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SOLIAN 100MG TABLETS

Active substance(s): AMISULPRIDE

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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)
× You have been diagnosed with a pituitary
tumour
× 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 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’

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

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

× 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

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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.
2. Before you take Solian
Do not take this medicine and tell
your doctor if:

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SENS DE DEROULEMENT
RECTO
(Intérieur bobine)

▲ You or someone else in your family has a
history of breast cancer
▲ You have high levels of prolactin
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Solian.

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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
• Clozapine used to treat schizophrenia
• 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
• 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
and have blurred vision 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
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
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• 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
remember 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:
Common (may affect up to 1 in 10 people)
• You have an unusual heart rate.
Uncommon (may affect up to 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).
• 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 (leukopenia
or neutropenia).
Rare (may affect up to 1 in 1000 people)
• 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 a 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.
Tell your doctor as soon as possible if you
have any of the following side effects:
Very Common (may affect more than 1 in
10 people)
• Trembling, muscle stiffness or spasm, slow
movement, producing more saliva than
usual or feeling restless.
Common (may affect up to 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 (may affect up to 1 in 100 people)
• Movements that you cannot control,
mainly of the face or tongue
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Other side effects include:
Common (may affect up to 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)
• Blurred vision
Uncommon (may affect up to 1 in 100 people)
• Slowing of the heart beat
• High blood sugar (hyperglycaemia)
• Feeling confused
• Nasal congestion
• A condition called ‘osteoporosis’. This is
when your bones are more likely to break.
• High levels of fat (triglycerides) or
cholesterol in the blood
• Accidental inhalation of food with risk of
pneumonia (lung infection)
• Increase in blood pressure
• Difficulty passing water (urine)
Rare (may affect up to in 1 in 1000 people)
• Noncancerous benign tumour (such as
prolactinoma)
• Feeling unwell, confused or weak, feeling
sick (nausea), loss of appetite, feeling
irritable. This could be an illness called a
syndrome of inappropriate antidiuretic
hormone secretion (SIADH)
• Tired, weak, confused, have muscles that
ache, are still or do not work well. This may
be due to low sodium levels in your 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 or search
for MHRA Yellow Card in the Google Play or
Apple App Store.
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 off-white,
flat-faced tablets engraved AMI 50. They are
available in blister packs of 30, 60, 90 or 150.
• Solian 100mg tablets are white to off-white,
flat-faced tablets engraved AMI 100 on one
side and a breakable bar on the other. They
are supplied in blister packs of 60.
• Solian 200mg tablets are white to off-white,
flat-faced tablets engraved AMI 200 on one side
and a breakable bar on the other. 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
Delpharm Dijon, 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 10/2017
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© Sanofi, 1999- 2017

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