RXULTI 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: 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 all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is RXULTI and what is it used for

RXULTI contains the active substance brexpiprazole, which belongs to a group of medicines called antipsychotics.

It is used to treat schizophrenia in adult and adolescent patients aged 13 years and older, a disease with 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 relapse during treatment.

2. What you need to know before you take RXULTI

Do not take RXULTI

• if you are allergic to brexpiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor immediately if

• you have a combination of fever, sweating, rapid breathing, muscle stiffness, numbness, and drowsiness (these 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 at the start of treatment.
• your family or caregiver notice that you are developing impulses or urges to behave in an unusual way for you and that 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 gambling addiction, excessive food intake, or excessive spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings. Your doctor may consider adjusting or interrupting the dose.
• you have 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 could be the case if other medications have decreased your white blood cell count in the past. Your doctor will regularly check your white blood cell count in your blood to minimize the risk of diseases called leukopenia, 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 in your blood is too low.

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

• had heart problems or a history of stroke, especially if you know you have other risk factors that may favor a stroke.
• dementia (loss of memory and other mental abilities), especially if you are elderly.
• irregular heartbeats or if someone else in your family has a history of irregular heartbeats (including the so-called QT interval prolongation observed with ECG monitoring). Tell your doctor if you are taking other medications known to prolong the QT interval.
• an electrolyte imbalance (problems with the amount of salts in the blood).
• had low or high blood pressure.
• a history of blood clots, or if someone else in your family has a history of blood clots, as schizophrenia medications have been associated with the formation of blood clots.
• had dizziness when standing up due to a drop in blood pressure, which can cause fainting.
• had problems with your movements, called extrapyramidal symptoms (EPS), in the past. These may include spasmodic movements, spasms, restlessness, or slow movements.
• have presented or begin to present restlessness and inability to stay still. These symptoms may occur early in treatment. Tell your doctor if this happens.
• diabetes or risk factors for diabetes (e.g., obesity or a family history of diabetes). Your doctor should regularly check 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 a feeling of weakness.
• a history of seizures (attacks) or epilepsy.
• ever inhaled food, stomach acid, or saliva into the lungs, causing a disease called aspiration pneumonia.
• an increase in prolactin hormone levels or have a tumor in the pituitary gland.

Weight gain

This medication may cause significant weight gain, which can affect your health. Therefore, your doctor will regularly check your weight and blood fats.

Body temperature

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

Children and adolescents

Children under 13 years of age should not take this medication. Safety and efficacy in these patients have not been evaluated.

Other medicines and RXULTI

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

RXULTI may increase the effect of medications used to lower blood pressure. Make sure to tell your doctor if you are taking 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:

• medicines to correct heart rhythm (such as quinidine),
• antidepressants or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, St. John's Wort),
• medicines to treat fungal infections (antifungals) (such as ketoconazole, itraconazole),
• certain medicines to treat HIV infection (such as ritonavir),
• anticonvulsants used to treat epilepsy (such as carbamazepine and phenobarbital),
• antibiotics to treat bacterial infections (such as clarithromycin),
• certain antibiotics used to treat tuberculosis (such as rifampicin),
• medicines such as moxifloxacin (an antibiotic) known to prolong the QT interval (an important measure of heart function on an electrocardiogram [ECG]),
• medicines that change the salt concentrations in your body (causing the so-called electrolyte imbalance); for example, water pills such as furosemide and bendroflumethiazide.
• medicines that increase an enzyme called creatine phosphokinase (CPK); for example, medicines known as statins, such as simvastatin, to reduce cholesterol levels in the blood,
• medicines that have an effect on the central nervous system, such as codeine (a cough suppressant) or morphine (used to treat severe pain).

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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

RXULTI is not recommended during pregnancy. If you are of childbearing age, you should use effective contraception while taking RXULTI. Babies of mothers who take this medication during the last three months of pregnancy may have symptoms such as tremors, muscle stiffness, and/or weakness, drowsiness, restlessness, breathing problems, and difficulty feeding. If your baby has any of these symptoms, you should contact your doctor.

Talk to your doctor about 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 using machines

There is a possibility that the medication may affect your ability to drive and use machines. Check that you do not feel dizzy or drowsy before starting to drive or operate machinery. 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 some sugars, consult them before taking this medication.

3. How to take RXULTI

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The medication is usually administered in increasing doses as follows:

For adults:

• 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 1 mg film-coated tablet of the dose prescribed by your doctor per day.

For pediatric patients:

• for the first 4 days, take one 0.5 mg film-coated tablet per day,
• from day 5 to 7, take one 1 mg film-coated tablet per day,
• from day 8 onwards, take one film-coated tablet of the dose prescribed by your doctor per day.

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

It does not matter if 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 discontinue the other medication or immediately and how to adjust the dose of RXULTI. Your doctor will also inform you about how to act if you switch from RXULTI to other medications.

Patient with kidney problems

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

Patient 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 the nearest hospital immediately. Remember to take the medicine package with you so that 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 for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for missed doses. If you forget two or more doses, consult your doctor.

If you stop taking RXULTI

If you stop taking this medication, you will lose its effects. Although you may feel better, do not change or stop your daily dose of RXULTI unless your doctor tells you to, as symptoms may recur.

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

4. Possible side effects

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

During treatment, you may have these serious side effects that require urgent medical attention.

Tell your doctor immediatelyif you have:

• thoughts or feelings related to self-harm or suicide or a suicide attempt (rare side effect- may affect up to 1 in 100 people).
• a combination of fever, sweating, rapid breathing, muscle stiffness, and drowsiness. These may be symptoms of malignant neuroleptic syndrome (the frequency is not known).
• irregular heartbeats that may be due to abnormal nerve impulses in the heart, abnormal readings during the cardiac examination (ECG) of QT interval prolongation - the frequency is not known.
• symptoms related to blood clots in the veins, especially in the legs (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 (rare side effect- may affect up to 1 in 100 people).

Other side effects

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

• during blood tests, your doctor may find high 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 inner restlessness and a compelling 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).

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

• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, hives),
• parkinsonism: a medical condition with many varied symptoms including slow or reduced movements, slow thinking, jerky movements when bending limbs (cogwheel rigidity), shuffling gait, taking small steps, tremors, little or no facial expression, muscle stiffness, drooling,
• dizziness when standing up due to a drop in blood pressure, which can cause fainting,
• cough,
• dental caries,
• flatulence,
• muscle pain,
• high blood pressure,
• during blood tests, your doctor may find high levels of triglycerides in the blood,
• during blood tests, your doctor may find elevated liver enzymes.

Other side effects (frequency not known):

seizures,

• muscle weakness, sensitivity, or pain, and particularly if you also feel unwell, have a high temperature, or have dark urine. These may be caused by an abnormal muscle breakdown that can be potentially fatal and cause kidney problems (a condition known as rhabdomyolysis),
• withdrawal symptoms in newborns if the mother has taken this medication during pregnancy,
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences,
• altered or increased sexual interest and behavior that is concerning for you or others, for example, increased sexual appetite,
• uncontrollable shopping,
• binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing RXULTI

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

Do not use this medicine after the expiry date which is stated on the blister and on the outer packaging after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of RXULTI film-coated tablets

• The active ingredient is brexpiprazole.

Each film-coated tablet contains 0.25 mg of brexpiprazole.

Each film-coated tablet contains 0.5 mg of brexpiprazole.

Each film-coated tablet contains 1 mg of brexpiprazole.

Each film-coated tablet contains 2 mg of brexpiprazole.

Each film-coated tablet contains 3 mg of brexpiprazole.

Each film-coated tablet contains 4 mg of brexpiprazole.

• The other ingredients are:

Tablet core:

Lactose monohydrate (see section 2 «RXULTI contains lactose»), corn starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, purified water.

Tablet coating:

Hypromellose (E 464), talc (E 553b), titanium dioxide (E 171).

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)

Appearance and Package Contents

RXULTI 0.25 mg film-coated tablets

Light brown, round, 6 mm in diameter, smooth, convex and beveled edge, engraved with BRX and 0.25 on one side.

RXULTI 0.5 mg film-coated tablets

Light orange, round, 6 mm in diameter, smooth, convex and beveled edge, engraved with BRX and 0.5 on one side.

RXULTI 1 mg film-coated tablets

Light yellow, round, 6 mm in diameter, smooth, convex and beveled edge, engraved with BRX and 1 on one side.

RXULTI 2 mg film-coated tablets

Light green, round, 6 mm in diameter, smooth, convex and beveled edge, engraved with BRX and 2 on one side.

RXULTI 3 mg film-coated tablets

Light purple, round, 6 mm in diameter, smooth, convex and beveled edge, engraved with BRX and 3 on one side.

RXULTI 4 mg film-coated tablets

White, round, 6 mm in diameter, smooth, convex and beveled edge, engraved with BRX and 4 on one side.

RXULTI tablets are supplied in an aluminum/PVC blister pack containing 10, 28 or 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Manufacturer

Elaiapharm

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

06560 Valbonne

France

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:

Other sources of information

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