CLOPIXOL DROPS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ZUCLOPENTHIXOL AS DIHYDROCHLORIDE

Available from:

LUNDBECK ISRAEL LTD.

ATC code:

N05AF05

Pharmaceutical form:

SOLUTION

Composition:

ZUCLOPENTHIXOL AS DIHYDROCHLORIDE 20 MG/ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

H.LUNDBECK A/S, DENMARK

Therapeutic group:

ZUCLOPENTHIXOL

Therapeutic area:

ZUCLOPENTHIXOL

Therapeutic indications:

Acute schizophrenia and other acute psychoses.

Authorization date:

2020-04-30

Patient Information leaflet

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

Summary of Product characteristics

1/10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clopixol Drops
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
Oral drops, clear, nearly colourless to yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute schizophrenia and 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. _
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.
2/10
_REDUCED LIVER FUNCTION _
Careful dosing and, if possible, a serum level determination is
advisable.
_METHOD OF ADMINISTRATION _
The drops are easily administered mixed in e.g. water, orange juice or
apple juice.
Turn the bottle completely upside down. If no drops come out, tap the
bottle lightly to start the flow.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients,
listed in section 6.1.
Impaired consciousness due to any cause (e.g. intoxication with
alcohol, barbiturates or opiates),
circulatory collapse, coma.
4.4
SPECIAL WARNINGS AND PRECA