Description
Amisulpride 60 x 100mgThis medicine contains the active ingredient amisulpride, which is a type of medicine known as an atypical antipsychotic.
It works in the brain, where it affects a neurotransmitter called
dopamine. Neurotransmitters are chemicals that are stored in nerve
cells and are involved in transmitting messages between the nerve
cells.
Dopamine is a neurotransmitter known to be involved in regulating
mood and behaviour, amongst other things. Schizophrenia is associated
with an overactivity of dopamine in the brain, and this may be
associated with the delusions and hallucinations that are a feature of
this disease.
Amisulpride works by blocking the receptors in the brain that
dopamine acts on. This prevents the excessive activity of dopamine and
helps to control psychotic illness.
Schizophrenic patients may experience 'positive symptoms' (such as
hallucinations, disturbances of thought, and hostility) and/or
'negative symptoms' (such as lack of emotion and social isolation).
Amisulpride has been shown to be effective for relieving both positive
and negative symptoms of schizophrenia, whereas the conventional
antipsychotics are usually less effective against the negative symptoms.
Amisulpride is also used by specialists to treat episodes of mania
in people with the psychiatric illness, bipolar affective disorder
(manic depression), though this is an unlicensed use of the medicine.
What is it used for?
Warning!
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This medicine may cause drowsiness. If affected do not drive or operate machinery. Alcohol should be avoided.
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You should not suddenly stop taking this medicine unless your doctor tells you otherwise.
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Consult your doctor immediately if you
experience abnormal movements, particularly of the face, lips, jaw and
tongue, while taking this medicine. These symptoms may be indicative of
a rare side effect known as tardive dyskinesia, and your doctor may ask
you to stop taking this medicine, or decrease your dose.
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Consult your doctor immediately if you
experience the following symptoms while taking this medicine: high
fever, sweating, muscle stiffness, faster breathing and drowsiness or
sleepiness. These symptoms may be due to a rare side effect known as
the neuroleptic malignant syndrome, and your treatment may need to be
stopped.
Use with caution in
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Abnormal rhythm of the heart beat (prolonged QT interval on an ECG)
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Decreased kidney function
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Elderly people
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History of epilepsy
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Low blood potassium levels (hypokalaemia)
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Parkinson's disease
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Slow heart rate of less than 55 beats per minute (bradycardia)
Not to be used in
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Breastfeeding
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Children less than 15 years of age
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Pregnancy
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Tumour of the adrenal gland (phaeochromocytoma)
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Tumours which grow rapidly in the presence of the hormone prolactin, eg tumours of the pituitary gland, breast cancer
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Women of child-bearing potential, unless effective contraception is used to prevent pregnancy
This medicine should not be used if you are
allergic to one or any of its ingredients. Please inform your doctor or
pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using
this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be
used during pregnancy or breastfeeding. However, other medicines may be
safely used in pregnancy or breastfeeding providing the benefits to the
mother outweigh the risks to the unborn baby. Always inform your doctor
if you are pregnant or planning a pregnancy, before using any medicine.
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The safety of this medicine in pregnancy has
not been established. It should not be taken by women who are pregnant,
and women who could get pregnant should use an effective method of
contraception to prevent pregnancy while taking this medicine. Seek
further medical advice from your doctor.
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It is not known whether this medicine passes
into breast milk. Mothers who need to take this medicine should not
breastfeed. Seek medical advice from your doctor.
Label warnings
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This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
Side effects
Medicines and their possible side
effects can affect individual people in different ways. The following
are some of the side effects that are known to be associated with this
medicine. Because a side effect is stated here, it does not mean that
all people using this medicine will experience that or any side effect.
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Dry mouth
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Difficulty in sleeping (insomnia)
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Impotence
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Shaking, usually of the hands (tremor)
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Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
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Weight gain
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Abnormal heart beats (arrhythmias)
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Low blood pressure (hypotension)
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Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects)
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Sleepiness
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Increased salivation
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Slow heart rate (bradycardia)
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High blood prolactin (milk producing hormone)
level (hyperprolactinaemia). Sometimes this can lead to symptoms such
as breast enlargement, production of milk and stopping of menstrual
periods.
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Anxiety and agitation
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with
this medicine, please read the information provided with the medicine
or consult your doctor or pharmacist.
How can this medicine affect other medicines?
This medicine must not be taken in
combination with any of the following medicines, as this could induce
an abnormal heart rhythm known as torsades de pointes: - certain
medicines used to treat abnormal heart rhythms (antiarrhythmics) such
as quinidine, disopyramide, procainamide, amiodarone, sotalol - bepridil - cisapride - sultopride - thioridazine - erythromycin given by injection into a vein (intravenous) - vincamine given by injection into a vein (intravenous) - halofantrine - pentamidine - sparfloxacin.
This medicine must also not be used in combination with levodopa, as these two medicines oppose the effect of each other.
The following medicines should be used with caution in combination
with this medicine, as they may increase the risk of abnormal heart
rhythms: - beta-blockers, eg propranolol - calcium channel blockers, eg diltiazem, verapamil - clonidine - digoxin - thiazide diuretics, eg bendrofluazide - loop diuretics, eg frusemide - stimulant laxatives, eg bisacodyl - amphotericin B given by injection into a vein - corticosteroids, eg prednisolone - tetracosactide - lithium - other antipsychotic medicines, eg haloperidol, pimozide - antidepressants, eg imipramine.
There may be an increased risk of drowsiness and sedation if this
medicine is taken with any of the following (which can also cause
drowsiness): - alcohol - tricyclic antidepressants, eg amitriptyline - opioid painkillers, eg morphine, codeine, dihydrocodeine - benzodiazepines, eg diazepam - sedating antihistamines, eg chlorpheniramine - sleeping tablets.
There may be an increased risk of a drop in blood pressure that
causes dizziness if this medicine is taken with medicines that reduce
blood pressure, for example antihypertensives.
This medicine may oppose the effect of dopamine agonists used to
treat Parkinson's disease, eg bromocriptine, cabergoline, ropinirole,
apomorphine.
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