Fluanxol 0.5mg film-coated tablets

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

FLUPENTIXOL DIHYDROCHLORIDE

可用日期:

Lundbeck Malaysia Sdn. Bhd.

INN（国际名称）:

FLUPENTIXOL DIHYDROCHLORIDE

每包单位数:

10 x10'sunits Units

厂商:

H. LUNDBECK A/S

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FLUANXOL 0.5MG FILM-COATED TABLETS
FLUPENTIXOL (AS DIHYDROCHLORIDE) (0.5MG)
1
WHAT IS IN THIS LEAFLET
1.
What Fluanxol is used for
2.
How Fluanxol works
3.
Before you take Fluanxol
4.
How to use Fluanxol
5.
While you are using Fluanxol
6.
Side effects
7.
Storage and Disposal of Fluanxol
8.
Product Description
9.
Manufacturer & Product Registration
Holder
10.
Date of Revision
WHAT FLUANXOL IS USED FOR
Fluanxol is used to treat depression in patients
who may, or may not also be showing signs of
anxiety.
Your doctor, however, may prescribe
Fluanxol for another purpose. Ask your doctor
if you have any questions about why Fluanxol
has been prescribed for you.
HOW FLUANXOL WORKS
Fluanxol contains the active substance
flupentixol. Fluanxol belongs to a group of
medicines that work by relieving the
symptoms of depressed mood.
BEFORE YOU USE FLUANXOL
When you must not use it
Do not take Fluanxol
•
If you are allergic (hypersensitive) to
flupentixol or to any of the other
ingredients of this medicine (listed in
section Ingredients)
•
If you have diminished consciousness.
Not recommended for excitable or agitated
patients
Fluanxol tablets are not suitable if you have a
severe depression, for example if you are
required to stay in hospital or requiring
electroconvulsive therapy (ECT).
Before you start to use it
Talk to your doctor or pharmacist before
taking Fluanxol if you:
•
have a liver problem
•
have a history of convulsions or fits
•
have diabetes (you may need an
adjustment of your antidiabetic
therapy)
•
have an organic brain syndrome
(which may be a resulting condition
after poisoning with alcohol or
organic solvents)
•
have risk factors for stroke (e.g.
smoking, hypertension)
•
have hypokalemia or
hypomagnesia (too little potassium
or magnesium in your blood or
genetic predisposition for any of
these
•
have a history of cardiovascular
disorders
•
use other antipsychotic medicine
•
are more excited or overactive than
normal, since this medicine m

产品特点

1.
NAME OF THE MEDICINAL PRODUCT
Fluanxol 0.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluanxol 0.5 mg:
Each tablet contains 0.5 mg flupentixol (as 0.5840 mg flupentixol
dihydrochloride
Excipients with known effect:
Lactose monohydrate
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet.
0.5mg: Round, slightly biconvex, yellow, film-coated tablet marked FD.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Depression involving anxiety, asthenia and lack of initiative.
Chronic neuroses with anxiety, depression, and inactivity.
Psychosomatic disorders with asthenic reactions.
Acute and situational anxiety and tension states in which a
sedative/hypnotic effect is not required and especially
when the patient is considered in danger of abusing minor
tranquillizers
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_Adults _
Initially 1 mg daily as a single morning dose or 0.5 mg twice daily.
After one week the dosage may be increased to 2
mg daily 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.
Patients often respond to flupentixol within two or three days. If no
effect has been observed within one week of
maximum dosage (3 mg daily) the drug should be withdrawn.
_Older patients _
Older patients should receive half the recommended dosages. The
initial dosage for older patient is 0.5 mg as a
single morning dose. After one week, if response is inadequate, dosage
may be increased to 1 mg daily. 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.
_Reduced renal function _
Flupentixol has not been studied in renal impairment. Increased
cerebral sensitivity to antipsychotics has been
noted in severe renal impairment.
_Reduced liver function _
Flupentixol has not been studied in hepatic impairment. It is
extensively metabolised by the liver and particular
caution shoul