Nozinan 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levomepromazine maleate

Available from:

Neuraxpharm UK Ltd

ATC code:

N05AA02

INN (International Name):

Levomepromazine maleate

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5000283653509

Patient Information leaflet

834184 4/4
834184 1/4
_PACK. ITEM:_
ARKHÉ S.N.C.
Tel. [phone]
fax [phone]
_BLISTER SIZE:_
1 - Prima realizzazione
2 - Nuovo testo da Paese
3 - Nuovo testo da Paese
4 - Mod. layout testo
5 - Mod. testo reg.
 REFLEX BLUE
SANOFI S.R.L.
Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.
22-03-2022
IST NOZINAN 25MG GB I02
ISTRUZIONE
GB: GREAT BRITAIN
834184
793953
62C0007 V.2.0
10010001011
167X315MM D.P.
4
-
-
10 PT SU 11,5 PT
4, 1 / 4
NOT KNOWN (FREQUENCY CANNOT BE ESTIMATED
FROM THE AVAILABLE DATA)
•
lack of periods in women, increased breast size
or breast growth in men, impotence, abnormal
milk production
•
high blood sugar (hyperglycaemia)
•
a change in body temperature
•
mood disorders, feeling anxious or confused
•
weight gain
•
vision problems including disorders affecting
the ability of your eyes to adapt to see close up
or far away (accommodation disorders), or
brownish deposits in the eye that do not
generally affect vision
In elderly people with dementia, a small increase
in the number of deaths has been reported for
patients taking antipsychotics compared with those
not receiving antipsychotics.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play or Apple
App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE NOZINAN TABLETS
Keep this medicine out of the sight and reach of
children.
Do not use the product after the expiry date ‘EXP’
(last day of the month stated) printed on the blister
and carton.
Store in the original container below 25ºC and
protect from light.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away any medicin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nozinan 25mg Tablets.
2
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Levomepromazine maleate 25 mg per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
.
Circular, greyish-white cream, biconvex uncoated tablet. One face with
Nozinan around a central 25 and a breakline on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nozinan is a neuroleptic with indications in psychiatry and general
medicine,
particularly in terminal illness. Clinically it is more sedative and
more potent than
chlorpromazine in the management of psychotic conditions and in the
relief of severe
chronic pain.
Psychiatry
As an alternative to chlorpromazine in schizophrenia especially when
it is desirable to
reduce psychomotor activity.
General medicine – Terminal illness
Adjunct therapy in the relief of pain and the accompanying distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage varies with the condition under treatment and the individual
response
of the patient.
1.
TERMINAL ILLNESS
Nozinan tablets 25 mg may be substituted for the injection if oral
therapy
is more convenient, the dosage being 12.5 – 50 mg every 4 – 8
hours.
_Elderly _
No specific dosage recommendations.
2.
PSYCHIATRIC CONDITIONS
Adults
•
_Ambulant patients:_ initially the total daily oral dose should not
exceed
25 – 50 mg usually divided into 3 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
compatible with sedation and other side effects.
•
_Bed patients: _initially the total daily oral dosage may be 100 –
200
mg, usually divided into 3 doses, gradually increased to 1 g daily if
necessary. When the patient is stable attempts should be made to
reduce the dosage to an adequate maintenance level.
Special populations
_ _
_Paediatric population _
Children are very susceptible to the hypotensive and soporific effects
of
levomepromazine. It