REXULTI tablets contain the active substance brexpiprazole.

REXULTI is a prescription medicine used to treat adults aged 18 and older who suffer from:

• Major depressive disorder (MDD): REXULTI is used in addition to your antidepressant medicine, when your doctor determines that the antidepressant alone did not adequately treat your depression.
• Schizophrenia: REXULTI is used to treat symptoms of schizophrenia. Your doctor may continue to prescribe REXULTI even when you are feeling better in order to prevent the re-emergence of symptoms.

Do not take REXULTI:
if you are allergic to brexpiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before taking REXULTI, tell your doctor if you:

• are an elderly person with dementia (loss of memory and other mental abilities);
• have diabetes or high blood sugar or a family history of diabetes or high blood sugar;
• have high levels of cholesterol, triglycerides, LDL-cholesterol, or low levels of HDL cholesterol;
• have or had seizures (convulsions);
• have or had low or high blood pressure;
• have or had heart problems or a stroke;
• have or had a low white blood cell count;
• have liver or kidney problems;

While taking REXULTI:

• tell your doctor if you have any of these symptoms of high blood sugar: feel very thirsty, feel sick to your stomach, need to urinate more than usual, feel very hungry, feel weak or tired, feel confused, or your breath smells fruity;
• tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat;
• tell your doctor immediately it you experience involuntary, irregular muscle movements, especially in the face, such as tongue and lips;
• tell your doctor immediately if you are having any thoughts or feelings about harming yourself. Suicidal thoughts and behavior have been reported during antipsychotic treatment;
• avoid getting over-heated or dehydrated. Do not over-exercise and drink plenty of water.
• tell your doctor immediately if you have problems with impulse control (i.e. urge to gamble, spend money, eat or other urges or sex addiction).
• tell your doctor immediately if you have or had a low number of white blood cells in your blood and get a fever or any other sign of infection. This may for example be the case if other medicines lowered your white blood cells in the past. Your doctor will regularly measure the white blood cells in your blood to minimise the risk for diseases called leukopenia, neutropenia and agranulocytosis. It is important that you get your blood checked regularly as this may be fatal. Your doctor will stop the treatment immediately if the white blood cells in your blood are too low.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. The safety and effectiveness in these patients was not evaluated.

Other medicines and REXULTI
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor can tell you if it is safe to take REXULTI with your other medicines. Do not start or stop any medicines while taking REXULTI without talking to your doctor first.

Taking REXULTI tablets with other medicines may require to change your dose of REXULTI tablets. It is especially important to mention to your doctor if you take any of the following:

• Blood pressure-lowering medicines,
• Medicines to correct heart rhythm (e.g. quinidine),
• Antidepressants (e.g. paroxetine, fluoxetine) or herbal remedy for depression (e.g. St John’s Wort),
• Medicines to treat fungal infections (e.g. ketoconazole),
• Antibiotic medicines (e.g. rifampicin, clarithromycin),
• Certain medicines to treat HIV infection (e.g. ritonavir).
• Medicines to treat epilepsy (e.g. carbamazepine)

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with REXULTI tablets, you should see your doctor.

REXULTI with food and alcohol
REXULTI can be taken regardless of meals.
Alcohol should be avoided.

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

The effect of REXULTI on your unborn baby is not known. Using REXULTI in the last trimester of pregnancy may cause muscle movement problems, medicine withdrawal symptoms, or both of these in your newborn.

It is not known if brexpiprazole passes into breast milk. You and your doctor should decide if you will take REXULTI during breastfeeding.

Driving and using machines
Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy.

REXULTI tablets contain lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Major Depressive Disorder:
The recommended dose in Major Depressive Disorder is 2 mg once daily. In order to reduce the risk of side effects the dose is increased gradually to reach the recommended dose.

The usual starting dose is 0.5 mg or 1 mg once daily for the first week, which is then increased gradually up to the target recommended dose of 2 mg. The maximum recommended daily dosage is 3 mg.

Schizophrenia
The recommended dose in Schizophrenia is 2-4 mg once daily. In order to reduce the risk of side effects the dose is increased gradually to reach the recommended dose.

The usual starting dose is 1 mg once daily for the first 4 days. This is increased to 2 mg from Day 5 through 7. From Day 8 the dose may be increased up to 4 mg once a day. The maximum recommended daily dosage is 4 mg.

The recommended dose for the continuation of treatment to prevent re-emergence of symptoms is 2-4 mg once daily.

Your doctor will advise on the best dose for you.

Try to take your REXULTI tablets at the same time each day. Swallow your tablets whole with water. Do not split, chew, or crush the tablets.

If you take more REXULTI than you should
If you have taken too many REXULTI tablets, contact your doctor right away even if there are no symptoms. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

If you forget to take REXULTI
Take the missed dose as soon as you remember. If you are close to your next dose, just skip the missed dose and take your next dose at your regular time. Do not take a double dose to make up for a forgotten dose.

If you stop taking REXULTI
If you stop taking REXULTI you may experience re-emergence of your symptoms. It is not recommended to stop taking REXULTI without prior consultation with your doctor.

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

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

Common (may affect up to 1 in 10 people):
Increased appetite, restlessness, insomnia, anxiety, inner restlessness, tremor, sedation extrapyramidal disorder (involuntory movments, slow and impaired voluntory movements, and changes in muscle tone), dizziness, somnolence, vision blurred (blurry vision), high blood pressure, diarrhoea, dry mouth, stomach pain , constipation,, rash , back pain, pain in arms and/or legs, fatigue, pain weight increased, increased blood prolactin (increased levels of hormone called “prolactin”), decreased blood cortisol (decreased levels of hormone called “cortisol”), Creatinine Phosphokinase Increased (increase in enzyme important for muscle function).muscle strain.

Uncommon (may affect up to 1 in 100 people):
Tension, parkinsonism (tremor, stiffness and shuffling), cough, tinnitus, palpitations (feeling your heartbeat) flatulence, salivary hypersecretion, night sweats, muscle pain.

Other side effect may also occur with low frequency:
Indigestion, agitation and hypersensitivity.Some people taking Rexulti have had unusual urges, such as gambling, eating that you cannot control (compulsive), compulsive shopping and other compulsive behaviours. If you or your family members notice that you are having unusual urges or behaviours, talk to your doctor Rexulti may cause serious side effects, including:

• Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of patients with dementiarelated psychosis.
• Risk of suicidal thoughts or actions. Antidepressant medicines, depression and other serious mental illnesses, may cause suicidal thoughts or actions. REXULTI is not approved for the treatment of people younger than 18 years of age.
  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manicdepressive illness) or suicidal thoughts or actions.
  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• new or worsening depression
• feeling very agitated or restless
• panic attacks
• new or worsening irritability
• an extreme increase in activity or talking (mania)
• attempts to commit suicide
• new or worsening anxiety
• acting on dangerous impulses
• trouble sleeping (insomnia)
• acting aggressive, being angry, or violent
• other unusual changes in behavior or mood”

These are not all the possible side effects of REXULTI. For more information, ask your doctor or pharmacist.

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 carton after EXP. The expiry date refers to the last day of that month.

Store REXULTI at room temperature, below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.