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Active substance(s): AMISULPRIDE

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Solian® 200mg Tablets
Solian® 400mg Tablets


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.
Your medicine is available using any one of the above names, but will be
referred to as Solian throughout this leaflet.
Other strengths are also available.
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
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 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.
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 breast-feeding’ section)
- You have breast cancer or something called ‘a prolactin dependent
- 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
- 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’
- 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.

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
- 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
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
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.
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.
- 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
- 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

Children 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
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
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
- 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)
- 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)
- 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
- Blurred vision
- 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
- Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite,
feeling irritable. This could be an illness called syndrome of inappropriate
antidiuretic hormone secretion (SIADH)
- Noncancerous benign tumour (such as prolactinoma)
- A condition called ‘osteoporosis’. This is when your bones are more likely
to break
- Nasal congestion
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:
By reporting side effects you can help provide more information on the
safety of this medicine.
Keep this medicine in a safe place where children cannot see or reach it.
Store between 15-25 C.
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.
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.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
What Solian contains
The tablets contain the active substance, amisulpride.
Each Solian 200mg tablet contains 200mg amisulpride.
Each Solian 400mg tablet contains 400mg amisulpride.
Solian tablets also contain sodium starch glycolate, lactose monohydrate,
microcrystalline cellulose, hypromellose, magnesium stearate.
Solian 400mg Tablets also contain polyoxyl 40 stearate and titanium dioxide
What Solian looks like and contents of the pack
Solian 200mg Tablets are white to off white, flat-faced scored tablets
engraved AMI 200.
Solian 400mg Tablets are white, film-coated, oblong scored tablets
engraved AMI 400.
Solian tablets are available in blister packs of 30 and 60 tablets.
Manufactured by: Sanofi Winthrop Industrie, 6 boulevard de l'Europe,
Quetigny 21800, France and procured from within the EU by Product
Licence holder Tenolol Ltd., 5, Sandridge Close, Harrow, HA1 1XD.
Repackaged by Servipharm Ltd.

PL 30900/2013
PL 30900/2014

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
Date of revision of leaflet: 22.11.16[13]

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)

Solian is a registered trademark of Sanofi-Aventis.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.