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LEVOMEPROMAZINE HYDROCHLORIDE 25MG/ML SOLUTION FOR INJECTION/INFUSION

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

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Package Leaflet: Information for the User

Nozinan 25mg/ml Solution for Injection/Infusion
(levomepromazine hydrochloride)
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.
 The name of this medicine is Nozinan® 25mg/ml Solution for
Injection/Infusion but it will be referred to as Nozinan Injection
throughout the remainder of this leaflet.

Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding, ask
your doctor or pharmacist before taking any medicine.

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

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.

1. What Nozinan Injection is and what it is used for

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.

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

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.

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.

This medicine is given by a healthcare professional either by injection
into a muscle or vein, or slowly via a needle under the 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

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 lightheaded 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, antidepressants 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 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.

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. 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 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.
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
 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
 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, feeling irritable. This could be something called a syndrome
of inappropriate antidiuretic secretion (SIADH)
Other side effects include:
Not known: frequency 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.
5. How to store Nozinan Injection





Keep out of the sight and reach of children.
Do not store above 25oC.
Keep the container in the outer carton to protect from light.
Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
 If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are no
longer required. This will help to protect the environment.

6. Further information
What Nozinan Injection contains
The active ingredient is levomepromazine hydrochloride.
Each 1ml ampoule contains 25mg levomepromazine hydrochloride.
The other ingredients are:
Ascorbic acid (E300), sodium sulphite anhydrous (E221), 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/infusion
supplied in clear glass ampoules with a 2ml capacity, containing 1ml of
solution.
Nozinan Injection is available in packs of 10 ampoules.
Manufactured by
SANOFI S.p.A., Località Valcanello, 03012 Anagni, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
Leaflet dated 17th March 2017
Leaflet coded xxxxxxxxx
PL 33532/0679

POM

Nozinan® is a registered trademark of Sanofi.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Package Leaflet: Information for the User

Levomepromazine Hydrochloride 25mg/ml Solution for Injection/Infusion
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.
 The name of this medicine is Levomepromazine Hydrochloride
25mg/ml Solution for Injection/Infusion but it will be referred to as
Levomepromazine Hydrochloride Injection throughout the remainder of
this 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
5. How to store Levomepromazine Hydrochloride Injection
6. Further information
1. What Levomepromazine Hydrochloride Injection 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)
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 lightheaded 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 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 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 Levomepromazine Hydrochloride 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 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 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
Levomepromazine Hydrochloride 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.
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 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.
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
 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
 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, feeling irritable. This could be something called a syndrome
of inappropriate antidiuretic secretion (SIADH)
Other side effects include:
Not known: frequency 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.
5. How to store Levomepromazine Hydrochloride Injection





Keep out of the sight and reach of children.
Do not store above 25oC.
Keep the container in the outer carton to protect from light.
Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
 If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are no
longer required. This will help to protect the environment.

6. Further information
What Levomepromazine Hydrochloride Injection contains
The active ingredient is levomepromazine hydrochloride.
Each 1ml ampoule contains 25mg levomepromazine hydrochloride.
The other ingredients are:
Ascorbic acid (E300), sodium sulphite anhydrous (E221), sodium
chloride and water for injections (see end of Section 2 for further,
important information on sodium).
What Levomepromazine Hydrochloride Injection looks like and
contents of the pack
Levomepromazine Hydrochloride Injection is a clear, colourless solution
for injection/infusion supplied in clear glass ampoules with a 2ml
capacity, containing 1ml of solution.
Levomepromazine Hydrochloride Injection is available in packs of 10
ampoules.
Manufactured by
SANOFI S.p.A., Località Valcanello, 03012 Anagni, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
Leaflet dated 17th March 2017
Leaflet coded xxxxxxxxx
PL 33532/0679

POM

Nozinan® is a registered trademark of Sanofi.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Expand Transcript

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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