Rxulti: detailed information

Patient Information Leaflet: Information for the User

RXULTI 0.25 mg film-coated tablets, 0.5 mg film-coated tablets, 1 mg film-coated tablets, 2 mg film-coated tablets, 3 mg film-coated tablets, 4 mg film-coated tablets

brexpiprazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RXULTI is and what it is used for
What you need to know before taking RXULTI
How to take RXULTI
Possible side 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 brexpiprazole, which belongs to a group of medicines called
antipsychotics.
It is used to treat schizophrenia in adult patients and adolescents aged 13 years and older, a condition characterised by symptoms such as hearing, seeing or feeling things that are not real, suspiciousness, disorganised speech and behaviour, and emotional flattening. People
with this condition may also feel depressed, guilty, anxious or tense.
RXULTI can help control symptoms and prevent relapses while treatment continues.

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
Contact your doctor immediately if

you experience a combination of fever, sweating, rapid breathing, muscle stiffness, and drowsiness or lethargy (these may be signs of neuroleptic malignant syndrome).
you have thoughts or feelings about harming yourself or committing suicide. Suicidal thoughts and behaviors are more likely at the beginning of treatment.
your family members or caregivers notice that you are developing impulses or urges to
behave in ways that are unusual for you and that you cannot resist the impulse, drive, or
temptation to carry out certain activities that could harm yourself or others.
Such phenomena are called impulse control disorders and may include behaviors such as gambling addiction, binge eating, excessive spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider adjusting the dose or discontinuing your treatment.
you have difficulty swallowing.
you have or have had a low white blood cell count and develop fever or any other signs of infection. This may occur, for example, if other medicines previously reduced your white blood cell count. Your doctor will regularly monitor your white blood cell count to minimize the risk of conditions called leukopenia, neutropenia, and agranulocytosis. Regular blood monitoring is important because this condition can be fatal. Your doctor will immediately stop treatment if your white blood cell count becomes too low. Contact your doctor or pharmacist before taking RXULTI, or during treatment, if you
have or have had heart problems or stroke in the past, especially if you know you have other risk factors for stroke.
have dementia (loss of memory and other mental abilities), particularly if you are elderly.
have irregular heartbeat or a family history of irregular heartbeat (including so-called QT interval prolongation observed on ECG monitoring). Inform your doctor if you are taking other medicines known to prolong the QT interval.
have an electrolyte imbalance (problems with the levels of salts in your blood).
have or have had low or high blood pressure.
have had previous episodes of blood clots or a family history of blood clots, as antipsychotic medicines have been associated with blood clot formation.
have experienced or experience dizziness upon standing due to a drop in blood pressure, which may lead to fainting.
have had or develop movement problems called extrapyramidal symptoms (EPS). These may include jerky movements, spasms, restlessness, or slowness of movement.
have never had or begin to develop restlessness and inability to sit still without moving. These symptoms may appear early during treatment. Inform your doctor if this occurs.
have diabetes or risk factors for diabetes (e.g., obesity, or a family history of diabetes). Your doctor will need to monitor your blood sugar regularly, as this medicine may increase it. Signs of high blood sugar include excessive thirst, passing large amounts of urine, increased appetite, and feeling weak.
have had previous seizures (fits) or epilepsy.
have ever inhaled food, stomach acid, or saliva into the lungs, causing a condition called aspiration pneumonia.
have elevated levels of the hormone prolactin, or a pituitary tumor.

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, avoid overheating or becoming dehydrated. Do not overexert yourself physically and drink plenty of water.
Children and adolescents
This medicine must not be used in children under 13 years of age. 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 take any other medicines.
RXULTI may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking a medicine to control your blood pressure.
Taking RXULTI together with certain other medicines may require your doctor to adjust the dose of RXULTI or of the other medicines. It is particularly important to inform your doctor about the following medicines:

medicines used to correct heart rhythm (e.g., quinidine),
antidepressants or herbal remedies used to treat depression and anxiety (e.g., fluoxetine, paroxetine, St. John’s wort),
antifungal medicines (e.g., ketoconazole, itraconazone),
certain medicines used to treat HIV infection (e.g., ritonavir),
anticonvulsants used to treat epilepsy (e.g., carbamazepine, phenobarbital),
antibiotics used to treat bacterial infections (e.g., clarithromycin),
certain antibiotics used to treat tuberculosis (e.g., rifampicin),
medicines such as moxifloxacin (an antibiotic) known to prolong the QT interval (an important measure of cardiac function detectable on electrocardiogram [ECG]),
medicines that alter salt concentrations in the body (causing so-called electrolyte imbalance), e.g., diuretics such as furosemide, bendroflumethiazide,
medicines that increase the level of an enzyme called creatine phosphokinase (CPK), e.g., medicines known to reduce blood cholesterol levels such as statins, e.g., simvastatin,
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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
RXULTI is not recommended during pregnancy. If you are of childbearing age, you must use an effective method of contraception while taking RXULTI.
Babies born to mothers who have taken this medicine during the last three months of pregnancy may show the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. Contact your doctor if your baby shows any of these symptoms.
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 using machines
This medicine may affect your ability to drive or operate machinery.
Check whether you feel dizzy or drowsy before driving or operating machinery. Do not drive or use tools or machines until you are certain that this medicine does not affect you negatively.
RXULTI contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take RXULTI

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is generally administered in increasing doses as follows:

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 at the dose prescribed by your doctor every day.

Paediatric 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 at the dose prescribed by your doctor every 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 previously taking other medicines for the treatment of schizophrenia before starting RXULTI, your doctor will decide whether to gradually or immediately discontinue the other medicine and how to adjust the dose of RXULTI. Your doctor will also advise you on what to do if you switch from RXULTI to another medicine.

Patients with renal problems
If you have renal impairment, your doctor may adjust the dose of this medicine.

Patients with hepatic problems
If you have hepatic impairment, your doctor may adjust the dose of this medicine.

If you take more RXULTI than you should
If you have taken more RXULTI than prescribed, contact your doctor or the nearest hospital immediately. Remember to bring the medicine pack with you so there is no doubt about 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 continue as usual. Do not take a double dose to make up for the forgotten dose. If you forget two or more doses, contact your doctor.

If you stop taking RXULTI
If you stop taking this medicine, you will lose the medicine's beneficial 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 questions about how to use this medicine, 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 experience the following serious side effects which require urgent medical
attention.
Immediately contact your doctor if you have:

thoughts or feelings about harming yourself, suicide or attempting suicide (uncommon side effect: may affect up to 1 in 100 people).
a combination of fever, sweating, muscle stiffness, and stupor or drowsiness. These may be signs of a condition known as neuroleptic malignant syndrome (frequency unknown).
irregular heart rhythm which may be due to abnormal nerve impulses in the heart, abnormalities in heart examination (ECG), prolongation of the QT interval: 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 causing chest pain and breathing difficulties (uncommon 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 increased levels of prolactin in the blood.

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

rash,
weight gain,
akathisia (unpleasant sensation of inner restlessness and an urgent need to constantly move),
dizziness,
tremor,
feeling of drowsiness,
diarrhoea,
nausea,
pain in the upper part of the abdomen,
back pain,
pain in arms, legs or both,
during blood tests, your doctor may find increased levels of creatine kinase (also known as creatine phosphokinase) (an enzyme important for muscle function) in the blood.

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

allergic reaction (e.g. swelling of mouth, tongue, face and throat, itching, hives),
parkinsonism: a medical condition with a wide range of symptoms including reduced or slow movements, slowed thinking, sudden jerking when bending limbs (cogwheel rigidity), shuffling gait, tremor, limited or absent facial expression, muscle stiffness, drooling,
dizziness upon standing due to a drop in blood pressure, which may lead to fainting,
cough,
dental cavities (dental caries),
flatulence,
muscle pain,
increased blood pressure,
during blood tests, your doctor may find increased levels of triglycerides in the blood,
during blood tests, your doctor may find increased levels of liver enzymes.

Other side effects (frequency unknown):

seizures,
muscle weakness, tenderness or pain, particularly if at the same time you do not feel well, have fever or dark-coloured urine. These symptoms may be caused by abnormal muscle breakdown which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis),
withdrawal symptoms in newborns if the mother took this medicine during pregnancy,
inability to resist the impulse, urge or temptation to carry out an action that could be harmful to you or others, which may include:
- strong urge to gamble excessively despite serious personal or family consequences,
- altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased sexual drive,
- excessive and uncontrollable shopping,
- uncontrolled eating (eating 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). Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 outer packaging following "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What RXULTI Film-Coated Tablets Contain

The active substance 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”), maize starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, purified water.

Tablet coating:
Hypromellose (E464), talc (E553b), titanium dioxide (E171).
RXULTI 0.25 mg film-coated tablets
Iron oxide (E172) (yellow, red, black)
RXULTI 0.5 mg film-coated tablets
Iron oxide (E172) (yellow, red)
RXULTI 1 mg film-coated tablets
Iron oxide (E172) (yellow)
RXULTI 2 mg film-coated tablets
Iron oxide (E172) (yellow, black)
RXULTI 3 mg film-coated tablets
Iron oxide (E172) (red, black)

Description of the Appearance of RXULTI Film-Coated Tablets and Package Contents

RXULTI 0.25 mg film-coated tablets
Light brown, round tablet, 6 mm in diameter, slightly convex with bevelled edges, engraved with the characters BRX and 0.25 on one side.

RXULTI 0.5 mg film-coated tablets
Light orange, round tablet, 6 mm in diameter, slightly convex with bevelled edges, engraved with the characters BRX and 0.5 on one side.

RXULTI 1 mg film-coated tablets
Light yellow, round tablet, 6 mm in diameter, slightly convex with bevelled edges, engraved with the characters BRX and 1 on one side.

RXULTI 2 mg film-coated tablets
Light green, round tablet, 6 mm in diameter, slightly convex with bevelled edges, engraved with the characters BRX and 2 on one side.

RXULTI 3 mg film-coated tablets
Light purple, round tablet, 6 mm in diameter, slightly convex with bevelled edges, engraved with the characters BRX and 3 on one side.

RXULTI 4 mg film-coated tablets
White, round tablet, 6 mm in diameter, slightly convex with bevelled edges, engraved with the characters 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 Authorization 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
H. 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:

België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Lundbeck A/S
Tél/Tel: +32 2 535 79 79 Tel: +45 36301311
Tél/Tel: +32 2 340 2828

България Luxembourg/Luxemburg
Lundbeck Export A/S Representative Office Lundbeck S.A.
Tel: +359 2 962 4696 Tél: +32 2 535 79 79
Tél: +32 2 340 2828

Česká republika Magyarország
Lundbeck Česká republika s.r.o. Lundbeck Hungaria Kft.
Tel: +420 225 275 600 Tel: +36 1 4369980

Danmark Malta
Otsuka Pharma Scandinavia AB H. Lundbeck A/S
Tel: +46 8 54528660 Tel: +45 36301311

Deutschland Nederland
Otsuka Pharma GmbH Lundbeck B.V.
Tel: +49 69 1700860 Tel: +31 20 697 1901

Eesti Norge
H. Lundbeck A/S Otsuka Pharma Scandinavia AB
Tel: +45 36301311 Tel: +46 8 54528660

Ελλάδα Österreich
Lundbeck Hellas S.A. Lundbeck Austria GmbH
Τηλ: +30 210 610 5036 Tel: +43 1 253 621 6033

España Polska
Otsuka Pharmaceutical S.A. Lundbeck Poland Sp. z o.o.
Tel: +34 93 208 10 20 Tel.: +48 22 626 93 00

France Portugal
Otsuka Pharmaceutical France SAS Lundbeck Portugal – Produtos Farmacêuticos,
Tél: +33 (0)1 47 08 00 00 Unipessoal Lda.
Tel: +351 21 00 45 900

Hrvatska România
Lundbeck Croatia d.o.o. Lundbeck Romania SRL
Tel.: +385 1 644 82 63 Tel: +40 21319 88 26
Tel.: +385 1 3649 210

Ireland Slovenija
Lundbeck (Ireland) Limited Lundbeck Pharma d.o.o.
Tel: +353 1 468 9800 Tel.: +386 2 229 4500

Ísland Slovenská republika
Vistor hf. Lundbeck Slovensko s.r.o.
Sími: +354 535 7000 Tel: +421 2 5341 42 18

Italia Suomi/Finland
Otsuka Pharmaceutical Italy S.r.l. Otsuka Pharma Scandinavia AB
Tel: +39 02 00 63 27 10 Tel: +46 8 54528660

Κύπρος Sverige
Lundbeck Hellas A.E. Otsuka Pharma Scandinavia AB
Τηλ.: +357 22490305 Tel: +46 8 54528660

Latvija
H. Lundbeck A/S
Tel: +45 36301311

Other Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.