MODECATE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUPHENAZINE DECANOATE

Available from:

Bristol-Myers Squibb Pharmaceuticals uc

ATC code:

N05AB02

INN (International Name):

FLUPHENAZINE DECANOATE

Dosage:

25 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

fluphenazine

Authorization status:

Marketed

Authorization date:

1977-02-22

Patient Information leaflet

Artwork Development & Prepress Department
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notes:
BMS ANAGNI (FR)
IE
---
130 X 592 (130 X 24) MM
5925 (ITF)
INS MODECATESINJ25/100MG/ML
130X296(24)
1135383A8
product name:
product code:
X
client:
country:
cutting die:
colors:
measures:
Pharma code:
31/10/2017
D. Stancul
X
03/11/2017
D. Stancul
BLACK - DIECUT
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MODECATE INJECTION 25 MG/ML
SOLUTION FOR INJECTION
MODECATE CONCENTRATE 100 MG/ML
SOLUTION FOR INJECTION
Fluphenazine Decanoate
Read all of this leaflet carefully before you start using 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 or
nurse.
-
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.
If you want to know more, or are not sure about anything, ask your
doctor.
IN THIS LEAFLET:
1. What Modecate is and what it is used for
2. What you need to know before you use Modecate
3. How to use Modecate
4. Possible side effects
5. How to store Modecate
6. Contents of the pack and other information
1. WHAT MODECATE IS AND WHAT IT IS USED FOR
This medicine is called Modecate and contains the active ingredient
fluphenazine
decanoate which belongs to a group of medicines called phenothiazines.
These
are classed as major tranquillisers and are used to treat nervous
disorders.
Modecate is used to treat and control chronic schizophrenia and other
mental
illnesses.
Modecate has a long lasting effect and is particularly useful if you
have difficulty
remembering to take tablets regularly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MODECATE
Do not use Modecate:
• If you are ALLERGIC (hypersensitive) to fluphenazine decanoate or
any of the
other ingredients (see section 6)
• If you take a high

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Modecate 25 mg/ml
Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 25mg Fluphenazine decanoate (250mg/10ml)
Excipients: contains 15mg benzyl alcohol (E1519) per ml and sesame
oil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (Injection)
A clear yellow, oily solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the long-term management
of psychotic disorders such as chronic schizophrenia,
the disturbed elderly,
severe
anxiety tension states and personality disorders.
Modecate is not intended for use in nonpsychotic disorders or for
short-term therapy (< 3 months).
Modecate has not
been shown to be effective in the management
of behavioural
complications in patients with
mental retardation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
The usual initial dose is 12.5mg but in the elderly this dose should
be 6.25mg. Subsequent dosage is usually 25mg
every two to four weeks,
with a range of 12.5 to 100mg depending on the patient’s response.
In those with no
previous therapy, treatment can be initiated by the oral route or
using a quick-acting agent before transferring to this
form.
Dosage should not exceed 100 mg. If doses greater than 50 mg are
deemed necessary, the next dose and succeeding
doses should be increased cautiously in increments of 12.5 mg.
Severely agitated patients may be treated initially with a
rapid-acting phenothiazine compound such as fluphenazine
hydrochloride injection.
When acute symptoms subsided,
25 mg (
1mL )
of
modecate
may be administered;
subsequent dosage is adjusted as necessary.
ELDERLY:
Elderly patients may be particularly susceptible to extrapyramidal
reactions. Therefore reduced maintenance dosage
may be required and a smaller initial dose (see above).
CHILDREN:
Not recommended for children.
NOTE: The dosage should not be increased without close supervision and
it should be noted that there is a variability
in