Amisulpride Aurovitas 400 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amisulpride Aurovitas 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Amisulpride Aurovitas contains an active substance 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, feel or hear things that do not exist (hallucinations), have strange and frightening thoughts (delusions), change your behaviour, and make you feel isolated. Sometimes, people with these symptoms may also feel tense, anxious, become suspicious or aggressive for no apparent reason (known as 'positive symptoms'), or become depressed and withdrawn (known as 'negative symptoms').

Amisulpride works by improving these disturbed thoughts, feelings, and behaviours. It is used to treat schizophrenia both at the onset of the illness and over the long term.

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

Do not take Amisulprida Aurovitas:

• If you are allergic to amisulpride or to any of the other ingredients of this medicine (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 tumor dependent on prolactin.
• If you have a pituitary tumor.
• If you have a tumor in the adrenal gland (called a pheochromocytoma).
• If you are being treated with levodopa, a medicine used to treat Parkinson's disease (see section ‘Other medicines and Amisulprida Aurovitas’ below).
• If you are taking medicines to treat heart rhythm disorders, or medicines that may cause abnormal heart rhythm when used together with amisulpride (see section ‘Other medicines and Amisulprida Aurovitas’ below).
• If the patient is under 15 years of age.

Do not take this medicine if any of the above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Amisulprida Aurovitas.

Warnings and precautions

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

Speak with 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 serious, 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 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 QT interval prolongation or a family history of it (this is a measurement of how your heart functions, which a doctor can detect using an electrocardiogram).
• You have previously had a stroke or your doctor has told you that you are at risk of having one.
• You or someone in your family has a history of blood clots, as medicines like this have been associated with clot formation.
• You are diabetic or have been told 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 how your heart works: consult your doctor before taking any medicine. See also the sections ‘Do not take Amisulprida Aurovitas’ and ‘Other medicines and Amisulprida Aurovitas’.
• You have been told you have low levels of potassium or magnesium in your blood.
• You are elderly. This is because such individuals are more likely to have low blood pressure or feel drowsy. A slight increase in deaths has been reported in elderly patients with dementia taking antipsychotics compared to those not taking them.
• You have a low number of blood cells (agranulocytosis). This means you may be more prone to infections than usual.
• You have frequent infections such as fever, severe chills, sore throat, or mouth ulcers. These may be symptoms 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 it. Close monitoring is required while you are being treated with Amisulprida Aurovitas.
• Amisulpride may increase prolactin levels. If you are found to have very high prolactin levels in your blood or have symptoms of a pituitary tumor (such as visual disturbances or headaches), a scan of the pituitary gland will be performed. Once a pituitary tumor is confirmed, treatment with amisulpride will be stopped (see section “Do not take Amisulprida Aurovitas”).
• Serious liver problems have been reported with amisulpride. Contact 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 apply to you, speak with 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 need to take any other medicines.

It is especially important that you inform your doctor if you are taking any of the following:

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 disorders (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 HIV patients).
• Intravenous erythromycin or sparfloxacin (antibiotics).
• Medicines for fungal infections, such as clotrimazole.
• Intravenous vincamine (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 could 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 may reduce your blood potassium levels, including diuretics, certain laxatives, intravenous amphotericin B, glucocorticoids (used for conditions such as asthma or rheumatoid arthritis), and tetracosactide (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 disorders.
• Medicines for severe pain called opioids, such as morphine or pethidine.
• Clonidine, used for migraines, hot flushes, or high blood pressure.
• Mefloquine, used to treat malaria.
• Medicines that may help you sleep, such as barbiturates and benzodiazepines.
• Painkillers such as tramadol and indometacin.
• Anaesthetics.
• Antihistamines such as promethazine, which may make you feel drowsy.

If you are unsure whether any of these apply to 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 medicine may enhance the effects of alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of amisulpride during pregnancy is not recommended, nor in women of childbearing potential who are not using contraception.

The following symptoms have been reported in newborns whose mothers took amisulpride during the third trimester of pregnancy (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 should contact your doctor.

Breastfeeding

You must not breastfeed while being treated with amisulpride. Consult your doctor about the best way to feed your baby if you are taking amisulpride.

Fertility

A decrease in fertility has been observed.

Driving and using machines

This medicine may cause blurred vision, reduced alertness, drowsiness, or sleepiness. If this occurs, do not drive or operate tools or machinery.

Amisulprida Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Amisulprida Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".

3. How to take Amisulpride Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How to take Amisulpride Aurovitas

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

Recommended dose

The amount of amisulpride you take will depend on your condition. Carefully follow your doctor's instructions.

Adults

• The usual dose ranges from 50 mg to 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 condition and your 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 condition and your kidney function.
• Your doctor may start with a lower dose if necessary.
• If needed, your doctor may prescribe up to 1,200 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 above 300 mg should be split, with half taken in the morning and the other half in the afternoon.

Elderly patients (patients over 65 years of age)

• Your doctor will closely monitor you, as amisulpride may cause sedation (dizziness) or a drop in blood pressure. Its use is not generally recommended due to limited experience in this age group.

Patients with kidney problems

• Your doctor may need to prescribe a lower dose. This could be half or one-third of the normal daily dose, depending on how well your kidneys are functioning.

Children under 18 years of age

The safety and efficacy of amisulpride have not been established in children and adolescents under 18 years of age. If absolutely necessary, treatment in adolescents aged 15 to 18 should be initiated and supervised by a physician experienced in treating schizophrenia in this age group.

Children and adolescents under 15 years of age must not take these tablets (see section 2, 'Do not take Amisulpride Aurovitas').

If you take more Amisulpride Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms may include: feeling restless or agitated, muscle stiffness, dizziness or drowsiness, which may lead to loss of consciousness.

If you forget to take Amisulpride Aurovitas

If you miss 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 a missed dose.

If you stop taking Amisulpride Aurovitas

Continue taking amisulpride as directed by your doctor. Do not stop taking this medicine just because you feel better. If you stop taking it, your condition may worsen or your symptoms may return. Unless otherwise instructed by your doctor, amisulpride 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.
• The original symptoms may reappear.

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

Blood tests

Amisulpride may alter the results of certain blood tests. This includes tests measuring a hormone called prolactin and liver function tests. If you are having blood tests, it is important to inform your doctor that you are taking amisulpride.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• You have high fever, sweating, muscle stiffness, rapid pulse, fast breathing, and feel confused, dizzy, or agitated. These may be symptoms of a rare but serious adverse effect called 'neuroleptic malignant syndrome', which is a potentially life-threatening complication.
• You notice an irregular heartbeat, have a rapid pulse, or chest pain, which could lead to a heart attack or other life-threatening cardiac disturbances.
• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through 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, raised rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Experiencing a seizure.
• Getting more infections than usual. This may be due to a blood disorder (agranulocytosis) or a decrease in white blood cell count (neutropenia).
• Having frequent infections such as fever, severe 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)

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

Tell your doctor as soon as possible if you experience any of the following adverse 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 improve if your doctor reduces your dose of amisulpride or prescribes an additional medicine).

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

• Uncontrollable movements, 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 sick or being sick, vomiting, dry mouth, indigestion.

• Weight gain.

• Increased levels of prolactin (a protein) in the blood, which may be detected in a blood test and cause:

• Breast pain or enlargement, unusual milk production (which may occur in both men and women).

• Menstrual disturbances such as missed periods.

• Sexual effects such as difficulty reaching orgasm or problems 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.

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

• Slowing of the heart rate.
• High blood sugar (hyperglycaemia).
• Increase in blood pressure.
• Difficulty passing urine.
• Increased liver enzymes, which may 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 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 (urticaria).
• Swelling beneath the skin (angioedema).
• Hyponatraemia (low sodium levels in the blood).
• Feeling unwell, confused or weak, nausea, loss of appetite, feeling irritable. These may 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 available data)

• Neonatal withdrawal syndrome may occur in newborn babies whose mothers took amisulpride during pregnancy.
• Restless legs syndrome (an uncomfortable sensation in the legs that is temporarily relieved by movement).
• Increased sensitivity of the skin to sunlight and ultraviolet rays.
• Falls due to reduced body balance, which may sometimes result in fractures.
• Rhabdomyolysis (breakdown of muscles associated with muscle pain).
• Elevated levels of creatine phosphokinase (a blood test indicating muscle damage).
• Mild chills, mild shortness of breath (dyspnoea), and muscle pain have also been observed.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• You have high fever, sweating, muscle stiffness, rapid pulse, fast breathing, and feel confused, dizzy, or agitated. These may be symptoms of a rare but serious adverse effect called 'neuroleptic malignant syndrome', which is a potentially life-threatening complication.
• You notice an irregular heartbeat, have a rapid pulse, or chest pain, which could lead to a heart attack or other life-threatening cardiac disturbances.
• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through 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, raised rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Experiencing a seizure.
• Getting more infections than usual. This may be due to a blood disorder (agranulocytosis) or a decrease in white blood cell count (neutropenia).
• Having frequent infections such as fever, severe 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)

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

Tell your doctor as soon as possible if you experience any of the following adverse 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 improve if your doctor reduces your dose of amisulpride or prescribes an additional medicine).

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

• Uncontrollable movements, 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 sick or being sick, vomiting, dry mouth, indigestion.

• Weight gain.

• Increased levels of prolactin (a protein) in the blood, which may be detected in a blood test and cause:

• Breast pain or enlargement, unusual milk production (which may occur in both men and women).

• Menstrual disturbances such as missed periods.

• Sexual effects such as difficulty reaching orgasm or problems 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.

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

• Slowing of the heart rate.
• High blood sugar (hyperglycaemia).
• Increase in blood pressure.
• Difficulty passing urine.
• Increased liver enzymes, which may 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 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 (urticaria).
• Swelling beneath the skin (angioedema).
• Hyponatraemia (low sodium levels in the blood).
• Feeling unwell, confused or weak, nausea, loss of appetite, feeling irritable. These may 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 available data)

• Neonatal withdrawal syndrome may occur in newborn babies whose mothers took amisulpride during pregnancy.
• Restless legs syndrome (an uncomfortable sensation in the legs that is temporarily relieved by movement).
• Increased sensitivity of the skin to sunlight and ultraviolet rays.
• Falls due to reduced body balance, which may sometimes result in fractures.
• Rhabdomyolysis (breakdown of muscles associated with muscle pain).
• Elevated levels of creatine phosphokinase (a blood test indicating muscle damage).
• Mild chills, mild shortness of breath (dyspnoea), and muscle pain have also been observed.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amisulpride Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amisulpride Aurovitas

• The active substance is amisulpride.

Each film-coated tablet contains 400 mg of amisulpride.

• The other components are:

Tablet core: 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 contents of the pack

Film-coated tablet.

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

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

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

Only some pack sizes may be 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy: Amisulpride Aurobindo

Portugal: Amissulprida Aurovitas

Spain: Amisulprida Aurovitas 400 mg film-coated tablets EFG

Date of the latest revision of this leaflet: February 2023

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