0.25 mg / 0.5 mg / 1 mg / 2 mg / 3 mg / 4 mg film-coated tablets
brexpiprazole
What RXULTI is and what it is used for
RXULTI contains the active substance brexpiprazole and belongs to a group of medicines called antipsychotics.
It is used to treat adult patients with schizophrenia – a disease with symptoms such as the person hearing, seeing, or experiencing things that are not there, being suspicious, speaking and behavingng inconsistently, and showing emotional flattening. People in this condition may also feel depressed, guilty, anxious, or tense.
RXULTI can help keep symptoms under control and prevent recurrence during further treatment.
What you need to know before taking 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 cautions
Tell your doctor immediately if you:
- experiencing a combination of fever, sweating, rapid breathing, muscle stiffness, and drowsiness or drowsiness (may be a sign of malignant neuroleptic syndrome)
- have thoughts of or a feeling of wanting to hurt yourself or commit suicide. The risk of suicidal thoughts and behaviors is greater at the beginning of treatment
- or your family/caregiver notices that you are developing impulses or requests to behave in a way that is unusual for you and that you cannot resist the impulse, the drive, or the temptation to perform activities that may harm yourself or others. This is called disturbed impulse control. It may include behavior such as gambling addiction, excessive eating or buying behavior, abnormally high sex drive, or increased preoccupation with constant thoughts of sex or sexual feelings. Your doctor may need to adjust the dose one or stop the medication
- experience difficulty swallowing
- have or have had a low number of white blood cells in the blood and get a fever or other signs of infection. This can happen, for example, if other medicines have previously reduced the number of white blood cells. Your doctor will regularly measure the number of white blood cells in your blood to reduce the risk of diseases called leukopenia, neutropenia, and agranulocytosis. You must get your blood tested regularly as these diseases can be fatal. Your doctor will stop treatment immediately if your white blood cell count is too low.
Talk to your doctor or pharmacist before taking RXULTI, or during treatment, if you have any
- or have had heart problems or strokes, especially if you know you have other risk factors for stroke
- dementia (loss of memory and other mental abilities), especially if you are older
- irregular heartbeat, or if someone in your family has had an irregular heartbeat (including so-called QT prolongation that can be detected by ECG examination). Tell your doctor if you are taking other medicines that are known to cause QT prolongation
- electrolyte disturbance (problems with the levels of salts in the blood)
- or had low or high blood pressure
- have previously had blood clots, or the presence of blood clots in the family, as anti-schizophrenia drugs have been linked to the formation of blood clots
- or had dizziness, due to a drop in blood pressure when getting up, which can make you faint
- or have previously had a movement problem called extrapyramidal symptoms (EPS). These may include jerky movements, spasms, restlessness, or slow movements.
- ever experienced or started to experience restlessness and an inability to sit still. These symptoms may occur early in treatment. Tell your doctor if this happens.
- diabetes or risk factors for diabetes (eg obesity or that someone in the family has diabetes ). Your doctor will need to check your blood sugar regularly as it may be elevated by this medicine. Signs of high blood sugar are excessive thirst, increased urine output, increased appetite, and feeling weak.
- have previously had seizures (seizures) or epilepsy
- ever inhaled food, stomach acid, or saliva into the lungs causing a disease called aspiration pneumonia
- increased levels of the hormone et prolactin or if you have a tumor of the pituitary gland.
Weight gain
This drug can cause a significant weight gain which can affect your health. Your doctor will therefore regularly check your weight and blood fats.
Body temperature
While taking RXULTI, you should avoid getting overheated or dehydrated. Do not exercise too hard and drink plenty of water.
Children and young people
Children and adolescents under 18 years of age should not use this medicine. The safety and efficacy of these patients have not been evaluated.
Other medicines and RXULTI
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
RXULTI may increase the effect of medicines used to lower blood pressure. Therefore, tell your doctor if you are taking any medicine to keep your blood pressure under control.
If you are receiving RXULTI at the same time as certain other medicines, your doctor may need to change the dose of RXULTI or one of your other medicines. It is especially important to mention the following medicines for your doctor:
- medicines to correct the heart rhythm (such as quinidine )
- antidepressants or (traditional) herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, St. John’s wort )
- medicines for fungal infections (such as ketoconazole, and itraconazole)
- certain medicines for the treatment of HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as indinavir, and ritonavir)
- antispasmodic drugs used to treat epilepsy
- antibiotics for the treatment of bacterial infections (eg clarithromycin)
- certain antibiotics used to treat tuberculosis (for example rifampicin)
- drugs are known to prolong the QT interval (an important measure of cardiac function in an electrocardiogram [ECG])
- drugs that change the concentration of salts in the body (which causes a so-called electrolyte disturbance)
- drugs that increase the levels of an enzyme called creatine phosphokinase (CPK)
- drugs that affect 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 the way medicine works.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take RXULTI during pregnancy. If you are of childbearing potential, you should use effective contraception while taking RXULTI. In newborns whose mothers have taken this medicine during the last three months of pregnancy, the following symptoms may occur: tremors, stiff and/or weak muscles, drowsiness, restlessness, difficulty breathing, and difficulty eating. If your child gets any of these symptoms, talk to your doctor.
Talk to your doctor about the best way to feed your baby while taking RXULTI. Your doctor will consider the benefits of treatment for you and the benefits of breastfeeding your baby.
Driving and using machines
There is a possibility that the drug may affect your ability to drive and use machines. Make sure you do not feel dizzy or sew before you start driving or handling machines. Do not drive or use any tools or machines until you know that this medicine will not adversely affect you.
RXULTI contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use RXULTI
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
You will usually receive the medicine in increasing doses as follows:
- for the first 4 days, take one 1 mg film-coated tablet per day
- from day 5 to day 7, take two 1 mg film-coated tablets per day
- From day 8 onwards, take a film-coated tablet of the strength prescribed by your doctor every day.
However, your doctor may need to reduce or increase the dose to a maximum of 4 mg once a day.
It does not matter if you take your medicine with or without food.
If you have taken other medicines for the treatment of schizophrenia before starting RXULTI, your doctor will decide if you should stop taking the other medicine gradually or immediately and how to adjust the dose of RXULTI. Your doctor will also tell you what to do if you switch from RXULTI to other medicines.
Patients with kidney problems
If you have kidney problems, your doctor may adjust your dose of this medicine.
Patients with liver problems
If you have liver problems, your doctor may adjust your dose of this medicine.
If you take more RXULTI than you should
Contact your doctor or local hospital immediately if you have taken more RXULTI than the dose you were prescribed. Remember to bring the medicine pack 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 to take your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. Contact a doctor if you miss two or more doses.
If you stop taking RXULTI
If you stop taking this medicine you will lose the effect the medicine. Even if you feel better, do not change or stop taking your daily dose of RXULTI unless your doctor tells you to. If you change or stop taking this medicine, your symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment, you may experience the following serious side effects that require immediate medical attention.
Tell your doctor immediately if you have:
- thoughts of or a feeling of wanting to harm yourself or commit suicide or attempted suicide ( less common side effects may affect up to 1 in 100 people).
- a combination of fever, sweating, muscle stiffness, and drowsiness or drowsiness. These symptoms may be signs of a condition called malignant neuroleptic syndrome (it is not known how many people are affected).
- abnormalities in the heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal measurements at the heart examination ( ECG ), or QT prolongation – it is not known how many people are affected.
- symptoms related to blood clots, especially in the legs (symptoms are swelling, pain, and redness of the leg), which can be transported to the lungs and cause chest pain and difficulty breathing ( less common side effect – may affect up to 1 in 100 people).
Other side effects are
Very common side effects (may affect more than 1 in 10 people):
- When analyzing blood samples, your doctor may detect elevated levels of prolactin in your blood.
Common side effects (may affect up to 1 in 10 people):
- rash
- weight gain
- akathisia (an unpleasant feeling of inner restlessness and a compulsive need to move constantly)
- dizziness
- shaking
- somnolence
- diarrhea
- nausea
- pain in the upper abdomen
- back pain
- pain in arms or legs or both
- When analyzing blood samples, your doctor may detect elevated levels of creatine kinase (also called creatine phosphokinase) in your blood (an enzyme that is important for muscle function).
Uncommon side effects (may affect up to 1 in 100 people):
- allergic reaction (eg swelling of the mouth, tongue, face, or throat and itching or hives )
- parkinsonism – a medical condition with many different symptoms, including decreased or slow movements, slow thinking, twitching when bending arms and legs (gear rigidity), haste gait, tremors, slight or non-existent facial expression, muscle stiffness, drooling
- dizziness due to a drop in blood pressure when getting up, which can make you faint
- cough
- tooth decay or cavities in the teeth ( caries )
- gas departure
- muscle pain
- high blood pressure
- When analyzing blood samples, your doctor may detect elevated levels of triglycerides in your blood
- When analyzing blood samples, your doctor may detect elevated levels of liver enzymes.
Other side effects (it is not known how many people are affected):
- seizures
- muscle weakness, tenderness, or pain, especially if you feel sick and have a fever or dark urine at the same time. This can be due to an abnormal breakdown of the muscles which can be life-threatening and lead to problems with the kidneys (a condition called rhabdomyolysis )
- withdrawal symptoms in newborns, if the mother took this medicine during pregnancy.
- inability to resist the impulse, drive, or temptation to perform an act that may be harmful to yourself and others, which may include:
- a strong impulse to excessive gambling despite serious personal or family consequences
- altered or increased sexual interest and behavior, of significant inconvenience to you or others, such as increased sexual drive
- uncontrollable, excessive buying behavior
- binge eating (eating large amounts of food for a short time) or compulsive eating (eating larger amounts of food than normal and more than is needed to satisfy hunger).
Tell your doctor if you experience any of the above behaviors. He or she will discuss how to manage or reduce the symptoms.
How to store 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 outer carton and the blister after “EXP”. or “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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 to protect the environment.
Contents of the packaging and other information
Content declaration
The active substance is brexpiprazole.
One film-coated tablet contains 0.25 mg of brexpiprazole.
One film-coated tablet contains 0.5 mg of brexpiprazole.
One film-coated tablet contains 1 mg of brexpiprazole.
One film-coated tablet contains 2 mg of brexpiprazole.
One film-coated tablet contains 3 mg of brexpiprazole.
One film-coated tablet contains 4 mg of brexpiprazole.
Other ingredients are:
Tablet core:
Lactose monohydrate, corn starch, microcrystalline cellulose, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and purified water.
Tablet coating:
Hypromellose, 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)
What the medicine looks like and the contents of the pack
RXULTI 0.25 mg film-coated tablets
Light brown, round, 6 mm in diameter, slightly convex with a beveled edge, embossed with BRX and 0.25 on one side.
RXULTI 0.5 mg film-coated tablets
Light orange, round, 6 mm in diameter, slightly convex with a beveled edge, embossed with BRX and 0.5 on one side.
RXULTI 1 mg film-coated tablets
Light yellow, round, 6 mm in diameter, slightly convex with a beveled edge, embossed with BRX and 1 on one side.
RXULTI 2 mg film-coated tablets
Light green, round, 6 mm in diameter, slightly convex with a beveled edge, embossed with BRX and 2 on one side.
RXULTI 3 mg film-coated tablets
Light purple, round, 6 mm in diameter, slightly convex with a beveled edge, embossed with BRX and 3 on one side.
RXULTI 4 mg film-coated tablets
White, round, 6 mm in diameter, slightly convex with a beveled edge, embossed with BRX and 4 on one side.
RXULTI film-coated tablets are supplied in aluminum / PVC blisters containing 10, 28, or 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands BV
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands
Manufacturer
Elaiapharm
2881 Route des Crêtes, ZI Les Bouillides-Sophia Antipolis,
06560 Valbonne
France
H. Lundbeck A / S
Ottiliavej 9
2500 Valby
Denmark
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienLundbeck SA / NVTel: +32 2 535 79 79Tel: +32 2 340 2828 | LithuaniaH. Lundbeck A / STel: +45 36301311 |
| BulgariaLundbeck Export A / S Representative OfficeTel: +359 2 962 4696 | Luxembourg / LuxemburgLundbeck SATel: +32 2 535 79 79Tel: +32 2 340 2828 |
| Czech RepublicLundbeck Czech Republic sroTel: +420 225 275 600 | HungaryLundbeck Hungaria Kft.Tel: +36 1 4369980 |
| DenmarkOtsuka Pharma Scandinavia ABTel: +46 8 54528660 | MaltaH. Lundbeck A / STel: +45 36301311 |
| GermanyOtsuka Pharma GmbHTel: +49 69 1700860 | The NetherlandsLundbeck BVTel: +31 20 697 1901 |
| EestiH. Lundbeck A / STel: +45 36301311 | NorwayOtsuka Pharma Scandinavia ABTel: +46 8 54528660 |
| GreeceLundbeck Hellas SA:Ηλ: +30 210 610 5036 | AustriaLundbeck Austria GmbHTel: +43 1 253 621 6033 |
| SpainOtsuka Pharmaceutical SATel: +34 93 208 10 20 | PolandLundbeck Poland Sp. z ooTel .: +48 22 626 93 00 |
| FranceOtsuka Pharmaceutical France SASTel: +33 (0) 1 47 08 00 00 | PortugalLundbeck Portugal LdaTel: +351 21 00 45 900 |
| CroatiaLundbeck Croatia dooTel .: +385 1 644 82 63Tel .: +385 1 3649 210 | RomaniaLundbeck Export A / SRepresentative of RomaniaTel: +40 21319 88 26 |
| IrelandLundbeck (Ireland) LimitedTel: +353 1 468 9800 | SloveniaLundbeck Pharma dooTel .: +386 2 229 4500 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicLundbeck Slovensko sroTel: +421 2 5341 42 18 |
| ItalyOtsuka Pharmaceutical Italy SrlTel: +39 02 00 63 27 10 | Finland / FinlandOtsuka Pharma Scandinavia ABTel: +46 8 54528660 |
| ΚύπροςLundbeck Hellas AE.:Ηλ .: +357 22490305 | SwedenOtsuka Pharma Scandinavia ABTel: +46 8 54528660 |
| LatviaH. Lundbeck A / STel: +45 36301311 | United Kingdom (Northern Ireland)Otsuka Pharmaceuticals Netherlands BVTel: +31 (0) 20 85 46 555 |