Label: information for the user

RXULTI 0.25 mg film-coated tablets

RXULTI 0.5 mg film-coated tablets

RXULTI 1 mg film-coated tablets

RXULTI 2 mg film-coated tablets

RXULTI 3 mg film-coated tablets

RXULTI 4 mg film-coated tablets

brexpiprazole

Read this label carefully before starting to take this medicine, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is RXULTI and what it is used for

2. What you need to know before starting to take RXULTI

3. How to take RXULTI

4. Possible side effects

5. Storage of RXULTI

6. Contents of the pack and additional information

RXULTI contains the active ingredient brexpiprazol, which belongs to a group of medications called antipsychotics.

It is used to treat schizophrenia in adult patients, a condition characterized by symptoms such as hearing, seeing, or feeling things that do not exist, distrust, incoherent speech and behavior, and emotional depression. People with this condition may also feel depressed, guilty, anxious, or tense.

RXULTI may help keep symptoms under control and prevent relapses while continuing treatment.

• If you are allergic to brexpiprazol or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Inform your doctor immediately if

• you experience a combination of fever, sweating, rapid breathing, muscle stiffness, numbness, and drowsiness (which may be signs of malignant neuroleptic syndrome).

•You have thoughts or feelings related to self-harm or suicide. Suicidal thoughts and behaviors are more likely to occur at the beginning of treatment.

•Your family or caregiver notice that you are developing impulses or urges to behave in an unusual way, and you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as excessive gaming, excessive food intake, excessive spending, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings. Your doctor may consider adjusting or discontinuing the dose.

• You have any difficulty swallowing.

•You have or have had a low white blood cell count in your blood and have a fever or any other sign of infection. For example, this may be the case if other medications have reduced the number of white blood cells in your blood in the past. Your doctor will regularly measure the white blood cells in your blood to minimize the risk of diseases called leucopenia, neutropenia, and agranulocytosis. It is essential to have regular blood tests, as this can be fatal. Your doctor will stop treatment immediately if your white blood cell count is too low.

Consult your doctor or pharmacist before taking RXULTI, or during treatment if you have

• or have had heart problems or a history of stroke, especially if you know you have other risk factors for stroke.
• Dementia (loss of memory and other mental abilities), especially if you are of advanced age.
• Irregular heartbeats or if someone in your family has a history of irregular heartbeats (including the condition known as prolonged QT interval, which is observed with ECG monitoring). Inform your doctor if you take other medications that are known to prolong the QT interval.
• Electrolyte imbalance (problems with the amount of salts in your blood).
• or have had low or high blood pressure.
• History of blood clots, or if someone in your family has a history of blood clots, as antipsychotic medications have been associated with blood clot formation.
• or have had dizziness when standing due to low blood pressure, which can cause fainting
• or have had problems with your movements, called extrapyramidal symptoms (EPS), in the past. These may include spasmodic movements, spasms, restlessness, or slow movements.
• You have ever or begin to experience restlessness and inability to remain still.

These symptoms may occur early in treatment. Inform your doctor if this happens.

• Diabetes or risk factors for diabetes (for example, obesity or if someone in your family has diabetes). Your doctor should regularly monitor your blood sugar levels, as they may increase with this medication. Signs of high blood sugar levels are: excessive thirst, large amounts of urine, increased appetite, and feeling weak.
• History of seizures (attacks) or epilepsy.
• You have ever inhaled food, stomach acid, or saliva into your lungs, causing a disease called aspiration pneumonia.
• You have an increase in prolactin hormone levels or have a pituitary gland tumor.

Weight Gain

This medication may cause significant weight gain that can affect your health. Therefore, your doctor will regularly monitor your weight and body fat.

Body Temperature

While taking RXULTI, you should avoid overheating or dehydration. Do not overexert yourself and drink plenty of water.

Children and Adolescents

Children and adolescents under 18 years of age should not take this medication. The safety and efficacy in these patients have not been evaluated.

Other Medications and RXULTI

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

RXULTI may increase the effect of medications used to lower blood pressure. Ensure you inform your doctor if you take a medication to keep your blood pressure under control.

Taking RXULTI with some medications may mean that your doctor will need to change the dose of RXULTI or the other medications. It is especially important to mention the following medications to your doctor:

• Medications to correct heart rhythm (such as quinidine),

•Antidepressants or plant-based medications used to treat depression and anxiety (such as fluoxetine, paroxetine, St. John's Wort),

• Medications to treat fungal infections (antifungals) (such as ketoconazole, itraconazole),

•Certain medications to treat HIV infection,

• Anticonvulsants used to treat epilepsy,

• Antibiotics to treat bacterial infections (such as clarithromycin),

• Certain antibiotics used to treat tuberculosis (such as rifampicin),

•Medications known to prolong the QT interval (an important measure of your heart's functioning in an electrocardiogram [ECG]),

• Medications that change the concentration of salt in your body (causing the condition known as electrolyte imbalance),

• Medications that increase an enzyme called creatine phosphokinase (CPK),

• Medications that have an effect on the central nervous system.

RXULTI with Food and Alcohol

RXULTI can be taken with or without food. Alcohol should be avoided as it may affect how this medication works.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy. If you are of childbearing age, you should use effective contraception while taking RXULTI. Babies born to mothers taking this medication during the last three months of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding difficulties. If your baby has any of these symptoms, you should contact your doctor.

Discuss with your doctor the best way to feed your baby if you are taking RXULTI. Your doctor will consider the benefit of treatment for you and the benefit of breastfeeding for your baby.

Driving and Operating Machines

There is a possibility that the medication may affect your ability to drive and operate machines. Check that you do not feel dizzy or drowsy before starting to drive or operate machines. Do not drive or use tools or machines until you know that this medication does not affect you negatively.

RXULTI contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The medication will usually be administered in increasing doses in the following way:

• For the first 4 days, take one 1 mg film-coated tablet per day,
• From day 5 to 7, take two 1 mg film-coated tablets per day,
• From day 8 onwards, take one film-coated tablet of the prescribed strength per day as indicated by your doctor.

However, your doctor may prescribe a lower or higher dose up to a maximum of 4 mg per day.

It does not matter whether you take the medication with or without food.

If you were taking other medications for schizophrenia before starting treatment with RXULTI, your doctor will decide whether to gradually or immediately discontinue the other medication and how to adjust the RXULTI dose. Your doctor will also inform you on how to act if you switch from RXULTI to other medications.

Patients with kidney problems

If you have kidney problems, your doctor may adjust the dose of this medication.

Patients with liver problems

If you have liver problems, your doctor may adjust the dose of this medication.

If you take more RXULTI than you should

If you have taken more RXULTI than the prescribed dose, contact your doctor or local hospital immediately. Remember to bring the medication packaging with you so it is clear what you have taken.

If you forget to take RXULTI

If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose and take the next dose at your usual time. Do not take a double dose to make up for the missed dose. If you forget two or more doses, consult your doctor.

If you interrupt treatment with RXULTI

If you interrupt treatment with this medication, you will lose its effects. Although you may feel better, do not modify or interrupt your daily dose of RXULTI unless your doctor tells you to, as symptoms may reappear.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During treatment, you may experience these severe side effects that require urgent medical attention.

Inform your doctorimmediatelyif you have:

• thoughts or feelings related to self-harm or suicide or a suicide attempt (infrequent side effect- may affect up to 1 in 100 people).

•a combination of fever, sweating, muscle stiffness, and drowsiness. These could be symptoms of the so-called malignant neuroleptic syndrome (the number of people affected is unknown).

•irregular heart rhythms that may be due to abnormal nerve impulses in the heart, abnormal readings during the electrocardiogram (ECG) of the prolongation of the QT interval - the number of people affected is unknown.

•symptoms related to blood clots in the veins, especially in the legs (your symptoms are swelling, pain, and redness of the leg), which can move through the blood vessels to the lungs and cause chest pain and difficulty breathing (infrequent side effect- may affect up to 1 in 100 people).

Other side effects

Frequent side effects (may affect more than 1 in 10 people):

•during blood tests, your doctor may find elevated levels of prolactin in the blood.

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

• skin rash,

• weight gain,

•akathisia (an uncomfortable feeling of internal restlessness and an urgent need to move constantly),

• dizziness,

• tremors,

• drowsiness,

• diarrhea,

• nausea,

• upper abdominal pain,

• back pain,

• pain in arms or legs or both,

•during blood tests, your doctor may find higher levels of creatine kinase (also called creatine phosphokinase) in the blood (an enzyme important for muscle function).

Infrequent side effects (may affect up to 1 in 100 people):

• allergic reaction (for example, swelling in the mouth, tongue, face, and throat, itching, urticaria),

•parkinsonism: a medical condition with many varied symptoms that include slow or decreased movements, slowness of thought, jerks when bending the limbs (rigidity in ratchet wheel), dragging the feet, taking steps, tremors, little or no facial expression, muscle stiffness, drooling,

•dizziness when standing due to a drop in blood pressure, which can cause fainting,

• cough,

• tooth decay,

• flatulence,

• muscle pain,

• high blood pressure,

•during blood tests, your doctor may find elevated levels of triglycerides in the blood,

• during blood tests, your doctor may find elevations in liver enzymes.

Other side effects (the number of people affected is unknown):

• convulsions,

•muscle weakness, sensitivity or pain, and particularly if you feel unwell, have a high temperature, or have dark urine. They may be caused by abnormal muscle deterioration that can be potentially fatal and cause kidney problems (a condition known as rhabdomyolysis),

•withdrawal symptoms in newborns if the mother has taken this medicine during pregnancy.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. Mediante thereporting of side effects you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the outer box after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of RXULTI film-coated tablets

• The active ingredient is brexpiprazol.

Each film-coated tablet contains 0.25 mg of brexpiprazol.

Each film-coated tablet contains 0.5 mg of brexpiprazol.

Each film-coated tablet contains 1 mg of brexpiprazol.

Each film-coated tablet contains 2 mg of brexpiprazol.

Each film-coated tablet contains 3 mg of brexpiprazol.

Each film-coated tablet contains 4 mg of brexpiprazol.

•The other components are:

Core of the tablet:

Lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose partially substituted, hydroxypropylcellulose, magnesium stearate, purified water

Coating of the tablet:

Hydroxypropylmethylcellulose, talc, titanium dioxide

RXULTI 0.25 mg film-coated tablets

Iron oxide E 172 (yellow, red, black)

RXULTI 0.5 mg film-coated tablets

Iron oxide E 172 (yellow, red)

RXULTI 1 mg film-coated tablets

Iron oxide E 172 (yellow)

RXULTI 2 mg film-coated tablets

Iron oxide E 172 (yellow, black)

RXULTI 3 mg film-coated tablets

Iron oxide E 172 (red, black)

RXULTI 4 mg film-coated tablets

Iron oxide E 172 (black)

The RXULTI tablets are supplied in an aluminium/PVC blister pack containing 10 or

28 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Responsible manufacturer

Elaiapharm

2881 Route des Crêtes, Z.I. Les Bouillides-Sophia Antipolis,

06560 Valbonne

France

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

For further information about this medicinal product, please consult the representative in your country of the marketing authorisation holder:

Last update of this leaflet: {MM/AAAA}

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.