SOLIAN 400MG TABLETS

Active substance: AMISULPRIDE

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MOCK-UP
By Khilod at 2:39 pm, Mar 17, 2010

Assessed against UK PIL dated June 2008

Solian® 400mg Tablets
Amisulpride 400mg Tablets
(amisulpride)

Your medicine is known by one of the above names, but will be referred to
as Solian throughout this:
Patient Information Leaflet
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, please 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 gets 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:
• 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 other medicines which could change your heart rate
such as medicines which are used to control your heart beat (see
‘Taking other medicines’ section)
• You are taking levodopa, a medicine to treat Parkinson’s disease (see
‘Taking other medicines’ section)
• The patient is under 15 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.
Taking 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
• You are diabetic or have been told you have an increased risk of having
diabetes
• You are elderly. This is because elderly people would be more likely to
get low blood pressure or feel sleepy
• 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 or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood
clots.
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;
• Medicines used to control your heart beat such as quinidine,
disopyramide, procainamide, amiodarone and sotalol
• Medicines which may lower potassium levels. This includes water
tablets such as bendrofluazide or hydrochlorothiazide, some laxatives,
glucocorticoids (used to treat severe asthma and other inflammatory
disorders), tetracosactides and amphotericin (used to treat fungal
infections)
• Levodopa, a medicine to treat Parkinson’s disease
Tell your doctor if you are taking any of the following medicines;
• Medicines for depression or to calm emotional and mental illness such
as pimozide, haloperidol, imipramine, thioridazine and lithium
• Medicines for severe pain called opiates such as morphine, pethidine or
methadone
• Medicines for high blood pressure and migraine such as clonidine,
diltiazem and verapamil, guanfacine and digitalis
• Medicines which help you sleep such as barbiturates and
benzodiazepines
• Pain-killers such as tramadol and indometacin
• Anaesthetics
• Antibiotics such as erythromycin (given by injection) or sparfloxacin
• Antihistamines such as promethazine which make you sleepy
• Pentamidine used for pneumonia
• 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
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 cannot 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
• 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
Children under 15 years of age
Solian Solution should not be given to children under 15 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:
• 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
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.
Uncommon (affects less than 1 in 100 people)
• You have an allergic reaction. The signs may include: a 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)
• 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
• Keep all medicines out of the reach and sight of children.
• Do not use after the expiry date printed on the carton, label or blister strip.
• If your doctor stops your treatment, return any unused tablets to a
pharmacist.
• If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.
• 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
Each tablet contains 400mg of the active ingredient amisulpride.
Each tablet also contains sodium starch glycollate, lactose monohydrate,
microcrystalline cellulose, magnesium stearate, hypromellose, polyoxyl 40
stearate and titanium dioxide (E171).
What Solian looks like and contents of the pack
The tablets are white, oblong, film-coated and marked ‘AMI breakline 400’
on one side and plain on the other side.
Solian 400mg Tablets are available as blister packs of 30 tablets
PL 10383/1492

Solian 400mg Tablets/Amisulpride 400mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Sanofi Winthrop Industrie – 6, Boulevard
De L’Europe, Quetigny, France. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 28 Sarum
Complex, Uxbridge, Middlesex UB8 2RZ.
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.
Leaflet date: 15.03.2010
®

Solian is a registered trade mark of sanofi-aventis, Paris, France.

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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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