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AMISULPRIDE 100MG/ML SUGAR FREE ORAL SOLUTION

Active substance(s): AMISULPRIDE / AMISULPRIDE

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Package leaflet: Information for the user

Amisulpride 100mg/ml Sugar Free Oral Solution
(amisulpride)
Read all of this leaflet carefully before you start taking
this medicine because it contains important
information for you.






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 only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

The name of your medicine is Amisulpride 100mg/ml Sugar
Free Oral Solution but it will be referred to as
‘Amisulpride' throughout this leaflet.
What is in this leaflet:
1. What Amisulpride is and what it is used for
2. What you need to know before you take Amisulpride
3. How to take Amisulpride
4. Possible side effects
5. How to store Amisulpride
6. Contents of the pack and other information

1. What Amisulpride is and what it is used for
Amisulpride belongs to a group of medicines called ‘antipsychotics’. 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. Amisulpride works by improving disturbed
thoughts, feelings and behaviour. It is used to treat
schizophrenia when it starts and also over the long term.

2. What you need to know before you take
Amisulpride
Do not take Amisulpride if:
 you are allergic (hypersensitive) to amisulpride or any of
the other ingredients of this medicine (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 breastfeeding (see ‘Pregnancy, breast-feeding and fertility’
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 ‘Other medicine and
Amisulpride’ 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 Amisulpride.
Warning and precautions
Talk to your doctor or pharmacist before taking Amisulpride
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 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 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 applies to you, talk to
your doctor or pharmacist before taking Amisulpride.

PIL/UK/MFG085/03/v4

Other medicines and Amisulpride
Tell to 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 Amisulpride can affect the way some other
medicines work. Also some medicines can affect the way
Amisulpride 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
 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 Amisulpride.
Amisulpride with food, drink and alcohol
take the solution with a drink that does not contain
alcohol
 do not drink alcohol while you are taking Amisulpride.
This is because it can affect the way the medicine works.


Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
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 Amisulpride 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.
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.
Amisulpride contains:
Methyl parahydroxybenzoate (E218), which may cause
allergic reactions (possibly delayed).

3. How to take Amisulpride
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
How much to take
The amount of Amisulpride you take will depend on your
illness. Follow your doctor’s instructions carefully.
Adults
the usual dose is between 0.5ml (50mg) and 8ml
(800mg) each day
 your doctor may start you on a lower dose if necessary
 if necessary your doctor can prescribe up to 12ml
(1200mg) each day
 doses up to 3ml (300mg) each day can be taken as a
single dose. Take the dose at the same time each day
 doses above 3ml (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 18 years of age
Amisulpride should not be given to children under 18 years
of age.
Route and method of administration
this medicinal product must be taken orally
take the solution with a drink that does not contain
alcohol
 use the measuring syringe provided in the pack to deliver
the required dose. Each 1ml 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.



TURN OVER

Instructions for the use of syringe:
a) Open the bottle: press the cap and turn it anticlockwise
(Figure 1).
b) Insert the syringe into the bottle and pull the piston
upward to the graduation mark corresponding to the
quantity in millilitres (ml) prescribed by your doctor
(Figure 2).



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 Amisulpride or prescribes an additional medicine).



Uncommon (affects less than 1 in 100 people)
movements that you cannot control, mainly of the face or
tongue.



c) Remove the syringe from the bottle (Figure 3). Empty the
syringe into any non-alcoholic drink by pushing the piston
to the bottom of the syringe and drink it immediately
(figure 4).

d) Wash the syringe with water and store in a clean place
(Figure 5).

If you take more Amisulpride than you should
If you take more Amisulpride 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 Amisulpride
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 Amisulpride
Keep taking Amisulpride until your doctor tells you to stop.
Do not stop taking Amisulpride just because you feel better.
If you stop, your illness may get worse or come back. Unless
your doctor tells you otherwise, Amisulpride 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 Amisulpride 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
Amisulpride.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Amisulpride can cause side effects,
although not everybody gets them.
Stop taking Amisulpride 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 lifethreatening 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

PIL/UK/MFG085/03/v4

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.
 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)
 blurred vision
 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 or pharmacist.
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 Amisulpride







Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and label after ‘Exp’. The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage
conditions.
Discard 60 days after first opening.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.

6. Contents of the pack and other information
What Amisulpride contains:
The active substance is amisulpride.
Each 1ml of oral solution contains 100mg of amisulpride.
The other ingredients are saccharin sodium (E954), sodium
gluconate (E576), glucono-delta-lactone (E575), hydrochloric
acid concentrated (E507), methyl parahydroxybenzoate
(E218), caramel flavour (containing propylene glycol
(E1520)) and purified water.
What Amisulpride looks like and contents of the pack:
Amisulpride oral solution is a clear, pale yellow colour
solution, supplied in an amber glass bottle, with a child
resistant, tamper evident plastic cap with a 5ml oral syringe
with 0.5ml graduation for measuring and administering the
dose.
Amisulpride oral solution is supplied in bottles containing 60
ml oral solution.
Marketing Authorisation Holder and Manufacturer:
Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
POM
If this leaflet is hard to see or read,
please call +44 (0) 208 515 3700 for help.
This leaflet was last revised in 11/2016.

Expand Transcript

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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