Package Leaflet: Information for the User

Amisulpride Aurovitas 200 mg Tablets EFG

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

• Keep this leaflet, as 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAmisulpride Aurovitasand what it is used for

2. What you need to know before you start takingAmisulpride Aurovitas

3. How to takeAmisulpride Aurovitas

4. Possible side effects

5. Storage ofAmisulpride Aurovitas

6. Contents of the pack and additional information

Amisulprida Aurovitas contains an active ingredient called amisulpride. It belongs to a group of medicines known as antipsychotics.

It is used to treat a condition called schizophrenia, which may cause you to see, hear or feel things that do not exist (hallucinations), have strange and frightening thoughts (delusions), change your behavior and make you feel lonely. Sometimes, people with these symptoms may also feel tense, anxious, become suspicious or aggressive without apparent reason (known as 'positive symptoms'), or become depressed and withdrawn (known as 'negative symptoms').

Amisulprida works by improving these altered thoughts, feelings and behaviors. It is used to treat schizophrenia in its early stages and also over the long term.

Do not take Amisulprida Aurovitas:

• If you are allergic to amisulpride or any of the other components of this medication (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, throat, and tongue.
• If you are pregnant, may become pregnant, or are breastfeeding (see section ‘Pregnancy, breastfeeding and fertility’).
• If you have breast cancer or any prolactin-dependent tumor.
• If you have a pituitary tumor.
• If you have a tumor in the adrenal gland (called pheochromocytoma).
• If you are being treated with levodopa, a medication used to treat Parkinson's disease (see below the section ‘Other medications and Amisulprida Aurovitas’).
• If you are taking medications to treat heart rhythm disorders, or medications that may cause abnormal heart rhythm when used with amisulpride (see below the section ‘Other medications and Amisulprida Aurovitas’).
• If the patient is under 15 years old.

Do not take this medication if you are affected by any of the above points. If you are unsure, speak with your doctor or pharmacist before taking Amisulprida Aurovitas.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amisulprida Aurovitas.

Speak with your doctor or pharmacist before taking this medication if:

• You havefever, rapid breathing, excessive sweating, decreased consciousness or muscle rigidity, which are symptoms of a severe, potentially life-threatening condition called “neuroleptic malignant syndrome”.Stop taking amisulpride immediately and contact your doctor.
• You have kidney problems.
• You have Parkinson's disease.
• You have had seizures (epileptic attacks).
• You have an abnormal heart rhythm.
• You have a heart condition or a family history of heart problems or sudden death.
• You have a prolonged QT interval or a family history of this condition (this is a measure to see how your heart works and a doctor may detect it using an electrocardiogram).
• You have had a previous stroke or your doctor has indicated that you are at risk of having one.
• If you or someone in your family has a history of blood clots, as this medication has been associated with the formation of blood clots.
• If you are diabetic or have been told that you are at risk of developing diabetes.
• If you have a slow heart rate (less than 55 beats per minute).
• If you are taking other medications that may affect how your heart works: consult your doctor before taking any medication. See also the sections ‘Do not take Amisulprida Aurovitas’ and ‘Other medications and Amisulprida Aurovitas’.
• If you have been told that you have low levels of potassium or magnesium in your blood.
• If you are an elderly person. This is because these people are more prone to having low blood pressure or feeling drowsy. There have been reports of a slight increase in deaths in elderly people with dementia taking antipsychotics compared to those who do not take them.
• You have a low number of blood cells (agranulocytosis). This means that you may catch infections more easily than usual.
• If you have frequent infections such as fever, strong chills, sore throat, or mouth ulcers. This may be a symptom of a blood disorder called leucopenia.
• If you or someone in your family has a history of breast cancer, as amisulpride may affect your risk of developing it. You should be closely monitored while taking Amisulprida Aurovitas.
• Amisulpride may increase prolactin levels. If you are found to have very high levels of prolactin in your blood or have symptoms of a pituitary tumor (such as visual defects or headaches), a scan of the pituitary gland will be performed. Once the diagnosis of a pituitary tumor is confirmed, treatment with amisulpride will be stopped (see section “Do not take Amisulprida Aurovitas”).
• Severe liver problems have been reported with amisulpride. Consult 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 points affect you, speak with your doctor or pharmacist before taking Amisulprida Aurovitas.

Other medications and Amisulprida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is especially important to inform your doctor if you are taking the following medications:

Do not take this medication and inform your doctor if you are taking:

• Levodopa, a medication for Parkinson's disease.
• Medications called ‘dopamine agonists’, such as ropinirole and bromocriptine.
• Medications to treat heart rhythm disorders (such as quinidine, disopyramide, amiodarone, and sotalol).
• Cisapride (used for stomach problems).
• Bepridil (used for angina/heart pain and changes in heart rhythm).
• Sultopride and thioridazine (for schizophrenia).
• Methadone (for pain and drug abuse).
• Halofantrine (for malaria prevention).
• Pentamidine (for treating infections in HIV patients).
• Erythromycin intravenously or ciprofloxacin (antibiotics).
• Medications for fungal infections, such as clotrimazole.
• Vincamine intravenously (used for various brain disorders).
• Clozapine, used for schizophrenia.
• Sucralfate used for stomach ulcers, intestinal ulcers, and stomach lining inflammation.
• Antacids used to neutralize stomach acid.

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

• Medications used to treat high blood pressure or other heart problems that may decrease your heart rate. This includes beta-blockers (such as nebivolol or bisoprolol, diltiazem, verapamil, clonidine, guanfacine, digoxin, or similar medications).
• Medications that may decrease your potassium levels in the blood, including diuretics, some laxatives, amphotericin B (intravenous administration), glucocorticoids (used for conditions such as asthma or rheumatoid arthritis), and tetracosactides (which may be used in clinical research).
• Medications for schizophrenia such as pimozide or haloperidol.
• Imipramine or lithium (used for depression).
• Some antihistamines such as astemizole and terfenadine (for allergies).
• Other antipsychotic medications used for mental health problems.
• Medications for strong pain called opioids, such as morphine or pethidine.
• Clonidine, used for migraines, hot flashes, or high blood pressure.
• Mefloquine, used for malaria.
• Medications that may help you sleep, such as barbiturates and benzodiazepines.
• Analgesics such as tramadol and indomethacin.
• Anesthetics.
• Antihistamines such as promethazine, which may make you feel drowsy.

If you are unsure whether any of these points affect you, speak with your doctor or pharmacist before taking amisulpride.

Taking Amisulprida Aurovitas with food, drinks, and alcohol

Swallow amisulpride tablets with plenty of water before meals.

Do not drink alcohol while taking amisulpride, as this medication may enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, may become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Amisulpride is not recommended during pregnancy or in fertile women who do not use contraceptive methods.

The following symptoms have been reported in newborns of mothers taking amisulpride during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.

If your baby develops any of these symptoms, contact your doctor.

Lactation

Do not breastfeed during treatment with amisulpride. Consult your doctor about the best way to feed your baby if you are taking amisulpride.

Fertility

Fertility has been observed to be decreased.

Driving and using machines

You may experience blurred vision, feel less alert, drowsy, or sleepy while taking this medication. If this happens, do not drive or use tools or machines.

Amisulprida Aurovitas contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

Amisulprida Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take Amisulprida Aurovitas

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

Recommended dose

The amount you take of amisulprida will depend on your illness. Follow your doctor's instructions carefully.

Adults

• The usual dose is between 50 mg and 800 mg per day. If you suffer from positive symptoms, the recommended dose is 400 mg to 800 mg per day, and your doctor will adjust it depending on the nature and severity of your illness and the functioning of your kidneys.
• If you have both positive and negative symptoms, your doctor will adjust the dose to control your positive symptoms properly. For maintenance treatment, your doctor will use the lowest effective dose.
• If you mainly suffer from negative symptoms, the recommended dose is 50 mg to 300 mg per day, and your doctor will adjust it depending on the nature and severity of your illness and the functioning of your kidneys.
• Your doctor may start with a low dose if necessary.
• Your doctor may prescribe up to 1,200 mg per day if necessary.
• Doses of up to 300 mg per day can be taken at once. Take your dose at the same time every day.
• Doses above 300 mg should be taken half in the morning and half in the afternoon.

Advanced age(patients over 65 years)

• Your doctor will keep you under strict control as amisulprida may cause drowsiness (dizziness) or a drop in blood pressure, and it is not generally recommended as there is limited experience in this age group.

Patients with kidney problems

• Your doctor may need to give you a smaller dose. It may be half or a third of the usual daily dose, depending on how well your kidneys are functioning.

Children under 18 years

The safety and efficacy of amisulprida have not been established in children and adolescents under 18 years. If necessary, treatment in adolescents between 15 and 18 years should be initiated and carried out by a doctor experienced in treating schizophrenia in this age group.

Children and adolescents under 15 years should not take these tablets (see section 2 'Do not take Amisulprida Aurovitas').

If you take more Amisulprida Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

You may experience symptoms such as: feeling restless or agitated, muscle stiffness, feeling dizzy or drowsy, which may lead to loss of consciousness.

If you forget to take Amisulprida Aurovitas

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Amisulprida Aurovitas

Continue taking amisulprida until your doctor tells you to. Do not stop taking this medication just because you feel better. If you stop taking it, your illness may worsen or symptoms may return. Unless your doctor tells you to, amisulprida should not be stopped abruptly. Sudden discontinuation of treatment may cause withdrawal symptoms such as:

• Feeling or being sick.
• Sweating.
• Difficulty sleeping or feeling restless.
• Muscle stiffness or unusual movements in your body.
• Initial symptoms may return.

To avoid these effects, it is essential to reduce the dose gradually following your doctor's instructions.

Blood tests

Amisulprida may affect the results of some blood tests. This includes tests to measure a hormone called prolactin, and liver function tests. If you are to have a blood test, inform your doctor that you are taking amisulprida.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Amisulprida Aurovitas and see a doctor or go to the hospital immediately if:

• You have high fever, sweating, muscle stiffness, rapid pulse, rapid breathing, and feel confused, dizzy, or agitated.These may be symptoms of a rare but serious side effect called‘malignant neuroleptic syndrome’, which is a potentially fatal complication.
• You notice an irregular heart rhythm, have a rapid pulse, or chest pain, which may lead to a heart attack or cardiac alteration that threatens your life.
• If you have blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness in your legs), which can move through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.

Rare: (may affect up to 1 in 100 people)

• You have an allergic reaction. Symptoms may include itchy and swollen rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• You have a seizure.
• You get more infections than usual. This may be due to a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia).
• You have frequent infections such as fever, intense chills, sore throat, or mouth ulcers. These may 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).

Inform your doctor as soon as possible if you experience any of the following side effects:

Very common: (may affect more than 1 in 10 people)

• Tremor, muscle stiffness, or spasms, slow movements, excessive salivation, or feeling restless.

Common: (may affect up to 1 in 10 people)

• Uncontrollable movements, mainly in the arms and legs(these symptoms may be reduced if your doctor lowers your amisulprida dose or prescribes an additional medication).

Rare: (may affect up to 1 in 100 people)

• Uncontrollable movements, mainly in the face or tongue.

Other side effects include:

Common: (may affect up to 1 in 10 people)

• Difficulty sleeping (insomnia) or feeling anxious or agitated.
• Feeling drowsy.
• Constipation, feeling or being nauseous, vomiting, dry mouth, indigestion.
• Weight gain.
• Increased levels of prolactin (a protein) in the blood, which may be seen in a blood test and cause:

• Chest pain or swelling, unusual milk production (which may occur in men and women).
• Menstrual changes such as missed periods.
• Sexual problems such as difficulty reaching orgasm or difficulty achieving or maintaining an erection.
• Unusual growth of the pituitary gland.

• Feeling dizzy (which may be due to a drop in blood pressure).
• Blurred vision.

Rare: (may affect up to 1 in 100 people)

• Decreased heart rate.
• High blood sugar (hyperglycemia).
• Increased blood pressure.
• Difficulty urinating.
• Increased liver enzymes that may be detected in a blood test.
• Confusion.
• Congestion.
• Osteopenia (low bone mineral density).
• Osteoporosis. This is when it is more likely that your bones will break.
• Development of a lung infection after inhaling food, liquids, saliva, or nasal secretions (aspiration pneumonia).
• Nutritional disorders such as hypertriglyceridemia (high levels of triglycerides in the blood) and hypercholesterolemia (high levels of cholesterol in the blood).

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

• Urticaria (hives).
• Swelling under the skin (angioedema).
• Hyponatremia (low levels of sodium in the blood).
• Feeling unwell, confusion, or weakness, nausea, loss of appetite, feeling irritable. These may be signs of a disease called syndrome of inappropriate antidiuretic hormone secretion (SIADH, in English).
• Benign pituitary tumor (non-cancerous), such as prolactinoma.

Unknown: (frequency cannot be estimated from available data)

• Sudden withdrawal syndrome may occur in newborns whose mothers used amisulprida during pregnancy.
• Restless legs syndrome (feeling unwell in the legs that is temporarily relieved by movement.
• Increased skin sensitivity to the sun and ultraviolet rays.
• Falls due to reduced body balance, which sometimes causes fractures.
• Rhabdomyolysis (muscle breakdown associated with muscle pain).
• Elevated levels of creatine phosphokinase (blood test indicating muscle damage).
• Mild chills, mild difficulty breathing (dyspnea), and muscle pain have also been observed.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Amisulprida Aurovitas and see a doctor or go to the hospital immediately if:

• You have high fever, sweating, muscle stiffness, rapid pulse, rapid breathing, and feel confused, dizzy, or agitated.These may be symptoms of a rare but serious side effect called‘malignant neuroleptic syndrome’, which is a potentially fatal complication.
• You notice an irregular heart rhythm, have a rapid pulse, or chest pain, which may lead to a heart attack or cardiac alteration that threatens your life.
• If you have blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness in your legs), which can move through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.

Rare: (may affect up to 1 in 100 people)

• You have an allergic reaction. Symptoms may include itchy and swollen rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• You have a seizure.
• You get more infections than usual. This may be due to a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia).
• You have frequent infections such as fever, intense chills, sore throat, or mouth ulcers. These may 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).

Inform your doctor as soon as possible if you experience any of the following side effects:

Very common: (may affect more than 1 in 10 people)

• Tremor, muscle stiffness, or spasms, slow movements, excessive salivvation, or feeling restless.

Common: (may affect up to 1 in 10 people)

• Uncontrollable movements, mainly in the arms and legs(these symptoms may be reduced if your doctor lowers your amisulprida dose or prescribes an additional medication).

Rare: (may affect up to 1 in 100 people)

• Uncontrollable movements, mainly in the face or tongue.

Other side effects include:

Common: (may affect up to 1 in 10 people)

• Difficulty sleeping (insomnia) or feeling anxious or agitated.
• Feeling drowsy.
• Constipation, feeling or being nauseous, vomiting, dry mouth, indigestion.
• Weight gain.
• Increased levels of prolactin (a protein) in the blood, which may be seen in a blood test and cause:

• Chest pain or swelling, unusual milk production (which may occur in men and women).
• Menstrual changes such as missed periods.
• Sexual problems such as difficulty reaching orgasm or difficulty achieving or maintaining an erection.
• Unusual growth of the pituitary gland.

• Feeling dizzy (which may be due to a drop in blood pressure).
• Blurred vision.

Rare: (may affect up to 1 in 100 people)

• Decreased heart rate.
• High blood sugar (hyperglycemia).
• Increased blood pressure.
• Difficulty urinating.
• Increased liver enzymes that may be detected in a blood test.
• Confusion.
• Congestion.
• Osteopenia (low bone mineral density).
• Osteoporosis. This is when it is more likely that your bones will break.
• Development of a lung infection after inhaling food, liquids, saliva, or nasal secretions (aspiration pneumonia).
• Nutritional disorders such as hypertriglyceridemia (high levels of triglycerides in the blood) and hypercholesterolemia (high levels of cholesterol in the blood).

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

• Urticaria (hives).
• Swelling under the skin (angioedema).
• Hyponatremia (low levels of sodium in the blood).
• Feeling unwell, confusion, or weakness, nausea, loss of appetite, feeling irritable. These may be signs of a disease called syndrome of inappropriate antidiuretic hormone secretion (SIADH, in English).
• Benign pituitary tumor (non-cancerous), such as prolactinoma.

Unknown: (frequency cannot be estimated from available data)

• Sudden withdrawal syndrome may occur in newborns whose mothers used amisulprida during pregnancy.
• Restless legs syndrome (feeling unwell in the legs that is temporarily relieved by movement.
• Increased skin sensitivity to the sun and ultraviolet rays.
• Falls due to reduced body balance, which sometimes causes fractures.
• Rhabdomyolysis (muscle breakdown associated with muscle pain).
• Elevated levels of creatine phosphokinase (blood test indicating muscle damage).
• Mild chills, mild difficulty breathing (dyspnea), and muscle pain have also been observed.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Amisulprida Aurovitas

• The active ingredient is amisulpride.

Each tablet contains 200 mg of amisulpride.

• The other components are: lactose monohydrate, methylcellulose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the packaging

Tablet.

White to off-white, uncoated, round tablets (12 mm in diameter), with a dividing line on one side and the mark ‘L 75’ on the other side. The tablet can be divided into equal doses.

Amisulprida Aurovitas is available in PVC transparent-Aluminium and PVC/PVdC transparent-Aluminium blister packs.

Packaging sizes: 12, 20, 30, and 60 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy:Amisulpride Aurobindo

Portugal:Amissulprida Aurovitas

Spain:Amisulprida Aurovitas 200mg tablets EFG

Last review date of this leaflet:February 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)