Nozinan 25 mg/ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOMEPROMAZINE HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N05AA; N05AA02

INN (International Name):

LEVOMEPROMAZINE HYDROCHLORIDE

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Phenothiazines with aliphatic side-chain; levomepromazine

Authorization status:

Marketed

Authorization date:

1983-01-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOZINAN® 25 MG/ML SOLUTION FOR INJECTION/INFUSION
_Levomepromazine Hydrochloride _
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP.
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.
WHAT IS IN THIS LEAFLET
1. What Nozinan is and what it is used for
2. What you need to know before Nozinan is given
3. How Nozinan is given
4. Possible side effects
5. How to store Nozinan
6. Contents of the pack and other information
1. WHAT NOZINAN IS AND WHAT IT IS USED FOR
Nozinan belongs to a group of medicines called phenothiazines.
Nozinan is used:
• In the treatment of schizophrenia and other mental disorders
• In the relief of severe pain and as a sedative to relieve anxiety
and distress associated with severe
pain, particularly in terminally ill patients. This medicine is given
by a healthcare professional either
by injection into a muscle or vein, or slowly via a needle under the
skin.
2. WHAT YOU NEED TO KNOW BEFORE NOZINAN IS GIVEN
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR IF:
• You are allergic (hypersensitive) to levomepromazine hydrochloride
or any of the ingredients of
Nozinan (listed in Section 6). Signs of an allergic reaction include:
a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
• If you are taking any of the following medicines:
o
citalopram and escitalopram
o
hydroxyzine
o
piperaquine
o
domperidone
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before receiving Nozinan if:
• You ar

Summary of Product characteristics

Health Products Regulatory Authority
05 April 2023
CRN009X64
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nozinan 25 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 25mg of Levomepromazine Hydrochloride.
Each 1ml also contains 0.5mg sodium sulphite and total sodium 2.7 mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, bright pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of schizophrenia and other major psychoses including
mania and hypomania.
As an adjunct in the relief of severe terminal pain with accompanying
anxiety, restlessness or distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration:
Intramuscular, Intravenous or Continuous subcutaneous Use.
_Recommended Dosage:_
Dosage varies with the condition and the individual response of the
patient.
_Adults:_
The usual daily dosage is 12.5 - 25 mg (0.5-1 ml) by intramuscular
injection or by the intravenous route after dilution with an
equal volume of normal saline immediately before use. In cases of
severe agitation, up to 50 mg (2 ml) may be used, repeated
every 6 to 8 hours.
Continuous subcutaneous infusion:
Nozinan may be administered over a 24-hour period via a syringe
driver. The required dose of Nozinan (25-200 mg per day)
should be diluted with the calculated volume of normal saline.
Diamorphine hydrochloride is compatible with this solution
and may be added if greater analgesia is required.
_Elderly:_
_No specific dosage recommendations._
4.3 CONTRAINDICATIONS

Hypersensitivity to levompromazine or any of the other ingredients
(see Section 6.1).

In combination with:
o
citalopram, escitalopram,
o
hydroxyzine
o
piperaquine
o
domperidone.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
05 April 2023
CRN009X64
Page 2 of 9
In case of a persistent fever, sore throat or infection under
levomepromazine use