The name of your medicine is APO-Amisulpride. It contains the active ingredient amisulpride. It is used to treat:
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Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
This medicine must not be taken by children up to the age of puberty. There is limited information on the use of amisulpride in adolescents, therefore the use of amisulpride from puberty to the age of 18 years is not recommended.
Do not take this medicine if:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had kidney or liver disease, Parkinson's disease or fits (seizures).
3. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
4. You suffer from lactose intolerance because APO-Amisulpride tablets contain lactose.
5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment.
7. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
8. You have problems with the heart and blood vessels.
9. You have, or have a history of blood clots.
10. You have hyperglycaemia (high sugar levels in the blood). Your doctor may recommend monitoring your blood sugar levels while you are taking amisulpride tablets.
11. You suffer from dementia.
Some medicines may be affected by amisulpride or may affect how well it works. These include:
If you are taking any of these medicines you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with amisulpride.
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
The tablets should be swallowed whole with a glass of water.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
Doses should be taken preferably before meals.
Continue taking your medicine for as long as your doctor tells you. It is important that you do NOT stop taking this medicine unless your doctor tells you. Do not stop taking this medicine just because you feel better.
Make sure you have enough to last over weekends and holidays.
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Tell your doctor that you are taking this medicine if:
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause drowsiness in some people.
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 this medicine. It is NOT recommended that you drink alcohol while taking this medicine.
Be careful while taking antihistamines, sleeping tablets or tablets to relieve pain while taking this medicine.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking amisulpride or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not. Some of the side effects are dose related, so it is important that you do not take more than the prescribed dose.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
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 this medicine for a few days.
Sometimes trembling, noticeable muscle stiffness or spasm, slowness of movement, excess saliva, restless, 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 this medicine is lowered by your doctor or if your doctor prescribes you an additional medicine.
After prolonged use in women, medicine of this type can cause:
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.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to Amisulpride, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine 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.
If your doctor or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.
Amisulpride 50 mg tablets - white to off-white 6.0mm, round, bi-convex tablets with breakline on one side.
Amisulpride 100 mg tablets - white to off-white 8.0mm, round, flat tablets with breakline on one side.
Amisulpride 200 mg tablets - white to off-white 11.0mm, round, flat tablets with breakline on one side.
Amisulpride 400 mg tablets - white to off-white, 18 x 8mm capsule shaped, film-coated tablets with breakline on one side.
Each tablet contains 50, 100, 200 or 400 mg of amisulpride as the active ingredient.
It also contains the following inactive ingredients:
The 400 mg tablets only also contain:
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Amisulpride 50 mg tablet (blister pack of 60, 90,100): AUST R 178900.
APO-Amisulpride 100 mg tablet (blister pack of 30, 50, 60, 90, 100): AUST R 178904.
APO-Amisulpride 200 mg tablet (blister pack of 50, 60, 90, 100): AUST R 178902.
APO-Amisulpride 400 mg tablet (blister pack of 10 (sample), 50, 60,90, 100): AUST R 178898.
Not all strengths, pack types and/or pack sizes may be available.