Clopixol

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Zuclopenthixol hydrochloride 11.82mg equivalent to 10 mg zuclopenthixol

Dostępny od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Nazwa):

Zuclopenthixol hydrochloride 11.82 mg (=10 mg zuclopenthixol)

Dawkowanie:

10 mg

Forma farmaceutyczna:

Tablet

Skład:

Active: Zuclopenthixol hydrochloride 11.82mg equivalent to 10 mg zuclopenthixol Excipient: Copovidone Ethanol Glycerol Hydrogenated castor oil Hypromellose as part of Opadry Red 02F250002 Iron oxide red as part of Opadry Red 02F250002 Lactose monohydrate Macrogol 6000 as part of Opadry Red 02F250002 Magnesium stearate Microcrystalline cellulose Potato starch Purified talc Titanium dioxide as part of Opadry Red 02F250002

Sztuk w opakowaniu:

Bottle, plastic, 60mL HDPE with CRC closure, 100 tablets

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

H Lundbeck A/S

Wskazania:

Acute and chronic schizophrenia and other psychoses, especially those with symptoms such as hallucinations, delusions, thought disturbances, agitation, restlessness, hostility or aggressiveness. Manic phase of manic depressive illness. Mental retardation associated with psychomotor hyperactivity, agitation, violence and other behavioural disturbances. Senile dementia with significant paranoid ideas, confusion, disorientation or behavioural disturbances.

Podsumowanie produktu:

Package - Contents - Shelf Life: Bottle, plastic, 60mL HDPE with CRC closure - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

Data autoryzacji:

1988-04-22

Ulotka dla pacjenta

1
CLOPIXOL

(CLO-PIK-SOL)
CLOPIXOL
 TABLETS 10 MG
CLOPIXOL
 ACUPHASE INJECTION 50 MG/ML
CLOPIXOL
 DEPOT INJECTION 200 MG/ML
_Zuclopenthixol hydrochloride _
_(zoo-clo-PEN-thic-sol high-dro-CLOR-ride)_
_ _
_Zuclopenthixol acetate _
_(zoo-clo-PEN-thic-sol AS-se-tate)_
_ _
_Zuclopenthixol decanoate _
_(zoo-clo-PEN-thic-sol deck-can-OH-ate)_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
Clopixol.
It does not contain all the
information that is known about
Clopixol. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you using this medicine
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT CLOPIXOL IS
USED FOR
Clopixol tablets are used for the
acute and long-term treatment of
schizophrenia and other mental
illnesses with disturbances in
thinking, emotional reactions and
behaviour.
It is also used to treat the manic
phase of manic depressive illness. A
manic phase is a mood of
excitement, over-activity and
uninhibited behaviour.
Clopixol Acuphase injection is used
for the initial treatment of acute
episodes of mental disorders. It is
also used to treat mania (a mental
condition characterised by episodes
of overactivity, elation or irritability)
and used in case of worsening of
chronic mental conditions.
Clopixol Depot injection is usually
used to prevent further episodes of
your illness.
Clopixol belongs to a group of
medicines called thioxanthene
neuroleptics. It helps to correct
chemical imbalances in the brain,
which may cause mental illness.
_ _
Your doctor, however, may prescribe
it for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’s prescription.
Clopixol is not addictive.

Charakterystyka produktu

NEW ZEALAND DATA SHEET
Clopixol v 2.0 April 2022
Page
1
of
15
1 NAME OF THE MEDICINE
Clopixol
®
10 mg Film-coated Tablets
Clopixol
®
Acuphase 50 mg/mL Injection
Clopixol
®
Depot 200 mg/mL Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Clopixol tablets _
Film-coated Tablets containing 10 mg zuclopenthixol as zuclopenthixol
hydrochloride.
_Clopixol Acuphase injection _
The 1 mL solution for injection contains 50 mg zuclopenthixol acetate
equivalent to 45.25 mg
zuclopenthixol.
The 2 mL solution for injection containing 100 mg zuclopenthixol
acetate equivalent to 90.50 mg
zuclopenthixol.
_Clopixol Depot injection _
The 1 ml solution for injection contains 200 mg zuclopenthixol
decanoate equivalent to 144.4 mg
zuclopenthixol.
Excipients with known effects in the tablets:
Sugars as lactose
Hydrogenated castor oil.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Clopixol 10 mg tablets are light red brown, round biconvex film-coated
tablets.
Clopixol Acuphase injection presents as a clear, yellowish oil.
Clopixol Depot injection presents as a clear, yellowish oil.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CLOPIXOL TABLETS
Acute and chronic schizophrenia and other psychoses, especially those
with symptoms such as
hallucinations, delusions, thought disturbances, agitation,
restlessness, hostility or aggressiveness.
Manic phase of manic depressive illness.
Mental
retardation
associated
with
psychomotor
hyperactivity,
agitation,
violence
and
other
behavioural disturbances.
Senile dementia with significant paranoid ideas, confusion,
disorientation or behavioural disturbances.
CLOPIXOL ACUPHASE INJECTION
Initial treatment of acute psychoses, mania and exacerbation of
chronic psychoses.
CLOPIXOL DEPOT INJECTION
Maintenance treatment. May be an advantage in the treatment of
noncompliant patients.
NEW ZEALAND DATA SHEET
Clopixol v 2.0 April 2022
Page
2
of
15
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
CLOPIXOL TABLETS
Dosage should be adjusted individually. In general