SOLIAN 100MG TABLETS

Active substance: AMISULPRIDE

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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:

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Phone 0845 372 7101 for help

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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
1. What Solian is and what it is
used for
Solian contains a medicine called amisulpride. This belongs to a group of medicines
called ‘anti-psychotics’. 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.

× 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 breast-feeding’ 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.
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.
▲ You are elderly. This is because
elderly people would be more likely to get low blood pressure or
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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
• Medicines which help you sleep such
as barbiturates and benzodiazepines
• Pain-killers such as tramadol and indometacin

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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.

• 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
breast-feed
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.
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
• 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
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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, 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.
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)
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)
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• 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)
Not known (frequency cannot be estimated
from the available data)
• Feeling confused
• High levels of fat (triglycerides) or cholesterol in the blood
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 Solian
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Solian after the expiry date
which is stated on the carton. The expiry

date refers to the last day of that month.
Do not use Solian if you notice that the
tablets become discoloured.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how 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 offwhite, flat-faced tablets engraved AMI 50.
They are available in blister packs of 30,
60, 90 or 150.
• Solian 100mg tablets are white to offwhite, flat-faced tablets engraved AMI 100.
They are supplied in blister packs of 60.
• Solian 200mg tablets are white to offwhite, flat-faced tablets engraved AMI
200. They are supplied in blister packs of
30, 60, 90, 120 or 150.
• Solian 400mg tablets are white, filmcoated, 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: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie, 6 Boulevard de
L’Europe, 21800 Quetigny, France
This leaflet does not contain all the information about your medicine. If you have
any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 06/2014.
© Sanofi, 1999- 201
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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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