Medication Guide App

SOLIAN 100MG/ML SOLUTION

Active substance: AMISULPRIDE

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LIQUID MANUFACTURIN

G

Packaging code : 302083
Old packaging code : 302023

Format : 157x250-PL3P8V
Plant barcode : 83

Update : 25/08/2014 - V1

Colors :
Pantone Reflex Blue

Packaging type : Leaflet
Country : UK
Languages : EN
Graphic designer : K.L.
Plant : Colomiers

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)
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 Solution
Keep this medicine in a safe place where children
cannot see or reach it.

Store below 25°C.
Do not use Solian Solution after the expiry date
which is stated on the carton and label. The
expiry date refers to the last day of that month.
Solian Solution should be disposed of 2 months
after opening
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 100mg/ml Solution contains
• Each 1ml of solution contains 100mg of the active
ingredient, amisulpride
• The other ingredients are Saccharin sodium,
sodium gluconate, glucono delta lactone,
hydrochloric acid, methyl parahydroxybenzoate,
propyl parahydroxybenzoate, potassium sorbate,
caramel flavour (tonka beans extract, vanillin,
benzaldehyde, acetyl methyl carbinol, gamma and
delta decalactones, esters from acetic, butyric and 2
methyl butyric acid, esters from ethyl and cinnamyl
alcohol, propylene glycol and ethyl alcohol) and
purified water
What Solian Solution looks like and contents
of the pack
• Solian Solution is a clear yellow liquid, with an
odour of caramel
• Solian Solution comes in a 60ml brown glass bottle,
with a child resistant cap. It is provided with a 5ml
oral syringe graduated in mg.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, United Kingdom
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Unither Liquid Manufacturing, 1-3 Allee de la Neste
Z.I d’En Sigal, 31770 Colomiers, 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 08/2014.
© Sanofi, 2001 - 2014
4

Fonts : Ocean Sans Pro SAN
Zapfs Dingbat
Min font size used : 8 pt
Logo version :

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Solian 100mg/ml Solution
Amisulpride
Is this leaflet hard to see or read?
Phone 0845 372 7101 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 Solution is and what it is used for
2. Before you take Solian Solution
3. How to take Solian Solution
4. Possible side effects
5. How to store Solian Solution
6. Further information
1. What Solian Solution is and what it
is used for
The name of your medicine is Solian 100mg/ml
Solution (called Solian Solution throughout this
leaflet). Solian Solution 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 Solution
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 Solution
Do not take this medicine and tell your
doctor if:
✕ You are allergic (hypersensitive) to
amisulpride or any of the other ingredients
of Solian Solution (listed in Section 6 below) 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 used 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 Solution.
Take special care with Solian Solution
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 are 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
1

302083 - 83

Product :SOLIAN 60ML UK

LIQUID MANUFACTURIN

G

Packaging code : 302083
Old packaging code : 302023

Format : 157x250-PL3P8V
Plant barcode : 83

Update : 25/08/2014 - V1

Colors :
Pantone Reflex Blue

Product :SOLIAN 60ML UK
Packaging type : Leaflet

Fonts : Ocean Sans Pro SAN
Zapfs Dingbat

Country : UK
Languages : EN

Min font size used : 8 pt

Graphic designer : K.L.
Plant : Colomiers

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
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Solian Solution.
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 Solution can affect the way
nsome other medicines work. Also some medicines
can affect the way Solian Solution 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
• Mefloquine used to treat malaria
• Medicines for high blood pressure and heart
problems such as diltiazem, verapamil,
guanfacine or digitalis
• Clonidine used for migraines, flushing or high
blood pressure
• Medicines which help you sleep such as
barbiturates and benzodiazepines
• Pain-killers such as tramadol or indometacin
• Anaesthetics

Logo version :

• 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
Solution.
Taking Solian Solution with food and drink
• Take the solution with a drink that does not
contain alcohol
• Do not drink alcohol while you are taking Solian
Solution. 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 Solution
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 Solution
Solian Solution contains small amounts of ethyl
alcohol (ethanol), less than 100mg per ml.
Solian solution also contains parahydroxybenzoates
(E216 propylhydroxybenzoate and E218
methylhydroxybenzoate), these may cause allergic
reactions (these may be delayed).
3. How to take Solian Solution
Always take Solian Solution 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
• Take the solution with a drink that does not
contain alcohol
• Use the graduated syringe to measure your
2

medicine. Each 1ml of solution contains
100mg of your medicine
• 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 Solution you take will
depend on your illness. Follow your doctor’s
instructions carefully.
Adults
• The usual dose is between 50mg (0.5ml) and
800mg (8ml) each day
• Your doctor may start you on a lower dose if
necessary
• If necessary your doctor can prescribe up to
1200mg (12ml) each day
• Doses up to 300mg (3ml) each day can be taken
as a single dose. Take the dose at the same time
each day
• Doses above 300mg (3ml) 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 18 years of age
Solian Solution should not be given to children
under 18 years of age
If you take more Solian Solution than you should
If you take more solution 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 Solution
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 Solution
Keep taking Solian Solution until your doctor tells
you to stop. Do not stop taking Solian Solution
just because you feel better. If you stop, your

illness may get worse or come back. Unless your
doctor tells you otherwise, Solian Solution 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 Solution 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 Solution.
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 Solution can cause side
effects, although not everybody gets them.
Stop taking Solian Solution 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)
3

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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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