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AMISULPRIDE 100MG/ML ORAL SOLUTION

Active substance(s): AMISULPRIDE

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Talk to your doctor or pharmacist if any of the following apply to you:
• if you suffer from kidney problems;
• if you have a history of epilepsy;
• if you suffer from Parkinson’s disease;
• if you are a diabetic or have been told you have an increased risk of
having diabetes;
• if you are elderly. This is because elderly people would be more likely
to get low blood pressure or feel sleepy;
• if you have heart disease, or a family history of heart problems;
• if you have had a stroke or your doctor has told you that you may be
at risk from a stroke.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amisulpride 100mg/ml Oral Solution
Amisulpride
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.

Take special care with Amisulpride Oral Solution:
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.
Using other medicines
Tell your doctor or pharmacist if you are taking any medicines listed
under section 2, Do not take Amisulpride Oral Solution.
Please also tell your doctor or pharmacist if you are taking any of the
following medicines:
• medicines that act on the brain (CNS depressants) including
anaesthetics, some antihistamines, medicines used to relieve pain
(narcotics), medicines to help you sleep (barbiturates,
benzodiazepines), or medicines that treat anxiety;
• clonidine (used to treat high blood pressure, migraine and
menopausal flushing) or its derivatives;
• medicines used to treat certain mental and emotional conditions
(antipsychotics);
• medicines which lower your blood pressure e.g. diltiazem;
• medicines to treat an irregular heartbeat (arrhythmias), e.g. quinidine,
disopyramide, amiodarone or sotalol;
• some medicines used to treat malaria or to help prevent you from
catching malaria e.g. mefloquine.

In this leaflet:
1. What Amisulpride Oral Solution is and what it is used for
2. Before you take Amisulpride Oral Solution
3. How to take Amisulpride Oral Solution
4. Possible side effects
5. How to store Amisulpride Oral Solution
6. Further information

1. What Amisulpride Oral Solution is and what it is used for
Your medicine is called Amisulpride 100mg/ml Oral Solution (called
Amisulpride Oral Solution throughout this leaflet).
What this medicine does
Amisulpride Oral Solution is one of a group of medicines called
neuroleptics. These are used to treat acute and chronic schizophrenia.
Symptoms of this condition can include sensing, seeing or hearing
things that do not exist, becoming withdrawn and having mistaken
beliefs or suspicions.

You must also inform your doctor or dentist that you are taking
Amisulpride Oral Solution before you have an anaesthetic.
Tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.

2. Before you take Amisulpride Oral Solution
Do not take Amisulpride Oral Solution
• if you are allergic (hypersensitive) to amisulpride or any of the
other ingredients of Amisulpride Oral Solution (see section 6,
Further information);
• if you have a tumour of the pituitary gland or breast cancer;
• if you have phaeochromocytoma (a tumour of the adrenal gland);
• if you are under 18 years of age;
• if you are breast-feeding;
• if you are taking a dopamine agonist e.g. levodopa used in
Parkinson’s disease, bromocriptine used in pituitary problems and
ropinirole used in restless leg syndrome.

Taking Amisulpride Oral Solution with food, drink and alcohol
A carbohydrate rich (starchy/sugary) meal may adversely effect how
this medicine works. Therefore you should take Amisulpride Oral Solution
before a meal and at about the same time(s) each day. Do not drink
alcohol whilst you are taking this medicine as the effects of alcohol may
be increased.

4. Possible side effects
Like all medicines, Amisulpride Oral Solution can cause side effects,
although not everybody gets them.
If you experience any of the following symptoms, contact your doctor
immediately and stop taking this medicine:
• 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.
• Severe allergic reaction (affecting fewer than 1 in 100 people). You
may have a red lumpy rash, difficulty breathing, swelling of face, lips
or eyelids, unexplained high temperature (fever) and feel faint. If the
swelling affects your throat and makes breathing and swallowing
difficult, go to hospital straight away.
• 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.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.
If you take more Amisulpride Oral Solution than you should
If you or someone else takes more Amisulpride Oral Solution than has
been prescribed, or you think a child has swallowed any Amisulpride
Oral Solution, contact your doctor, pharmacist or hospital emergency
department immediately and take your Amisulpride Oral Solution with
you.
• Symptoms of overdose may include sleepiness, coma, low blood
pressure, shaking, slowed movement, increased saliva, stiffness and
restlessness.
If you forget to take Amisulpride Oral Solution
• If you forget to take a dose, do not worry. Take the next dose when it
is due.
• Do not take double the amount to make up for a forgotten dose.
If you stop taking Amisulpride Oral Solution
• Do not stop taking Amisulpride Oral Solution suddenly as this may
cause side effects.
• Speak to your doctor before you stop taking Amisulpride Oral
Solution.
• Your doctor will tell you how to reduce your dose slowly over a
number of weeks or months to help lower the chance of you getting
withdrawal symptoms.
• Stopping Amisulpride Oral Solution suddenly can lead to withdrawal
symptoms such as:
- feeling or being sick
- problems sleeping
- feeling restless
- unusual body movements or muscle stiffness
- your original condition may come back

If the following side effect occurs, speak to your doctor immediately.
• You experience unexplained infections or fevers. This may be the
result of lower white blood cell counts and your doctor may need to
check your blood.
Very common side effects (affecting more than 1 in 10 people):
• Trembling, muscle stiffness, excess saliva, slowed movement or
restlessness. Your doctor may give you another medicine to reduce
these symptoms. The effects are generally mild at low doses.
Common side effects (affecting up to 1 in 10 people):
• Neck spasms, rolling of the eyes, lockjaw. Your doctor may
give you another medicine to treat these symptoms
• Feeling drowsy
• Sleeplessness, agitation, anxiety
• Difficulty in reaching orgasm
• Problems with digestion such as constipation, feeling or being sick,
dry mouth
• Weight gain
• Milk production from the breasts (in women), breast pain
• Stopping of menstrual periods
• Enlarged breasts in men
• Difficulty in getting, or maintaining, an erection (impotence)
• Feeling dizzy when you stand up if sitting, or sit up after lying down
(which can be due to low blood pressure)

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Leaflet Guide

Important information about some of the other ingredients in
Amisulpride Oral Solution
Amisulpride Oral Solution contains parahydroxybenzoates (E216 propyl
parahydroxybenzoate and E218 methyl parahydroxybenzoate). These
may cause allergic reactions (possibly delayed). This medicinal
product contains 0.17mmol (4.02mg) sodium (salt) per 1ml of oral
solution. To be taken into consideration by patients on a controlled
sodium (salt) diet.
This medicinal product also contains small amounts of ethanol
(alcohol), less than 0.5mg per 1ml of oral solution.

3. How to take Amisulpride Oral Solution
Your doctor will prescribe the most appropriate dose to treat your
condition. Always take Amisulpride Oral Solution exactly as your
doctor has told you. Check with your doctor or pharmacist if you are
not sure.
• Take your medicine by mouth.
• Take your medicine with a drink that does not contain alcohol.
• Take before a meal.
A 5ml graduated syringe is provided with your medicine. Use the
syringe to withdraw, from the bottle, the amount of Amisulpride Oral
Solution that has been prescribed for you by your doctor.

The conversion of milligrams (mg) to millilitres (ml) is provided in the table
below:
Amount of solution (ml)
0.5
1
2
3
4
5

Amount of medicine (mg)
50
100
200
300
400
500

Adults and the elderly
• The usual dose is between 0.5ml (50mg amisulpride) and 8ml (800mg
amisulpride) each day.
• This may be increased to 12ml (1200mg amisulpride) daily.
• Dosages up to 3ml (300mg amisulpride) can be taken once daily.
• Dosages greater than 3ml (300mg amisulpride) should not be taken all
at once. Your doctor will tell you how much to take and when to take
it.
In the elderly, Amisulpride Oral Solution may increase the risk of low
blood pressure or may make you feel sleepier; therefore your doctor may
want to monitor you more closely and may decide to reduce the dose
you are taking.

(continued overleaf)

Patients with kidney problems
• If you suffer from kidney problems, your doctor may choose to give
you a lower dose of Amisulpride Oral Solution.

Amisulpride 100mg/ml
Oral Solution - Leaflet PIL

Figure A

Driving and using machines
When taking this medicine you may feel drowsy or find that your
reaction time is impaired. Do not drive and do not use any tools or
machines until you are sure that you are not affected.

Each 1ml of solution contains 100mg of your medicine. Each 0.5ml of
solution contains 50mg of your medicine (see Figure A).

Children under 18 years of age
• Amisulpride Oral Solution should not be given to children under 18
years of age.

pharmaceuticals ltd

Pregnancy and breast-feeding
• Do not take Amisulpride Oral Solution if you are breast-feeding.
• If you are a woman of child bearing age, you should talk to your
doctor about the use of appropriate contraception while taking this
medicine.
• If you are pregnant, or thinking of becoming pregnant, ask your
doctor or pharmacist for advice before taking Amisulpride Oral
Solution.
The following symptoms may occur in newborn babies, of mothers that
have used Amisulpride Oral 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.

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Reason for new version:

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Uncommon side effects (affecting fewer than 1 in 100 people):
• Uncontrollable movements of the face or tongue (tardive dyskinesia)
• Seizures, convulsions. If you have a history of epilepsy your doctor will
monitor you closely while taking this medicine as your seizure
threshold may be reduced and you may experience more seizures
• Liver enzyme test changes (you may get increased levels of certain
liver enzymes)
• High blood sugar (hyperglycaemia) which may result in the need to
urinate more frequently, feeling tired, feeling thirsty or experiencing
blurred vision
• Slowing of the heartbeat
Other side effects:
• Rash (hives) or swelling of the skin
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.
Also you can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.
In elderly people with dementia, there has been a small increase in the
number of deaths reported for patients taking antipsychotics
compared with those not receiving antipsychotics.

5. How to store Amisulpride Oral Solution
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton and the bottle
label. The expiry date refers to the last day of that month.
The medicinal product does not require any special storage
conditions.
Once opened, use within 2 months.
Do not use if you notice any visible signs of damage to the bottle or
deterioration in your medicine. Return it to your pharmacist.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that have
passed the expiry date or have been open for more than 2 months.
These measures will help to protect the environment.

Artwork amended
by Design Cognition

6. Further information
What Amisulpride Oral Solution contains
- The active substance is amisulpride. Each 1ml of oral solution
contains 100mg amisulpride.
- The other ingredients are saccharin sodium, sodium gluconate,
gluconolactone, hydrochloric acid (used to adjust the pH), methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
potassium sorbate, caramel flavour (containing glycerol (E422) and
ethanol) and purified water (see section 2, Before you take
Amisulpride Oral Solution).
What Amisulpride Oral Solution looks like and contents of the pack
Amisulpride Oral Solution is a colourless to brown yellowish clear
solution. It is available in an amber glass bottle containing 60ml of
medicine. The pack also contains a 5ml, plastic oral dosing syringe.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 1st Floor,
85 King William Street, London EC4N 7BL, UK.
Tel:
00 44 (0)1283 495 280
Fax:
00 44 (0)1283 495 290
Email:
medinfo@focuspharma.co.uk
Manufacturer
One-Pharma S.A. 60th km of the Athens-Lamia Highway (Schimatari),
Greece.
For any information about this medicinal product, please contact the
Marketing Authorisation Holder, details provided above.

For information in large print, audio
CD or Braille please telephone
00 44 (0)1283 495 280 or email
medinfo@focuspharma.co.uk.
This leaflet was last revised in 06/2015.

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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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