Lurobran

Leaflet attached to the packaging: patient information

Lurobran, 18.5 mg, coated tablets

Lurobran, 37 mg, coated tablets

Lurobran, 74 mg, coated tablets

Lurobran, 111 mg, coated tablets

Lurobran, 148 mg, coated tablets

Lurasidone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lurobran and what is it used for
• 2. Important information before taking Lurobran
• 3. How to take Lurobran
• 4. Possible side effects
• 5. How to store Lurobran
• 6. Contents of the packaging and other information

1. What is Lurobran and what is it used for

Lurobran contains the active substance lurasidone, which belongs to a group of medicines called antipsychotics. It is used to treat symptoms of schizophrenia in adult patients (aged 18 and over) and adolescents aged 13-17. Lurasidone works by blocking receptors in the brain that dopamine and serotonin attach to. Dopamine and serotonin are neurotransmitters (substances that enable nerve cells to communicate with each other) associated with the occurrence of schizophrenia symptoms. By blocking these receptors, lurasidone helps to normalize brain activity, reducing schizophrenia symptoms.

Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspiciousness, withdrawal, incoherent speech, and flattening of behavior and emotions. People with this disorder may also experience depression, anxiety, guilt, or tension. This medicine is used to alleviate schizophrenia symptoms.

2. Important information before taking Lurobran

When not to take Lurobran:

• if the patient is allergic to lurasidone or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking medicines that may affect the level of lurasidone in the blood, i.e.:
• antifungal medicines, such as itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole, or voriconazole
• antibiotics, such as the antibiotic clarithromycin or telithromycin
• HIV medicines, such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir
• medicines for chronic hepatitis, such as boceprevir and telaprevir
• the antidepressant nefazodone
• the tuberculosis medicine rifampicin
• medicines used to treat epilepsy, such as carbamazepine, phenobarbital, and phenytoin
• the herbal medicine St. John's Wort (Hypericum perforatum).

Warnings and precautions

It may take a few days for this medicine to start working fully. If you have any questions about this medicine, you should contact your doctor.

Before starting to take Lurobran or during treatment, you should discuss this with your doctor, especially if:

• the patient has suicidal thoughts or has shown suicidal behavior
• the patient has Parkinson's disease or dementia
• the patient has been diagnosed with a condition characterized by high fever and muscle stiffness (called malignant neuroleptic syndrome) or has experienced muscle stiffness and tremors or had problems with movement (extrapyramidal symptoms) or abnormal movements of the tongue or face (tardive dyskinesia). Note that this medicine may cause such symptoms
• the patient has heart disease or is taking medicines for heart disease that may cause low blood pressure, or has a family history of heart rhythm disorders (including QT prolongation)
• the patient has a history of epilepsy or seizures
• the patient or a family member has had blood clots, as antipsychotic medicines may cause blood clots
• the patient has enlarged breasts (in men, gynecomastia), milk secretion from the breasts (galactorrhea), absence of menstruation, or erectile dysfunction
• the patient has diabetes or is prone to diabetes
• the patient has reduced kidney function
• the patient has reduced liver function
• the patient's weight has increased
• the patient experiences a drop in blood pressure when standing up, which may cause fainting
• the patient is addicted to opioids (treated with buprenorphine), has severe pain (treated with opioids), depression, or other conditions treated with antidepressants. Taking these medicines with Lurobran may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition (see "Lurobran and other medicines").

If any of the above conditions apply to the patient, they should tell their doctor, who may decide to change the dose of the medicine, monitor the patient's condition more closely, or stop taking Lurobran.

Children and adolescents

This medicine should not be given to children under the age of 13.

Lurobran and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• any medicines that affect the brain, as they may negatively affect the action of Lurobran on the brain
• blood pressure-lowering medicines, as this medicine may also lower blood pressure
• medicines for Parkinson's disease and restless legs syndrome (e.g., levodopa), as this medicine may weaken their effect
• medicines containing ergot alkaloid derivatives (used to treat migraines) and other medicines, including terfenadine and astemizole (used to treat hay fever and other allergic symptoms), cisapride (used to treat digestive problems), pimozide (used to treat mental illnesses), quinidine (used to treat heart conditions), and bepridil (used to treat chest pain)
• medicines containing buprenorphine (used to treat opioid addiction), opioids (used to treat severe pain), or antidepressants, such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Lurobran and cause symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, excessive reflexes, increased muscle tension, and body temperature above 38°C. If such symptoms occur, the patient should contact their doctor.

If the patient is taking any of these medicines, they should tell their doctor, who may decide to change the dose of such a medicine during treatment with Lurobran.

The following medicines may increase the level of lurasidone in the blood:

• diltiazem (used to treat high blood pressure)
• erythromycin (an antibiotic used to treat infections)
• fluconazole (used to treat fungal infections)
• verapamil (used to treat high blood pressure or chest pain)

The following medicines may decrease the level of lurasidone in the blood:

• amprenavir, efavirenz, etravirine (used to treat HIV infection)
• aprepitant (used to treat nausea and vomiting)
• armodafinil, modafinil (used to treat sleepiness)
• bosentan (used to treat high blood pressure or finger ulcers)
• nafcillin (used to treat infections)
• prednisone (used to treat inflammatory diseases)
• rufinamide (used to treat epilepsy)

If the patient is taking any of these medicines, they should tell their doctor, who may decide to change the dose of Lurobran.

Lurobran with food, drink, and alcohol

While taking this medicine, the patient should avoid drinking alcohol, as alcohol enhances the negative effects of the medicine.

While taking this medicine, the patient should not drink grapefruit juice. Grapefruit may affect the action of this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

This medicine should not be used during pregnancy, unless agreed upon with the doctor.

If the doctor decides that the potential benefits of treatment during pregnancy outweigh the potential risk to the unborn child, they will closely monitor the child's condition after birth. This is because newborns whose mothers took lurasidone in the last trimester of pregnancy (the last 3 months) may experience symptoms such as:

• tremors, muscle stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding.

If the child experiences any of these symptoms, the patient should contact their doctor.

It is not known whether lurasidone passes into breast milk. If the patient is breastfeeding or plans to breastfeed, they should discuss this with their doctor.

Driving and using machines

While taking this medicine, the patient may experience drowsiness, dizziness, or vision disturbances (see section 4 "Possible side effects"). The patient should not drive vehicles, ride a bicycle, or operate any tools or machines until it is known that the medicine does not affect them in a negative way.

Lurobran contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Lurobran

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

The doctor will determine the dose of the medicine for the individual patient, taking into account:

• the patient's response to the prescribed dose
• any other medicines the patient is taking (see section 2, "Lurobran and other medicines")
• any kidney or liver problems the patient may have.

Adults (aged 18 and over)

The recommended initial dose is 37 mg once a day.

The doctor may increase or decrease this dose within the range of 18.5 mg to 148 mg once a day.

The maximum dose should not exceed 148 mg once a day.

Higher doses (111 mg and 148 mg) are not intended for initial treatment but for maintenance treatment in adults.

Adolescents aged 13-17

The recommended initial dose is 37 mg of lurasidone once a day.

The dose may be increased or decreased by the doctor within the range of 37 to 74 mg once a day.

The maximum daily dose should not exceed 74 mg.

Higher doses (111 mg and 148 mg) are not recommended for children and adolescents.

How to take Lurobran

The patient should swallow the tablet(s) whole with water to avoid the bitter taste.

The patient should take the dose of the medicine regularly, every day at the same time, which makes it easier to remember to take the medicine.

This medicine should be taken with food or immediately after a meal, which facilitates the absorption of the medicine by the body and enables it to work better.

Taking a higher dose of Lurobran than recommended

If the patient takes a higher dose of Lurobran than recommended, they should contact their doctor immediately.

The patient may experience drowsiness, fatigue, abnormal body movements, problems standing and walking, dizziness due to low blood pressure, and abnormal heart rhythm.

Missing a dose of Lurobran

The patient should not take a double dose to make up for a missed dose.

If the patient misses one dose of the medicine, they should take the next dose the next day.

If the patient misses two or more doses, they should contact their doctor.

Stopping treatment with Lurobran

If the patient stops taking this medicine, they will lose its effects.

The patient should not stop taking this medicine unless their doctor advises them to do so, as the symptoms of the illness may return.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should seek medical help immediately if they experience any of the following symptoms:

• severe allergic reaction characterized by fever, swelling of the mouth, face, lips, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure (hypersensitivity). Such reactions are common (may affect up to 1 in 10 people).
• severe rash with blisters on the skin, in the mouth, eyes, and genital area (Stevens-Johnson syndrome). This reaction occurs with an unknown frequency.
• fever, sweating, muscle stiffness, and altered consciousness. These may be symptoms of a condition called malignant neuroleptic syndrome. These reactions are rare (may affect up to 1 in 1000 people).
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If the patient experiences any of these symptoms, they should seek medical help immediately.

Adults may also experience the following side effects:

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

• feeling of restlessness and inability to sit still
• nausea (feeling sick)
• insomnia.

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

• parkinsonism: a medical term that includes many symptoms, such as excessive saliva production; drooling; muscle tremors when bending limbs; slow, limited, or disturbed body movements; lack of facial expression; muscle tension; neck stiffness; muscle stiffness; walking with small, quick steps, with foot dragging, and lack of normal arm movements when walking; persistent blinking in response to tapping on the forehead (abnormal reflexes)
• disorders of speech, abnormal muscle movements; a set of symptoms called extrapyramidal symptoms (EPS), which include abnormal, purposeless, involuntary muscle movements
• rapid heartbeat
• high blood pressure
• dizziness
• muscle spasms and stiffness
• vomiting
• diarrhea
• back pain
• rash and itching
• indigestion
• dry mouth or excessive salivation
• abdominal pain
• drowsiness, fatigue, agitation, and anxiety
• weight gain
• increased activity of the enzyme creatine phosphokinase (found in muscles), observed in blood tests
• increased level of creatinine (a measure of kidney function), observed in blood tests
• decreased appetite.

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

• slurred speech
• nightmares
• difficulty swallowing
• irritation of the stomach lining
• sudden feeling of anxiety
• seizures (fits)
• chest pain
• muscle pain
• temporary loss of consciousness
• feeling of spinning
• disturbances in the conduction of electrical impulses in the heart
• slow heart rate
• joint pain
• difficulty walking
• stiffened body posture
• increased level of prolactin in the blood, increased level of glucose in the blood (blood sugar), increased activity of certain liver enzymes (observed in blood tests)
• drop in blood pressure when standing up, which may cause fainting
• common cold
• hot flashes
• blurred vision
• excessive sweating
• pain when urinating
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• low level of sodium in the blood, which may cause fatigue and disorientation, muscle tremors, seizures, and coma (hyponatremia)
• lack of energy (lethargy)
• gas in the intestines (bloating with gas)
• neck pain
• erectile dysfunction
• painful menstrual bleeding or absence of menstruation
• decreased number of red blood cells (which distribute oxygen in the body).

Rare (may affect up to 1 in 1000 people):

• rabdomyolysis, a breakdown of muscle fibers that releases the contents of muscle fibers (myoglobin) into the bloodstream, characterized by muscle pain, nausea, confusion, abnormal heart rate and rhythm, and possibly dark urine
• increased number of eosinophils (a type of white blood cell)
• swelling under the skin (angioedema)
• intentional self-harm
• stroke
• kidney failure
• decreased number of white blood cells (which fight infections)
• chest pain, milk secretion from the breasts
• sudden death.

Frequency not known (frequency cannot be estimated from the available data):

• decreased number of neutrophils (a type of white blood cell)
• sleep disorders
• in newborns, symptoms such as agitation, increased or decreased muscle tone, muscle tremors, drowsiness, breathing problems, or feeding difficulties may be observed
• abnormal breast enlargement
• in the elderly with dementia, a small increase in the number of deaths has been observed in patients taking antipsychotic medicines compared to those not taking these medicines.

Adolescents may experience the following side effects:

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

• feeling of restlessness and inability to sit still
• headache
• drowsiness
• nausea (feeling sick).

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

• increased or decreased appetite
• abnormal dreams
• difficulty sleeping, tension, agitation, anxiety, and irritability
• physical weakness, fatigue
• depression
• psychotic disorders: a medical term referring to many mental illnesses that cause disturbances in thinking and perception; patients with psychoses lose contact with reality
• schizophrenia symptoms
• difficulty concentrating
• feeling of spinning
• abnormal, involuntary movements (dyskinesia)
• abnormal muscle tension, including neck stiffness and involuntary eye movements
• parkinsonism: a medical term that includes many symptoms, such as excessive saliva production; drooling; muscle tremors when bending limbs; slow, limited, or disturbed body movements; lack of facial expression; muscle tension; neck stiffness; muscle stiffness; walking with small, quick steps, with foot dragging, and lack of normal arm movements when walking; persistent blinking in response to tapping on the forehead (abnormal reflexes)
• rapid heartbeat
• difficulty urinating (constipation)
• dry mouth or excessive salivation
• vomiting
• excessive sweating
• muscle stiffness
• erectile dysfunction
• increased activity of the enzyme creatine phosphokinase (found in muscles), observed in blood tests
• increased level of prolactin in the blood, observed in blood tests
• weight gain or loss.

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

• hypersensitivity
• common cold, throat and nose infection
• increased thyroid activity, thyroid inflammation
• aggressive behavior, impulsive behavior
• apathy
• confusion
• depressed mood
• loss of contact with normal thought processes (dissociative disorders)
• hallucinations (hearing or seeing things)
• thoughts of murder
• difficulty sleeping
• increased or decreased sexual desire
• lack of energy
• changes in mood
• obsessive thoughts
• feeling of intense and overwhelming anxiety (panic attack)
• performing involuntary, purposeless movements (psychomotor agitation)
• muscle overactivity (hyperkinesia), inability to rest (restlessness)
• uncontrolled desire to move the legs (restless legs syndrome), uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• sleep disorders
• suicidal thoughts
• thought disorders
• instability (feeling of spinning)
• changes in taste
• memory disorders
• abnormal sensation on the skin (paresthesia)
• feeling of wearing a tight band around the head (tension headache), migraines
• difficulty focusing, blurred vision
• increased sensitivity to sound
• heart palpitations, changes in heart rhythm
• drop in blood pressure when standing up, which may cause fainting
• high blood pressure
• abdominal pain or discomfort
• lack of or decreased saliva production
• diarrhea
• indigestion
• dry mouth
• toothache
• partial or complete hair loss, abnormal hair growth
• rash, hives
• muscle spasms and stiffness, muscle pain
• joint pain, pain in the arms and legs, jaw pain
• presence of bilirubin in the urine, presence of protein in the urine, kidney function markers
• pain or difficulty urinating, frequent urination, kidney function disorders
• sexual function disorders
• difficulty with ejaculation
• abnormal breast enlargement, breast pain, milk secretion from the breasts
• absence of menstruation or irregular menstruation
• uncontrolled sounds and movements (Tourette's syndrome)
• chills
• difficulty walking
• feeling unwell
• chest pain
• fever
• intentional overdose
• effect on thyroid function, observed in blood tests increased level of cholesterol in the blood, increased level of triglycerides in the blood, decreased level of high-density lipoprotein (HDL), decreased level of low-density lipoprotein (LDL)
• increased level of glucose in the blood, increased level of insulin in the blood, increased activity of certain liver enzymes (observed in blood tests)
• increased or decreased level of testosterone in the blood, increased level of thyroid-stimulating hormone (TSH) in the blood, observed in blood tests
• changes in the electrocardiogram (ECG)
• decreased level of hemoglobin, decreased number of white blood cells (which fight infections), observed in blood tests

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lurobran

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP".

The expiry date refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging and other information

What Lurobran contains

• The active substance of the medicine is lurasidone.

18.5 mg, coated tablets:

Each coated tablet contains lurasidone hydrochloride, equivalent to 18.6 mg of lurasidone.

37 mg, coated tablets:

Each coated tablet contains lurasidone hydrochloride, equivalent to 37.2 mg of lurasidone.

74 mg, coated tablets:

Each coated tablet contains lurasidone hydrochloride, equivalent to 74.5 mg of lurasidone.

111 mg, coated tablets:

Each coated tablet contains lurasidone hydrochloride, equivalent to 111.75 mg of lurasidone.

148 mg, coated tablets:

Each coated tablet contains lurasidone hydrochloride, equivalent to 149 mg of lurasidone.

• Other ingredients are:

Tablet core:

Mannitol; cornstarch; microcrystalline cellulose; sodium croscarmellose; hypromellose type 2910; colloidal anhydrous silica; magnesium stearate.

Coating (tablets of 18.5 mg, 37 mg, and 111 mg strength):

Hypromellose type 2910; titanium dioxide (E 171); macrogol; Carnauba wax.

Coating (tablets of 74 mg and 148 mg strength):

Hypromellose type 2910; titanium dioxide (E 171); macrogol; yellow iron oxide (E 172); indigo carmine (E 132); Carnauba wax.

What Lurobran looks like and contents of the pack

• Lurobran 18.5 mg tablets are white to off-white, round, biconvex, coated tablets, 6 mm in diameter, with "L" engraved on one side and smooth on the other.
• Lurobran 37 mg tablets are white to off-white, round, biconvex, coated tablets, 8 mm in diameter, with "I" engraved on one side and smooth on the other.
• Lurobran 74 mg tablets are green to light green, oval, biconvex, coated tablets, 12 x 7 mm in size, with "I" engraved on one side and smooth on the other.
• Lurobran 111 mg tablets are white to off-white, oval, biconvex, coated tablets, 15 x 8 mm in size, with "C" engraved on one side and smooth on the other.
• Lurobran 148 mg tablets are green to light green, oval, biconvex, coated tablets, 16 x 9 mm in size, with "L" engraved on one side and smooth on the other.

Lurobran coated tablets are available in packs containing 28 tablets in aluminum/aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.

Szamocka 8

01-748 Warsaw

e-mail: biuro@exeltis.com

Manufacturer

Laboratorios Liconsa S.A.

Avda. Miralcampo, 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Isaq

Spain:

Lurobran

Poland:

Lurobran

Sweden:

Lurobran

Date of last revision of the leaflet: