NOZINAN 25MG/ML INJECTION

Active substance: LEVOMEPROMAZINE HYDROCHLORIDE

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Nozinan 25mg/ml Injection

Ref: 1170/210814/1/F

(levomepromazine hydrochloride)
Patient Information Leaflet
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.
Your medicine is called Nozinan 25mg/ml Injection
but will be referred to as Nozinan Injection
throughout the leaflet.

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

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)
• 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
• have epilepsy
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.

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.
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

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.

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 sun
light
• 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

5 How to store Nozinan Injection
Expiry Date
The injection must not be used after the expiry date.
If you are not sure when this is, check with your
doctor or pharmacist.
Storage of your Nozinan Injection
Your hospital pharmacist will normally keep the
injection for you in a safe place, out of the sight and
reach of children and protected from light.
Do not store above 25oC
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6 Further information
What Nozinan Injection contains
The active ingredient in Nozinan Injection is
levomepromazine hydrochloride.
1ml of solution contains 25mg of levomepromazine
hydrochloride.
The injection also contains the following inactive
ingredients: ascorbic acid (E300), sodium sulphite
anhydrous, sodium chloride and Water for Injections
What Nozinan Injection looks like and contents
of the pack
Nozinan Injection is essentially sodium free as it
contains less than 1mmol sodium (23mg) per
millilitre.
Nozinan comes in pack size 10 x 1ml ampoules
Manufacturer and Licence Holder
Your medicine is manufactured by
SANOFI-AVENTIS S.p.A, Localita Valcanello, 03012
Anagni, Italy and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
Nozinan is a registered trademark of May & Baker
Limited.

POM

PL 15184/1170

Leaflet revision date: 21/08/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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.

Ref: 1170/210814/1/B

Ref: 1170/210814/2/F

Levomepromazine Hydrochloride 25mg/ml Injection
Patient Information Leaflet
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.
Your medicine is called Levomepromazine
hydrochloride 25mg/ml Injection but will be referred
to as Levomepromazine hydrochloride Injection
throughout the leaflet.

In this leaflet:
1 What Levomepromazine hydrochloride
Injection is and what it is used for
2 Before Levomepromazine hydrochloride

Injection is given
3 How Levomepromazine hydrochloride

Injection is given

4 Possible side effects

Additional tests will be done by your doctor at the
start of treatment, if you are being given
Levomepromazine hydrochloride 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.
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 Levomepromazine
hydrochloride 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 Levomepromazine
hydrochloride Injection
Avoid alcohol while you are having these injections.

5 How to store Levomepromazine

hydrochloride Injection
6 Further information

1

What Levomepromazine hydrochloride
is and what it is used for

Levomepromazine hydrochloride 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 Levomepromazine
hydrochloride Injection is given

You MUST NOT be given levomepromazine
hydrochloride 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)

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 levomepromazine
hydrochloride 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
Levomepromazine hydrochloride Injections as it may
make you feel drowsy, confused, dizzy or
lightheaded.
Important information about some of the
ingredients of Levomepromazine hydrochloride
Injection
Sodium - this medicinal product is essentially
‘sodium-free’ as it contains less than 1mmol sodium
(23mg) per millilitre.

3 How Levomepromazine hydrochloride
Take special care with levomepromazine
hydrochloride 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
• find it difficult, or are unable, to eat
• are an alcoholic
• have epilepsy

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 Levomepromazine
hydrochloride 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 Levomepromazine hydrochloride 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.

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
4 Possible side effects
Like all medicines, Levomepromazine hydrochloride
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 sun
light
• 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 ilness 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)

How to store Levomepromazine
hydrochloride Injection

Expiry Date
The injection must not be used after the expiry date.
If you are not sure when this is, check with your
doctor or pharmacist.
Storage of your Levomepromazine
hydrochloride Injection
Your hospital pharmacist will normally keep the
injection for you in a safe place, out of the reach and
sight of children and protected from light.
Do not store above 25oC
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6 Further information
What Levomepromazine hydrochloride Injection
contains
The active ingredient in Levomepromazine
hydrochloride Injection is levomepromazine
hydrochloride.
1ml of solution contains 25mg of levomepromazine
hydrochloride.
The injection also contains the following inactive
ingredients: ascorbic acid (E300), sodium sulphite
anhydrous, sodium chloride and Water for Injections
What Levomepromazine hydrochloride Injection
looks like and contents of the pack
Levomepromazine hydrochloride Injection is
essentially sodium free as it contains less than
1mmol sodium (23mg) per millilitre.
Nozinan comes in pack size 10 x 1ml ampoules
Manufacturer and Licence Holder
Your medicine is manufactured by
SANOFI-AVENTIS S.p.A, Localita Valcanello, 03012
Anagni, Italy and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1170

Leaflet revision date: 21/08/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Other side effects include:
• high blood sugar (hyperglycaemia)
• Feeling confused
Ref: 1170/210814/2/B

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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