Clopixol Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ZUCLOPENTHIXOL DIHYDROCHLORIDE

Available from:

Lundbeck Limited 2nd Floor, Building 3 Abbey View, Everard Close, St Albans ALI 2PS, United Kingdom

ATC code:

N05AF05

INN (International Name):

ZUCLOPENTHIXOL DIHYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ZUCLOPENTHIXOL DIHYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-02-14

Patient Information leaflet

Package leaflet: Information for the user
CLOPIXOL
® 2 MG, 10 MG AND 25 MG FILM-COATED TABLETS
ZUCLOPENTHIXOL (AS DIHYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours

If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
WHAT CLOPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOPIXOL TABLETS
3.
HOW TO TAKE CLOPIXOL TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CLOPIXOL TABLETS
6.
FURTHER INFORMATION
1. WHAT CLOPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Clopixol 2 mg, 10 mg or 25 mg filmcoated
tablets (called
Clopixol Tablets in this leaflet). Clopixol Tablets contain the active
substance zuclopenthixol
and belong 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.
Clopixol Tablets
are used for the treatment of schizophrenia and other psychoses.
Your doctor, however, may prescribe Clopixol Tablets for another
purpose. Ask your doctor
if you have any questions about why Clopixol Tablets have been
prescribed for you.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOPIXOL TABLETS
DO NOT TAKE CLOPIXOL TABLETS

If you are allergic to zuclopenthixol, other thioxanthene drugs or
antipsychotic drugs or
any of the other ingredients of this medicine (listed in section 6).

If you are feeling less alert than usual, or are drowsy or sleepy or
have serious problems
with yo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAMES OF THE MEDICINAL PRODUCTS
Clopixol
2 mg film-coated tablets
Clopixol
10 mg film-coated tablets
Clopixol
25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mg film-coated tablets
Each tablet contains 2 mg zuclopenthixol (as dihydrochloride)
10 mg film-coated tablets
Each tablet contains 10 mg zuclopenthixol (as dihydrochloride)
25 mg film-coated tablets
Each tablet contains 25 mg zuclopenthixol (as dihydrochloride)
Excipients with known effect:
Lactose monohydrate
Hydrogenated castor oil.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
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
The treatment of psychoses, especially schizophrenia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology_ _
_Adults _
The dosage range is 4-150 mg/day in divided doses. The usual initial
dose is 20-30
mg/day (sometimes with higher dosage requirements in acute cases),
increasing as
necessary. The usual maintenance dose is 20-50 mg/day.
Maximum dosage per single dose is 40 mg.
When transferring patients from oral to depot antipsychotic treatment,
the oral
medication should not be discontinued immediately, but gradually
withdrawn over a
period of several days after administering the first injection.
_Older patients _
In accordance with standard medical practice, initial dosage may need
to be reduced
to a quarter or half the normal starting dose in the frail or older
patients.
_Paediatic population _
Clopixol is not indicated for use in children due to lack of clinical
experience.
_Patients with renal impairment _
Clopixol can be given in usual doses to patients with reduced renal
function. Where
there is renal failure dosage should be reduced to half the normal
dosage.
_Patients with hepatic impairment _
Use with caution in patients with liver disease (see section 4.