SOLIAN 100MG TABLETS

Active substance: AMISULPRIDE

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Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans /
Zapf Dingbats
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 477565
Couleur (s) / Color(s) : 2

sanofi aventis

Code AC / Item : 503432
Description AC : Notice Solian
Destination :
Grande Bretagne
Date / Version : 30-01-13 V2
Dimension :
210x170 mm
Type :
Double roul.

Noir + Bleu PMS Reflex Blue U
Plan N° : N 93

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

PACKAGE LEAFLET: INFORMATION FOR THE USER
Solian 50mg Tablets
Solian 100mg Tablets
Solian 200mg Tablets
Solian 400mg Film-coated Tablets
Amisulpride

2. Before you take Solian
Do not take this medicine and tell your
doctor if:
× You are allergic (hypersensitive) to amisulpride
or any of the other ingredients of Solian (listed
in Section 6)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
× You are pregnant, might become pregnant or
are breast-feeding (see ‘Pregnancy and breastfeeding’ section)
× You have breast cancer or something called ‘a
prolactin dependent tumour’
× You have a tumour on the adrenal gland (called
phaeochromocytoma)
× You are taking levodopa, a medicine to treat
Parkinson’s disease (see ‘Taking other medicines’ section)
× The patient is under 18 years old
Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your doctor or pharmacist before taking Solian.

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
• 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 any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Solian is and what it is used for
2. Before you take Solian
3. How to take Solian
4. Possible side effects
5. How to store Solian
6. Further Information

*503432*

Take special care with Solian
Check with your doctor or pharmacist before
taking your medicine if:
▲ You have kidney problems
▲ You have Parkinson’s disease
▲ You have ever had fits (epileptic seizures)
▲ You have an unusual heart rate (rhythm)
▲ You have heart disease or family history of
heart problems
▲ Your doctor has told you that you might have a
stroke
▲ If you or someone else in your family has a
history of blood clots, as medicines like these
have been associated with formation of blood
clots
▲ You are diabetic or have been told you have an
increased risk of having diabetes
▲ You have a slow heart beat (less than 55 beats
per minute)
▲ You have been told you have a low amount of
potassium in your blood.

1. What Solian is and what it is used for

Solian contains a medicine called amisulpride.
This belongs to a group of medicines called ‘antipsychotics’. It is used to treat an illness called
schizophrenia.
Schizophrenia can make you feel, see or hear
things which do not exist, have strange and frightening thoughts, change how you act, and make
you feel alone. Sometimes people with these
symptoms may also feel tense, anxious or depressed. Solian works by improving disturbed
thoughts, feelings and behaviour. It is used to
treat schizophrenia when it starts and also over
the long term.
503432

SENS DE DEROULEMENT
RECTO
(Intérieur bobine)

1

Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans /
Zapf Dingbats
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 477565
Couleur (s) / Color(s) : 2

sanofi aventis

Code AC / Item : 503432
Description AC : Notice Solian
Destination :
Grande Bretagne
Date / Version : 30-01-13 V2
Dimension :
210x170 mm
Type :
Double roul.

Noir + Bleu PMS Reflex Blue U
Plan N° : N 93

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

▲ You are elderly. This is because elderly people
would be more likely to get low blood pressure
or feel sleepy. A small increase in the number
of deaths of elderly people with dementia has
been reported for patients taking antipsychotics compared to those not receiving antipsychotics.
▲ You have a low number of white blood cells
(agranulocytosis). This means you may get
infections more easily than usual
▲ You have frequent infections such as fever,
severe chills, sore throat or mouth ulcers.
These could be signs of a blood problem called
‘leukopenia’
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Solian.

• Medicines which help you sleep such as barbiturates and benzodiazepines
• Pain-killers such as tramadol and indometacin
• Anaesthetics
• Antihistamines such as promethazine which
make you sleepy
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Solian.
Taking Solian with food and drink
• Swallow Solian tablets with plenty of water
before a meal
• Do not drink alcohol while you are taking
Solian. This is because it can affect the way the
medicine works
Pregnancy and breast-feeding
Do not take this medicine if:
• You are breast-feeding or planning to breastfeed
The following symptoms may occur in newborn
babies, of mothers that have used Solian 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.
Talk to your doctor before taking this medicine if
you are pregnant, might become pregnant or
think you may be pregnant.
Driving and using machines
You may feel less alert, drowsy or sleepy
while taking this medicine. If this happens, do
not drive or use any tools or machines.
Important information about some of the
ingredients of Solian
Solian contains lactose, a type of sugar. If you
have been told by your doctor that you can not
tolerate some sugars, talk to your doctor before
taking this medicinal product.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is
because Solian can affect the way some other
medicines work. Also some medicines can affect
the way Solian works.
In particular, do not take this medicine,
and tell your doctor if you are taking any of
the following medicines;
• Levodopa, a medicine to treat Parkinson’s
disease
• Drugs called 'dopamine agonists' such as
ropinirole and bromocriptine
Tell your doctor if you are taking any of the
following medicines;
• Medicines used to control your heart beat
such as quinidine, disopyramide, amiodarone and sotalol
• Other anti-psychotic medicines used for
mental problems
• Medicines for severe pain called opiates
such as morphine or pethidine
• Medicines for high blood pressure and heart
problems such as diltiazem, verapamil,
guanfacine and digitalis
• Clonidine used for migraines, flushing or
high blood pressure
• Mefloquine used to treat malaria

3. How to take Solian
Always take Solian exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
503432

2

Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans /
Zapf Dingbats
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 477565
Couleur (s) / Color(s) : 2

sanofi aventis

Code AC / Item : 503432
Description AC : Notice Solian
Destination :
Grande Bretagne
Date / Version : 30-01-13 V2
Dimension :
210x170 mm
Type :
Double roul.

Noir + Bleu PMS Reflex Blue U
Plan N° : N 93

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

Solian should not be stopped suddenly.
Stopping treatment suddenly may cause withdrawal
effects such as:
• Feeling or being sick
• Sweating
• Difficulty sleeping or feeling very restless
• Muscle stiffness or unusual body movements
• Your original condition may come back
Blood Tests
Taking Solian may affect the results of some
blood tests. These include tests to measure the
hormone called ‘prolactin’ and liver tests. If you
are going to have a blood test, it is important to
tell your doctor you are taking Solian.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

• Swallow the tablets whole with a drink of water.
Do not chew your tablets
• Take before a meal
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
How much to take
The amount of Solian you take will depend on your
illness. Follow your doctor’s instructions carefully.
Adults
• The usual dose is between 50mg and 800mg
each day
• Your doctor may start you on a lower dose if
necessary
• If necessary your doctor can prescribe up to
1200mg each day
• Doses up to 300mg each day can be taken as a
single dose. Take the dose at the same time
each day
• Doses above 300mg should be taken as half in
the morning and half in the evening
Elderly
• Your doctor will need to keep a close check on
you as you are more likely to have low blood
pressure or sleepiness due to this medicine
People with kidney problems
• Your doctor may need to give you a lower dose
Chidren under 18 years of age
Solian should not be given to children under 18
years of age
If you take more Solian than you should
If you take more tablets than you should, tell a
doctor or go to a hospital casualty department
straight away. Take the medicine pack with you.
This is so the doctor knows what you have taken.
The following effects may happen: feeling restless
or shaky, rigid muscles, feeling drowsy or sleepy
which could lead to a loss of consciousness.
If you forget to take Solian
If you forget a dose, take it as soon as you remenber it. However, if it is nearly time for the next
dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Solian
Keep taking Solian until your doctor tells you to
stop. Do not stop taking Solian just because you
feel better. If you stop, your illness may get worse
or come back. Unless your doctor tells you otherwise,

4. Possible side effects
Like all medicines, Solian can cause side effects,
although not everybody gets them.
Stop taking Solian and see a doctor or go to a
hospital straight away if:
• You have a high temperature, sweating, stiff
muscles, fast heartbeat, fast breathing and feel
confused, drowsy or agitated. These could be
the symptoms of a serious but rare side effect
called ‘neuroleptic malignant syndrome’
• You have an unusual heart rate, very fast heart
rate or chest pain which could result in a heart
attack or life-threatening heart disorder.
• You have 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.
• You get more infections than usual. This could
be because of a blood disorder (agranulocytosis)
or a decrease in the number of white blood
cells (neutropenia)
Uncommon (affects less than 1 in 100 people)
• You have an allergic reaction. The signs may
include: an itchy, lumpy rash, swallowing or
breathing problems, swelling of your lips, face,
throat or tongue
• You have a fit (seizure)
503432

3

Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans /
Zapf Dingbats
Texte corps mini / Text size mini : 10 pt
Code actuel / Current code : 477565
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 93

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

Tell your doctor as soon as possible if you have
any of the following side effects:
Very Common (affects more than 1 in 10 people)
• Trembling, muscle stiffness or spasm, slow
movement, producing more saliva than usual or
feeling restless.
Common (affects less than 1 in 10 people)
• Movements that you cannot control, mainly of
the arms and legs
(These symptoms can be reduced if your doctor
lowers your dose of Solian or prescribes an additional medicine)
Uncommon (affects less than 1 in 100 people)
• Movements that you cannot control, mainly of
the face or tongue
Other side effects include:
Common (affects less than 1 in 10 people)
• Difficulty sleeping (insomnia) or feeling anxious
or agitated
• Feeling drowsy or sleepy
• Constipation, feeling or being sick, dry mouth
• Putting on weight
• Unusual production of breast milk in women
and men, breast pain
• Menstrual period stops
• Breast enlargement in men
• Difficulty in getting or maintaining an erection,
or in ejaculating
• Feeling dizzy (which can be due to low blood
pressure)
Uncommon (affects less than 1 in 100 people)
• Slowing of the heart beat
• High blood sugar (hyperglycaemia)
Tell your doctor or pharmacist if any of the
side effects get serious or lasts longer than a
few days, or if you notice any side effects not listed in this leaflet.
5. How to store Solian

sanofi aventis

Code AC / Item : 503432
Description AC : Notice Solian
Destination :
Grande Bretagne
Date / Version : 30-01-13 V2
Dimension :
210x170 mm
Type :
Double roul.

to dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further Information
What Solian contains
The tablets contain 50mg, 100mg, 200mg or
400mg of the active substance, amisulpride.
• The other ingredients in Solian are sodium
starch glycolate, lactose monohydrate, microcrystalline cellulose, hypromellose and magnesium stearate. Solian 400mg tablets also contain
polyoxyl 40 stearate and titanium dioxide
(E171).
What Solian looks like and contents of the pack
• Solian 50mg tablets are white to off-white, flatfaced tablets engraved AMI 50. They are available in blister packs of 30, 60, 90 or 150.
• Solian 100mg tablets are white to off-white, flatfaced tablets engraved AMI 100. They are supplied in blister packs of 60.
• Solian 200mg tablets are white to off-white, flatfaced tablets engraved AMI 200. They are supplied in blister packs of 30, 60, 90, 120 or 150.
• Solian 400mg tablets are white, film-coated,
oblong scored tablets engraved AMI 400. They
are supplied in blister packs of 30, 60 or 90.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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 Winthrop Industrie, 6 Boulevard de
L’Europe, 21800 Quetigny, France

Keep this medicine in a safe place where children
This leaflet does not contain all the information
cannot see or reach it.
about your medicine. If you have any questions
Do not use Solian after the expiry date which is
or are not sure about anything, ask your doctor or
stated on the carton. The expiry date refers to the
pharmacist.
last day of that month.
Do not use Solian if you notice that the tablets
This leaflet was last revised in 02/2013.
become discoloured.
© Sanofi, 1999- 2013
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how 503432
4

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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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