Solian®
amisulpride
Consumer Medicine Information
What is in this leaflet
This leaflet is designed to provide answers to some
common questions about this medicine. It does not contain all the available
information.
All medicines have risks and benefits. Your doctor
has weighed the risks of you taking Solian against the benefits this medicine
is expected to have for you.
If you have any concerns about taking this
medicine, ask your doctor or pharmacist.
Keep this leaflet with this medicine. You may need to read it again.
What Solian is used for
The name of your medicine is Solian. It contains
the active ingredient called amisulpride.
Solian belongs to a group of medicines called
antipsychotics. Solian is used to treat symptoms of schizophrenia.
Schizophrenia is a condition which affects the way
you think, feel and/or act. Schizophrenia may cause symptoms such as
hallucinations (eg hearing, seeing or sensing things which are not there),
delusions, unusual suspiciousness, emotional and social withdrawal. People with
schizophrenia may also feel depressed, anxious or tense.
Your doctor may have prescribed Solian for another
reason.
Ask your doctor if you have any questions about why
Solian has been prescribed for you.
Before taking it
When you must not take it
Do not take Solian if:
you have an ALLERGIC REACTION to
Solian or any of the ingredients listed at the end of this leaflet.
Signs of an allergic reaction may include a skin rash, itching, shortness
of breath or swelling of the face, lips or tongue.
you are breastfeeding or plan to
breastfeed.you are taking the following
medicines
- medicines used to treat irregular heart rhythm such as quinidine,
disopyramide, amiodarone and sotalol
- cisapride
- antibiotics such as erythromycin and pentamidine, given as an injection
into the veins
- levodopa, a medicine used in Parkinson's disease
- thioridazone, an antipsychotic
- methadone, medicine used to treat pain or addiction
the packaging is torn or shows signs
of tampering or the tablets do not look quite right.the expiry date on the pack has
passed.
Do not take Solian if you have or have had any of
the following medical conditions:
phaeochromocytoma, a rare tumour of
the adrenal glands which sit near the kidneystumour of the pituitary gland, a
small gland at the base of the brainbreast cancerliver disease
Solian must not be taken by children up to the age
of puberty. There is limited information on the use of Solian in adolescents
and its use is not recommended from puberty to the age of 18 years. If you are
not yet 18 years of age, ask your doctor if Solian is right for you.
Before you start to take it
Your doctor must know about all the following
before you start to take Solian.
Tell your doctor if:
you have had an allergic reaction to
any medicine which you have taken previously to treat your current
condition.you are pregnant or intend to become
pregnant. Solian is not recommended for use in pregnancy. If you need to
take Solian during pregnancy you should discuss the benefits and risks of
taking it with your doctor. Newborns of mothers who have taken Solian
during pregnancy need to be carefully monitored.you suffer from lactose intolerance
because Solian tablets contain lactose.you have kidney or liver disease,
Parkinson's disease or fits (seizures).you have problems with the heart and
blood vessels.you have, or have a history of blood
clots.you have hyperglycaemia (high sugar
levels in the blood) or a family history of diabetes. Your doctor may
recommend monitoring your blood sugar levels while you are taking Solian.you suffer from dementia.you have mental/mood changes or
suicidal thoughts. Patients (and caregivers of patients) need to monitor
for any worsening of their condition and/or the development of thoughts of
suicide, suicidal behaviour or thoughts of harming themselves. Seek
medical advice immediately if these symptoms present.you have risk factors for stroke.you have a history, or family
history, of breast cancer.
Taking other medicines
Tell your doctor or pharmacist if you are taking
any other medicines, including any that you buy without a prescription from
your pharmacy, supermarket or health food store.
Some medicines and Solian may interfere with each
other. These include:
medicines used to treat irregular
heart rhythm such as quinidine, disopyramide, amiodarone and sotalolother medicines used to treat heart
problems such as diltiazem, verapamil, clonidine, digoxin and drugs known
as beta blockers (e.g. propranolol)intravenous amphotericin B, an
anti-fungal given by injection into the veinsother antipsychotics such as
thioridazine, clozapine, chlorpromazine, trifluperazine, pimozide,
haloperidol, imipramine and lithiumdiureticsstimulant laxativesglucocorticosteroidsdiagnostics drugs such as
tetracosactidesmedicines taken for anxiety or to
help you sleepanaesthetics (a medicine used during
surgery)medicines taken for depressionsome strong pain killersantihistamines, medicines to treat
allergies, which cause drowsinesssome medicines taken to control
blood pressure
If you are unsure about any medicine you are
taking, you should check with your doctor or pharmacist. They will have more
information on medicines to be careful of while you are taking Solian.
How to take it
How much to take
Your doctor will tell you how many Solian tablets
you should take, or the amount of Solian Solution you should take. The dosage
is adjusted for each individual and can range from 50mg a day up to 800mg a
day. In some cases your doctor may increase the dose to 1200mg a day.
When taking Solian Solution, the dosage syringe
supplied should be used to measure the correct dose. Each 1mL marking is equal
to 100mg.
After introducing the measuring syringe into the
bottle, draw the plunger of the measuring syringe up to the graduation mark
corresponding to the number of milligrams to be administered.
Solian tablets and Solian Solution should be taken
once or twice a day as advised by your doctor. Your doctor may increase or
decrease your dose depending on your condition.
Do not take more than the dose your doctor has
recommended.
How to take it
Solian tablets should be swallowed whole with a
glass of water.
Solian Solution is swallowed. It may be mixed with
water if preferred.
When to take it
Solian tablets and Solian Solution should
preferably be taken before meals. Take your prescribed dose at about the same
time each day.
How long do I take it
It is important that you do NOT stop taking Solian
unless your doctor tells you. Do not stop taking your Solian just because you
feel better. It is very important to continue Solian because it will help you
stay well.
If you forget to take it
If you forget to take your medicine, take your dose
as soon as you remember. Do not take a double dose to make up for the dose that
you missed.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons
Information Centre (telephoneAustralia13 11 26 orNew
Zealand0800 POISON or
0800 764766), or go to Accident and Emergency at your nearest hospital, if
you think that you or anyone else may have taken too much Solian. Show the
doctor your pack of tablets or bottle. Do this even if there are no signs of
discomfort or poisoning.
If you have taken too much Solian, the most common
signs are drowsiness and slurred speech.
While you are using it
Things you must do
It is very important to continue taking Solian
because it will help you stay well.
Tell all doctors, dentists and pharmacists who are
treating you that you are taking Solian.
While you are taking Solian, tell your doctor or
pharmacist before you start any new medicine.
Tell your doctor immediately, or go to the nearest
hospital, if you have any of the following suicidal thoughts or mental/mood
changes:
thoughts or talk of death or suicidethoughts or talk of self-harm or
harm to othersany recent attempts of self-harmincrease in aggressive behaviour,
irritability or agitationdepressed mood or worsening of
depression
Occasionally, the symptoms of depression may
include thoughts of suicide or self-harm. These symptoms may continue to get
worse during the early stages of treatment until the effect of the medicine
becomes apparent. All mentions of suicide or violence must be taken seriously.
Things to be careful of
Solian may cause drowsiness in some people.
Be careful driving or operating machinery until you
know how Solian affects you.
Be careful if you are elderly or unwell. Some
people may experience side effects such as drowsiness, confusion, dizziness and
unsteadiness, which may increase the risk of a fall.
The effects of alcohol could be made worse while
taking Solian. It is NOT recommended that you drink alcohol while taking
Solian.
Be careful while taking antihistamines, sleeping
tablets or tablets to relieve pain while taking this medicine. Solian can increase
drowsiness caused by medicines affecting your nervous system.
Things you must NOT do
Do not drive or operate machinery until you know
how Solian affects you.
Do not give Solian to anyone else. Your doctor has prescribed it for you and
your condition.
Side Effects
Tell your doctor or pharmacist as soon as possible
if you do not feel well while you are taking Solian.
Like other medicines, Solian can cause some side
effects. If they occur, most are likely to be minor and temporary. However,
some may be serious and may need medical attention. Some of the side effects
are dose related, so it is important that you never exceed your prescribed
dose.
While you are taking Solian
Tell your doctor if you notice any of the following
and they worry you:
drowsinessweight gaindizzinessincreased appetitenauseavomitingconstipationdry mouthblurred visioninsomniaanxietyagitationproblems with orgasm
These are the most common side effects of Solian.
Some people may feel dizzy in the early stages of
treatment, especially when getting up from a lying or sitting position. This
side effect usually passes after taking Solian for a few days.
Sometimes trembling, noticeable muscle stiffness or
spasm, slowness of movement, excess saliva, restlessness, an overwhelming urge
to move and either distress or movements such as pacing, swinging of the legs
while seated, rocking from foot to foot, or both can occur. This will usually
be reduced if your dose of Solian is lowered by your doctor or if your doctor
prescribes you an additional medicine.
High blood sugar has been reported in patients
taking Solian. Symptoms of high sugar levels in the blood include passing more
urine than normal, persistent excessive thirst, increased appetite with a loss
in weight and weakness.
Tell your doctor immediately or go to Accident and
Emergency at your nearest hospital if you notice any of the following:
muscle twitchingabnormal movements mainly of the
face or tonguefeverunexplained infectionsfaster breathingsweatingmuscle stiffness
If this occurs, stop taking Solian immediately and
contact your doctor.
After prolonged use in women, medicines of this
type can cause:
breast painmilk secretionan absence of their monthly periodchanges in the regularity of their
periods
Tell your doctor if your monthly periods are absent
for six months or more.
After prolonged use in men, medicines of this type
can cause breast enlargement or impotence.
Incidences of abnormal liver function have been
occasionally reported.
Do not be alarmed by this list of possible side
effects. You may not experience any of them.
Tell your doctor if you notice any symptoms that
worry you, even if you think the problems are not connected with the medicine
or are not listed in this leaflet.
After taking it
Storage
Keep your tablets in the blister pack until it is
time to take them. If you
take the tablets out of the blister pack they may not keep well.
Store Solian Solution in the original bottle. Solian Solution has an expiry of two months
once opened. Any solution remaining after this should be discarded.
Keep Solian tablets in a cool, dry place where the
temperature stays below 30°C.
Solian Solution should be stored in a cool, dry
place where the temperature stays below 25°C.
Do not store Solian or any other medicine in the
bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines.
There will be an expiry date (month, year) on your
Solian container. The medicine should not be taken after this date.
Disposal
If your doctor tells you to stop taking Solian or
the tablets or Solution have passed their expiry date, ask your pharmacist what
to do with the amount left over.
Product description
What it looks like
Solian tablets are available in three different
strengths:
The 100 mg strength is a white, flat faced,
breakable tablet, marked "AMI 100".
The 200 mg strength is a white, flat faced,
breakable tablet, marked "AMI 200".
The 400 mg strength is a white, film-coated,
breakable, oblong tablet, marked "AMI 400".
The 100 mg strength is available in a pack size of
30 tablets.
The 200 mg strength is available in a pack size of
60 tablets.
The 400 mg strength is available in a pack size of
60 tablets.
Solian Solution is a clear yellow coloured liquid.
It is available in 60mL brown glass bottles.
Ingredients
Active Ingredient:
Solian 100 tablets - 100 mg amisulpride per tablet.
Solian 200 tablets - 200 mg amisulpride per tablet.
Solian 400 tablets - 400 mg amisulpride per tablet.
Solian Solution - 100mg amisulpride per mL.
Inactive Ingredients:
The tablets also contain:
sodium starch glycollate type Alactose monohydratemicrocrystalline cellulose (E 460)hypromellose (E 464)magnesium stearate (E 470)
The 400 mg tablets also contain:
PEG 40 stearatetitanium dioxide (E 171).
The oral liquid also contains:
Gesweet®Hydrochloric acid (E 507)Methyl hydroxybenzoatePropyl hydroxybenzoatePotassium sorbate (E 202)Caramel Flavour®Water - purified
Manufacturer
Solian is distributed inAustraliaby:
sanofi-aventisaustraliapty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Australia
Solian is distributed inNew Zealandby:
sanofi-aventisnew
zealandlimited
56 Cawley Street,
Ellerslie
Auckland
New Zealand
The Australian Registration numbers for Solian are
as follows:
Solian 100*: AUST R 96422
Solian 200*: AUST R 96425
Solian 400*: AUST R 74272
Solian Solution 100mg/mL: AUST R 94484
*Not marketed inNew Zealand
This leaflet was prepared in August 2017.
®Registered Trademark.
solian-ccdsv12-cmiv14-aug17
Published by MIMS November 2017
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