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SOLIAN (AMISULPRIDE): MEDICATION GUIDE

This leaflet provides answers to some common questions about Solian (Amisulpride) tablets and oral solution. 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 Solian, ask your doctor, pharmacist, or other healthcare professional.

Keep this leaflet with Amisulpride (Solian). You may need to read it again.


What Solian (Amisulpride) tablets and oral solution are used for?

Solian contains the active ingredient Amisulpride.

Solian belongs to a group of medicines called antipsychotics. Solian (Amisulpride) oral solution and tablets are 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), unusual suspiciousness, delusions, emotional and social withdrawal. People with schizophrenia may also feel depressed, anxious or tense.

Your physician may have prescribed Solian for another reason.

Ask your healthcare provider if you have any questions about why Solian has been prescribed for you.


Before taking Solian (Amisulpride)

When you must not take this medication

Do not take Amisulpride (Solian) tablets and oral solution 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 disopyramide, quinidine, amiodarone and sotalol
    - cisapride
    - antibiotics such as pentamidine and erythromycin, given as an injection into the veins
    - levodopa, a medicine used in Parkinson's disease
    - thioridazone, an antipsychotic medicine
    - methadone, medication 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 Amisulpride (Solian) oral solution and tablets if you have or have had any of the following medical conditions:

  • phaeochromocytoma, a rare tumour of the adrenal glands which sit near the kidneys
  • tumour of the pituitary gland, a small gland at the base of the brain
  • breast cancer
  • liver disease

    Solian must not be taken by children up to the age of puberty. There is limited information on the use of Amisulpride (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 this drug is right for you.


    Before you start to take Amisulpride (Solian)

    Your healthcare professional must know about all the following before you start to take Solian.

    Tell your doctor if:

  • you are pregnant or intend to become pregnant. Solian (Amisulpride) tablets and oral solution are 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 this medicine during pregnancy need to be carefully monitored.
  • you have had an allergic reaction to any medicine which you have taken previously to treat your current condition.
  • you suffer from lactose intolerance because Solian tablets contain lactose.
  • you have problems with the heart and blood vessels.
  • you have kidney or liver disease, Parkinson's disease or fits (seizures).
  • you have, or have a history of blood clots.
  • you suffer from dementia.
  • 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 (Amisulpride) oral solution and tablets.
  • 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 a history, or family history, of breast cancer.
  • you have risk factors for stroke.

    Taking other medicines

    Tell your doctor, pharmacist, or other healthcare professional if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

    Some medications and Solian may interfere with each other. These include:

  • drugs used to treat irregular heart rhythm such as quinidine, amiodarone, disopyramide and sotalol
  • other medicines used to treat heart problems such as verapamil, diltiazem, clonidine, digoxin and drugs known as beta blockers (e.g. propranolol)
  • amphotericin B intravenous, an anti-fungal given by injection into the veins
  • other antipsychotics such as chlorpromazine, thioridazine, trifluperazine, haloperidol, pimozide, imipramine and lithium preparations
  • stimulant laxatives
  • diuretics
  • diagnostics drugs such as tetracosactides
  • glucocorticosteroids
  • medicines taken for depression
  • medications taken for anxiety or to help you sleep
  • some strong analgetics, pain killers
  • some medications taken to control blood pressure
  • antihistamines, medicines to treat allergies, which cause drowsiness

    If you are unsure about any medicine you are taking, you should check with your physician or pharmacist. They will have more information on medicines to be careful of while you are taking Solian.


    How to take Solian (Amisulpride)?

    How much to take

    Your healthcare provider will tell you how many Amisulpride tablets you should take, or the amount of Solian oral solution you should take. The dosage is adjusted for each individual and can range from 50 mg a day up to 800 mg a day. In some cases your doctor may increase the dose to 1200 mg a day.

    When taking Solian solution, the dosage syringe supplied should be used to measure the correct dose. Each 1 ml marking is equal to 100 mg.

    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 healthcare professional. Your doctor may increase or decrease your dose depending on your condition.

    Do not take more than the dose your healthcare provider has recommended.

    How to take Amisulpride (Solian) tablets and oral solution

    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 Amisulpride (Solian) oral solution and tablets

    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 this medication

    It is important that you do not stop taking Amisulpride (Solian) tablets and oral solution unless your doctor tells you. Do not stop taking this drug just because you feel better. It is very important to continue Solian because it will help you stay well.

    If you forget to take this medicine

    If you forget to take Amisulpride (Solian) oral solution and tablets, 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, pharmacist, other healthcare professional or a poisons information centre, 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 physician your pack of tablets or bottle. Do this even if there are no signs of discomfort or poisoning.

    If you have taken too much Amisulpride (Solian), the most common signs are drowsiness and slurred speech.


    While you are using Solian (Amisulpride) tablets and oral solution

    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 this medication.

    While you are taking Solian, tell your healthcare provider before you start any new medicine.

    Tell your healthcare professional 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 suicide
  • thoughts or talk of self-harm or harm to others
  • any recent attempts of self-harm
  • increase in aggressive behaviour, irritability or agitation
  • depressed 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 (Amisulpride) oral solution and tablets 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 Amisulpride. 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 (Amisulpride) affects you.

    Do not give this drug to anyone else.

    Your physician has prescribed it for you and your condition.


    Side Effects

    Tell your doctor, pharmacist, or other healthcare professional as soon as possible if you do not feel well while you are taking Amisulpride (Solian) tablets and oral solution.

    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 healthcare provider if you notice any of the following and they worry you:

  • weight gain
  • drowsiness
  • dizziness
  • nausea
  • increased appetite
  • vomiting
  • dry mouth
  • constipation
  • insomnia
  • agitation
  • anxiety
  • problems with orgasm

    These are the most common side effects of Amisulpride (Solian) oral solution and tablets.

    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 healthcare provider 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 healthcare professional immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • abnormal movements mainly of the face or tongue
  • muscle twitching
  • fever
  • faster breathing
  • unexplained infections
  • sweating
  • muscle stiffness

    If this occurs, stop taking Amisulpride (Solian) immediately and contact your doctor. After prolonged use in women, medicines of this type can cause:

  • breast pain
  • milk secretion
  • an absence of their monthly period
  • changes in the regularity of their periods

    Tell your doctor or pharmacist 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, pharmacist, or other healthcare professional 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 Solian (Amisulpride) tablets and oral solution

    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 oral solution should be stored in a cool, dry place where the temperature stays below 25°C.

    Do not store Solian (Amisulpride) oral solution and tablets 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 medication should not be taken after this date.

    Disposal

    If your physician tells you to stop taking Solian (Amisulpride) or the tablets or solution have passed their expiry date, ask your pharmacist what to do with the amount left over.


    Product description

    What Amisulpride (Solian) tablets and oral solution 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 60 ml 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 - 100 mg amisulpride per ml.

    Inactive Ingredients

    The tablets also contain:

  • microcrystalline cellulose (E 460)
  • sodium starch glycollate type A
  • lactose
  • magnesium stearate (E 470)
  • hypromellose (E 464)

    The 400 mg tablets also contain:

  • polyoxyl 40 stearate
  • titanium dioxide (E 171).

    The oral liquid also contains:

  • Gesweet
  • Methyl hydroxybenzoate
  • Hydrochloric acid (E 507)
  • Propyl hydroxybenzoate
  • Caramel Flavour
  • Potassium sorbate (E 202)
  • Water purified

    Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.

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