NOZINAN 25MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: LEVOMEPROMAZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nozinan® 25mg/ml
Solution for
Injection/Infusion

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.

levomepromazine
hydrochloride

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Phone 0845
372 7101 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

▲ find it difficult, or are unable, to eat
▲ are an alcoholic
▲ have epilepsy

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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:
X 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)
▲ 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

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.
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.

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.

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

DESCRIPTION:

10 pt.

89027095

VERSION:

2 a

OLD CODE:

19 NOV 2013

COUNTRY:

NOZINAN 25MG/ML

MIN. FONT SIZE: CODE:

89027095
(int. version 2)

LOGO VERSION:

//

U.K.
DIMENSION mm:

89025246 160 x 420 (PREP. A 160 x 210)

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

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,
convulsions, 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.

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
• 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.
• an illness where the removal of bile
from the liver is blocked (cholestasis).
Signs include jaundice, rash or fever,
and the colour of your water (urine)
becomes darker
• you have discolouration of the skin or
eyes, pain in the abdomen (stomach) or a
bloated feeling, severe itching, pale or
bloody stools, extreme weakness, nausea
or loss of appetite. This could be caused
by an infection or injury to the liver

• you have a fit (seizure)
• tired, weak, confused, have muscles
that ache, are still or do not work well.
This may be due to low sodium levels
in your blood
• feeling unwell, confused and/or weak,
feeling sick (nausea), loss of appetite,
feeling irritable. This could be something
called a syndrome of inappropriate
antidiuretic hormone secretion (SIADH)
Other side effects include:
• high blood sugar (hyperglycaemia)
• Feeling confused
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.
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.
By reporting side effects you can help
provide more information on the safety
of this medicine.

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: 0845 372 7101
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
November 2013
© Sanofi, 2013

89027095

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

DESCRIPTION:

10 pt.

89027095

VERSION:

2 a

OLD CODE:

19 NOV 2013

COUNTRY:

NOZINAN 25MG/ML

MIN. FONT SIZE: CODE:

89027095
(int. version 2)

LOGO VERSION:

//

U.K.
DIMENSION mm:

89025246 160 x 420 (PREP. A 160 x 210)

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

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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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