Skip to Content

LEVOMEPROMAZINE HYDROCHLORIDE 25MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): LEVOMEPROMAZINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Nozinan® 25mg/ml Solution for
Injection or Infusion

2592
23.05.14[2]

(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 will be referred to as Nozinan Injection throughout the
following 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 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 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. 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 sight and reach of children.
Do not store above 25oC. Keep ampoule in the outer carton to 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 (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. It is supplied in
packs of 10 colourless glass vials.
MANUFACTURER AND PRODUCT LICENCE HOLDER:
Manufactured by Sanofi-Aventis S.p.A., Localita Valcanello, 03012 Anagni,
Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/2592

Leaflet revision and issue date (Ref.) 23.05.14[2]
Nozinan is a trademark of May & Baker Limited.

Levomepromazine Hydrochloride
25mg/ml Solution for Injection or
Infusion

2592
23.05.14[2]

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 will be referred to as Levomepromazine Hydrochloride
Injection throughout the following 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 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. Levomepromazine Hydrochloride 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
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 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 LEVOMEPROMAZINE HYDROCHLORIDE INJECTION IS
STORED
Keep out of the sight and reach of children.
Do not store above 25oC. Keep ampoule in the outer carton to protect from
light.
Do not use Levomepromazine Hydrochloride 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 Levomepromazine Hydrochloride Injection contains
The active ingredient is levomepromazine hydrochloride (25mg/ml) per vial.
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. It is supplied in packs of 10 colourless glass vials.
MANUFACTURER AND PRODUCT LICENCE HOLDER:
Manufactured by Sanofi-Aventis S.p.A., Localita Valcanello, 03012 Anagni,
Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/2592

Leaflet revision and issue date (Ref.) 23.05.14[2]

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.

Hide