AMISULPRIDE AUROVITAS 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amisulprida Aurovitas 400 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Amisulprida Aurovitas and what is it used for

Amisulprida Aurovitas contains the active substance amisulpride. It belongs to a group of medicines called antipsychotics.

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become distrustful or aggressive without apparent reason (so-called 'positive symptoms'), or become depressed and withdrawn (so-called 'negative symptoms').

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

2. What you need to know before you take Amisulprida Aurovitas

Do not take Amisulprida Aurovitas:

• If you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include: rash, difficulties to swallow or breathe, swelling of the lips, throat, and tongue.
• If you are pregnant, may become pregnant or are breast-feeding (see section ‘Pregnancy, breast-feeding and fertility’).
• If you have breast cancer or a tumor dependent on prolactin.
• 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 medicine used to treat Parkinson's disease (see also the section ‘Other medicines and Amisulprida Aurovitas’).
• If you are taking medicines to treat heart rhythm problems, or medicines that may cause abnormal heart rhythm when used at the same time as amisulpride (see also the section ‘Other medicines and Amisulprida Aurovitas’).
• If the patient is under 15 years of age.

Do not take this medicine if you are affected by any of the above points. If you are not sure, talk to your doctor or pharmacist before taking Amisulprida Aurovitas.

Warnings and precautions

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

Talk to your doctor or pharmacist before taking this medicine if:

• You have fever, rapid breathing, excessive sweating, decreased consciousness or muscle stiffness, which are symptoms of a severe, potentially life-threatening disorder called “neuroleptic malignant syndrome”. Stop taking amisulpride immediately and contact your doctor.
• You have kidney problems.
• You have Parkinson's disease.
• You have ever had seizures (epileptic fits).
• You have an abnormal heart rhythm.
• You have a heart condition or a family history of heart problems or sudden death.
• You have a prolongation of the QT interval or cases of this in your family (this is a measure to see how your heart works and a doctor can detect it using an electrocardiogram).
• You have had a stroke or your doctor has told you that you are at risk of having one.
• If you or someone in your family has a history of blood clots, as medicines like this have been associated with the formation of clots.
• If you are diabetic or have been told that you have a high risk of getting diabetes.
• If you have a slow heart rate (less than 55 beats per minute).
• If you are taking other medicines that can affect how your heart works: talk to your doctor before taking any medicine. See also the sections ‘Do not take Amisulprida Aurovitas’ and ‘Other medicines 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 likely to have low blood pressure or feel drowsy. A slight increase in deaths has been reported 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 you may get infections more easily than usual.
• If you get frequent infections such as fever, severe chills, sore throat or mouth ulcers. This may be a sign of a blood problem called leucopenia.
• If you or someone in your family has a history of breast cancer, as amisulpride may affect the risk of getting it. You should be closely monitored while being treated with Amisulprida Aurovitas.
• Amisulprida 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 headache), a scan of the pituitary gland will be performed. Once a pituitary tumor is diagnosed, treatment with amisulpride will be discontinued (see section “Do not take Amisulprida Aurovitas”).
• 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 yellowing of the eyes or skin.

If you are not sure if any of these points apply to you, talk to your doctor or pharmacist before taking Amisulprida Aurovitas.

Other medicines and Amisulprida Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to tell your doctor if you are taking these medicines:

In particular, do not take this medicine and inform your doctor if you are taking:

• 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 and sotalol).
• Cisapride (used for stomach problems).
• Bepridil (used for angina/chest pain and changes in heart rhythm).
• Sultopride and thioridazine (for schizophrenia).
• Methadone (for pain and drug abuse).
• Halofantrine (to prevent malaria).
• Pentamidine (to treat infections in patients with HIV).
• Erythromycin intravenously or sparfloxacin (antibiotics).
• Medicines for fungal infections, such as clotrimazole.
• Vincamine intravenously (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 neutralize stomach acidity.

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

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

If you are not sure if any of these points apply to you, talk to your doctor or pharmacist before taking amisulpride.

Taking Amisulprida Aurovitas with food, drinks and alcohol

Swallow the amisulpride tablets with plenty of water before meals.

Do not drink alcohol while being treated with amisulpride, as this medicine can enhance the effects of alcohol.

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 or pharmacist for advice before taking this medicine.

Pregnancy

The use of amisulpride is not recommended during pregnancy or in women of childbearing potential who are not using any contraceptive method.

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

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

Breast-feeding

You should not breast-feed during treatment with amisulprida. Talk to your doctor about the best way to feed your baby if you are taking amisulprida.

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, do not drive or use tools or machines.

Amisulprida Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

Amisulprida Aurovitas contains sodium

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

3. How to take Amisulprida Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take Amisulprida Aurovitas

• Take this medicine 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 medicine is too strong or too weak, do not change the dose yourself, but talk to your doctor.

Recommended dose

The amount of amisulpride you 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 400 mg to 800 mg per day, and your doctor will adjust it depending on the nature and severity of your illness and kidney function.
• If you have both positive and negative symptoms, your doctor will adjust the dose to adequately control the positive symptoms. 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 kidney function.
• Your doctor may start with a low dose if necessary.
• If necessary, your doctor may prescribe up to 1,200 mg per day.
• Doses up to 300 mg per day can be taken in one single intake. Take your dose at the same time each day.
• Doses above 300 mg should be taken half in the morning and half in the afternoon.

Elderly(patients over 65 years)

• Your doctor will keep you under close supervision as amisulpride may cause sedation (dizziness) or a drop in blood pressure, and it is not generally recommended as there is only limited experience in this age group.

Patients with kidney problems

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

Children under 18 years

The safety and efficacy of amisulpride in children and adolescents under 18 years have not been established. If treatment is imperative, treatment in adolescents between 15 and 18 years should be initiated and carried out by a doctor with experience 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

You may experience symptoms such as: feeling restless or agitated, muscle stiffness, feeling dizzy or drowsy, which can 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 it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Amisulprida Aurovitas

Continue taking amisulpride until your doctor tells you to stop. Do not stop taking this medicine just because you feel better. If you stop taking it, your illness may get worse or your symptoms may come back. Unless your doctor tells you to, amisulpride should not be stopped abruptly. A sudden interruption of treatment can cause withdrawal symptoms such as:

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

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

Blood tests

Amisulprida may alter the results of some blood tests. This includes tests to measure a hormone called prolactin, and liver tests. If you are going to have a blood test, it is important that you tell your doctor that you are taking amisulprida.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• You have a high fever, sweating, muscle stiffness, rapid pulse, rapid breathing, and feel confused, dizzy, or agitated. These can be symptoms of a rare but serious adverse effect called 'neuroleptic malignant syndrome', which is a potentially life-threatening complication.
• You notice your heartbeat is altered, you have a rapid pulse or chest pain, which can lead to a heart attack or some cardiac alteration that threatens your life.
• If 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 immediate medical attention.

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

• Having an allergic reaction. Symptoms may include: itchy and swollen rash, problems swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Suffering a seizure.
• If 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).
• If you have frequent infections such as fever, intense chills, sore throat, or mouth ulcers. These can be signs of a blood problem called "leukopenia".

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

• Having more infections than usual. This could be due to a blood disorder (agranulocytosis).

Tell your doctor as soon as possible if you have any of the following adverse effects:

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

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

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

• Movements that cannot be controlled, mainly in the arms and legs (these symptoms can be reduced if your doctor lowers the dose of amisulpride or prescribes an additional medication).

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

• Movements that cannot be controlled, mainly in the face or tongue.

Other adverse 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 sick, vomiting, dry mouth, indigestion.
• Weight gain.
• Increased levels of prolactin (a protein) in the blood, which can be seen in a test and cause:

• Chest pain or increase, unusual milk production (which can occur in men and women).
• Menstrual irregularities such as failures.
• Sexual effects such as problems reaching orgasm or difficulty getting or maintaining an erection.
• Unusual growth of the pituitary gland.

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

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

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

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

• Urticaria (hives).
• Swelling under the skin (angioedema).
• Hyponatremia (low sodium levels in the blood).
• Feeling unwell, confused, or weak, nausea, loss of appetite, feeling irritable. These can be signs of a disease called syndrome of inadequate secretion of antidiuretic hormone (SIADH, by its English acronym).
• 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 amisulpride during pregnancy.
• Restless legs syndrome (feeling of discomfort in the legs that is temporarily relieved by movement.
• Increased sensitivity of the skin to the sun and ultraviolet rays.
• Falls due to reduced body balance, which sometimes causes fractures.
• Rhabdomyolysis (muscle breakdown associated with muscle pain).
• High levels of creatine phosphokinase (blood test indicating muscle damage).
• Low-intensity chills, difficulty breathing (dyspnea) of low intensity, and muscle pain have also been observed.

Reporting of Adverse Effects:

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

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• You have a high fever, sweating, muscle stiffness, rapid pulse, rapid breathing, and feel confused, dizzy, or agitated. These can be symptoms of a rare but serious adverse effect called 'neuroleptic malignant syndrome', which is a potentially life-threatening complication.
• You notice your heartbeat is altered, you have a rapid pulse or chest pain, which can lead to a heart attack or some cardiac alteration that threatens your life.
• If 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 immediate medical attention.

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

• Having an allergic reaction. Symptoms may include: itchy and swollen rash, problems swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Suffering a seizure.
• If 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).
• If you have frequent infections such as fever, intense chills, sore throat, or mouth ulcers. These can be signs of a blood problem called "leukopenia".

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

• Having more infections than usual. This could be due to a blood disorder (agranulocytosis).

Tell your doctor as soon as possible if you have any of the following adverse effects:

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

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

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

• Movements that cannot be controlled, mainly in the arms and legs (these symptoms can be reduced if your doctor lowers the dose of amisulpride or prescribes an additional medication).

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

• Movements that cannot be controlled, mainly in the face or tongue.

Other adverse 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 sick, vomiting, dry mouth, indigestion.
• Weight gain.
• Increased levels of prolactin (a protein) in the blood, which can be seen in a test and cause:

• Chest pain or increase, unusual milk production (which can occur in men and women).
• Menstrual irregularities such as failures.
• Sexual effects such as problems reaching orgasm or difficulty getting or maintaining an erection.
• Unusual growth of the pituitary gland.

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

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

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

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

• Urticaria (hives).
• Swelling under the skin (angioedema).
• Hyponatremia (low sodium levels in the blood).
• Feeling unwell, confused, or weak, nausea, loss of appetite, feeling irritable. These can be signs of a disease called syndrome of inadequate secretion of antidiuretic hormone (SIADH, by its English acronym).
• 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 amisulpride during pregnancy.
• Restless legs syndrome (feeling of discomfort in the legs that is temporarily relieved by movement.
• Increased sensitivity of the skin to the sun and ultraviolet rays.
• Falls due to reduced body balance, which sometimes causes fractures.
• Rhabdomyolysis (muscle breakdown associated with muscle pain).
• High levels of creatine phosphokinase (blood test indicating muscle damage).
• Low-intensity chills, difficulty breathing (dyspnea) of low intensity, and muscle pain have also been observed.

Reporting of Adverse Effects:

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

5. Conservation of Amisulprida Aurovitas

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Amisulprida Aurovitas

• The active ingredient is amisulpride.

Each film-coated tablet contains 400 mg of amisulpride.

• The other components are:

Core of the tablet: lactose monohydrate, methylcellulose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Coating: basic butyl methacrylate copolymer, titanium dioxide (E171), talc, macrogol 6000, and magnesium stearate.

Appearance of the Product and Package Contents

Film-coated tablet.

White to off-white film-coated tablets, with a rounded capsule shape, biconvex, with a dividing line on one side and the mark 'L 76' on the other side. The tablet can be divided into equal doses. The size is 18.1 mm x 7.9 mm.

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

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

It is possible that only some package sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 400 mg film-coated tablets EFG

Date of the last revision of this prospectus:February 2023

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