Nozinan 25mg/Ml Injection
Ref: 1170/250216/1/F
Nozinan 25mg/ml Injection
(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:
^ What Nozinan Injection is and what it is used for
^ Before Nozinan Injection is given ^3 How Nozinan Injection is given ^ Possible side effects ^ How to store Nozinan Injection Further information
^ 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.
^ 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
• 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 1 mmol sodium (23mg) per millilitre.
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.
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.
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: 25/02/16
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
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:
^ What Levomepromazine hydrochloride Injection is and what it is used for
'a Before Levomepromazine hydrochloride Injection is given
^ How Levomepromazine hydrochloride Injection is given
Possible side effects
" How to store Levomepromazine hydrochloride Injection
Further information
^ 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.
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 1 mmol sodium (23mg) per millilitre.
^ 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 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 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.
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 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.
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.
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.
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 1 mmol 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: 25/02/16
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 1170/250216/2/B