protected from light. Protect from heat.
Do not freeze
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
What Modecate contains
- Each 1 ml of the injection contains 25 mg fluphenazine decanoate
- The other ingredients are sesame oil and benzyl alcohol.
What Modecate looks like and contents of the pack
Modecate look like pale yellow clear oily liquid supplied in 1 ml clear glass
ampoules.
Pack sizes are 1, 5 and 10 ampoules.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Modecate is manufactured by Bristol-Myers Squibb S.R.L., Contrada
Fontana del Ceraso, 03012 Anagni (FR), Italy and procured from within the
EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge
Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

Modecate 25 mg/ml Injection- PL 20636/2273

Leaflet issue and revision date (Ref): 28.07.15[6]
Modecate is trademark of E.R. Squibb & Sons Limited

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)

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.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl alcohol and sesame oil.
6.2 Incompatibilities
None. Pro
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 between 15º C and 30º C. Protected from light. Protect from heat.
Do not freeze
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.
10 DATE OF REVISION OF THE TEXT

28.07.15[6]

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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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