AMISULPRIDE 50 mg Tablet

Зміст інструкції

1. Amisulpride Aurobindo 50 mg tablets
   1. What is Amisulpride Aurobindo and what it is used for
   2. What you need to know before taking Amisulpride Aurobindo
   3. How to take Amisulpride Aurobindo
   4. Possible side effects
   5. How to store Amisulpride Aurobindo
   6. Contents of the pack and other information

Amisulpride Aurobindo 50 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Amisulpride Aurobindo is and what it is used for
• 2. What you need to know before you take Amisulpride Aurobindo
• 3. How to take Amisulpride Aurobindo
• 4. Possible side effects
• 5. How to store Amisulpride Aurobindo
• 6. Contents of the pack and other information

1. What is Amisulpride Aurobindo and what it is used for

Amisulpride Aurobindo contains a medicine called amisulpride. It belongs to a group of
medicines called “antipsychotics”. It is used in the treatment of a disease called
schizophrenia. Schizophrenia can cause you to perceive, see or hear things that do not exist (hallucinations),
have strange and fearful thoughts (delusions), change your behavior or make you feel alone. Sometimes
people who experience these symptoms may feel tense, anxious, and become suspicious or
aggressive for no apparent reason (these are so-called “positive symptoms”) or become depressed and
isolate themselves (these are so-called “negative symptoms”). Amisulpride Aurobindo works by improving
disturbed thoughts, feelings and behaviors. It is used to treat schizophrenia at the beginning and
also in the long term.

2. What you need to know before taking Amisulpride Aurobindo

Do not take Amisulpride Aurobindo if

• You are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• You are pregnant, suspect you may be pregnant or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• You have breast cancer or a tumour known as “prolactin-dependent”.
• You have a pituitary tumour.
• You have a tumour of the adrenal glands (known as a phaeochromocytoma).
• You are taking levodopa, a medicine to treat Parkinson’s disease (see section “Other medicines and Amisulpride Aurobindo”).
• You are taking medicines to treat heart rhythm disorders or medicines that can cause an abnormal heart rhythm if used at the same time as amisulpride (see below section “Other medicines and Amisulpride Aurobindo”).
• The patient is under 15 years of age.

Do not take this medicine if any of the above conditions apply to you. If you have
any doubts, ask your doctor or pharmacist before taking Amisulpride Aurobindo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amisulpride Aurobindo.

Consult your doctor or pharmacist before taking this medicine if:

• you develop fever, rapid breathing, excessive sweating, loss of consciousness orrigid muscleswhich are symptoms of a serious – potentially fatal – condition called “neuroleptic malignant syndrome”. Stop taking Amisulpride Aurobindo immediately and contact your doctor.
• you have problems with your kidneys;
• you suffer from Parkinson’s disease;
• you have had convulsions (fits);
• you have an unusual heart rate (rhythm);
• you have heart disease or a family history of heart problems or sudden death;
• you have a prolonged QT interval or a family history of prolonged QT interval (this is a measure of how your heart works and can be identified by a doctor using an electrocardiogram);
• you have had a stroke or your doctor has told you that you are at risk of stroke;
• you or someone in your family has a history of blood clots, because medicines similar to this one have been associated with blood clot formation;
• you have diabetes or have been told that you are at increased risk of developing diabetes;
• you have a low heart rate (less than 55 beats per minute);
• you are taking other medicines that can affect heart function: check with your doctor before taking any other medicine. See also the section “Do not take Amisulpride Aurobindo” and “Other medicines and Amisulpride Aurobindo”;
• you have been found to have low levels of potassium or magnesium in your blood;
• you are elderly, because elderly people are more likely to have a drop in blood pressure or become drowsy. A small increase in deaths of elderly people with dementia has been reported in patients taking antipsychotics compared to those not taking them;
• you have a low number of white blood cells (agranulocytosis). This means you may develop infections more easily than usual;
• you have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia;
• you or someone in your family has a history of breast cancer, as amisulpride can affect the risk of developing breast cancer. Therefore, you should be under strict medical supervision during treatment with Amisulpride Aurobindo;
• amisulpride can increase prolactin levels. If you find very high levels of prolactin in your blood or symptoms of a pituitary tumour (such as visual disturbances and headaches), imaging of the pituitary gland will be performed. Once a diagnosis of pituitary tumour is confirmed, treatment with amisulpride will be stopped (see section “Do not take Amisulpride Aurobindo”);
• serious liver problems have been reported with Amisulpride Aurobindo. Tell your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellowing of the eyes or skin.

If you are not sure whether any of these conditions apply to you, talk to your doctor or pharmacist
before taking Amisulpride Aurobindo.

Other medicines and Amisulpride Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. It is particularly important to inform your doctor that you are taking:

In particular, do not take this medicine and talk to your doctor if you are taking any of the
following medicines:

• Levodopa, a medicine to treat Parkinson’s disease.
• Medicines called “dopamine agonists” such as ropinirole and bromocriptine.
• Medicines to treat heart rhythm problems (such as quinidine, disopyramide, amiodarone, sotalol).
• Cisapride (used to treat problems with the stomach).
• Bepridil (used to treat angina/chest pain and heart rhythm disturbances).
• Sultopride or thioridazine (for schizophrenia).
• Methadone (for pain and drug abuse).
• Alofantrine (to prevent malaria).
• Pentamidine (to treat patients with HIV infection).
• Erythromycin for injection or sparfloxacin (antibiotics).
• Medicines for fungal infections, such as clotrimazole.
• Vincamine for injection (used for various brain disorders).
• Clozapine used to treat schizophrenia.
• Sucralfate used to treat stomach ulcers, intestinal ulcers and inflammation of the stomach lining.
• Antacids used to treat stomach acidity.

Tell your doctor if you are taking any of the following medicines:

• Medicines used to treat high blood pressure and other heart problems, which can slow down the heart rate. These include beta-blockers (such as nebivolol or bisoprolol, diltiazem, verapamil, clonidine, guanfacine, digoxin or medicines similar to digoxin.
• Medicines that can lower the level of potassium in your blood, including diuretics, some laxatives, amphotericin B (for injection), glucocorticoids (used for conditions such as asthma or rheumatoid arthritis) and tetracosactide (can be used in diagnostic research).
• Medicines used to treat schizophrenia, such as pimozide and haloperidol.
• Imipramine or lithium (used to treat depression).
• Some antihistamines such as astemizole and terfenadine (for allergies).
• Other antipsychotic medicines, used for mental health problems.
• Medicines to treat severe pain, called opioids such as morphine and pethidine.
• Clonidine, used for migraines, hot flushes or high blood pressure.
• Mefloquine, used to treat malaria.
• Medicines that promote sleep, such as barbiturates and benzodiazepines.
• Painkillers such as tramadol and indometacin.
• Anaesthetics.
• Antihistamines that can cause drowsiness, such as promethazine.

If you are not sure whether any of the above conditions apply to you, talk to your doctor or
pharmacist before taking Amisulpride Aurobindo.

Amisulpride Aurobindo with food, drinks and alcohol

• Swallow Amisulpride Aurobindo tablets with plenty of water before a meal.
• Do not drink alcohol while taking Amisulpride Aurobindo, as Amisulpride Aurobindo can increase the effects of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Amisulpride Aurobindo is not recommended during pregnancy and in women of childbearing potential who are not
using effective contraceptive measures.
The following symptoms may occur in newborns from mothers who have used Amisulpride
Aurobindo tablets during the last trimester (last three months of pregnancy): tremors, muscle rigidity
and/or muscle weakness, drowsiness, agitation, breathing problems and feeding disorders.
If your baby develops any of these symptoms, you may need to contact your doctor.

Breastfeeding
You should not breastfeed during therapy with Amisulpride Aurobindo. Talk to your doctor about the
best way to feed your baby if you are taking Amisulpride Aurobindo.

Fertility
A decrease in fertility has been observed.

Driving and using machines
Your vision may become blurred, you may feel less alert, dizzy or sleepy while taking this
medicine. If this happens, do not drive or use tools or machines.

Amisulpride Aurobindo contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking
this medicine.

Amisulpride Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

3. How to take Amisulpride Aurobindo

Take this medicine always exactly as your doctor has told you. If you have any doubts ask your doctor or pharmacist.

How to take Amisulpride Aurobindo

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water. Do not chew the tablets.
• You can take it during or between meals.
• If you feel that the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

Recommended dose
The amount of Amisulpride Aurobindo you have to take will depend on your illness. Follow
carefully your doctor’s instructions.

Adults

• The usual dose is between 50 mg and 800 mg per day. If you suffer from “positive” symptoms the recommended dose is between 400 mg and 800 mg per day and will be adjusted by your doctor according to the nature and severity of the illness and kidney function. If you suffer from both positive and negative symptoms, your doctor will adjust the dose so that there is adequate control of the positive symptoms. For maintenance treatment your doctor will use the lowest possible dose that will be effective for you. If you suffer from predominantly negative symptoms, the recommended dose is between 50 mg and 300 mg per day and will be adjusted by your doctor according to the nature and severity of the illness and kidney function.
• Your doctor may start you on a lower dose if necessary.
• If necessary your doctor may prescribe up to 1200 mg per day.
• Doses up to 300 mg per day can be taken as a single dose. Take the dose every day at the same time.
• Doses over 300 mg must be taken half in the morning and half in the evening.

Elderly patients over 65 years

• Your doctor will need to monitor you carefully because Amisulpride Aurobindo can cause sedation (drowsiness) or a decrease in blood pressure and is generally not recommended because experience is limited in this age group. People with kidney problems
• Your doctor may need to give you a lower dose. This may be half or one third of the usual daily dose, depending on how your kidneys are functioning.

Children under 18 years of age
The efficacy and safety of Amisulpride Aurobindo in children and adolescents under 18 years of age have not
been established. If absolutely necessary, treatment of adolescents from 15 to 18 years of age
must be started and conducted by a doctor specialized in the treatment of schizophrenia in this
age group.
Children and adolescents under the age of 15 should not take this medicine (see paragraph 2 “Do not take Amisulpride Aurobindo”).

If you take more Amisulpride Aurobindo than you should
If you take more tablets than you should, inform your doctor immediately or go to the emergency room
of the nearest hospital. Bring the package of the medicine with you, so that the doctor knows
what you have taken. The following effects may occur: feeling of restlessness or tremor,
muscle stiffness, feeling of numbness or drowsiness that could lead to loss of
consciousness.

If you forget to take Amisulpride Aurobindo
If you forget a dose, take it as soon as you remember. However, if it is almost time for the next dose,
skip the forgotten dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amisulpride Aurobindo
Continue to take Amisulpride Aurobindo until your doctor tells you to stop. Do not stop
taking Amisulpride Aurobindo just because you feel better. If you stop, your illness may
worsen or return to its original state. Unless your doctor tells you otherwise, Amisulpride
Aurobindo should not be stopped abruptly.
Abrupt discontinuation of treatment can cause withdrawal symptoms such as:

• feeling unwell/sick, nausea or vomiting;
• sweating;
• difficulty sleeping or extreme restlessness;
• muscle stiffness or abnormal body movements;
• your condition may return to its original state.

To avoid these effects it is important to reduce the dose gradually according to your doctor’s instructions.

Blood tests
Taking Amisulpride Aurobindo may affect the results of some blood tests. These
include tests to measure a hormone called “prolactin” and liver tests. If you have to
undergo a blood test, it is important that you inform your doctor that you are taking Amisulpride
Aurobindo.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Amisulpride Aurobindo and see a doctor or go immediately to hospital if:

• you have a high temperature, sweating, muscle stiffness, fast heartbeat, fast breathing and feeling confused, drowsy or agitated. These can be symptoms of a rare but serious side effect called “Neuroleptic Malignant Syndrome”, which is a potentially life-threatening complication;
• you have an unusual heartbeat, very fast heartbeat or chest pain which can result in a heart attack or life-threatening heart problems;
• you have blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms seek medical attention immediately.

Uncommon: may affect up to 1 in 100 people

• You have an allergic reaction. Signs can include: skin rash with bumps and itching, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• You have convulsions (fits).
• You get more infections than usual. This may be due to a decrease in the number of white blood cells (neutropenia).
• You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called “leucopenia”.

Rare: may affect up to 1 in 1,000 people

• You get more infections than usual. This may be due to a blood disorder (agranulocytosis).

Tell your doctor immediately if you experience any of the following side effects:

Very common: may affect more than 1 in 10 people

• Tremor, stiffness or spasms of the muscles, slowness of movement, increased salivation, feeling restless.

Common: may affect up to 1 in 10 people

• Uncontrollable movements, especially of the arms and legs. (these symptoms may be reduced if your doctor lowers the dose of Amisulpride Aurobindo or prescribes you another medicine).

Uncommon: may affect up to 1 in 100 people

• Uncontrollable movements, especially of the face and tongue.

Other side effects include:

Common: may affect up to 1 in 10 people

• Difficulty falling asleep (insomnia) or feeling anxious or agitated.
• Feeling sleepy.
• Constipation, feeling unwell or sick, vomiting, dry mouth, indigestion.
• Weight gain.
• Increased levels of prolactin in the blood (a protein), which can be shown in a laboratory test and may cause: pain or enlargement of the breasts, unusual milk production from the breasts (which can occur in both women and men);
• Menstrual problems such as absence of periods.
• Sexual problems such as difficulty reaching orgasm, or difficulty achieving and maintaining an erection.
• Unusual growth of the pituitary gland.
• Dizziness (due to low blood pressure).
• Blurred vision.

Uncommon: may affect up to 1 in 100 people

• Slowing of the heartbeat.
• High blood sugar levels (hyperglycaemia).
• Increased blood pressure.
• Difficulty urinating.
• Increased liver enzymes, which can be observed in blood tests.
• Confusion.
• Nasal congestion.
• Osteopenia (low bone mineral density).
• Osteoporosis. This is when your bones are more likely to break.
• Damage to the liver tissue.
• Develops a lung infection after inhaling food, liquids, saliva or nasal secretions (“aspiration pneumonia” ab ingestis).
• Nutritional disorders such as hypertriglyceridaemia (high levels of triglycerides in the blood) and hypercholesterolaemia (high levels of cholesterol in the blood).

Rare: may affect up to 1 in 1,000 people

• Hives.
• Swelling under the skin (angioedema).
• Hyponatraemia (low levels of sodium in the blood).
• Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. These may be signs of a condition called inappropriate antidiuretic hormone secretion syndrome (SIADH).
• Benign (non-cancerous) pituitary tumour such as a prolactinoma.

Frequency not known: cannot be estimated from available data

• Withdrawal syndrome can occur in newborns whose mothers used Amisulpride Aurobindo during pregnancy.
• Restless legs syndrome (an uncomfortable sensation in the legs temporarily relieved by movement and symptoms).
• Increased sensitivity of the skin to the sun and ultraviolet rays.
• Falls due to reduced body balance, sometimes leading to fractures.
• Rhabdomyolysis (breakdown of muscle tissue associated with muscle pain).
• Elevated levels of creatine phosphokinase (blood test indicating muscle damage).
• Mild chills, mild shortness of breath (dyspnoea) and muscle pain have also been observed.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Amisulpride Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amisulpride Aurobindo contains

• The active ingredient is amisulpride. Each tablet contains 50 mg of amisulpride.
• The other ingredients are: For 50 mg:Lactose monohydrate, methyl cellulose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Description of the appearance of Amisulpride Aurobindo and contents of the pack
Tablets.

Amisulpride Aurobindo 50 mg tablets
Tablets from white to almost white, round (diameter 6.5 mm), uncoated with a score line
on one side and imprinted with “L 73” on the other side. The tablet can be divided into two equal doses.
Amisulpride Aurobindo is available in blister packs made of transparent PVC – aluminium and
transparent PVC/PVdC – aluminium.
Blister packs:
12, 20, 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Amisulpride Aurobindo
Portugal: Amissulprida Aurovitas