CLOPIXOL DROPS 20MGML

País: Malàisia

Idioma: anglès

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

ingredients actius:

ZUCLOPENTHIXOL DIHYDROCHLORIDE

Disponible des:

Lundbeck Malaysia Sdn. Bhd.

Designació comuna internacional (DCI):

ZUCLOPENTHIXOL DIHYDROCHLORIDE

Unidades en paquete:

20ml mL

Fabricat per:

H. LUNDBECK A/S

Informació per a l'usuari

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CLOPIXOL® ORAL DROPS, SOLUTION
ZUCLOPENTHIXOL, AS HYDROCHLORIDE (20MG/ML)
1
WHAT IS IN THIS LEAFLET
1.
What Clopixol is used for
2.
How Clopixol works
3.
Before you take Clopixol
4.
How to use Clopixol
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Clopixol
8.
Product Description
9.
Manufacturer &Product
Registration Holder
10.
Date of Revision
WHAT CLOPIXOL IS USED FOR
Clopixol is used for the treatment of
schizophrenia and other related
psychoses. It is also used for the
treatment of mania and to control
agitation and aggressiveness in
mentally handicapped.
Your doctor, however, may prescribe
Clopixol for another purpose. Ask
your doctor if you have any questions
about why Clopixol has been
prescribed for you.
HOW CLOPIXOL WORKS
Clopixol contains the active
substance zuclopenthixol. Clopixol
belongs to a group of medicines
known as antipsychotics (also called
neuroleptics).
These medicines act on nerve
pathways in specific areas of the
brain and help to correct certain
chemical imbalances in the brain that
are causing the symptoms of your
illness.
BEFORE YOU USE CLOPIXOL
When you must not use it
Do not take Clopixol
•
If you are allergic (hypersensitive)
to zuclopenthixol or any of the
other ingredients of this medicine
(listed in section Ingredients).
•
If you have diminished
consciousness.
Before you start to use it
Talk to your doctor or pharmacist before
taking Clopixol if you:
•
Have a history of 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.
•
or someo

Fitxa tècnica

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CLOPIXOL® DROPS 20MG/ML
(ZUCLOPENTHIXOL)
1.
NAME OF THE MEDICINAL PRODUCT
Clopixol 20 mg/ml oral drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg zuclopenthixol (as 23.64 mg zuclopenthixol
dihydrochloride)
1 drop = 1 mg
_Excipients with known effect: _
Ethanol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops, solution
Clear, nearly colourless to yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute and chronic schizophrenia and other psychoses, especially with
symptoms such as hallucinations,
delusions, thought disturbances as well as agitation, restlessness,
hostility and aggressiveness.
Manic phase of manic-depressive illness.
Mental retardation associated with psychomotor hyperactivity,
agitation, violence, and other behavioural
disturbances.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_Adults _
Dosage should be individually adjusted according to the condition of
the patient. 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 dose
at bedtime.
_Acute schizophrenia and other acute psychoses. Severe acute states of
agitation. Mania._
Usually 10-50 mg/day, increased if necessary by 10 (to 20) mg every 2
to 3 days up until 100-150 mg divided in
2-3 doses per day.
_Chronic schizophrenia and other chronic psychoses_
Maintenance dosage usually 20-40 mg/day.
_Agitation in mentally retarded patients_
6-20 mg/day, if necessary increased to 25-40 mg/day.
_Older patients _
Older patients should receive dosages in the lower end of the dosage
range.
_Children _
Clopixol is not recommended for use in children due to lack of
clinical experience.
_Reduced renal function _
Zuclopentixol can be given in non-adjusted doses to patients with
reduced kidney-function. Zuclopentixol is
eliminated renally in small extents (roughly 10%, primarily as
metabolites) hence dose-adjust