APOSUPRID 400 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, the patient should not take the following medicines with ApoSuprid and should inform their doctor if they are taking any of the following medicines:
   5. The patient should inform their doctor if they are taking any of the following medicines:
   6. ApoSuprid with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Pregnancy
   9. Breastfeeding
   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 a higher dose of ApoSuprid than recommended
   7. Missing a dose of ApoSuprid
   8. Stopping ApoSuprid treatment
   9. Blood tests
7. Possible side effects
   1. The patient should stop taking ApoSuprid and contact their doctor or go to the nearest hospital immediately if they experience any of the following:
   2. The patient should contact their doctor immediately if they experience any of the following side effects:
   3. Other side effects:
   4. Reporting side effects
8. How to store ApoSuprid
9. Package contents 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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. Package contents and other information

1. What is ApoSuprid and what is it used for

ApoSuprid contains the active substance amisulpride. It belongs to a group of medicines called "antipsychotics". It is used to treat a disease called schizophrenia. Schizophrenia can cause the patient to feel, see, or hear things that do not exist (hallucinations), have strange and frightening thoughts (delusions), change their behavior, and 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 withdraw (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 the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, and tongue.
• if the patient is pregnant, thinks she may be pregnant, or is breastfeeding (see section "Pregnancy, breastfeeding, and fertility"),
• if the patient has breast cancer or tumors whose growth is dependent on prolactin levels,
• if the patient has a pituitary tumor,
• if the patient has a pheochromocytoma (a tumor of the adrenal gland),
• if the patient is taking levodopa, a medicine used to treat Parkinson's disease (see section "ApoSuprid and other medicines"),
• -if the patient is 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 the patient, they must not take this medicine. In case of doubt, the patient should consult their doctor or pharmacist before taking ApoSuprid.

Warnings and precautions

Before starting ApoSuprid, the patient should discuss the following with their doctor or pharmacist:

• if they have fever, rapid breathing, excessive sweating, decreased consciousness, or muscle stiffness, which are symptoms of a severe, potentially life-threatening condition called "neuroleptic malignant syndrome". The patient should stop taking ApoSuprid immediately and contact their doctor;
• if the patient has kidney disease;
• if the patient has Parkinson's disease;
• if the patient has seizures (epilepsy);
• if the patient has irregular heart rhythm;
• if the patient has heart disease or has had heart disease or sudden death in their family;
• if the patient or their family members have had a prolonged QT interval (a measure of heart function that can be determined by a doctor based on an electrocardiogram);
• if the patient has had a stroke or their doctor has informed them that they are at risk of having a stroke;
• if the patient or their family members have had blood clots, as the use of this type of medicine is associated with the formation of blood clots;
• if the patient has diabetes or has been informed that they are at risk of developing diabetes;
• if the patient has a slow heart rate (less than 55 beats per minute);
• if the patient is taking other medicines that may affect heart function. The patient should consult their doctor before taking other medicines. See also: "When not to take ApoSuprid", "ApoSuprid and other medicines";
• if the patient has been informed that they have low potassium or magnesium levels in their blood;
• if the patient is elderly: older people are more likely to experience low blood pressure or excessive sedation. In older people with dementia, there have been slightly more deaths in those taking antipsychotic medicines compared to those not taking antipsychotic medicines;
• if the patient has a low white blood cell count (agranulocytosis). This means they can get infections more easily than usual;
• if the patient has frequent infections, fever, chills, severe throat pain, or mouth ulcers. These may be symptoms of a blood disorder called "leukopenia";
• if the patient or their family members have had breast cancer, as amisulpride may affect the risk of developing breast cancer. The doctor will closely monitor the patient while they 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, a pituitary imaging test will be performed. If a pituitary tumor is confirmed, amisulpride treatment will be discontinued (see section "When not to take ApoSuprid");
• severe liver function disorders have been reported during ApoSuprid treatment. The patient should contact their doctor immediately if they 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, the patient should consult their doctor or pharmacist before taking ApoSuprid.

ApoSuprid and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription.

In particular, the patient should not take the following medicines with ApoSuprid and should inform their doctor if they are taking any of the following medicines:

The patient should inform their doctor if they 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 patients with HIV)
• 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.

The patient should inform their doctor if they 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 to treat 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 to treat allergies) that cause drowsiness, such as promethazine

If the patient is unsure whether any of the above situations apply to them, they should inform their doctor if they are taking ApoSuprid.

ApoSuprid with food, drink, and alcohol

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

The patient should not drink alcohol while taking ApoSuprid, as it may enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy

ApoSuprid is not recommended during pregnancy and in women of childbearing age 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, restlessness, breathing difficulties, feeding difficulties. If the patient notices such symptoms in their child, they should contact their doctor.

Breastfeeding

The patient should not breastfeed while taking ApoSuprid. If the patient is taking ApoSuprid, they should discuss the best way to feed their baby with their doctor.

Fertility

A decrease in fertility has been observed.

Driving and using machines

ApoSuprid may cause blurred vision, decreased alertness, dizziness, or drowsiness. If the patient experiences any of these symptoms, they should not drive or operate any tools or machines.

ApoSuprid contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their 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 considered "sodium-free".

3. How to take ApoSuprid

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

How to take ApoSuprid

• The medicine should be taken orally
• The tablets should be swallowed whole with water. The tablets should not be chewed.
• The medicine should be taken between meals.
• If the patient feels that the effect of the medicine is too weak or too strong, they should consult their doctor. The patient should not change the dose of the medicine themselves.

Recommended dose

The dose of ApoSuprid depends on the severity of the disease. The patient should follow their doctor's instructions exactly.

Adults

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

The doctor may start treatment with a lower dose if necessary.

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

Patients over 65 years old

• Close medical supervision is necessary, 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

• The 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 should 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 should not take this medicine (see section 2 "When not to take ApoSuprid").

Taking a higher dose of ApoSuprid than recommended

If the patient takes more ApoSuprid than recommended, they should contact their doctor or go to the nearest hospital immediately. They should take the tablets, leaflet, and (or) packaging of the medicine with them, so the doctor knows what medicine has been taken. The patient may experience symptoms such as: restlessness or trembling, muscle stiffness, drowsiness, which can lead to loss of consciousness.

Missing a dose of ApoSuprid

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

Stopping ApoSuprid treatment

The patient should continue taking ApoSuprid as long as their doctor recommends. The patient should not stop taking ApoSuprid just because they feel better. If the patient stops treatment, their condition may worsen or recur. ApoSuprid should not be stopped abruptly unless the doctor advises it. Stopping the medicine abruptly may cause withdrawal symptoms, such as:

• Nausea or vomiting
• Sweating
• Difficulty sleeping or feeling anxious
• Muscle stiffness or unusual body movements
• The patient's condition may worsen

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

Blood tests

Taking ApoSuprid may affect some blood test results, such as prolactin levels and liver function tests. If the patient is going to have a blood test, they should inform their doctor that they are taking ApoSuprid. If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking ApoSuprid and contact their doctor or go to the nearest hospital immediately if they 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, but rare, condition called neuroleptic malignant syndrome, which can be life-threatening.
• Abnormal heart function, very rapid heart rate, 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 bloodstream to the lungs, causing chest pain and breathing difficulties. If the patient notices such symptoms, they should contact their 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 (epilepsy)
• 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, throat pain, 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)

The patient should contact their doctor immediately if they experience any of the following side effects:

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

• Trembling, muscle stiffness, or 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 the 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, abnormal milk production (which 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 tissue 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)
• Chills of mild intensity, breathing difficulties (dyspnea) of mild intensity, and muscle pain have also been observed.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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, more information can be gathered on the safety of this medicine.

5. How to store ApoSuprid

The medicine should be kept out of sight and reach of children. The patient should not take this medicine after the expiry date stated on the packaging and blister after: EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What ApoSuprid contains

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

Coated tablets 400 mg:
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 Warszawa
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 tablets
Amisulpride arrow lab 400 mg film-coated 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