Active ingredient
- amisulpride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0012.
Amisulpride 50mg, 100mg, 200mg & 400mg Tablets
PATIENT INFORMATION LEAFLET
AMISULPRIDE 50MG, 100MG, 200MG AND 400MG TABLETS
Read all of this leaflet carefully before you start taking this medicine
In this leaflet:
1. What amisulpride is and what it is used for
2. Before you take amisulpride
3. How to take amisulpride
4. Possible side effects
5. How to store amisulpride
6. Further information
1. What amisulpride is and what it is used for
The name of your medicine is Amisulpride 50mg, 100mg, 200mg or 400mg Tablets (called amisulpride throughout this leaflet). This belongs to a group of medicines ‘antipsychotics’.
It is used to treat schizophrenia.
How Amisulpride works
Schizophrenia can make you feel, see or hear things which do not exist, have strange and frightening thoughts, change how you act, and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed. Amisulpride works by improving disturbed thoughts, feelings and behaviour.
2. Before you take amisulpride
Do not take amisulpride and tell your doctor if:
Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking amisulpride.
Warnings and precautions
Severe liver problems have been reported with amisulpride.
Talk to your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellow discolouration of the eyes or skin.
Take special care and check with your doctor before taking amisulpride if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amisulpride.
Taking amisulpride with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because amisulpride can affect the way some other medicines work. Also some medicines can affect the way amisulpride works.
Do not take this medicine, and tell your doctor, if you are taking:
Tell your doctor if you are taking any of the following:
Taking amisulpride with food and drink
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Amisulpride is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
If you use amisulpride during the last three months of pregnancy, your baby may suffer from agitation, increased muscle tension, involuntary trembling of the body, sleepiness, breathing problems or difficulty in feeding. Talk to your doctor, if your baby develops any of these symptoms.
Breast-feeding
You should not breast-feed during therapy with amisulpride. Talk to your doctor about the best way to feed your baby if you are taking amisulpride.
Driving and using machines
You may feel less alert, drowsy or sleepy and have blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of amisulpride
3. How to take amisulpride
Always take amisulpride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
How much to take:
Adults and children
Children
This medicine is not recommended in people under 18 years old.
If you take more amisulpride than you should
If you take more tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling restless or shaky, rigid muscles, feeling drowsy or sleepy which could lead to a loss of consciousness.
If you forget to take amisulpride
If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. However, do not take a double dose to make up for a forgotten tablet.
If you stop taking amisulpride
Keep taking amisulpride until your doctor tells you to stop. Do not stop taking your medicine just because you feel better as your illness may get worse or come back. Unless your doctor tells you otherwise, amisulpride should not be stopped suddenly as this may cause withdrawal effects such as muscle stiffness or unusual body movements.
Blood Tests
Taking amisulpride may affect the results of some blood tests. These include tests to measure the hormone called ‘prolactin’ and liver tests. If you are going to have a blood test, it is important to tell your doctor you are taking amisulpride.
If you have any further questions about this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, amisulpride can cause side effects, although not everybody gets them.
Stop taking amisulpride and see a doctor or go to a hospital straight away if:
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Tell your doctor as soon as possible if you have any of the following side effects:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Other side effects include:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Not known (frequency cannot be estimated from available data)
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store amisulpride
6. Further information
What Amisulpride 50mg, 100mg, 200mg or 400mg Tablets contain
Each tablet contains 50mg, 100mg, 200mg or 400mg of amisulpride as the active substance.
The other ingredients are, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hypromellose and magnesium stearate. The 400mg tablet also contains macrogol ester and titanium dioxide (E171).
What amisulpride looks like and contents of the pack
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder is:
Manufacturer is:
This leaflet was last revised in: October 2019.
‘Zentiva’ is a registered trademark © 2019 Zentiva.
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