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NOZINAN 25MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: LEVOMEPROMAZINE HYDROCHLORIDE

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Patient information Leaflet

By alik at 12:30 pm, Oct 23, 2014

Assessed against
MOCK UPdesferrioxamine (for iron poisoning)


Nozinan® 25/mg/ml Solution for Injection or
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.
Your medicine is available in the above name, but will be
referred to as Nozinan Injection throughout the remainder of 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)



UK PIL dated
adrenaline (epinephrine) in patients overdosed with
antipsychotic drugs
November 2013

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 breastfeeding, 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 25°C.
Store in the original package. 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
Nozinan injections contain the active ingredient
levomepromazine hydrochloride (25mg/ml) per vial.
Each 1ml of solution contains 25mg levomepromazine
hydrochloride.
Also contains other ingredients ascorbic acid, sodium sulphite
anhydrous, sodium chloride and water for injections (see end of
Section 2 for further, important information on Sodium).
Nozinan Injection is a clear, colourless solution for injection. It is
supplied in packs of 10 colourless glass vials.
Manufactured by: Gruppo Lepetit Srl, Localita Valcanello 03012
Anagni, Italy. Procured from within the EU. Product Licence
holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by
Maxearn Ltd, Bolton BL6 4SA.
PL 20774/1393 Nozinan 25/mg/ml Solution for Injection or
Infusion
Date of issue: 23rd October 2014

POM

Nozinan is a registered trade mark of May and Baker Limited UK.

PP1/1393/V4

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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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