Rxulti 0.5 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
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 the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What RXULTI is and what it is used for
- What you need to know before taking RXULTI
- How to take RXULTI
- Possible adverse effects
- How to store RXULTI
- Contents of the pack and other information
1. What RXULTI is and what it is used for
RXULTI contains the active substance brexpiprazol, 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 condition characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, incoherent speech and behavior, and emotional flatness. People with this disorder may also feel depressed, guilty, anxious, or tense.
RXULTI can help keep symptoms under control and prevent relapses during treatment.
2. 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 precautions
Inform your doctor immediately if
- you experience a combination of fever, sweating, rapid breathing, muscle stiffness, numbness, and drowsiness (these may be signs of neuroleptic malignant syndrome).
- you have thoughts or feelings about harming yourself or suicide. Suicidal thoughts and behaviors are more likely at the beginning of treatment.
- your family or caregiver notices that you are developing urges or impulses to behave in ways that are unusual 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 eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may consider adjusting or stopping your dose.
- you have difficulty swallowing.
- you have or have had low white blood cell counts and develop fever or any other sign of infection. For example, this could be the case if other medicines have previously lowered your white blood cell count. Your doctor will regularly monitor your white blood cells to minimize the risk of conditions called leukopenia, neutropenia, and agranulocytosis. It is important to have regular blood tests, as these conditions can be life-threatening. 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
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have or have had heart problems or a history of stroke, especially if you know you have other risk factors that may increase the likelihood of stroke.
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have dementia (loss of memory and other mental abilities), particularly if you are elderly.
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have irregular heartbeats or if someone in your family has a history of irregular heartbeats (including the so-called QT interval prolongation seen on ECG monitoring). Inform your doctor if you are taking other medicines known to prolong the QT interval.
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have an electrolyte imbalance (problems with salt levels in the blood).
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have or have had low or high blood pressure.
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have a history of blood clots, or if someone in your family has a history of blood clots, as antipsychotic medicines have been associated with blood clot formation.
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have or have had dizziness upon standing due to a drop in blood pressure, which may lead to fainting.
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have or have had movement problems, called extrapyramidal symptoms (EPS), in the past. These may include spasmodic movements, spasms, restlessness, or slow movements.
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have ever experienced or begin to experience restlessness and inability to stay still. These symptoms may occur early during treatment. Inform your doctor if this happens.
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have diabetes or risk factors for diabetes (e.g., obesity or a family history of diabetes). Your doctor should regularly monitor your blood sugar levels, as they may increase with this medicine. Signs of high blood sugar include excessive thirst, passing large amounts of urine, increased appetite, and feeling weak.
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have a history of seizures (fits) or epilepsy.
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have ever inhaled food, stomach acid, or saliva into the lungs, causing a condition called aspiration pneumonia.
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have elevated levels of the hormone prolactin or have a tumor in the pituitary gland.
Weight gain
This medicine may cause significant weight gain, which may affect your health. Therefore, your doctor will regularly monitor your weight and blood lipid levels.
Body temperature
While taking RXULTI, you should avoid becoming overheated or dehydrated. Do not exercise excessively and drink plenty of fluids.
Children and adolescents
Children under 13 years of age should not take this medicine. Safety and efficacy in these patients have not been established.
Other medicines and RXULTI
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
RXULTI may enhance the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control your blood pressure.
Taking RXULTI with certain medicines may require your doctor to adjust the dose of RXULTI or the other medicines. It is especially important to tell your doctor about the following medicines:
- medicines used 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 for fungal infections (antifungals) (such as itraconazole), ketoconazole (used to treat Cushing’s syndrome when the body produces too much cortisol),
- certain medicines for HIV infection (such as ritonavir),
- anticonvulsants used to treat epilepsy (such as carbamazepine and phenobarbital),
- antibiotics for 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 alter salt concentrations in your body (causing so-called electrolyte imbalance); for example, diuretic tablets such as furosemide and bendroflumethiazide,
- medicines that increase an enzyme called creatine phosphokinase (CPK); for example, medicines known as statins, such as simvastatin, used to lower blood cholesterol levels,
- medicines that affect 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 medicine works.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
RXULTI is not recommended during pregnancy. If you are of childbearing age, you should use effective contraception while taking RXULTI. Babies born to mothers who take this medicine during the last three months of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, 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
This medicine may affect your ability to drive or use machines. Check whether you feel dizzy or drowsy before driving or operating machinery. Do not drive or use tools or machines until you are sure this medicine does not affect you negatively.
RXULTI contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take RXULTI
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The medicine is generally 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 day 7, take two 1 mg film-coated tablets per day,
- from day 8 onwards, take one film-coated tablet of the dose prescribed by your doctor each day.
For pediatric patients:
- for the first 4 days, take one 0.5 mg film-coated tablet per day,
- from day 5 to day 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 each day.
However, your doctor may prescribe a lower or higher dose up to a maximum of 4 mg once daily.
It does not matter whether you take the medicine with or without food.
If you were taking other medicines to treat schizophrenia before starting treatment with RXULTI, your doctor will decide whether to discontinue the other medicine gradually or immediately, and how to adjust the dose of RXULTI. Your doctor will also inform you about what to do if you switch from RXULTI to other medicines.
Patients with kidney problems
If you have kidney problems, your doctor may adjust the dose of this medicine.
Patients with liver problems
If you have liver problems, your doctor may adjust the dose of this medicine.
If you take more RXULTI than you should
If you have taken more RXULTI than the dose prescribed to you, contact your doctor or the nearest hospital immediately. Remember to bring the medicine 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 for your 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 missed doses. If you miss two or more doses, consult your doctor.
If you stop taking RXULTI
If you stop treatment with this medicine, you will lose its effects. Even if you feel better, do not change or stop your daily dose of RXULTI unless instructed by your doctor, as symptoms may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
During treatment, you may experience these serious adverse effects that require urgent medical attention.
Tell your doctor immediately if you have:
- thoughts or feelings about harming yourself or suicide, or a suicide attempt (uncommon adverse effect – may affect up to 1 in 100 people).
- a combination of fever, sweating, muscle stiffness, and drowsiness. These could be symptoms of a condition called neuroleptic malignant syndrome (frequency unknown).
- irregular heart rhythms due to abnormal nerve impulses in the heart, or abnormal readings on a heart test (ECG) showing QT interval prolongation – frequency unknown.
- symptoms related to blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs and cause chest pain and difficulty breathing (uncommon adverse effect – may affect up to 1 in 100 people).
Other adverse effects
Very common adverse effects (may affect more than 1 in 10 people):
- during blood tests, your doctor may find elevated levels of prolactin in the blood.
Common adverse effects (may affect up to 1 in 10 people):
- rash,
- weight gain,
- akathisia (a distressing inner restlessness and an urgent need to keep moving),
- dizziness,
- tremors,
- drowsiness,
- diarrhea,
- nausea,
- upper abdominal pain,
- back pain,
- pain in arms or legs or both,
- during blood tests, your doctor may find increased levels of creatine kinase (also known as creatine phosphokinase) in the blood (an enzyme important for muscle function).
Uncommon adverse effects (may affect up to 1 in 100 people):
- allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, hives),
- parkinsonism: a medical condition with various symptoms including slow or reduced movements, slowed thinking, jerky movements when bending limbs (cogwheel rigidity), shuffling gait, tremors, reduced or absent facial expression, muscle stiffness, drooling,
- dizziness upon standing due to a drop in blood pressure, which may lead to fainting,
- cough,
- dental caries,
- 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 increased liver enzymes.
Other adverse effects (frequency unknown):
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seizures,
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muscle weakness, tenderness, or pain, particularly if you also feel unwell, have a high temperature, or have dark urine. These may be caused by abnormal muscle breakdown, which can be potentially life-threatening and lead to kidney problems (a condition known as rhabdomyolysis),
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withdrawal symptoms in newborns if the mother took this medicine during pregnancy,
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inability to resist the impulse, instinct, or temptation to carry out an action that may be harmful to you or others, which may include:
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strong urge to gamble excessively despite serious personal or family consequences,
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altered or increased sexual interest and concerning behavior for you or others, for example, increased libido,
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uncontrollable excessive shopping,
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binge eating (consuming large amounts of food in a short period of time) 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 adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of RXULTI
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after "EXP". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.
6. Contents of the pack and other information
Composition of RXULTI film-coated tablets
- The active substance 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:
Tablet core:
Monohydrate lactose, maize 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 of the product and contents of the pack
RXULTI 0.25 mg film-coated tablets
Light brown, round, 6 mm in diameter, smooth, convex with bevelled edges, 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 with bevelled edges, engraved with BRX and 0.5 on one side.
RXULTI 1 mg film-coated tablets
Light yellow, round, 6 mm in diameter, smooth, convex with bevelled edges, engraved with BRX and 1 on one side.
RXULTI 2 mg film-coated tablets
Light green, round, 6 mm in diameter, smooth, convex with bevelled edges, engraved with BRX and 2 on one side.
RXULTI 3 mg film-coated tablets
Light purple, round, 6 mm in diameter, smooth, convex with bevelled edges, engraved with BRX and 3 on one side.
RXULTI 4 mg film-coated tablets
White, round, 6 mm in diameter, smooth, convex with bevelled edges, engraved with BRX and 4 on one side.
RXULTI tablets are supplied in aluminium/PVC blisters containing 10, 28 or 56 film-coated tablets.
Only some pack sizes may be marketed.
Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
The Netherlands
Manufacturer
Elaiapharm
2881 Route des Crêtes, Z.I. Les Bouillides-Sophia Antipolis,
06560 Valbonne
France
- Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark
Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium Lundbeck S.A./N.V. Tel/Tel: +32 2 535 79 79 Tel/Tel: +32 2 340 2828 | Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40 |
| Luxembourg/Luxembourg Lundbeck S.A. Tel: +32 2 535 79 79 Tel: +32 2 340 2828 |
Czech Republic Swixx Biopharma s.r.o. Tel: +420 242 434 222 | Hungary Swixx Biopharma Kft. Tel.: +36 1 9206 570 |
Denmark Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 | Malta
Tel: +45 36301311 |
Germany Otsuka Pharma GmbH Tel: +49 69 1700860 | Netherlands Lundbeck B.V. Tel: +31 20 697 1901 |
Estonia Swixx Biopharma OÜ Tel: +372 640 1030 | Norway Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 |
Greece Swixx Biopharma Μ.Α.Ε Tel: +30 214 444 9670 | Austria Lundbeck Austria GmbH Tel: +43 1 253 621 6033 |
Spain Otsuka Pharmaceutical S.A. Tel: +34 93 208 10 20 | Poland Swixx Biopharma Sp. z o.o. Tel.: +48 22 4600 720 |
France Otsuka Pharmaceutical France SAS Tél: +33 (0)1 47 08 00 00 | Portugal Lundbeck Portugal – Produtos Farmacêuticos, Unipessoal Lda. Tel: +351 21 00 45 900 |
Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500 | Romania Swixx Biopharma S.R.L Tel: +40 37 1530 850 |
Ireland Lundbeck (Ireland) Limited Tel: +353 1 468 9800 | Slovenia Swixx Biopharma d.o.o. Tel: +386 1 2355 100 |
Iceland Vistor Tel: +354 535 7000 | Slovakia Swixx Biopharma s.r.o. Tel: +421 2 20833 600 |
Italy Otsuka Pharmaceutical Italy S.r.l. Tel: +39 02 00 63 27 10 | Finland Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 |
Cyprus Swixx Biopharma Μ.Α.Ε Tel: +30 214 444 9670 | Sweden Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 |
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50 |
Date of the most recent review 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.