Nozinan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Levomepromazine maleate 100mg equivalent to levompromazine 74.1mg;  ;  

Available from:

Clinect NZ Pty Limited

INN (International Name):

Levomepromazine maleate 100 mg (Equiv to 100 mg methotrimeprazine maleate)

Dosage:

100 mg

Pharmaceutical form:

Tablet

Composition:

Active: Levomepromazine maleate 100mg equivalent to levompromazine 74.1mg     Excipient: Calcium carbonate Macrogol 6000 Polyvinyl acetate Potato starch Sodium laurilsulfate Stearic acid

Units in package:

Blister pack, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

EGIS Pharmaceutical PLC

Therapeutic indications:

Psychiatry As an alternative to Largactil in schizophrenia, especially when it is desirable to reduce psychomotor activity.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

NOZINAN
®
Page 1
_ _
NOZINAN
® TABLETS
_LEVOMEPROMAZINE MALEATE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nozinan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOZINAN IS USED
FOR
Nozinan is a type of neuroleptic used
in both psychiatry and severe pain.
It is not known exactly how Nozinan
has these effects.
The effect of Nozinan is to relieve
severe pain without making you feel
sick or vomit. It relieves the anxiety
and distress associated with severe
pain. Nozinan can also be used to
treat schizophrenia.
Your doctor, however, may prescribe
Nozinan 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.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NOZINAN IF YOU HAVE:
•
liver disease
•
heart disease
•
urinary or prostate problems
•
increased pressure in the eye
(glaucoma)
•
a history of a lack of white blood
cells (agranulocytosis)
DO NOT TAKE NOZINAN IF YOU ARE
ALLERGIC TO IT OR OTHER MEDICINES
SIMILAR TO NOZINAN CALLED
PHENOTHIAZINES OR ARE ALLERGIC TO
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
If you experience an allergic
reaction, seek medical help right
away.
DO NOT TAKE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you take it after the expiry date has
passed, it may

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
NOZINAN TABLETS
Nozinan 25 mg and 100 mg tablets*
* New Zealand formulation not marketed.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levomepromazine maleate 25mg equivalent to 18.5 mg levomepromazine
base.
Levomepromazine maleate 100mg equivalent to 74.1 mg levomepromazine
base.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
White, biconvex film-coated tablets indented 'L25' and 'L100'
respectively on one face with a break-line on the
reverse. The diameter of the 25 mg tablets is 8.7 mm and the 100 mg
tablets 11.0 mm.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PSYCHIATRY
As an alternative to Largactil in schizophrenia, especially when it is
desirable to reduce psychomotor activity.
GENERAL MEDICINE
Alone or together with appropriately modified doses of analgesics and
narcotics, in the relief of severe pain
and accompanying anxiety and distress.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage varies with the condition and the individual response of the
patient.
The below recommended doses refer to the amount of levomepromazine
maleate contained in the Nozinan
tablets.
_TERMINAL ILLNESS _
Nozinan tablets 25 mg may be substituted for the injection if oral
therapy is more convenient.
The dosage is 12.5 - 50 mg every 4 - 8 hours.
ELDERLY
No specific dosage recommendations.
_PSYCHIATRY _
ADULTS
Ambulant patients:
2
Initially the total daily dose should not exceed 25 - 50 mg, usually
divided into three doses.
A larger portion of the dosage may be taken at bedtime to minimise
diurnal sedation.
The dosage is then gradually increased to the most effective level
coupled with minimum side-effects.
Bed patients:
Initially the total dosage may be 100 mg to 200 mg, usually divided
into three doses, gradually increased to 1
g daily if necessary.
Attempts should be made when the patient is stable to reduce the
dosage to an adequate maintenance level.
CHILDREN
Children are very susceptible to the hypotensive and soporific effects
of levomepromazine. It