CLOPIXOL 10 MG TABLETS

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

ZUCLOPENTHIXOL AS DIHYDROCHLORIDE

זמין מ:

LUNDBECK ISRAEL LTD.

קוד ATC:

N05AF05

טופס פרצבטיות:

FILM COATED TABLETS

הרכב:

ZUCLOPENTHIXOL AS DIHYDROCHLORIDE 10 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

H.LUNDBECK A/S, DENMARK

קבוצה תרפויטית:

ZUCLOPENTHIXOL

איזור תרפויטי:

ZUCLOPENTHIXOL

סממני תרפויטית:

Acute schizophrenia .Other acute psychoses.

תאריך אישור:

2020-04-30

עלון מידע

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is marketed only with prescription
_ _
CLOPIXOL
CLOPIXOL
CLOPIXOL
CLOPIXOL
Drops
COMPOSITION
(active
ingredient):
Zuclopenthixol
(as
dihydrochloride
) 20 mg/ml
(1 drop = 1
mg) 2 MG
Tablets
COMPOSITION
(active
ingredient):
Zuclopenthixol
(as
dihydrochloride
)
2 mg
10 MG
Tablets
COMPOSITION
(active
ingredient):
Zuclopenthixol
(as
dihydrochloride
)
10 mg
25 MG
Tablets
COMPOSITION
(active
ingredient):
Zuclopenthixol
(as
dihydrochloride
)
25 mg
Inactive ingredients: See section 6
-
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This leaflet contains concise information about the
medicine. If you
have any further questions, ask your doctor or pharmacist.
-
This medicine was prescribed to treat your illness. Do not pass it to
others. It
may harm them even if it seems to you that their illness is similar to
you own.
-
This medicine is not intended to be used by children.
1.
WHAT IS THE MEDICINE BEING USED FOR?
CLOPIXOL can be taken to treat acute schizophrenia and other acute
psychoses.
THERAPEUTIC GROUP: anti-psychotic drugs, Thioxanthene derivative.
CLOPIXOL contains the active substance zuclopenthixol. It belongs to
the
antipsychotic drug group (which is also called the neuroleptic group).
These
medicines affect certain neural pathways in the brain and helps
correct certain cases
of chemical imbalance in the brain that cause your symptoms.
2.
BEFORE USING THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF
-
You are sensitive (allergic) to the active ingredient (zuclopenthixol)
or any of
the other ingredients of Clopixol (listed in section 6).
-
If you are affected by alcohol, strong pain medication (morphine), or
anti-
epileptic drugs (phenobarbital).
-
If you have a severe drop in blood pressure or heart failure.
-
Please note: Unconscious patients should not be given Clopixol.
WARNINGS AND PRECAUTIONS
BEFORE USING CLOPIXOL, TELL YOUR DOCTOR IF:
-
You have a liver disease.
-
You suffe

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clopixol 2 mg tablets
Clopixol 10 mg tablets
Clopixol 25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clopixol 2 mg
Each tablet contains 2 mg zuclopenthixol (as 2.364 mg
zuclopenthixol dihydrochloride)
Clopixol 10 mg
Each tablet contains 10 mg zuclopenthixol (as 11.82 mg
zuclopenthixol dihydrochloride)
Clopixol 25 mg
Each tablet contains 25 mg zuclopenthixol (as 29.55 mg
zuclopenthixol dihydrochloride)
Excipients with known effect:
Clopixol 2 mg contains 17.4 mg lactose monohydrate.
Clopixol 10 mg contains 21.6 mg lactose monohydrate.
Clopixol 25 mg contains 22.0 mg lactose monohydrate.
Hydrogenated castor oil
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Tablets, film-coated
Description of the tablets:
2 mg:
Round, biconvex, pale red, film-coated tablet.
10 mg:
Round, biconvex, light red-brown film-coated tablet.
25 mg: Round, biconvex, red-brown, film-coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute schizophrenia, other acute psychoses.
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: _
2/10
Usually 10-50 mg/day. In moderate to severe cases initially 20 mg/day
increased, if necessary, by 10-
20 mg every 2 to 3 days to 75 mg or more daily. Maximum dosage per
single dose is 40 mg and a total
of 150 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 _
Clopixol can be given in usual doses to patients with reduced renal
function.
_ _
_REDUCED LI