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NOZINAN 25MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: LEVOMEPROMAZINE HYDROCHLORIDE

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suffer from slow or irregular heartbeats/palpitations
(Torsades de Pointes) or have a family history of
heart problems
or someone else in your family have a history of
blood clots, as medicines like these have been
associated with formation of blood clots
are diabetic or have been told that you have an
increased risk of diabetes
already know you have low levels of potassium,
calcium or magnesium in your blood
find it difficult, or are unable, to eat
are an alcoholic
Additional tests will be done by your doctor at the
start of treatment, if you are being given Nozinan
Injection for a long period of time, or if you are
taking other medicines at the same time such as
heart drugs, anti-depressants or drugs for mental
health disorders. These tests might include an ECG
(electrocardiogram) to check your heart is working
normally and/or blood tests.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nozinan® 25mg/ml
Solution for
Injection/Infusion
levomepromazine
hydrochloride
Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you start
receiving this medicine.
- Please keep this leaflet. You may need to read it
again
- If you have any further questions, ask your doctor
- If you suffer from any side effects that get serious,
or if you notice any side effects not listed in this
leaflet, please tell your doctor
In this leaflet:
1. What Nozinan Injection is and what it is used for
2. Before Nozinan Injection is given
3. How Nozinan Injection is given
4. Possible side effects
5. How to store Nozinan Injection
6. Further information

1. WHAT NOZINAN INJECTION
IS AND WHAT IT IS USED FOR

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including those obtained without a prescription, as
they may change the way Nozinan Injection works.
These include:
• medicines for the treatment of irregular heartbeats
• antidepressants and drugs for other mental health
disorders (i.e. antipsychotics)
• desferrioxamine (for iron poisoning)
• adrenaline (epinephrine) in patients overdosed
with antipsychotic drugs
Food and drink with Nozinan Injection
Avoid alcohol while you are having these injections.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant
or breast-feeding, ask your doctor or pharmacist
before taking any medicine.
The following symptoms may occur in newborn
babies, of mothers that have used Nozinan
Injection in the last trimester (last three months
of their pregnancy): shaking, muscle stiffness
and/or weakness, sleepiness, agitation, breathing
problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need
to contact your doctor.

i

Nozinan Injection belongs to a group of medicines
called phenothiazines. It is used for 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. BEFORE NOZINAN INJECTION IS GIVEN
You MUST NOT be given Nozinan Injection
if you have:
✕ an allergy (hypersensitivity) to levomepromazine
hydrochloride or any of the other ingredients in
the product (see Section 6 and end of Section 2)
Take special care with Nozinan Injection
Consult your doctor if you:
have liver problems
are elderly, frail or have heart disease as you may
feel faint or light-headed when you are given the
injection. (if you receive a large initial dose, you
will have to stay in bed)

Driving and using machines
Do not drive or operate machinery whilst receiving
Nozinan Injections as it may make you feel drowsy,
confused, dizzy or lightheaded.
Important information about some of the
ingredients of Nozinan Injection
Sodium - this medicinal product is
essentially ‘sodium-free’ as it contains
less than 1mmol sodium (23mg) per millilitre.

CROMinFOTO s.n.c.

Via G. Tartini, 2- 2 0 15 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

89025246
(int. version 4)

TYPE OF MATERIAL:

DESCRIPTION:

LEAFLET

Nozinan 25 mg/1 ml

06 MAR 2013

COUNTRY:

UK

MIN. FONT SIZE: CODE:

10 pt.

89025246

VERSION:

4 a

OLD CODE:

DIMENSION mm:

89024662 160 x 210

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

LOGO VERSION:

//

• heat stroke
• high temperature, sweating, pale complexion,
difficulty in passing urine
• colicky abdominal pain with bloody diarrhoea
• skin irritation or burning due to sensitivity to sunlight
• unwanted and persistent erections
• Blood clots in the veins especially in the legs
(symptoms include swelling, pain and redness in
the leg), which may travel through blood vessels
to the lungs causing chest pain and difficulty in
breathing. If you notice any of these symptoms
seek medical advice immediately.
Other side effects include:
• high blood sugar (hyperglycaemia)
If any of these side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor
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.

3. HOW NOZINAN INJECTION IS GIVEN
Your doctor will prescribe the appropriate
dosage for your condition.
The medicine will be given to you by a healthcare
professional, either by injection into a muscle or
vein or slowly via a needle under your skin.
Adults, including the elderly
• The usual dose is half to one vial by injection,
although up to two vials may be used. This dose
may be repeated every 6 to 8 hours if required
Alternatively a dose of up to 8 vials diluted with
saline may be infused over 24 hours. Nozinan Tablets
25mg may be given instead of Nozinan Injection if
oral therapy is more convenient.
Children
• If the injection is given to children, the dose will
be calculated according to their weight; usually
0.35mg - 3.0mg/kg/day
If you are given more Nozinan Injection than
you should
As this product will be given to you under medical
supervision, it is unlikely that you will be given too
much. However, speak to your doctor or nurse if you
are worried.
Symptoms of overdose include: drowsiness or loss of
consciousness, low blood pressure, irregular heartbeats
and hypothermia (abnormally low body temperature).
If a Nozinan Injection is missed
Contact your doctor or nurse as soon as you remember
to arrange another appointment for your next injection.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

5. HOW NOZINAN INJECTION IS STORED
Keep out of the reach and sight of children. Protect
from light. Do not use Nozinan Injection after the
expiry date which is stated on the pack. Medicines
should not be disposed of via wastewater or
household waste. Your hospital pharmacist will
dispose of any medicine no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Nozinan Injection contains
The active ingredient is levomepromazine
hydrochloride (25mg/ml) per vial.
The other ingredients are ascorbic acid, sodium
sulfite, sodium chloride and Water for injections
(see end of Section 2 for further, important
information on Sodium).
What Nozinan Injection looks like and contents
of the pack
Nozinan Injection is a clear, colourless solution for
injection. It is supplied in packs of 10 colourless
glass vials.
Marketing Authorisation Holder: Sanofi, One
Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer:
SANOFI-AVENTIS S.P.A.
Loc. Valcanello
03012 Anagni, (FR)
ITALY
® Nozinan is a registered trade mark.
This leaflet was last revised in 03/2013
© Sanofi, 2013
89025246

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nozinan Injection can cause side
effects, although not everybody gets them.
Allergic reaction - if following your injection you
experience symptoms such as skin rash, swelling or
breathing difficulties, inform your doctor
immediately. This may be an indication that you
are sensitive to the medicine and should not be
given a repeat dose.
Frequent side effects include: sleepiness, weakness
and dry mouth.
Tell your doctor IMMEDIATELY if you experience
any of the following:
• dizziness, feeling faint or loss of alertness
• fever, ulceration of the mouth or throat, or sore
throat
• stiffness, shaking (tremor) or slow movement
• low blood pressure, especially in elderly patients
• heart palpitations (usually rapid or irregular
heartbeats)
• blood abnormalities
• jaundice (yellowing of the skin and eyes)
• constipation, which may become severe and stop
food moving through the bowel

CROMinFOTO s.n.c.

Via G. Tartini, 2- 2 0 15 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

89025246
(int. version 4)

TYPE OF MATERIAL:

DESCRIPTION:

LEAFLET

Nozinan 25 mg/1 ml

06 MAR 2013

COUNTRY:

UK

MIN. FONT SIZE: CODE:

10 pt.

89025246

VERSION:

4 a

OLD CODE:

DIMENSION mm:

89024662 160 x 210

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

LOGO VERSION:

//

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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