FLUANXOL DEPOT 20 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUPENTIXOL DECANOATE

Available from:

LUNDBECK ISRAEL LTD

ATC code:

N05AF01

Pharmaceutical form:

OILY SOLUTION FOR INJECTION

Composition:

FLUPENTIXOL DECANOATE 20 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

H. LUNDBECK A/S, DENMARK

Therapeutic group:

FLUPENTIXOL

Therapeutic area:

FLUPENTIXOL

Therapeutic indications:

Schizophrenia, mania.

Authorization date:

2013-08-31

Patient Information leaflet

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190x600
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IL-608209 (067) / 133116
IL-608208 (067) / 128673
2014-11-10/09:22/HESP
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If you have been treated with Fluanxol tablets and you are being
transferred to
Fluanxol Depot you may be asked to continue taking the tablets for
several days
Your doctor may decide to adjust the amount given, or the interval
between
injections, from time to time.
Older people
doses in the lower end of the dosage range.
Use in Children
Fluanxol Depot is not intended for children and infants.
Do not take more than the recommended dose.
weak, talk to your doctor
Duration of treatment
It is important that you continue to receive your medicine at regular
intervals as
instructed by the doctor.
Even if there is an improvement in your health, do not stop treatment
with this
medicine without consulting the doctor or the pharmacist. If you stop
your
treatment too soon your symptoms may return.
Your doctor decides the duration of treatment.
If you get more Fluanxol Depot than you should
Your medicine will be given by your doctor /nurse. In the unlikely
event that you
receive too much Fluanxol Depot you may experience the following
symptoms:
blood pressure, weak pulse, fast heart rate, pallor, restlessness,
high or low body
temperature.
Changes in heart rate including irregular heart beat or slow heart
rate has been
seen when Fluanxol Depot has been given in overdose together with
medicines
Symptomatic and supportive treatment will be initiated by the doctor
or the nurse.
Continue the treatment for as long as your doctor recommended.
Even if your medical situation has improved, do not stop taking the
medicine
without consulting a doctor.
Do not take medicines in the dark! Check the label and the dose each
time you take
your medicine. Wear glasses if you need them.
For further questions about how to use the medicine, ask your doctor
or a
pharmacist.
SIDE EFFCTS
from any of them.
You should contact your doctor or go to the hospital straight away if
you
experience any of the following symptoms:
Uncommon
Unusual movements of t

Summary of Product characteristics

רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ
Summary of product characteristics - Physician Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
FLUANXOL® DEPOT 20 MG /ML
FLUANXOL® DEPOT 100 MG /ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flupentixol decanoate 20 mg/ml.
Flupentixol decanoate 100 mg/ml.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
OILY SOLUTION FOR INJECTION. INTRAMUSCULAR (IM).
20 MG/ML:
CLEAR, COLOURLESS TO SLIGHTLY YELLOWISH OIL, PRACTICALLY FREE FROM
PARTICLES.
100 MG/ML:
CLEAR, YELLOWISH TO YELLOW OIL, PRACTICALLY FREE FROM PARTICLES.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Schizophrenia and mania.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults _
Dosage and interval between injections should be adjusted for each
individual patient so as to
achieve a maximum suppression of psychotic symptoms with a minimum of
side effects.
_Flupentixol decanoate 20 mg/ml _
In the maintenance treatment the dosage range would normally be 20-40
mg (1-2 ml) at intervals of
2 to 4 weeks depending on the response.
Some patients may need larger doses or need them at shorter intervals.
Flupentixol decanoate 20
mg/ml is unsuitable for patients in whom sedation is required.
Injection volumes larger than 2 ml
should be distributed between two injection sites.
If volumes larger than 2-3 ml of the 20 mg/ml solution are required
the more concentrated solutions
(flupentixol decanoate 100 mg/ml) should be preferred.
During an exacerbation or acute relapse of the illness single
injections of as much as 400 mg
fortnightly (or in the occasional cases weekly for a short period) may
be required.
_Flupentixol decanoate 100 mg/ml _
Dosage range lies between 50 mg (0.5 ml) every 4 weeks to 300 mg (3
ml) every 2 weeks but
some patients may require up to 400 mg (4 ml) weekly. Injection
volumes larger than 2 ml should
be distributed between two injection sites.
Adequate control of severe psychotic symptoms by the concentrated
injection f