Amisulpride Aurobindo: detailed information

Package leaflet: Information for the user

Amisulpride Aurobindo 50 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amisulpride Aurobindo is and what it is used for
What you need to know before taking Amisulpride Aurobindo
How to take Amisulpride Aurobindo
Possible side effects
How to store Amisulpride Aurobindo
Contents of the pack and other information

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

Amisulpride Aurobindo contains a medicine called amisulpride. It belongs to a group of
medicines known as "antipsychotics". It is used in the treatment of a condition called
schizophrenia. Schizophrenia may cause you to perceive, see or hear things that do not exist (hallucinations),
have strange or fearful thoughts (delusions), change your behaviour, or make you feel withdrawn. Sometimes,
people experiencing these symptoms may feel tense, anxious, and become suspicious or
aggressive for no apparent reason (these are known as "positive symptoms") or may feel depressed and
withdrawn (these are known as "negative symptoms"). Amisulpride Aurobindo works by improving
disturbed thoughts, feelings, and behaviours. It is used to treat schizophrenia both at the onset and over the long term.

2. What you should know before taking Amisulpride Aurobindo

Do not take Amisulpride Aurobindo if

You are allergic to amisulpride or to any of the excipients of this medicine (listed in section 6). Signs of an allergic reaction include 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 (called phaeochromocytoma).
You are taking levodopa, a medicine used to treat Parkinson’s disease (see section “Other medicines and Amisulpride Aurobindo”).
You are taking medicines to treat heart rhythm disorders or medicines that may cause an abnormal heart rhythm when used together with amisulpride (see section “Other medicines and Amisulpride Aurobindo” below).
The patient is under 15 years of age.

Do not take this medicine if any of the conditions listed above 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, reduced consciousness or rigid muscles, which are symptoms of a serious, potentially fatal condition called “neuroleptic malignant syndrome”. Stop taking Amisulpride Aurobindo immediately and contact your doctor.
You have kidney problems;
You suffer from Parkinson’s disease;
You have had seizures (epileptic 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 long QT interval or a family history of long QT interval (this is a measure of how the heart functions 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 slow heart rate (less than 55 beats per minute);
You are taking other medicines that may affect heart function: check with your doctor before taking any other medicine. See also 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, as elderly people are more likely to experience low blood pressure or drowsiness. A small increase in deaths among elderly patients with dementia has been reported in patients taking antipsychotics compared to those not taking them;
You have a low white blood cell count (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 disorder called leucopenia;
You or someone in your family has a history of breast cancer, as amisulpride may affect the risk of developing breast cancer. Therefore, you should be closely monitored by a doctor during treatment with Amisulpride Aurobindo;
Amisulpride may increase prolactin levels. If very high prolactin levels in the blood or symptoms of a pituitary tumour (such as visual disturbances and headaches) occur, imaging of the pituitary gland will be performed. Once a diagnosis of pituitary tumour is confirmed, treatment with amisulpride will be discontinued (see section “Do not take Amisulpride Aurobindo”);
Serious liver problems have been reported with Amisulpride Aurobindo. Inform your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellowing of the eyes or skin.

If you are unsure whether any of these conditions apply to you, discuss them with 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 medicine. It is particularly important to inform your doctor if you are taking:
In particular, do not take this medicine and discuss it with your doctor if you are taking any of the
following medicines:

Levodopa, a medicine used 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 stomach problems).
Bepridil (used to treat angina/chest pain and heart rhythm disturbances).
Sultopride or thioridazine (for schizophrenia).
Methadone (for pain and drug addiction).
Halofantrine (to prevent malaria).
Pentamidine (to treat HIV infection).
Erythromycin by injection or sparfloxacin (antibiotics).
Medicines for fungal infections, such as clotrimazole.
Vincamine by 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.

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

Medicines used to treat high blood pressure and other heart problems, which may slow the heart rate. These include beta-blockers (such as nebivolol or bisoprolol), diltiazem, verapamil, clonidine, guanfacine, digoxin or medicines similar to digoxin.
Medicines that may lower potassium levels in the blood, including diuretics, some laxatives, amphotericin B (by injection), glucocorticoids (used for diseases such as asthma or rheumatoid arthritis) and tetracosactide (which may be used in diagnostic testing).
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 conditions.
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.
Analgesics such as tramadol and indometacin.
Anaesthetics.
Antihistamines that may cause drowsiness, such as promethazine.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or
pharmacist before taking Amisulpride Aurobindo.
Amisulpride Aurobindo with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think 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 age who do not
use effective contraception.
The following symptoms may occur in newborns whose mothers have taken Amisulpride
Aurobindo tablets during the third trimester (last three months of pregnancy): tremors, muscle stiffness
and/or muscle weakness, drowsiness, agitation, breathing difficulties and feeding problems.
If your baby develops any of these symptoms, you may need to contact your doctor.
Breastfeeding
You must not breastfeed during treatment 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
You may experience blurred vision, feel less alert, drowsy or sleepy while taking this
medicine. If this happens, you must not drive or operate tools or machinery.
Amisulpride Aurobindo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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 exactly as prescribed by your doctor. If you have any doubts, consult 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 may take them 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; instead, consult your doctor.

Recommended dose
The amount of Amisulpride Aurobindo you should take depends on your condition. Always follow your doctor's instructions carefully.

Adults

The usual dose ranges from 50 mg to 800 mg daily. If you have "positive" symptoms, the recommended dose is between 400 mg and 800 mg per day, adjusted by your doctor according to the nature and severity of your illness and your renal function. If you have both positive and negative symptoms, your doctor will adjust the dose to ensure adequate control of positive symptoms. For maintenance treatment, your doctor will use the lowest possible dose that remains effective for you. If you mainly have negative symptoms, the recommended dose is between 50 mg and 300 mg per day, adjusted by your doctor based on the nature and severity of your illness and renal function.
Your doctor may start you on a lower dose if necessary.
If needed, your doctor may prescribe up to 1200 mg per day.
Doses up to 300 mg per day may be taken as a single dose. Take your dose at the same time each day.
Doses exceeding 300 mg should be divided, with half taken in the morning and half in the evening.

Elderly patients over 65 years

Your doctor should monitor you closely, as Amisulpride Aurobindo may cause sedation (drowsiness) or a drop in blood pressure. It is generally not recommended in this age group due to limited experience.

Patients with renal impairment

Your doctor may need to give you a lower dose. This could be half or one-third of the usual daily dose, depending on how well 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 in adolescents aged 15 to 18 years should be initiated and supervised by a specialist experienced in treating schizophrenia in this age group.
Children and adolescents under 15 years of age must not take this medicine (see section 2, “Do not take Amisulpride Aurobindo”).

If you take more Amisulpride Aurobindo than you should
If you take more tablets than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine pack with you so that the doctor knows what you have taken. The following effects may occur: restlessness or tremor, muscle stiffness, drowsiness or sedation 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 your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten one.

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

malaise/feeling unwell, 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 gradually reduce the dose according to your doctor’s instructions.

Blood tests
Taking Amisulpride Aurobindo may affect the results of certain blood tests. These include tests measuring the hormone called "prolactin" and liver function tests. If you are due to have a blood test, it is important that you inform your doctor that you are taking Amisulpride Aurobindo.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Amisulpride Aurobindo and see a doctor or go to hospital immediately if:

you have a high body temperature, sweating, muscle stiffness, rapid heartbeat, shortness of breath, and feel confused, drowsy, or agitated. These may be symptoms of a serious but rare side effect called "Neuroleptic Malignant Syndrome", which is a potentially life-threatening condition;
you have an unusual heartbeat, very fast heartbeat, or chest pain that could lead to a heart attack or life-threatening heart problems;
you develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, seek immediate medical help.

Uncommon: may affect up to 1 in 100 people

You have an allergic reaction. Signs may include: skin rash with lumps and itching, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
You have seizures (epileptic fits).
You get more infections than usual. This may be due to a decrease in 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 disorder 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, muscle stiffness or spasms, slowness of movement, increased salivation, feeling restless.

Common: may affect up to 1 in 10 people

Uncontrolled movements, especially of the arms and legs. (These symptoms may be reduced if your doctor reduces your dose of Amisulpride Aurobindo or prescribes another medicine.)

Uncommon: may affect up to 1 in 100 people

Uncontrolled movements, especially of the face and tongue.

Other side effects include:
Common: may affect up to 1 in 10 people

Difficulty sleeping (insomnia) or feeling anxious or restless.
Drowsiness.
Constipation, feeling unwell, nausea, dry mouth, indigestion.
Weight gain.
Increased blood levels of prolactin (a protein), which may be detected in a laboratory test and may cause: breast tenderness or enlargement, unusual milk production from the breasts (which can occur in both women and men);
Menstrual problems such as absence of menstruation.
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

Slowed heart rate.
High blood sugar levels (hyperglycaemia).
Increased blood pressure.
Difficulty urinating.
Increased liver enzymes, which may be seen in blood tests.
Confusion.
Nasal congestion.
Osteopenia (low bone mineral density).
Osteoporosis. This is when your bones are more likely to break.
Liver tissue damage.
Develop 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 sodium levels in the blood).
Feeling unwell, confused, or weak, feeling sick (nausea), loss of appetite, feeling irritable. These could be signs of a condition called Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).
Benign (non-cancerous) pituitary tumour such as prolactinoma.

Not known: frequency cannot be estimated from the available data

Withdrawal syndrome may occur in newborns whose mothers have used Amisulpride Aurobindo during pregnancy.
Restless legs syndrome (uncomfortable sensation in the legs temporarily relieved by movement).
Increased sensitivity of the skin to sunlight and ultraviolet rays.
Falls due to impaired body balance, which sometimes lead to fractures.
Rhabdomyolysis (muscle breakdown associated with muscle pain).
Elevated levels of creatine phosphokinase (a blood test indicating muscle damage).
Low-intensity chills, low-intensity breathing difficulties (dyspnoea), and muscle pain have also been observed.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Amisulpride Aurobindo contains

The active substance is amisulpride. Each tablet contains 50 mg of amisulpride.
The other components are: For 50 mg: Monohydrate lactose, methyl cellulose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Description of the appearance of Amisulpride Aurobindo and the 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 transparent PVC – aluminium and transparent PVC/PVdC – aluminium blister packs.
Blister pack sizes:
12, 20, 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Italy: Amisulpride Aurobindo
Portugal: Amissulprida Aurovitas