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NOZINAN 25MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): LEVOMEPROMAZINE HYDROCHLORIDE / LEVOMEPROMAZINE HYDROCHLORIDE / LEVOMEPROMAZINE HYDROCHLORIDE

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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

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 such as amitriptyline
and amitriptylinoxide 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.

Is this leaflet hard
to see or read?
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

i

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

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.

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.

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)
▲ s u ff e r f r o m s l o w o r i r r e g u l a r
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
▲ have epilepsy

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.

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

89032027
(int. version 1)

-

GRAFICA - FOTOCOMPOSIZIONE

TYPE OF MATERIAL:

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

DESCRIPTION:

LEAFLET FOLDED NOZINAN 25MG/1ML
CODE:

VERSION: OLD CODE:

DIE CUT:

89032027 1 a 89031305 I014
678400
660268

COUNTRY:

U.K.

DIMENSIONS mm:

160 x 420 (160 x 210)

27 GIU 2017
LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:

//

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

12 pt.

• you have discolouration of the skin or
eyes, pain in the abdomen (stomach)
or a bloated feeling, severe itching,
pale or bloody stools, e xtre me
weakness, nausea or loss of appetite.
This could be caused by an infection or
injury to the liver
• tired, weak, confused, have muscles
that ache, are stiff 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,
fe e ling ir r itable . This could be
something called a syndrome of
inappropriate antidiuretic secretion
(SIADH)
Other side effects include:
Not k nown: fre que nc y cannot be
estimated from the available data:
• 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.

S y m p t o m s o f o v e rd o s e i n c l u d e :
drowsiness or loss of consciousness,
c o n vu l sions , low blood pres sure ,
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
SEEK medical help immediately if you
have any of the following allergic
reactions:
Allergic reaction - if following your
injection you experience symptoms
such as skin rash, swelling or breathing
d i ffi c u l t i e s , i n f o r m y o u r d o c t o r
immediately. This may be an indication
that you are sensitive to the medicine
and should not be given a repeat dose.
Very common: may affect more than 1 in
10 people:
• sleepiness
• dry mouth
Common: may affect up to 1 in 10 people:
• weakness
Tell your doctor IMMEDIATELY if you
experience any of the following:
Common: may affect up to 1 in 10 people:
• low blood pressure, especially in elderly
patients
• heat stroke
• alteration of heart rhythm (called
‘prolongation of QT interval’ seen on
ECG, electrical activity of the heart)
Uncommon: may affect up to 1 in 100
people:
• stiffness, shaking (tremor) or slow
movements
• you have a fit (seizure)
• blood abnormalities
• constipation, which may become
severe and stop food moving through
the bowel
Rare: may affect up to 1 in 1,000 people:
• heart palpitations (usually rapid or
irregular heartbeats)
• jaundice (yellowing of the skin and
eyes)
Not known: frequency cannot be
estimated from the available data:
• dizziness, feeling faint or loss of
alertness
• 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
• a serious but rare side effect is
neuroleptic malignant syndrome. Signs
of this include a high fever, sweating,
stiff muscles, fast heart rate, fast
breathing and drowsiness or confusion.
There may also be difficulty in walking
and shaking or involuntary muscle
movements. Rarely there may be rolling
of the eyes. If these symptoms develop
please contact your doctor immediately.
• high temperature, sweating, pale
complexion, difficulty passing urine
• colicky abdominal pain with bloody
diarrhoea
• skin irritation or burning due to
sensitivity to sunlight
• unwanted and persistent erections
• 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

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,
anhydrous sodium sulphite, 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 S.P.A.
Via Valcanello, 4
03012 Anagni, (FR)
ITALY
® Nozinan is a registered trade mark.
This leaflet was last revised in
06/2017
89032027
© Sanofi, 1993 - 2017
678400

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

89032027
(int. version 1)

-

GRAFICA - FOTOCOMPOSIZIONE

TYPE OF MATERIAL:

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

DESCRIPTION:

LEAFLET FOLDED NOZINAN 25MG/1ML
CODE:

VERSION: OLD CODE:

DIE CUT:

89032027 1 a 89031305 I014
678400
660268

COUNTRY:

U.K.

DIMENSIONS mm:

160 x 420 (160 x 210)

27 GIU 2017
LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:

//

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

12 pt.

Expand view ⇕

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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