APOSUPRID 200 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. ApoSuprid, 200 mg, tablets
3. ApoSuprid, 400 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is ApoSuprid and what is it used for
5. Important information before taking ApoSuprid
   1. When not to take ApoSuprid
   2. Warnings and precautions
   3. ApoSuprid and other medicines
   4. In particular, do not take the following medicines with ApoSuprid and inform your doctor if you are taking any of the following medicines:
   5. Tell your doctor if you are taking any of the following medicines:
   6. ApoSuprid with food, drink, and alcohol
   7. Pregnancy, breast-feeding, and fertility
   8. Pregnancy
   9. Breast-feeding
   10. Fertility
   11. Driving and using machines
   12. ApoSuprid contains lactose
   13. ApoSuprid contains sodium
6. How to take ApoSuprid
   1. How to take ApoSuprid
   2. Recommended dose
   3. Adults
   4. Patients with kidney problems
   5. Use in children and adolescents
   6. Taking more than the recommended dose of ApoSuprid
   7. Missing a dose of ApoSuprid
   8. Stopping treatment with ApoSuprid
   9. Blood tests
7. Possible side effects
   1. Stop taking ApoSuprid and contact your doctor or go to the nearest hospital immediately if you experience any of the following:
   2. Contact your doctor immediately if you experience any of the following side effects:
   3. Other side effects:
   4. Reporting side effects
8. How to store ApoSuprid
9. Contents of the pack and other information
   1. What ApoSuprid contains
   2. What ApoSuprid looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 03/2023

Leaflet accompanying the packaging: information for the user

ApoSuprid, 200 mg, tablets

ApoSuprid, 400 mg, coated tablets

Amisulpride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is ApoSuprid and what is it used for
• 2. Important information before taking ApoSuprid
• 3. How to take ApoSuprid
• 4. Possible side effects
• 5. How to store ApoSuprid
• 6. Contents of the pack and other information

1. What is ApoSuprid and what is it used for

ApoSuprid contains a medicine called amisulpride. It belongs to a group of medicines called "antipsychotics". It is used to treat a disease called schizophrenia. Schizophrenia can make you feel, see, or hear 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, restless, become suspicious or aggressive without a clear reason (these are called "positive symptoms") or show symptoms of depression and withdrawal (these are called "negative symptoms"). ApoSuprid works by improving disturbed thoughts, feelings, and behaviors. It is used to treat initial schizophrenia and its long-term treatment.

2. Important information before taking ApoSuprid

When not to take ApoSuprid

• if you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may appear as: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, and tongue.
• if you are pregnant, think you may be pregnant, or are breast-feeding (see section "Pregnancy, breast-feeding, and fertility"),
• if you have breast cancer or tumors whose growth is dependent on prolactin levels,
• if you have a pituitary tumor,
• if you have a pheochromocytoma (a tumor of the adrenal gland),
• if you are taking levodopa, a medicine used to treat Parkinson's disease (see section "ApoSuprid and other medicines"),
• -if you are taking medicines used to treat heart rhythm disorders or medicines that may cause heart rhythm disorders when taken at the same time as amisulpride (see section "ApoSuprid and other medicines" below),

if any of the above situations apply to you, do not take this medicine. In case of doubt, consult your doctor or pharmacist before taking ApoSuprid.

Warnings and precautions

Before taking ApoSuprid, discuss with your doctor or pharmacist if:

• you have fever, rapid breathing, excessive sweating, decreased consciousness, or muscle stiffness, which are symptoms of a severe, potentially life-threatening disorder called "malignant neuroleptic syndrome". You should stop taking ApoSuprid immediately and contact your doctor;
• you have kidney disease;
• you have Parkinson's disease;
• you have seizures (epilepsy);
• you have irregular heart rhythm;
• you have heart disease or have had heart disease or sudden death in your family;
• you or a family member have had a prolonged QT interval (a measure of heart function that can be determined by a doctor based on an electrocardiogram);
• you have had a stroke or your doctor has informed you that you are at risk of having a stroke;
• you or a family member have had blood clots, as the use of this type of medicine is associated with the formation of blood clots;
• you have diabetes or have been informed that you are at risk of developing diabetes;
• you have slow heart rate (less than 55 beats per minute);
• you are taking other medicines that may affect heart function. Before taking other medicines, consult your doctor. See also: "When not to take ApoSuprid", "ApoSuprid and other medicines";
• you have been informed that you have low potassium or magnesium levels in your blood;
• you are elderly: older people are more likely to experience low blood pressure or excessive sedation. In older people with dementia, slightly more deaths have been reported when taking antipsychotic medicines compared to those not taking antipsychotic medicines;
• you have a low white blood cell count (agranulocytosis). This means you can get infections more easily than usual;
• you have frequent infections, fever, chills, severe sore throat, or mouth ulcers. These may be symptoms of a blood disorder called "leukopenia";
• you or a family member have had breast cancer, as amisulpride may affect the risk of developing breast cancer. Your doctor will monitor you closely while you are taking ApoSuprid;
• amisulpride may increase prolactin levels. If very high prolactin levels are found in the blood or symptoms of a pituitary tumor (such as vision problems and headaches) are detected, an imaging study of the pituitary gland will be performed. After confirming the diagnosis of a pituitary tumor, amisulpride treatment will be discontinued (see section "When not to take ApoSuprid");
• severe liver dysfunction has been reported during amisulpride treatment. You should contact your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin.

In case of doubt about the occurrence of any of the above conditions, consult your doctor or pharmacist before taking ApoSuprid.

ApoSuprid and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those available without a prescription.

In particular, do not take the following medicines with ApoSuprid and inform your doctor if you are taking any of the following medicines:

tell 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 used to treat heart rhythm disorders (such as quinidine, disopyramide, amiodarone, sotalol)
• Cisapride (used to treat stomach problems)
• Bepridil (used to treat angina/chest pain and changes in heart rhythm)
• Sultopride or thioridazine (used to treat schizophrenia)
• Methadone (used to treat pain and drug addiction)
• Halofantrine (used to prevent malaria)
• Pentamidine (used to treat infections in HIV-infected patients)
• Erythromycin given intravenously or sparfloxacin (antibiotics)
• Medicines used to treat fungal infections, such as clotrimazole
• Vincamine given intravenously (used to treat 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 acid.

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

• Medicines used to treat high blood pressure or other heart problems that may slow down heart function. These include beta-blockers (such as nebivolol or bisoprolol), diltiazem, verapamil, clonidine, guanfacine, digoxin, or digoxin-like medicines
• Medicines that cause potassium loss, including diuretics, certain laxatives, amphotericin B (given intravenously), glucocorticoids (used to treat asthma or rheumatoid arthritis), and tetracosactide (which may be used in clinical trials)
• Medicines used to treat schizophrenia, such as pimozide or haloperidol
• Imipramine or lithium (used to treat depression)
• Certain antihistamines, such as astemizole and terfenadine (used for allergies)
• Other antipsychotic medicines used to treat mental health problems
• Medicines used to treat severe pain called opioids, such as morphine or pethidine
• Clonidine used to treat migraine, flushing, or high blood pressure
• Mefloquine used to treat malaria
• Sleep aids, such as barbiturates and benzodiazepines
• Pain relievers, such as tramadol and indomethacin
• Anesthetics
• Antihistamines (used for allergies) that cause drowsiness, such as promethazine

If you are unsure whether any of the above situations apply to you, tell your doctor if you are taking ApoSuprid.

ApoSuprid with food, drink, and alcohol

• ApoSuprid tablets should be swallowed whole with a large amount of water, before a meal.
• Do not drink alcohol while taking ApoSuprid, as it may enhance the effects of alcohol.

Alcohol may increase the sedative effects of ApoSuprid.

Pregnancy, breast-feeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

ApoSuprid is not recommended during pregnancy and in women of childbearing potential who are not using effective contraception.
In newborns whose mothers took ApoSuprid during the last trimester (last three months) of pregnancy, the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, feeding difficulties. If you notice any of these symptoms in your baby, contact your doctor.

Breast-feeding

Do not breast-feed while taking ApoSuprid. If you are taking ApoSuprid, discuss with your doctor the best way to feed your baby.

Fertility

A decrease in fertility has been observed.

Driving and using machines

ApoSuprid may cause blurred vision, reduced alertness, dizziness, or drowsiness. If you experience any of these symptoms, do not drive or operate any tools or machines.

ApoSuprid contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

ApoSuprid contains sodium

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

3. How to take ApoSuprid

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

How to take ApoSuprid

• Take the medicine by mouth
• Swallow the tablets whole with water. Do not chew the tablets.
• Take the medicine between meals.
• If you feel that the effect of the medicine is too weak or too strong, talk to your doctor. Do not change the dose of the medicine yourself.

Recommended dose

The dose of ApoSuprid depends on the severity of the disease. Follow your doctor's instructions exactly.

Adults

• The usual dose is between 50 mg and 800 mg per day. If you have positive symptoms, the recommended dose is between 400 mg and 800 mg of amisulpride per day. Your doctor will adjust the dose of the medicine individually for each patient, depending on the type and severity of symptoms and kidney function. If you have both positive and negative symptoms, your doctor will adjust the dose of the medicine individually for each patient to achieve adequate control of positive symptoms. In maintenance treatment, your doctor will use the smallest effective dose. If you have mainly negative symptoms, the recommended dose is between 50 mg and 300 mg of amisulpride per day. Your doctor will adjust the dose of the medicine individually for each patient, depending on the type and severity of symptoms and kidney function.

Your doctor may start with a lower dose if necessary.

• Your doctor may prescribe up to 1200 mg per day if necessary.
• Doses below 300 mg per day can be taken once a day, preferably at the same time every day.
• For doses above 300 mg per day, take half the dose in the morning and the other half in the evening.

Patients over 65 years old

• Close medical supervision is required, as ApoSuprid may cause sedation (drowsiness) or low blood pressure, and is generally not recommended due to limited experience in this age group.

Patients with kidney problems

• Your doctor will usually recommend a lower dose of the medicine. The dose may be reduced to half or one-third of the usual dose, depending on kidney function.

Use in children and adolescents

The efficacy and safety of ApoSuprid in children and adolescents under 18 years of age have not been established.
If it is absolutely necessary, treatment of adolescents aged 15 to 18 years must be initiated and carried out by a doctor with experience in treating schizophrenia in this age group.
Children and adolescents under 15 years of age must not take this medicine (see section 2. "When not to take ApoSuprid").

Taking more than the recommended dose of ApoSuprid

If you take more than the recommended dose of ApoSuprid, contact your doctor or go to the nearest hospital immediately. Take the tablets, leaflet, and/or packaging of the medicine with you so that the doctor knows what medicine has been taken. You may experience symptoms such as: restlessness or trembling, muscle stiffness, drowsiness, which can lead to loss of consciousness.

Missing a dose of ApoSuprid

Take the medicine as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with ApoSuprid

Continue taking ApoSuprid until your doctor tells you to stop. Do not stop taking ApoSuprid just because you feel better. If you stop treatment, your condition may worsen or come back. Do not stop taking ApoSuprid suddenly unless your doctor tells you to.
Sudden stopping of treatment may cause withdrawal symptoms, such as:

• Nausea or vomiting
• Sweating
• Difficulty sleeping or feeling anxious
• Muscle stiffness or unusual body movements
• Return of the disease symptoms

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

Blood tests

Taking ApoSuprid may affect some of your blood test results, such as prolactin levels and liver function tests. If you are going to have a blood test, tell your doctor that you are taking ApoSuprid.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking ApoSuprid and contact your doctor or go to the nearest hospital immediately if you experience any of the following:

• High body temperature, sweating, muscle stiffness, rapid heart rate, rapid breathing, disorientation, dizziness, or agitation. These may be symptoms of a severe, potentially life-threatening disorder called malignant neuroleptic syndrome.
• Abnormal heart function, very rapid heartbeat, or chest pain, which can lead to a heart attack or life-threatening heart disease
• Blood clots in the veins, especially in the legs (symptoms include itching, pain, and redness of the limbs). These clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately.

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

• Allergic reaction. Symptoms may include an itchy, lumpy rash, difficulty swallowing or breathing, swelling of the lips, face, throat, and tongue
• Seizures (fits)
• More infections than usual. This may be due to a decrease in the number of white blood cells (neutropenia)
• Frequent infections, such as fever, severe chills, sore throat, or mouth ulcers. These may be symptoms of a blood disorder called "leukopenia"

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

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

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

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

• Trembling, stiffness, or muscle spasms, slowed movements, excessive saliva production, restlessness

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

• Uncontrolled movements, mainly of the hands and feet. (These symptoms can be alleviated if your doctor reduces the dose of ApoSuprid or prescribes an additional medicine)

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

• Uncontrolled movements mainly of the face or tongue

Other side effects:

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

• Difficulty sleeping (insomnia) or feeling anxious or agitated
• Drowsiness
• Constipation, nausea, or vomiting, dry mouth, indigestion
• Weight gain
• Increased prolactin levels (a protein) in the blood, which can be seen in test results and may cause:
• Breast pain or enlargement, unusual milk production (can occur in both women and men)
• Menstrual disorders, such as absence of menstruation
• Sexual disorders, such as problems achieving orgasm or difficulty getting or maintaining an erection
• Abnormal growth of the pituitary gland
• Dizziness (which can be caused by low blood pressure)
• Blurred vision

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

• Slow heart rate
• High blood sugar levels (hyperglycemia)
• High blood pressure
• Difficulty urinating
• Increased liver enzyme activity, seen in blood tests
• Disorientation
• Stuffy nose
• Osteopenia (low bone mineral density)
• Osteoporosis. A condition in which bones are more prone to fractures
• Liver damage
• Developing pneumonia (aspiration pneumonia) after choking on food, liquid, saliva, or nasal discharge
• 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)

• Hives (urticaria)
• Swelling under the skin (angioedema)
• Hyponatremia (low sodium levels in the blood)
• Feeling unwell, confusion, or weakness, nausea, loss of appetite, irritability. These may be symptoms of a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• A benign (non-cancerous) pituitary tumor, such as a prolactinoma

Frequency not known: (frequency cannot be estimated from the available data)

• Withdrawal syndrome may occur in newborns whose mothers took ApoSuprid during pregnancy
• Restless legs syndrome (an unpleasant feeling in the legs, temporarily relieved by movement and symptoms)
• Increased sensitivity of the skin to sunlight and ultraviolet radiation
• Falls caused by balance disorders, sometimes leading to fractures
• Rhabdomyolysis (muscle breakdown associated with muscle pain)
• Elevated creatine phosphokinase levels (a blood test indicating muscle damage)
• Observed mild chills, mild breathing difficulties (dyspnea), and mild muscle pain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ApoSuprid

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 the month stated.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ApoSuprid contains

• The active substance is amisulpride. Each tablet contains 200 mg of amisulpride. Each coated tablet contains 400 mg of amisulpride
• The other ingredients are: 200 mg tablets:lactose monohydrate, methylcellulose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate

400 mg coated tablets:
Core:lactose monohydrate, methylcellulose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Coating:basic butyl methacrylate copolymer, titanium dioxide (E 171), talc, macrogol 6000, magnesium stearate.

What ApoSuprid looks like and contents of the pack

Tablet
ApoSuprid, 200 mg, tablets
White or almost white, round (diameter 12.0 mm) uncoated tablets with a break line on one side and the marking "L 75" on the other side. The tablet can be divided into equal doses.
Coated tablet
ApoSuprid, 400 mg, coated tablets
White or almost white, capsule-shaped, biconvex coated tablets with a break line on one side and the marking "L 76" on the other side. The size of the tablets is 18.1 mm x 7.9 mm. The tablet can be divided into equal doses.
ApoSuprid is available in transparent PVC/Aluminum and transparent PVC/PVdC/Aluminum blisters.
Pack sizes: 15, 20, 30, 50, 60, 80, 100, 120, or 150 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Arrow Génériques
26 avenue Tony Garnier
69007 Lyon
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Amisulprid AB 50 mg/ 100 mg/ 200 mg tablets
Amisulprid AB 400 mg film-coated tablets
France:
Amisulpride arrow lab 100 mg/ 200 mg scored tablets
Amisulpride arrow lab 400 mg film-coated scored tablets
Germany:
Amisulprid PUREN 50 mg/ 100 mg/ 200 mg tablets
Amisulprid PUREN 400 mg film-coated tablets
Poland:
ApoSuprid
Portugal:
Amissulprida Aurobindo
Spain:
Amisulprida Aurobindo 100 mg/ 200 mg tablets EFG
Amisulprida Aurobindo 400 mg film-coated tablets EFG

Date of last revision of the leaflet: 03/2023