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NOZINAN 25MG TABLETS

Active substance: LEVOMEPROMAZINE MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nozinan® 25mg Tablets
levomepromazine maleate

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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
1. What Nozinan Tablets are
and what they are used for
Nozinan Tablets belong to a group of medicines called
phenothiazines and are used for:
• schizophrenia
• the relief of pain and accompanying distress in
terminally ill patients.

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 stiff ness 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.

2. Before you take Nozinan Tablets
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).

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.

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.

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.

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.

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.
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.

• 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:
4. Possible side effects
• high blood sugar (hyperglycaemia)
Like all medicines, Nozinan Tablets can cause side effects, • feeling confused
In elderly people with dementia, a small increase in the
although not everybody gets them.
number of deaths has been reported for patients taking
antipsychotics compared with those not receiving
STOP taking the tablets and SEEK medical help
immediately if you have any of the following allergic antipsychotics.
reactions:
• difficulty breathing or swallowing, swelling of the face, If any of these side effects get serious, or if you
notice any side effects not listed in this leaflet,
lips, tongue or throat
• severe itching of the skin, with a red rash or raised
please tell your doctor.
lumps.
Very common: may affect more than 1 in 10 people:
Reporting of side effects
• sleepiness
If you get any side effects, talk to your doctor, pharmacist
• dry mouth
or nurse. This includes any possible side effects not listed
Common: may affect up to 1 in 10 people:
in this leaflet. You can also report side effects directly via
• weakness
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
Tell your doctor IMMEDIATELY if you experience any
information on the safety of this medicine.
of the following:
Common: may affect up to 1 in 10 people:
5. How to store Nozinan Tablets
• low blood pressure, especially in elderly patients
• heat stroke
Keep out of the reach and sight of children.
• Alteration of heart rhythm (called ‘prolongation of QT
Store in the original container below 25ºC and protect
interval’ seen on ECG, electrical activity of the heart)
from light.
Uncommon: may affect up to 1 in 100 people:
Do not use the product after the expiry date ‘EXP’ (last
• stiffness, shaking (tremor) or slow movements
day of the month stated) printed on the blister and
• you have a fit (seizure)
carton.
• blood abnormalities
Medicines should not be disposed of via wastewater or
• constipation, which may become severe and stop food
household waste. Ask your pharmacist how to dispose of
moving through the bowel
any medicine no longer required. These measures will
Rare: may affect up to 1 in 1,000 people:
help to protect the environment.
• heart palpitations (usually rapid or irregular
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 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 S.p.A.
Strada Statale 17, Km 22,
67019 Scoppito (L’Aquila),
Italy
This leaflet was last revised in January 2015
© Sanofi, 2015

89028064

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

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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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