FLUDECATE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUPHENAZINE DECANOATE

Available from:

UNIPHARM TRADING LTD, ISRAEL

ATC code:

N05AB02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FLUPHENAZINE DECANOATE 25 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

UNIPHARM TRADING LTD, ISRAEL

Therapeutic group:

FLUPHENAZINE

Therapeutic area:

FLUPHENAZINE

Therapeutic indications:

Fludecate is a long acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g. chronic schizophrenics).Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation.

Authorization date:

2022-06-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS(
– 1986
The medicine is dispensed with a doctor’s prescription only
FLUDECATE
SOLUTION FOR INTRAMUSCULAR INJECTION
COMPOSITION:
Each 1 ml ampoule contains:
Fluphenazine decanoate 25 mg
Inactive and allergenic ingredients in the preparation – see section
2 “Important information about some of the ingredients of the
medicine” and section 6 “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them even if it seems to you that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
FLUDECATE is a long-term antipsychotic given by injection, intended
for use in patients in need of a long-term antipsychotic )e.g., to
treat
chronic schizophrenia(.
THERAPEUTIC GROUP: phenothiazine derivative, antipsychotic.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to fluphenazine decanoate, sesame
oil or any of the additional ingredients contained in the medicine
)for the list of inactive ingredients, please see section 6 –
“Further
information”(.
• You suffer from hypersensitivity to antipsychotics, especially
phenothiazine derivatives, which manifests by jaundice as a
result of cholestasis, allergic skin disease and other allergic
reactions.
• You suffer from severe poisoning as a result of use of depressants
of the central nervous system )e.g., certain painkillers ]opiates[,
hypnotics, other medicines for the treatment of mental disorders
]antidepressants, antipsychotics, tranquillizers[( or alcohol.
• You suffer from prolactin-dependent tumors )e.g., breast cancer,
a tumor in the pituitary gland(.
• You suffer from an excessive reduction in the number of white
cells )leukopenia( or other disorders of the

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCTS
FLUDECATE Solution for injection
2
.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of Fludecate contains 25 mg/ml of fluphenazine decanoate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for intramuscular injection
Yellow, oily viscous, clear solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fludecate is a long-acting parenteral antipsychotic drug intended for
use in the management
of patients requiring prolonged parenteral neuroleptic therapy (e.g.
chronic schizophrenics).
Fluphenazine Decanoate Injection has not been shown effective in the
management of
behavioral complications in patients with mental retardation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The response to fluphenazine decanoate differs from patient to
patient. The dosage, duration
of use and intervals between injections for relapse prevention must be
adjusted to the
individual response, the indication and the severity of the disease.
For this, the principle of
having as low a dose and as short a duration of treatment as possible
should be followed.
In general, 12.5-100 mg fluphenazine decanoate is injected at
intervals of 3 (2-4) weeks after
the conclusion of antipsychotic treatment with short-acting
neuroleptics. If treatment is
continued with oral neuroleptics (and other medicinal products, see
section 4.5), a sufficient
safety margin needs to be allowed for, given that Fludecate acts for
2-4 weeks.
The maximum single dose should not exceed 100 mg. If doses above 50 mg
are necessary,
the dose should be cautiously increased in 12.5 mg steps up to the
target dose.
Once
remission
has
occurred
-
especially
with
accompanying
stabilizing
socio-
and
psychotherapeutic measures - lower doses (12.5-25 mg fluphenazine
decanoate every 3 (2-4)
weeks)
are
frequently
sufficient
for
relapse
prevention.
However,
doses
of
2.5 mg
fluphenazine decanoate every 2 weeks or 50 mg every 2 weeks may also
be necessary.
If very low doses are used, it may be nec