Fluanxol Film Coated Tablets, 0.5mg

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

FLUPENTIXOL

Fáanlegur frá:

Lundbeck Limited

ATC númer:

N05AF01

INN (Alþjóðlegt nafn):

FLUPENTIXOL

Lyfjaform:

FILM-COATED TABLET

Samsetning:

FLUPENTIXOL 0.5 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

PSYCHOLEPTICS

Leyfisstaða:

Authorised

Leyfisdagur:

2006-04-18

Upplýsingar fylgiseðill

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUANXOL® 0.5 MG AND 1 MG FILM-COATED TABLETS
FLUPENTIXOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 FLUANXOL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL
3. HOW TO TAKE FLUANXOL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FLUANXOL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT FLUANXOL IS AND WHAT IT IS USED FOR
Fluanxol contains the active substance flupentixol. Fluanxol belongs
to a group of medicines known as
antidepressants. These medicines act on nerve pathways in specific
areas of the brain and help to correct
certain chemical imbalances that are causing the symptoms of your
illness.
Fluanxol is used to treat depression in patients who may, or may not,
also be showing signs of anxiety.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL
DO NOT TAKE FLUANXOL

If you are allergic (hypersensitive) to flupentixol, other
thioxanthene drugs or antipsychotic drugs or to
any of the other ingredients of this medicine (listed in section 6).

If you are feeling less alert than usual, or are drowsy or sleepy, or
have serious problems with your
blood circulation

If
you
suffer
with
severe
depression,
which
needs
you
to
stay
in
hospital
or
if
you
need
electroconvulsive therapy (ECT)

If you suffer from periods of excitement, overactivity or mania.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fluanxol if you:

have a heart condition (including an irregular heart beat) or

Vara einkenni

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluanxol® 0.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
0.5
mg
film-coated
tablet
contains
0.5
mg
flupentixol
(as
0.5840
mg
flupentixol
dihydrochloride)
Excipients with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
0.5 mg Film-coated tablet
Round, slightly biconvex, yellow, film-coated tablet marked FD.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of depression (with or without anxiety).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The standard initial dosage is 1 mg as a single morning dose. After
one week the dose may be
increased to 2 mg if there is inadequate clinical response. Daily
dosage of more than 2 mg should be
in divided doses up to a maximum of 3 mg daily.
_Older patients _
Older patients should receive half the recommended dosages. The
standard initial dosage is 0.5 mg
as a single morning dose. After one week, if response is inadequate,
dosage may be increased to 1
mg once a day.
Caution should be exercised in further increasing the dosage but
occasional patients may require up
to a maximum of 1.5 mg a day which should be given in divided doses.
_Children _
Flupentixol is not recommended for use in children due to lack of
clinical experience.
_Patients with reduced renal function _
Flupentixol
has
not
been
studied
in
renal
impairment.
Increased
cerebral
sensitivity
to
antipsychotics has been noted in severe renal impairment (see section
4.4).
_Patients with reduced hepatic function _
Page 2 of 9
Flupentixol has not been studied in hepatic impairment. It is
extensively metabolised by the liver
and particular caution should be used in this situation and serum
level monitoring is advised (see
section 4.4).
Patients often respond within 2-3 days. If no effect has been observed
within one week at maximum
dosage the drug should be withdrawn.
Method of administration
The tablets are swallowed w