NOZINAN 25MG TABLETS

Active substance: LEVOMEPROMAZINE MALEATE

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Nozinan® 25mg Tablets
levomepromazine maleate
Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you
start taking this medicine.
- Please keep this leaflet. You may need to
read it again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others; it may harm them,
even if their symptoms are the same as yours.
- 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.
In this leaflet:
1. What Nozinan Tablets are and what they
are used for
2. Before you take Nozinan Tablets
3. How to take Nozinan Tablets
4. Possible side effects
5. How to store Nozinan Tablets
6. Further information
1. What Nozinan Tablets are
and what they are used for

i

Nozinan Tablets belong to a group of medicines
called phenothiazines and are used for:
• schizophrenia
• the relief of pain and the accompanying
distress in terminally ill patients.
2. BEFORE YOU TAKE NOZINAN TABLETS
Do NOT take Nozinan Tablets if:
You are allergic (hypersensitive) to
levomepromazine maleate or any of
the other ingredients in the product
(see Section 6).
Take special care with Nozinan Tablets
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 take the tablets (if you have 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
• suffer from dementia and are elderly
• have been told by your doctor that you
might have a stroke
• are diabetic or have been told you have an
increased risk of having 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.
Additional tests will be done by your doctor
at the start of treatment if you are taking
Nozinan Tablets 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.
If you have to go to the dentist or hospital for
any reason, tell them that you are taking
Nozinan Tablets.
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 Tablets work.
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.
Taking with food and drink
Avoid alcohol while you are taking these tablets.
Pregnancy and breast-feeding
If you are pregnant, planning to become
pregnant or breast-feeding, ask your doctor or
pharmacist before taking Nozinan Tablets or
any other medicine.
The following symptoms may occur in
newborn babies, of mothers that have used
Nozinan Tablets 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 if taking
Nozinan Tablets as they may make you feel
drowsy, confused, dizzy or lightheaded.
3. HOW TO TAKE NOZINAN TABLETS
Always take this medicine exactly as your
doctor has told you; you should check with
him/her if you are not sure. The tablets should
be swallowed whole with a glass of water.
Schizophrenia
Adults - the initial dose is usually 1 to 2 tablets
a day, divided into three doses. If you are
confined to bed, the initial dose may
be 4 to 8 tablets a day, divided into
three doses. These doses may be

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nozinan Tablets can cause
side effects, although not everybody gets them.
STOP taking the tablets and SEEK medical
help immediately if you have any of the
following allergic reactions:
• difficulty breathing or swallowing, swelling
of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or
raised lumps.
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
• 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
• 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.
Other side effects include:
• high blood sugar (hyperglycaemia).
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.
If any of these side effects get serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor.
5. HOW TO STORE NOZINAN TABLETS
Keep out of the reach and sight of children.
Store in the original container below 25ºC and
protect from light.
Do not use the product after the expiry date
‘EXP’ (last day of the month stated) printed on
the blister and carton.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of any medicine
no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Nozinan Tablets contain
The active ingredient is levomepromazine
maleate, 25mg per tablet.
The other ingredients are potato starch,
calcium hydrogen phosphate, magnesium
stearate and sodium lauryl sulfate.
What Nozinan Tablets look like and
contents of the pack
The tablets are round, greyish-white or cream,
with one side marked ‘NOZINAN 25’ and a
break line on the other side. They are
supplied in blister packs containing 84 tablets
or plastic bottles containing 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi
One Onslow Street, Guildford
Surrey, GU1 4YS, UK
Tel: 01483 505515 - Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
sanofi-aventis S.p.A.
Viale Europa 11, 21040 Origgio VA, Italy
® Nozinan is a registered trade mark.
This leaflet was last revised in 07/2012
© Sanofi, 2012

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599514-TO-NOZT084-PIL10A

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increased in small steps until a suitable dose
is found for you.
Elderly - your doctor will decide whether
these tablets are appropriate for you and will
tell you how many to take.
Children - will normally be given no more
than 1 1/2 tablets a day.
Pain management
Adults and Elderly - 1/2 to 2 tablets every four
to eight hours; the dose may be varied until a
suitable dose is found for you.
Children - these tablets are NOT
recommended for children for treating pain.
If you take more Nozinan Tablets than you
should
If you, or a child, accidentally swallow too
many tablets, contact your doctor or nearest
hospital casualty department immediately.
Symptoms of overdose include: drowsiness or
loss of consciousness, low blood pressure,
irregular heartbeats, hypothermia
(abnormally low body temperature) and
severe extrapyramidal dyskinesias
(involuntary movements).
If you forget to take Nozinan Tablets
If you miss a dose, just take your tablets as
soon as you remember then carry on as
before. Do not take a double dose to make up
for the forgotten one.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

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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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