NOZINAN 25MG TABLETS

Active substance: LEVOMEPROMAZINE MALEATE

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Code:
Update:
Local code:
Current item code:

4850062A
V06 - 20-11-2013
599514
4850061A

Product/Item type:

Istruzione in bobina - Fronte
Nozinan 25 mg cpr

Country:

UK

Artwork by:
Plant:
Supplier code:

Technical Data

For sanofi-aventis use only

Format:
Plant barcode:
Colours:

Origgio
Origgio

157 x 262,5 mm
729

- P Reflex Blue C
- XXXX
- XXXX

- XXXX
- XXXX
- XXXX

1

sanofi-aventis S.p.A.

SENSO DI
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Assembly Card:
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360/03
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REJECTED

Impianti di proprietà

TEXT

GDO - Graphic Department Origgio

SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Nozinan® 25mg Tablets
levomepromazine maleate

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
• have epilepsy.
Additional tests will be done by your doctor at
the start of treatment if you are taking Nozinan

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
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 11/2 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.

75 mm

Is this leaflet hard to see or read?
Phone 0845 372 7101 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

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.

GDO - Graphic Department Origgio

Code:
Update:
Local code:
Current item code:

4850062A
V06 - 20-11-2013
599514
4850061A

Product/Item type:

Istruzione in bobina - Fronte
Nozinan 25 mg cpr

Country:

UK

Artwork by:
Plant:
Supplier code:

Origgio
Origgio

Technical Data

For sanofi-aventis use only

Format:
Plant barcode:
Colours:

157 x 262,5 mm
729

- P Reflex Blue C
- XXXX
- XXXX

- XXXX
- XXXX
- XXXX

Fonts: Ocean Sans Pro SAN Light / Light Italic / Bold
Minimum point size of text:
Assembly Card:
Layout of Cutting:
Technical Card:
Technical Constraint:

sanofi-aventis S.p.A.

9 pt
360/03
000
0000000
0000000

APPROVAL DATE:
REJECTED

Impianti di proprietà

1

SIGNATURE:

Vietata la manomissione - Rendere dopo la stampa

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.
• 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
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 hormone secretion (SIADH)
Other side effects include:
• high blood sugar (hyperglycaemia).
• Feeling confused
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.
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 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: 0845 372 7101
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 November 2013
© Sanofi, 2013

4850062A
599514-TO-NOZT084-PIL10A

44 mm

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, convulsions, 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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