Aposuprid

Package leaflet: Information for the user

ApoSuprid, 200 mg, tablets
ApoSuprid, 400 mg, coated tablets
Amisulpridum
Please read all of this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What ApoSuprid is and what it is 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 ApoSuprid is and what it is used for

ApoSuprid contains a medicine called amisulprid. It belongs to a group of medicines called "antipsychotics". It is used in the treatment of a condition called schizophrenia. Schizophrenia may cause a person to feel, see or hear things that do not exist (hallucinations), to have strange and frightening thoughts (delusions), and to change their behaviour and emotional responses, often leading to withdrawal. Sometimes people with these symptoms may also feel tense, restless, become suspicious or aggressive for no apparent reason (these are known as "positive symptoms"), or may show signs of depression and social withdrawal (these are known as "negative symptoms"). ApoSuprid works by improving disturbed thoughts, feelings and behaviours. It is used in the initial treatment of schizophrenia, as well as for its long-term management.

2. Important information before using ApoSuprid

When not to use ApoSuprid

• if the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• if the patient is pregnant, suspects she may be pregnant, or is breastfeeding (see section "Pregnancy, breastfeeding and fertility"),
• if the patient has breast cancer or tumours whose growth is dependent on prolactin levels,
• if the patient has a pituitary gland tumour,
• if the patient has a chromaffin tumour of the adrenal gland (phaeochromocytoma),
• if the patient is taking levodopa, a medicine used in the treatment of Parkinson's disease (see section "ApoSuprid with other medicines"),
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may

cause heart rhythm disturbances when taken at the same time as amisulpride
(see section "ApoSuprid with other medicines" below),

• in patients under 15 years of age.

If any of the above situations apply, this medicine must not be used.
If in doubt, consult a doctor or pharmacist before starting treatment with ApoSuprid.
Warnings and precautions
Talk to your doctor or pharmacist before taking ApoSuprid if:

• the patient experiences fever, rapid breathing, excessive sweating, reduced consciousness or muscle stiffness, which are symptoms of a serious, potentially fatal condition called "neuroleptic malignant syndrome". The medicine ApoSuprid must be stopped immediately and the doctor contacted;
• the patient has kidney disease;
• the patient has Parkinson's disease;
• the patient has seizures (epilepsy);
• the patient has irregular heart rhythm (arrhythmia);
• the patient has heart disease or a family history of heart disease or sudden death;
• the patient or a family member has long QT interval (a measure of heart function, which can be determined by a doctor from an electrocardiogram);
• the patient has had a stroke or the doctor has informed the patient of a risk of stroke;
• the patient or a family member has had blood clots, as use of this type of medicine may increase the risk of blood clots;
• the patient has diabetes or has been told they are at increased risk of developing diabetes;
• the patient has a slow heart rate (less than 55 beats per minute);
• the patient is taking other medicines that may affect heart function. Before taking other medicines, contact the doctor. See also: "When not to use ApoSuprid", "ApoSuprid with other medicines";
• the patient has been told they have low levels of potassium or magnesium in the blood;
• the patient is elderly: low blood pressure and excessive sedation occur more frequently in older people. In elderly patients with dementia, a slightly higher number of deaths has been observed when treated with antipsychotic medicines compared to patients not treated with antipsychotics;
• the patient has a low white blood cell count (agranulocytosis). This means infections may occur more easily than usual;
• the patient has frequent infections, fever, chills, severe sore throat or mouth ulcers. These may be symptoms of a blood disorder called "leukopenia";
• the patient or a family member has had breast cancer, because use of amisulpride may affect the risk of developing breast cancer. The doctor will closely monitor the patient during treatment with ApoSuprid;
• amisulpride may increase prolactin levels. If very high prolactin levels in the blood or symptoms of a pituitary tumour (such as visual disturbances and headaches) occur, an imaging test of the pituitary gland will be performed. After confirmation of a pituitary tumour diagnosis, treatment with amisulpride will be discontinued (see section "When not to use ApoSuprid");
• severe liver function disturbances have been reported during treatment with ApoSuprid. Contact the doctor immediately if fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellowing of the eyes or skin occur.

If in doubt about any of the above conditions, contact a doctor or pharmacist before starting
treatment with ApoSuprid.
ApoSuprid with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription, as well as any medicines the patient plans to take.
In particular, do not take the following medicines together with ApoSuprid and inform the doctor
if the patient is taking any of the following medicines:

• Levodopa, a medicine used in the treatment of Parkinson's disease
• Medicines called "dopamine agonists", such as ropinirole and bromocriptine
• Medicines used to treat heart rhythm disorders (e.g. quinidine, disopyramide, amiodarone, sotalol)
• Cisapride (used to treat gastrointestinal problems)
• Bepridil (used to treat angina/chest pain and heart rhythm disturbances)
• 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 patients)
• Intravenous erythromycin or sparfloxacin (antibiotics)
• Medicines used to treat fungal infections, such as clotrimazole
• Intravenous vinpocetine (used for various brain function disorders)
• Clozapine used to treat schizophrenia
• Sucralfate used to treat stomach ulcers, intestinal ulcers and inflammatory conditions of the stomach lining
• Medicines that neutralise gastric acid used to reduce stomach acidity.

Inform the doctor if the patient is taking any of the following medicines:

• Medicines used to treat high blood pressure or other heart problems that may slow heart function. These include beta-blockers (e.g. nebivolol or bisoprolol), diltiazem, verapamil, clonidine, guanfacine, digoxin or digoxin-like medicines
• Medicines that cause potassium loss, including diuretics, certain laxatives, intravenous amphotericin B, glucocorticosteroids (used to treat asthma or rheumatoid arthritis) and tetracosactide (which may be used in clinical studies)
• 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 for mental health problems
• Strong painkillers called opioids, such as morphine or pethidine
• Clonidine used to treat migraine, flushing or high blood pressure
• Mefloquine used to treat malaria
• Medicines that help with sleep, such as barbiturates and benzodiazepines
• Painkillers, such as tramadol and indometacin
• Anaesthetics
• Antihistamines (used for allergies) that cause drowsiness, such as promethazine

If you are unsure whether any of the above situations apply to the patient, inform the doctor if the patient is 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 alcohol effects may be intensified.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should
consult a doctor or pharmacist before using this medicine.
Pregnancy
ApoSuprid is not recommended during pregnancy and in women of childbearing potential who are not using effective contraception.
In a newborn whose mother took ApoSuprid during the last trimester (last three months) of pregnancy, the following symptoms may occur: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, feeding problems. If such symptoms are observed in your child, contact a doctor.
Breastfeeding
Do not breastfeed while taking ApoSuprid. If ApoSuprid is used, discuss with the doctor the best way to feed the baby.
Fertility
Reduced ability to conceive has been observed.
Driving and using machines
ApoSuprid may cause blurred vision, reduced alertness, dizziness or drowsiness. If these symptoms occur, do not drive or operate any tools or machines.
ApoSuprid contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
ApoSuprid contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use ApoSuprid

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
How to use ApoSuprid

• This medicine should be taken orally.
• Tablets should be swallowed whole with water. Do not chew the tablets.
• 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. Do not change the dose independently.

Recommended dose
The dosage of ApoSuprid depends on the severity of the disease. You must strictly follow the instructions
provided by your doctor.
Adults

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

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

• If needed, the doctor may prescribe up to 1200 mg per day.

• Doses below 300 mg per day may be taken once daily, preferably always at the same time.

• For doses exceeding 300 mg per day, half of the dose should be taken in the morning and the other half in the evening.

Elderly patients over 65 years of age

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

Patients with kidney impairment

• The doctor usually recommends a lower dose. 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 absolutely necessary, treatment of adolescents aged 15 to 18 years must be initiated and
supervised by a doctor experienced in treating schizophrenia in this age group.
Children and adolescents under 15 years of age must not use this medicine (see section 2. "When not to use ApoSuprid").
Taking more ApoSuprid than recommended
If you take more ApoSuprid than recommended, contact your doctor immediately or go to the nearest hospital.
Bring the tablets, the package leaflet, and/or the packaging with you so the doctor knows which medicine has been taken. Symptoms that may occur include:
restlessness or tremor, muscle stiffness, drowsiness, which may lead to loss of consciousness.
If you miss a dose of ApoSuprid
Take the missed dose 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 a missed dose.
Stopping ApoSuprid
Continue taking ApoSuprid for as long as your doctor advises. Do not stop taking ApoSuprid because you feel better. If
the patient stops treatment, the condition may worsen or relapse. ApoSuprid should not
be stopped suddenly unless instructed by the doctor.
Sudden discontinuation of treatment may cause withdrawal symptoms such as:

• Nausea or vomiting
• Sweating
• Difficulty falling asleep or feeling restless
• Muscle stiffness or unusual body movements
• Recurrence of 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 certain blood test results. This includes measurements of prolactin hormone levels and liver function tests. If the patient plans to have a blood test, they should inform the doctor about taking ApoSuprid.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking ApoSuprid and contact your doctor immediately or
go to the nearest hospital if the patient experiences any of the following:

• High body temperature, sweating, muscle stiffness, rapid heartbeat, fast breathing, confusion, dizziness, or agitation. These may be symptoms of a severe but rare condition called neuroleptic malignant syndrome, which is a complication that can lead to death.
• Irregular heart function, very rapid heartbeat, or chest pain, which may lead to heart attack or life-threatening heart disease.
• Blood clots in the veins, especially in the legs (symptoms include itching, pain, and redness in the limbs). These clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, contact your doctor immediately.

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

• Allergic reaction. Symptoms may include itchy, lumpy rash, difficulty swallowing and breathing, swelling of lips, face, throat, and tongue.
• Seizures (fits).
• More frequent infections than usual. This may be due to a reduced 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 frequent infections than usual. This may be due to a blood disorder (agranulocytosis).

Contact your doctor immediately if the patient experiences any of the
following adverse effects:
Very common: (may affect more than 1 in 10 people)

• Tremor, muscle stiffness or spasms, slowed movement, excessive salivation, restlessness.

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

• Uncontrolled movements, mainly of hands and feet. (These symptoms may be reduced 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 adverse effects:
Common: (may affect up to 1 in 10 people)

• Difficulty sleeping (insomnia) or feelings of anxiety or agitation.
• Drowsiness.
• Constipation, nausea or vomiting, dry mouth, indigestion.
• Weight gain.
• Increased prolactin (a protein) levels in the blood, which will be evident in blood tests and may cause:
• Breast pain or enlargement, abnormal milk production (may occur in both women and men).
• Menstrual disorders, such as absence of periods.
• Sexual disorders, such as problems achieving orgasm or difficulty in achieving or maintaining erection.
• Abnormal growth of the pituitary gland.
• Dizziness (which may be due to low blood pressure).
• Blurred vision.

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

• Slowed heart rate.
• High blood sugar (hyperglycemia).
• Increased blood pressure.
• Difficulty urinating.
• Increased liver enzyme activity, seen in blood tests.
• Confusion.
• Nasal congestion.
• Osteopenia (low bone mineral density).
• Osteoporosis – a condition in which bones are more prone to fracture.
• Liver tissue damage.
• Developing lung infection (aspiration pneumonia) after choking on food, liquid, saliva, or nasal secretions.
• 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 (rash).
• Swelling under the skin (angioedema).
• Hyponatremia (low sodium levels in the blood).
• Malaise, confusion, or weakness, nausea, loss of appetite, irritability. These may be symptoms of a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• Benign (non-cancerous) pituitary tumor, such as prolactinoma.

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

• Withdrawal syndrome may occur in newborns whose mothers took ApoSuprid during pregnancy.
• Restless legs syndrome (unpleasant sensations in the legs, temporarily relieved by movement).
• Increased skin sensitivity to sunlight and ultraviolet rays.
• Falls due to impaired body balance, sometimes leading to fractures.
• Rhabdomyolysis (muscle breakdown associated with muscle pain).
• Elevated creatine kinase levels (a blood test indicating muscle damage).
• Mild chills, mild breathing difficulties (dyspnea), and muscle pain have also been observed.

Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, tell your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps 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 pack after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required 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. Such measures 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.
• Other ingredients are:
  Tablets 200 mg: monohydrate lactose, methylcellulose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
  Coated tablets 400 mg:
  Tablet core: monohydrate lactose, 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 (12.0 mm in diameter), uncoated tablets with a score line on one side and the imprint “L 75” on the other. 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 score line on one side and the imprint “L 76” on the other. 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 Aluminium blisters and transparent PVC/PVdC Aluminium blisters.
Pack sizes: 15, 20, 30, 50, 60, 80, 100, 120 or 150 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Amisulprid AB 50 mg/ 100 mg/ 200 mg tabletten
Amisulprid AB 400 mg filmomhulde tabletten
France: Amisulpride arrow lab 100 mg/ 200 mg comprimé sécable
Amisulpride arrow lab 400 mg comprimé pelliculé sécable
Germany: Amisulprid PUREN 50 mg/ 100 mg/ 200 mg Tabletten
Amisulprid PUREN 400 mg Filmtabletten
Poland: ApoSuprid
Portugal: Amissulprida Aurobindo
Spain: Amisulprida Aurobindo 100 mg/ 200 mg comprimidos EFG
Amisulprida Aurobindo 400 mg comprimidos recubiertos con película EFG