Package leaflet: Information for the user

PHENOZINE (Fluphenazine Decanoate Injection USP 25mg/ml, 1ml )

Read all of this leaflet carefully before you starts having this medicine because it contains important information
for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See Section 4.
What is in this leaflet
1. What Fluphenazine Decanoate Injection USP 25mg/ml is and what it is used for.
2. What you need to know before you use Fluphenazine Decanoate Injection USP 25mg/ml.
3. How to use Fluphenazine Decanoate Injection USP 25mg/ml.
4. Possible side effects.
5. How to store Fluphenazine Decanoate Injection USP 25mg/ml.
6. Contents of the pack and other information.
1. What Fluphenazine Decanoate Injection USP 25mg/ml is and what it is used for
Fluphenazine Decanoate Injection USP 25mg/ml is a medicine from the group of phenothiazine for the long-term
treatment and prevention in certain mental or psychological disorders.
Fluphenazine Decanoate Injection USP 25mg/ml is used for long-term treatment and prevention of relapses in certain
mental or psychological disorders (for more information, see the Summary of Product Characteristics).
2. What you need to know before you use Fluphenazine Decanoate Injection USP 25mg/ml
Do not use Fluphenazine Decanoate Injection USP 25mg/ml :
 If you are allergic to fluphenazine decanoate, sesame oil or any of the other ingredients of this medicine (listed in
section 6).
 With hypersensitivity to antipsychotics, especially phenothiazine, this has manifested as jaundice due to bile stasis,
allergic skin disorder and other allergic reactions.
 With acute toxicity with CNS depressants (e.g. certain painkillers [opiates], sleeping pills [hypnotics], other medicines
for treating mental or psychological disorders [antidepressants, antipsychotics, tranquillisers]) or alcohol.
 With existing prolactin-dependent tumors (e.g. breast cancer, prolactinoma).
 With excessive reduction in white blood cells (leucopenia) and other disorders of the blood-forming (hematopoietic)
system.
 With severe blood cell or bone marrow damage.
 With Parkinson's disease.
 With a history of confirmed neuroleptic malignant syndrome.
 With severe liver disorders.
 With severe depression.
 With coma.

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 For children aged under 12 years.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Fluphenazine Decanoate Injection USP
Take special care when using Fluphenazine Decanoate Injection USP with:
- Liver and kidney dysfunction.
- Adrenal tumors (pheochromocytoma).
- Pre-existing damage to the heart, congenital, or a family history of, prolonged QT interval (specific changes in the
electrocardiogram [ECG]), coronary heart disease, conduction disturbance, and arrhythmia.
- Very low or high blood pressure (hypotension, hypertension, orthostatic dysregulation).
- Slow heartbeat (bradycardia), low potassium levels in the blood (hypokalemia).
- Concomitant treatment with medicinal products which can likewise prolong the QT interval on ECG or cause
hypokalemia or other mineral imbalances.
- A history of organic brain disorders and epileptic seizures.
- Suspected or neurologically identifiable subcortical brain damage.
- Depression.
- Chronic respiratory problems and asthma.
- Reduced consciousness.
- Glaucoma, narrowing of the opening from the stomach into the duodenum (pyloric stenosis), enlarged prostate
(prostatic hyperplasia), problems passing water (urine retention).
- Patients who are exposed to high temperatures.
- Use of organophosphate insecticides.
In these cases, your doctor will perform a rigorous risk-benefit assessment before using Fluphenazine Decanoate
Injection.
Concomitant treatment with other antipsychotics should be avoided (see "Other medicines and Fluphenazine Decanoate
Injection USP 25mg/ml").
Increased mortality in elderly patients with dementia:
Among elderly patients with dementia who have been treated with antipsychotics, a slight rise has been reported in the
number of deaths compared to those taking no antipsychotics.
(Also) take special care:
• If you are at increased risk of stroke or have a temporarily reduced supply of blood to the brain.
• If you or a relative have already had venous thromboses (blood clots) because this medication has been linked to the
development of blood clots.
If you have risk factors for stroke (e.g. smoking, high blood pressure), you should take special care when using
Fluphenazine Decanoate Injection USP 25mg/ml.
Special care is recommended with patients with a history of neurologically identifiable subcortical brain damage and
seizures as major seizures can occur. Epileptics should only be treated with Fluphenazine Decanoate Injection USP
25mg/ml while taking concomitant anticonvulsants.
Caution is advised when treating patients with depression for whom Fluphenazine Decanoate Injection USP 25mg/ml
should only be used in conjunction with an antidepressant.
Warnings:
Prior to treatment with Fluphenazine Decanoate Injection USP 25mg/ml your blood count (including differential blood

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count and platelet count) must be monitored. If the blood count is abnormal. treatment with Fluphenazine Decanoate
Injection must not be given (see section 4 "Possible side effects”)
During treatment, regular blood counts (leucocyte counts and differential blood counts) should be performed. After the
start of the treatment, monitoring should be carried out weekly if possible in the first 4 months; in the case of
unremarkable findings, a monthly blood count check appears sufficient thereafter. If the leucocyte count falls sharply -
especially if it falls below 3000/mm'- or if there are other blood count changes, treatment with Fluphenazine Decanoate
Injection USP 25mg/ml must be discontinued immediately and replaced with other forms of therapy. If necessary
intensive care measures must be performed. Blood counts should be monitored until they return to normal. The patient
should be advised not to self-medicate for fever, inflammations of the gums and lining of the mouth, sore throat or strep
tonsillitis and flu-like symptoms, especially if these symptoms occur within the first three months of starting on the
medication, but to seek immediate medical attention.
In patients with organic brain damage, atherosclerotic cerebrovascular disease and depression, particular caution should
be exercised when treating with Fluphenazine Decanoate Injection USP 25mg/ml (can sometimes intensify symptoms of
depression). In case of diseases of the basal ganglia (e.g. Parkinson's disease), Fluphenazine Decanoate Injection USP
25mg/ml should only be used in exceptional cases and treatment should be discontinued if the symptoms worsen.
In patients with epileptic seizures, it should be taken into account that Fluphenazine Decanoate Injection USP 25mg/ml
may increase the possibility of having a seizure. The onset of seizures is facilitated by high doses at the start of treatment,
rapid dose increases and abrupt discontinuation of high doses. If you suffer from epilepsy, the use of antipsychotics for
psychiatric indications is not an absolute contraindication provided you continue taking anticonvulsant medication.
Body weight, blood glucose and serum lipid levels and tooth status should be monitored at regular intervals.
Conduction disturbances can occur especially in elderly patients and patients with pre-existing damage to the heart.
Circulatory status (including ECG) should be monitored at regular intervals during therapy, and a baseline ECG should
be available for later follow-up. Existing hypokalemia should be corrected prior to treatment.
When high fever and muscle rigidity occur, neuroleptic malignant syndrome should be considered (see section 4
"Possible side effects") which is often misdiagnosed as catatonia. Since further administration of an antipsychotic may be
life-threatening, differential diagnosis is crucial (including drug history, checking for rigor, fever, increase in creating
kinase activity in the blood, increases in myoglobin in the blood and urine).
Fatal cases are particularly prominent in patients with pre-existing psycho-organic syndrome, mental retardation, and
opiate and alcohol dependence. Depending on the dose (according to the therapy intervals), symptoms may persist for
some time following i.m. injection.
In this case, please contact a doctor immediately.
Although the incidence of certain movement disorders (tardive dyskinesia) has not been adequately researched. it
appears that these are more common in older people, especially older women. The risk of these movement disorders, and
especially of irreversibility, is likely to increase with the duration of therapy and the level of dosage. However, tardive
dyskinesia can develop even after a short treatment period and low doses. Antipsychotic therapy can also mask the
symptoms of tardive dyskinesia. Once the medication is withdrawn this then becomes apparent. There is currently no
known safe treatment for these symptoms.
Regular checks on kidney and liver function are also recommended. If liver function is impaired, the doses must be
adjusted. Particularly in elderly patients, special care should be taken because of their increased sensitivity. The
anticholinergic side effects are often more pronounced. Elderly patients, especially older women, may develop
extrapyramidal side effects (gait disturbances, proximal movement disorders, tremor, stiffness of the skeletal muscles, in

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some cases brain damage which is not easily reversible) even at low doses. The sedative effect is more pronounced in
elderly patients. Low blood pressure can be more common.
Children and adolescents:
There are no adequate studies available on the efficacy and tolerance of fluphenazine decanoate in children and
adolescents. Fluphenazine Decanoate Injection should therefore only be prescribed for children aged over 12 years and
adolescents with careful assessment of the risks/benefits.
Elderly patients:
Caution should be exercised in elderly or infirm patients as well as patients with organic changes to the brain, circulatory
and respiratory failure (chronic obstructive pulmonary disease) as well as renal or hepatic impairment (observe dosage
instructions!).
Other medicines and Fluphenazine Decanoate Injection USP 25mg/ml
Tell your doctor or pharmacist if you are taking /using, have recently taken/used or might take/use any other medicines.
Concomitant use with other CNS depressants (e.g. psychotropic drugs [used to treat mental or emotional disorders],
sleeping pills, some painkillers, anesthetics or other medicines used, for example, to treat allergies or colds
(antihistamines] can result in a mutual intensification of the effects and side effects (especially sedation and lowering
blood pressure).
If patients who are on antipsychotics undergo surgery they must be closely monitored for any fall in blood pressure
(hypotension). The dose of anesthetics or CNS depressants may need to be reduced.
Concomitant administration of tricyclic antidepressants and fluphenazine decanoate leads to a rise in plasma levels of
antidepressant. Increased toxicity of both active substances (anticholinergic effect, lowering of the seizure threshold, but
primarily effects on the heart [prolonged QT interval]) is to be expected. For this reason this combination is not
recommended.
Avoid concomitant use of medicinal products which can likewise prolong the QT interval (e.g. class IA or Ill
antiarrhythmic, macrolide antibiotics. antihistamines, antimalarial, antidepressants, other antipsychotics), cause low
blood potassium or other mineral imbalances (e.g. certain medicines to promote urine production [diuretics]) or inhibit
the breakdown of fluphenazine decanoate in the liver (e.g. paroxetine, fluoxetine).
When combined with lithium salts plasma levels of fluphenazine may be elevated thereby increasing the risk of
extrapyramidal motor side effects (gait disturbances, proximal movement disorders, tremor. rigidity of the skeletal
muscles, in isolated cases brain damage which is not easily reversible). Conversely, lithium plasma levels may also be
elevated. In very rare cases there have been reports of severe neurotoxic syndrome when antipsychotics and lithium are
administered concomitantly.
The effect of levodopa or dopamine agonists (e.g. bromocriptine, amantadine, cabergoline) may be impaired in
concomitant therapy.
If antipsychotics are used in conjunction with other dopamine antagonists (e.g. metoclopramide, alizapride) the
extrapyramidal motor effects may be intensified.
If fluphenazine decanoate is combined with medicinal products which likewise have an anticholinergic action (e.g.
antidepressants, atropine, biperiden) the anticholinergic effects may be cumulatively intensified. This may manifest itself
in visual disturbances, increased intraocular pressure, dry mouth, rapid heartbeat, constipation, problems when urinating,
saliva secretion disorders, speech impediment or memory disorders. There is an increased risk of pharmacogenic
delirium. At the same time the efficacy of fluphenazine may be impaired.
Combination with sympathomimetic can lead to hypertensive crises. Hypotension in patients who are on fluphenazine

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decanoate should not be treated with epinephrine as administering epinephrine may cause a further fall in blood pressure
("adrenaline reversal"). In cases of severe shock, however, norepinephrine (noradrenaline) may be given.
Fluphenazine generally enhances the blood pressure-lowering effect of antihypertensive. This can cause increased
orthostatic circulatory dysregulation. For example, there may be dizziness, "spots before the eyes" and rapid pulse. There
are, however, also reports of paradoxical reactions (guanethidine, clonidine, methyldopa )
Co-administration of fluphenazine decanoate and MAO inhibitors can lead to a (further) fall in blood pressure as well as
extrapyramidal motor effects.
Concomitant treatment with anthelmintic drugs containing piperazine (worming medications) leads to an increased risk
of extrapyramidal motor side effects.
Clonidine can impair the antipsychotic effect of fluphenazine decanoate.
Co-administration of fluphenazine decanoate and cimetidine can reduce plasma levels of fluphenazine.
Co-administration of pentetrazol can trigger seizures.
Phenothiazine can increase the tendency to metrizamide-induced seizures. Fluphenazine decanoate should therefore not
be given for least 48 hours before and 24 hours after a myelogram.
Co-administration of fluphenazine decanoate with amphetamines or anorectics (appetite suppressants) can lead to
antagonistic pharmacological reactions.
Concomitant use of products containing reserpine is not recommended.
Respiratory depression caused by polypeptide antibiotics (e.g. colistin, polymixin B) may be exacerbated by
fluphenazine decanoate.
The effect of anticoagulants (blood thinners) may be enhanced. Coagulation status must therefore be monitored regularly
at shorter intervals for patients on concomitant anticoagulants.
Co-administration of anticonvulsants such as barbiturates or carbamazepine can result in increased metabolism
offluphenazine.
Co-administration of fluphenazine decanoate and phenytoin can lead to a change in the metabolism of phenytoin,
possibly resulting in toxic plasma levels.
Due to the increase in prolactin triggered by phenothiazine, the response to administering gonadorelin may be impaired.
Fluphenazine decanoate should not be combined with clozapine as there may be an increased risk of a blood count
disorder.
Co-administration of fluphenazine decanoate and propranolol increases plasma levels of both medicinal products.
There have been isolated reports of patients who developed acute, severe, reversible Parkinsonism on combination
therapy with a serotonin re-uptake inhibitor and fluphenazine decanoate.
There are indications that there is increased risk of dyskinesia with co-administration of phenylalanine and
antipsychotics.
As there have been reported cases where patients with elevated dehydroepiandrosterone levels failed to respond to
treatment with antipsychotics, patients who are on fluphenazine decanoate therapy should avoid replacement with
dehydroepiandrosterone.
There have been reports of an increased risk of epileptic seizures in schizophrenic patients who were taking products
containing evening primrose oil during treatment with phenothiazine.
Caffeine potentially counteracts the antipsychotic properties of phenothiazine. However the data is contradictory.
The metabolic status of insulin-dependent diabetics may become unstable during phenothiazine therapy (especially at

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high doses) and may necessitate dietary and medicinal measures and/or an adjustment of the dose of antidiabetic drugs
Treatment with fluphenazine decanoate may falsify the results of a pregnancy test (false positive result).
Note:
The patient should be informed that no other medicinal products-including over-the-counter medications - should be
taken without the knowledge of their doctor.
Fluphenazine Decanoate Injection USP 25mg/ml with food, drink and alcohol
During treatment with Fluphenazine Decanoate Injection USP 25mg/ml you should avoid alcohol, as alcohol will alter
and enhance the effects of fluphenazine in an unpredictable way.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy:
The safety of the use of Fluphenazine Decanoate Injection USP 25mg/ml in pregnancy has not been established.
Therefore. you should use Fluphenazine Decanoate Injection in pregnancy only if your doctor considers it to be
absolutely necessary and after very careful assessment of the therapeutic benefit to you as the mother against the risk of
damage to the fetus or your child.
The class of active substance used crosses the placenta. To avoid reversible side effects in newborn infants following
treatment you require, ii is recommended that antipsychotics are administered at as low doses as possible during the last
weeks of pregnancy.
Newborns of mothers who have been exposed to fluphenazine during the third trimester (last three months of pregnancy)
may display the following symptoms: tremor, muscle rigidity and/or weakness, drowsiness, restlessness, breathing
problems and difficulty in breast- feeding. If your baby develops any of these symptoms, you should contact your doctor.
Breast-feeding;
Fluphenazine, the active substance in Fluphenazine Decanoate Injection USP 25mg/ml, passes into breast milk. You
should therefore not breast-feed during treatment.
Driving and using machines
Even when used as instructed, this medicinal product may alter the ability to react to the extent that the ability to drive or
use machines is impaired. This applies to a greater degree in association with alcohol. Driving, using machines or other
hazardous activities are therefore to be avoided at least during the initial phase of treatment. In each case the decision is
taken by the doctor based on the individual response and respective dose
3. How to use Fluphenazine Decanoate Injection USP 25mg/ml
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The response to fluphenazine decanoate differs from patient to patient. The dosage, duration of administration and length
of intervals between injections to prevent relapses must be adapted to the individual patient response, the indication and
the severity of the disease. The principle here is to keep the dose as low and duration of treatment as short as possible.
Unless otherwise prescribed by your doctor, the recommended dose is:
Unless prescribed otherwise, 12.5-100 mg fluphenazine decanoate is injected at 3 (2-4) weekly intervals following
withdrawal of existing antipsychotic therapy with direct-acting antipsychotics. When continuing therapy with oral
neuroleptics (and other medicinal products, see section "Other medicines and Fluphenazine Decanoate Injection"), a
sufficient margin of safety should be observed as the effect of Fluphenazine Decanoate Injection USP 25mg/ml lasts for

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2-4 weeks.
The maximum single dose should not exceed 100 mg. If doses of more than 50 mg are necessary, the dose should be
increased carefully to the final dose in 12.5 mg increments.
To prevent relapse following remission (subsidence of symptoms) lower doses of 12.5-25 mg fluphenazine decanoate
every 3 (24) weeks are frequently sufficient - especially with accompanying stabilizing socio- and psychotherapeutic
measures. However, doses of 2.5 mg fluphenazine decanoate every 2 weeks may also be sufficient or 50 mg every 2
weeks may be necessary.
The specified doses refer to adult patients with stable circulation.
A single dose takes effect between Day 2 and Day 5 after administration. In chronic cases this is often even later.
Note: As Fluphenazine Decanoate Injection USP 25mg/ml is an oil-based solution for injection, avoid intravenous
injection.
Before opening the ampoule, make sure it is in a vertical position for a few minutes so that the entire solution can collect
in the lower part of the ampoule. Aspiration of the solution into the syringe should be done slowly enough to allow
quantitative withdrawal. Dilution of the solution or mixing with other solutions is not possible.
Specific dosage instructions:
Fluphenazine Decanoate Injection should not be used for initial therapy or for elderly or infirm patients and other
patients at high risk of side effects (e.g. patients with impaired liver or kidney function, organic changes to the brain,
circulatory and respiratory weakness).
Caution should be exercised when dispensing to patients with glaucoma, urine retention and prostatic hyperplasia
(enlarged prostate) due to the anticholinergic effects of fluphenazine.
How and when to administer Fluphenazine Decanoate Injection USP 25mg/ml
Fluphenazine Decanoate Injection USP 25mg/ml is only administered by slow, deep intramuscular injection into a major
muscle (exercise caution with thrombolysis therapy!) using a dry needle and syringe to avoid clouding of the solution.
The interval between doses is at least 2, and on average 3(2-4) weeks.
In isolated cases the effect can last up to 6 weeks in patients who are in remission.
Duration of administration
Your doctor will decide on the duration of treatment depending on the nature and severity of your illness. The aim should
be to use the lowest maintenance dose required. The need to continue treatment should be constantly reviewed.
Following long-term therapy any injection dose of more than 25 mg fluphenazine decanoate must be reduced gradually
in very small stages over a long period and in close contact between doctor and patient.
Note: Fluphenazine decanoate products are oil-based solutions for injection. Avoid intra-arterial (into an artery) and
intravenous (into a vein) injections as there is a risk of necrosis. Paravenous (adjacent to a vein) injections cause severe
pain.
The solution for injection must not be mixed with other medicinal products in the syringe.
After opening the ampoule discard any residues.
If you receive more Fluphenazine Decanoate Injection USP 25mg/ml than you should
Due to the relatively broad therapeutic range. intoxication generally only occurs with stronger overdoses.
Symptoms:
In case of overdose, the known side effects in particular may be more severe, depending on the dose administered:
• severe drowsiness ranging through to loss of consciousness or coma

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• excitation and delirious confusion
• extrapyramidal disorders: acute dyskinesia or dystonia, involuntary tongue protrusion, gaze spasms, laryngeal or
pharyngeal spasms
• seizures
• hyperthermia or hypothermia,
• Cardiac disorders: rapid heartbeat (tachycardia), slow heartbeat (bradycardia), ECG changes such as arrhythmia
(prolonged PQ/QT interval, torsade de pointes), cardiovascular failure (rapid with massive overdose)
• fall or rise in blood pressure
• loss of motor control
• blurred vision, increased intraocular pressure
• impaired intestinal motility
• absence of bowel motility
• urine retention
• respiratory disorders: reduced respiratory drive or even respiratory arrest or the possible development of pneumonia
In such cases, immediately inform a doctor who will assess the severity and any further measures that may be required.
If you forget to use Fluphenazine Decanoate Injection USP 25mg/ml or are given too little
If signs of illness recur or intensify or become abnormal before your next visit to the doctor, contact your doctor
immediately. Otherwise, continue treatment according to the schedule. Do not take a double dose to make up for a
forgotten dose.
If you stop using Fluphenazine Decanoate Injection USP 25mg/ml
If you want to interrupt the treatment, you must first discuss this with your doctor. Do not stop the medication without
consulting your doctor. This may jeopardies the success of treatment and put you in danger!
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following categories are used as a basis for evaluating frequency of side effects.
Very common: may affect more than 1 in 10 people
Common: may affect 1 to 10 people out of 100
Uncommon: may affect 1 to 10 people out of 1000
Rare: may affect 1 to 10 people out of 10,000
Very rare: may affect fewer than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data.
The following side effects are to be expected when using Fluphenazine Decanoate Injection USP 25mg/ml:
Central nervous system
Extrapvramidal motor symptoms (disorders of involuntary movement}:
Treatment with fluphenazine decanoate can very commonly lead to early dyskinesia (muscle tension and movement
disorders [involuntary tongue protrusion, wry neck, jaw spasms, gaze spasms, rigidity of the back muscles]) and
heightened reflexes -- especially in the first few days and weeks following the injection. Parkinson's syndrome (tremor,
rigidity, immobility, excessive salivation), inability to stay still and restlessness (akathisia) generally occur later on.
Children develop extrapyramidal motor disorders even at low doses.
The onset of early dyskinesia or Parkinson's syndrome requires a reduction in dose or treatment with an anticholinergic

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antiparkinson agent. However. This medication should only be given if required and not routinely. If antiparkinson
medication is required which is eliminated more rapidly than fluphenazine decanoate, to avoid the onset or deterioration
of extrapyramidal motor symptoms ii may be necessary to continue this antiparkinson medication even after
discontinuing fluphenazine decanoate. It must be borne in mind that intraocular pressure may increase with co-
administration of fluphenazine decanoate and anticholinergic drugs including antiparkinson medication.
Treating an inability to stay still and restlessness (akathisia) is difficult. Initially, a reduction in dose may be tried but if
this is not successful treatment with tranquilizers or beta-blockers may be tried.
After prolonged. High-dose therapy or after discontinuing therapy (especially in the elderly and women), tardive
dyskinesia may occur. Symptoms include persistent, irreversible involuntary movements of the jaw and facial muscles
and arms and legs. There is currently no known safe treatment for these symptoms.
At the first signs of dyskinesia in the tongue and face muscles. Discontinuing antipsychotic therapy should be
considered. Prolonged treatment with Fluphenazine Decanoate Injection USP 25mg/ml may mask tardive dyskinesia
which only becomes apparent after treatment is withdrawn.
Neuroleptic malignant syndrome:
Treatment with antipsychotics may result in potentially fatal neuroleptic malignant syndrome. Symptoms include fever
above 40°C, muscle rigidity, palpitations and high blood pressure, clouding of consciousness or even coma. Increase in
myoglobin and creating kinase activity (CK). Increase in white blood cell count. Liver dysfunction and acute renal
failure. Requiring the immediate withdrawal of medication. Treatment is difficult. The following measures are
recommended:
• No further use of the medicinal product.
• Treating hyperthermia by cooling as antipyretics may not be effective with high fever,
• Treatment for mineral and fluid imbalances. Cardiovascular symptoms, infections, respiratory and renal complications.
• Attempted treatment with dantrolene infusions (3 to 10 mg/kg body weight daily) combined with bromocriptine (7.5 to
30 mg/day po.)
Other CNS effects:
Fatigue and noticeable flattening are common. Particularly at the start of treatment, but agitation. Excitability, light-
headedness or depression can also occur. With long-term therapy, lethargy, dizziness. headache, confused dreams,
symptoms of delirium (common in combination with anticholinergic drugs), seizures, dysregulation of body temperature
as well as uncommon speech, memory and sleep disorders are also possible. Isolated cases of reversible central paresis
(paralysis) have been reported.
During treatment with Fluphenazine Decanoate Injection USP 25mg/ml there may also be changes in the EEG
(measurement of brain activity) and in CSF protein. As with other antipsychotic drugs. Psychotic processes may be
reactivated or exacerbated in rare cases.
Cardiovascular system
A fall in blood pressure or circulatory disorders when changing from lying or sitting to standing or acceleration of the
heartbeat (circulatory instability) is common. Especially at the start of treatment and in patients with adrenal tumors.
Damage to the cerebral vessels, kidney or heart.
In the event of a severe drop in blood pressure. Appropriate emergency procedures must be initiated.
High blood pressure is also possible. The use of fluphenazine decanoate may cause a delay in the conduction of the heart
(excitation and repolarization disturbances) that are visible on an ECG and may lead to life-threatening cardiac
arrhythmia (torsade de pointes). If this is the case, treatment with fluphenazine decanoate should be discontinued.

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Irregular or rapid heartbeat (rare). Cardiac arrest and sudden unexplained death have been reported with drugs from the
therapeutic class of antipsychotics which includes Fluphenazine Decanoate Injection USP 25mg/ml. Cardiac arrhythmia
is more common with higher doses and in pre-disposed patients.
Autonomic nervous system / gastrointestinal tract
These side effects occur mainly at the start of therapy and then generally decline as treatment continues.
Uncommonly there may be visual disturbances. Dry mouth, sweating, salivation, increased passage of urine, fever,
feeling of nasal congestion. Increased intraocular pressure, constipation and voiding disorders.
There have also been uncommon reports of nausea. Vomiting, diarrhea and loss of appetite. These effects can normally
be alleviated by reducing the dose or extending the interval between doses.
Very rarely it can lead to life-threatening intestinal paralysis.
Liver and gall ducts
There have been uncommon reports of temporary increases in liver enzymes. Bile outflow disorders (intrahepatic
cholestasis) and jaundice.
Endocrine system
Therapy with fluphenazine decanoate has an impact on sexual function. Causing a decrease in sexual interest, impotence
as well as menstrual disorders and lactation (galactorrhea) or breast enlargement in men. In addition. Disorders of
glucose (sugar) metabolism may occur. Like other antipsychotics, fluphenazine decanoate can cause weight gain,
impaired ADH secretion (over- or under-production of a particular hormone that regulates the body's fluid balance) and
reduced blood sodium levels.
Blood and blood vessels
There have been uncommon reports of blood count changes including various forms of low white cell count
(neutropenia, agranulocytosis [rare]), low platelet count (thrombocytopenia), low blood cell count of all cell lines
(pancytopenia) and eosinophilia.
You must therefore comply with your doctor's request to attend the required blood count tests. If you develop symptoms
of inflammation in the mouth and throat. Fever and flu-like infections, tell your doctor immediately.
Rarely there may be blood clots in the leg and pelvis
There have been blood clots in the veins. Especially in the legs (with swelling, pain and redness of the legs). This may
enter the lungs via the bloodstream, causing chest pain and difficulty breathing. If you notice any of these symptoms,
seek medical advice immediately.
Skin and hypersensitivity reactions
Fluphenazine decanoate can trigger allergic skin reactions of all degrees of severity, itching and sensitivity of the skin to
sunlight (lake care in the sun!).
Respiratory problems, asthma and bronchopneumonia, laryngeal edema, antineurotic edema (Quince’s edema),
anaphylactic reactions, pigmentation disorders, lupus erythematosus-type conditions (red, inflamed skin) and peripheral
edema have all been reported.
Other possible side effects
Cerebral edema, retinitis pimentos’ (retinal damage), pigment deposits in the lens and cornea.
In hospitalized psychotic patients there occurred sudden, unexpected and unexplained deaths with phenothiazine therapy,
with earlier brain damage or seizures likely to play a role as predisposing factors. High doses should therefore be avoided
for patients with known epilepsy.

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In rare cases, sesame oil can trigger severe allergic reactions.
If you experience any side effects, notify your doctor so that he or she can decide on the severity and any further action
that may be required. Side effects generally subside after the dose is reduced and can usually be avoided or minimized by
careful individual adjustment of the dose.
Reporting side effects
If you experience any side effects, talk to your doctor or pharmacist
This includes any possible side effects not listed in this leaflet.
5. How to store Fluphenazine Decanoate Injection USP 25mg/ml
Keep this medicine out of the sight and reach of children!
Do not use this medicine after the expiry date which is stated on the carton and ampoule after "verwendbar bis" (use by).
The expiry date refers to the last day of that month.
After opening the ampoule, discard residues.
Storage conditions:
Store the ampoules in the carton to protect against light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fluphenazine Decanoate Injection USP 25mg/ml contains
Sr. No. Excipients Name Pharmacopeias Functions
1 Benzyl Alcohol USP Preservative
2 Sesame oíl USP Solvent
What Fluphenazine Decanoate Injection USP 25mg/ml looks like and contents of the pack
Fluphenazine Decanoate Injection USP 25mg/ml is a Light yellow colored oily solution.
It comes in 1ml amber glass ampoule having blue dot on neck and sealed, paper label such 10 ampoules in a
tray and each tray packed in a printed carton with leaflet.
Manufactured by: -----
This leaflet was last revised in February, 2024.

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