FLUANXOL 3 mg tablets

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

FLUPENTIXOL AS DIHYDROCHLORIDE

Saadav alates:

LUNDBECK ISRAEL LTD

ATC kood:

N05AF01

Ravimvorm:

TABLETS

Koostis:

FLUPENTIXOL AS DIHYDROCHLORIDE 3 MG

Manustamisviis:

PER OS

Retsepti tüüp:

Required

Valmistatud:

LUNDBECK A/S, DENMARK

Terapeutiline rühm:

FLUPENTIXOL

Terapeutiline ala:

FLUPENTIXOL

Näidustused:

Schizophrenia, mania.

Loa andmise kuupäev:

2010-07-31

Infovoldik

0660
190x600
925644
Black
IL-067-22-3-134 / 133662
IL-626002 (067-02) / 119778
2014-11-28 / 14:17 / MOVB
2
3
Do not exceed the recommended dosage.
consult the doctor or pharmacist.
How to take Fluanxol
Swallow with a drink of water. Do not chew the tablets. There is no
information
about crushing or splitting of the tablet.
Duration of treatment
As with other antipsychotic medicines it may take a few weeks before
you feel any
improvement.
Continue to take the tablets for as long as your doctor recommended.
Even if your medical situation has improved, do not stop taking the
medicine
without consulting the doctor or the pharmacist.
If you stop your treatment too soon your symptoms may return.
If you mistakenly took higher dosage
If you think that you or anyone else may have taken too many Fluanxol
tablets
contact your doctor or the nearest hospital immediately. Do this even
if there are no
signs of discomfort or poisoning. Take the Fluanxol container with you
if you go to a
doctor or hospital.
Symptoms of overdose may include:
•
Drowsiness
•
Unconsciousness
•
M
•
Convulsions
•
Low 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 has been given in overdose together with medicines
known
If you forget to take Fluanxol
If you forget to take a dose, take the next dose at the usual time. Do
not take a
double dose to make up for a forgotten tablet
If you stop taking Fluanxol
Do not stop taking Fluanxol even if you begin to feel better, unless
you are told to do so
by your doctor.
Do not take medicines in the dark. Check the label and the dose each
time you take
a medicine. Wear glasses if you need them.
If you have any further questions about the use of this medicine, ask
your doctor or
pharmacist.
SIDE EFFCTS
You should contact your doctor or go to the hospital straight away if
you
experience any of the following symptoms:
•
Unusual movements of the mouth and

Toote omadused

1
.
Physician Prescribing Information- Fluanxol tabs 3 mg
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluanxol 3 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluanxol 3 mg:
Each tablet contains 3 mg flupentixol (as 3.504 mg flupentixol
dihydrochloride)
Excipients with known effect:
Lactose monohydrate
3 mg: Sunset yellow FCF (E110),
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Coated tablet
3mg:
Round,slightly biconvex, ochre-, film coated tablet.
4.
CLINICAL PARTICULARS
1.4
THERAPEUTIC INDICATIONS
Schizophrenia and mania
1.4
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Schizophrenia and
Dosage should be individually adjusted according to the patient's
condition. In
general, small doses should be used initially and increased to the
optimal effective
level as rapidly as possible based on the therapeutic response. The
maintenance
dose can usually be given as a single morning dose.
Initially 3-15 mg/day divided in two or three daily doses, increased,
if necessary, to
40 mg/day.
Maintenance dose usually is 5-20 mg/day.
Older patients
Older patients usually should receive dosages in the lower end of the
dosage range.
Reduced renal function
Flupentixol can be given in usual doses to patients with reduced renal
function.
Reduced liver function
Careful dosing and, if possible, a serum level determination is
advisable .
Children
Flupentixol is not recommended for use in children due to lack of
clinical experience.
2
Method of administration
The tablets are swallowed with water.
1.4
CONTRA-INDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Circulatory collapse, depressed level of consciousness due to any
cause (e.g.
intoxication with alcohol, barbiturates or opiates), coma.
1.1
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The possibility of development of neuroleptic malignant syndrome
(hyperthermia,
muscle rigidity, fluctuating consciousness, instability of the
autonomous nervous
system) exists with any neur