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NOZINAN 25MG TABLETS

Active substance(s): LEVOMEPROMAZINE MALEATE / LEVOMEPROMAZINE MALEATE / LEVOMEPROMAZINE MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nozinan® 25mg Tablets
levomepromazine maleate

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.

PACK. ITEM:
21-11-2016
IST NOZINAN 25MG GBI01

Istruzione

89031270

62C0018 V.1.0

1011100101

89028064

167x315mm
singola
2

1/2
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9,5 pt su 11 pt

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).

Sanofi S.p.A.

Pain management
Adults and Elderly – ½ 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.

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

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 1 ½
tablets a day.

Arkhé S.n.c.

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.

Tel. 0862.404140
fax 0862.090006

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.

GB: GREAT BRITAIN

 Reflex Blue

3. How to 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).

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.

2 - Mod. testo reg.

2. Before you take Nozinan Tablets

1 - Prima realizzazione

Taking other medicines
Please
tell
your doctor or pharmacist if you are taking
Is this leaflet hard to see or read?
or have recently taken any other medicines, including
Phone 0845 372 7101 for help
those obtained without a prescription, as they may
Read all of this leaflet carefully before you start
change the way Nozinan Tablets work.
taking this medicine.
These include:
-- Please keep this leaflet. You may need to read it
• medicines for the treatment of irregular heartbeats
again.
• antidepressants such as amitriptyline and
-- If you have any further questions, ask your doctor
amitriptylinoxide and drugs for other mental health
or pharmacist.
disorders (i.e. antipsychotics)
-- This medicine has been prescribed for you. Do not
pass it on to others; it may harm them, even if their • desferrioxamine (for iron poisoning)
• adrenaline (epinephrine) in patients overdosed with
symptoms are the same as yours.
antipsychotic drugs.
-- If you suffer from any side effects that get serious,
or if you notice any side effects not listed in this
Taking with food and drink
leaflet, please tell your doctor.
Avoid alcohol while you are taking these tablets.
In this leaflet:
Pregnancy and breast-feeding
1. What Nozinan Tablets are and what they are used for
If you are pregnant, planning to become pregnant or
2. Before you take Nozinan Tablets
breast-feeding, ask your doctor or pharmacist before
3. How to take Nozinan Tablets
taking Nozinan Tablets or any other medicine. The
4. Possible side effects
following symptoms may occur in newborn babies, of
5. How to store Nozinan Tablets
mothers that have used Nozinan Tablets in the last
6. Further information
trimester (last three months of their pregnancy):
shaking, muscle stiff ness and/or weakness, sleepiness,
1. What Nozinan Tablets are
agitation, breathing problems, and difficulty in
and what they are used for
feeding. If your baby develops any of these symptoms
Nozinan Tablets belong to a group of medicines called you may need to contact your doctor.
phenothiazines and are used for:
Driving and using machines
• schizophrenia
Do not drive or operate machinery if taking Nozinan
• the relief of pain and accompanying distress in
Tablets as they may make you feel drowsy, confused,
terminally ill patients.
dizzy or lightheaded.

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.
4. Possible side effects
Like all medicines, Nozinan Tablets can cause side
effects, although not everybody gets them.

PACK. ITEM:
21-11-2016
IST NOZINAN 25MG GBI01

Istruzione

GB: GREAT BRITAIN

2 - Mod. testo reg.

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.

 Reflex Blue

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

89028064

167x315mm
singola

6. Further information

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© Sanofi, 2016

9,5 pt su 11 pt

This leaflet was last revised in November 2016

2/2

Manufacturer
Sanofi S.p.A.
Strada Statale 17, Km 22,
67019 Scoppito (L’Aquila),
Italy

Sanofi S.p.A.

Marketing Authorisation Holder
Sanofi,
One Onslow Street,
Guildford
Surrey, GU1 4YS, UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

What Nozinan Tablets look like and contents of
the pack
The tablets are round, greyish-white 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.

-

Arkhé S.n.c.

Tel. 0862.404140
fax 0862.090006

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.

89031270

62C0018 V.1.0

1011100101

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.

89031270

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

Other side effects include:
Not known: frequency cannot be estimated from the
available data:
• 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.

1 - Prima realizzazione

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.
Very common: may affect more than 1 in 10 people:
• sleepiness
• dry mouth
Common: may affect up to 1 in 10 people:
• weakness

• 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)

Expand Transcript

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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