Lurobran

Patient Information Leaflet

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
Lurasidonum
Please read this leaflet carefully before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Lurobran is and what it is 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 pack and other information

1. What Lurobran is and what it is used for

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

Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, extreme suspiciousness, social withdrawal, disorganized speech, and blunted behaviors and emotions. Individuals with this disorder may also experience depression, anxiety, guilt, or tension. This medicine is used to alleviate the symptoms of schizophrenia.

2. Important information before taking Lurobran

When not to take Lurobran:

• if the patient is allergic to lurazidone or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking medicines that may affect the blood concentration of lurazidone, such as:
  • antifungal medicines, such as itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole or voriconazole
  • antimicrobial medicines, such as the antibiotic clarithromycin or telithromycin
  • medicines for HIV infection, such as cobicistat, indinavir, nelfinavir, ritonavir and saquinavir
  • medicines for chronic hepatitis, such as boceprevir and telaprevir
  • an antidepressant medicine, nefazodone
• a medicine for tuberculosis, rifampicin
• medicines used for epileptic seizures, such as carbamazepine, phenobarbital and phenytoin
• a herbal medicine used to treat depression, St John’s wort ( Hypericum perforatum ).

Warnings and precautions
It may take several days before this medicine starts to work fully. If you have any questions about this medicine, please contact your doctor.
Before starting to take Lurobran or during treatment, discuss this with your doctor, especially if:

• the patient has suicidal thoughts or exhibits suicidal behaviour
• the patient has Parkinson’s disease or dementia
• the patient has ever been diagnosed with a condition characterised by high fever and muscle stiffness (called neuroleptic malignant syndrome), or has ever experienced muscle stiffness and tremors, or had movement problems (extrapyramidal symptoms), or abnormal movements of the tongue or face (tardive dyskinesia). Please note that this medicine may cause such conditions
• the patient has heart disease or is taking medicines used for heart disease that may cause low blood pressure, or if a family member of the patient has heart rhythm disorders (including QT prolongation)
• the patient has a history of seizures or epilepsy
• the patient or a family member has had blood clots, as antipsychotic medicines may increase the risk of blood clots
• the patient has enlarged breasts (in men, gynaecomastia), lactation (milk discharge from the breasts), 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 body weight has increased
• the patient experiences a drop in blood pressure upon standing, which may cause fainting
• the patient has opioid dependence (treated with buprenorphine), severe pain (treated with opioids), depression or other conditions treated with antidepressants. Using these medicines together with Lurobran may lead to serotonin syndrome, a potentially life-threatening condition (see “Lurobran and other medicines”).

If any of the above conditions apply to the patient, inform the doctor, who may consider it necessary to adjust the dose, monitor the patient more closely, or discontinue treatment with Lurobran.
Children and adolescents
This medicine should not be given to children under 13 years of age.
Lurobran and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken. This is particularly important if the patient is taking:

• any medicines acting on the brain, as they may negatively affect the action of Lurobran on the brain
• medicines that lower blood pressure, 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 migraine), 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 psychiatric disorders), quinidine (used to treat heart conditions), bepridil (used to treat chest pain)
• medicines containing buprenorphine (used to treat opioid dependence), 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 controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, hyperreflexia, increased muscle tension, body temperature above 38°C. If such symptoms occur, contact your doctor immediately.

If the patient is taking any of these medicines, inform the doctor, who may consider it necessary to adjust the dose of such medicines during treatment with Lurobran.
The following medicines may increase the blood concentration of lurazidone:

• 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 blood concentration of lurazidone:

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

If the patient is taking any of these medicines, inform the doctor, who may consider it necessary to adjust the dose of Lurobran.
Lurobran, food, drink and alcohol
While taking this medicine, avoid drinking alcohol, as alcohol may worsen the adverse effects of the medicine.
Do not drink grapefruit juice while taking this medicine. Grapefruit may affect the action of this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy unless agreed with your doctor.
If your doctor considers that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn child, the newborn will be closely monitored after birth. This is because newborns whose mothers took lurazidone during the third trimester of pregnancy (last 3 months) may experience the following symptoms:

• tremor, muscle stiffness and (or) muscle weakness, drowsiness, agitation, breathing difficulties and feeding difficulties.

If the baby shows any of these symptoms, contact your doctor.
It is not known whether lurazidone passes into human milk. If the patient is breastfeeding or planning to breastfeed, she should discuss this with her doctor.
Driving and operating machinery
During treatment with this medicine, drowsiness, dizziness or blurred vision may occur (see section 4 “Possible side effects”). Do not drive, ride a bicycle or operate any tools or machinery until it is known whether this medicine affects the patient adversely.
Lurobran contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered to be “sodium-free”.

3. How to take Lurobran

This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult your doctor or pharmacist.
The doctor will determine the appropriate dose for each individual patient, taking into account:

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

Adults (aged 18 years and above)
The recommended starting dose is 37 mg once daily.
The doctor may increase or decrease this dose within the range of 18.5 mg to 148 mg once daily.
The maximum dose should not exceed 148 mg once daily.
Higher doses (111 mg and 148 mg) are not intended for use as recommended initial treatment doses,
but for maintenance treatment in adults.

Adolescents aged 13–17 years
The recommended starting dose is 37 mg of lurazidone once daily.
The doctor may increase or decrease the dose within the range of 37 mg to 74 mg once daily.
The maximum daily dose should not exceed 74 mg.
Higher doses (111 mg and 148 mg) are not recommended for use in children and adolescents.

How to take Lurobran
The tablet(s) should be swallowed whole with water to avoid tasting their bitter flavour.
The patient should take the medicine regularly every day at the same time, which helps with remembering
to take the dose. This medicine should be taken with food or immediately after a meal, as this facilitates
absorption into the body and enables better effectiveness.

Taking more Lurobran than recommended
If more Lurobran has been taken than recommended, contact your doctor immediately.
The patient may experience drowsiness, fatigue, abnormal body movements, difficulty standing or walking,
dizziness due to low blood pressure, and abnormal heart function.

Missing a dose of Lurobran
Do not take a double dose to make up for a missed dose. If the patient misses one dose, they should take
the next dose the following day. If the patient misses two or more doses, they should contact their doctor.

Stopping Lurobran
If the patient stops taking this medicine, they will lose its therapeutic effects. Do not discontinue
treatment with this medicine unless advised by the doctor, as symptoms of the illness may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Seek immediate medical help if the patient experiences any of the following symptoms:

• Severe allergic reaction presenting as fever, swelling of the oral cavity, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (hypersensitivity). Such reactions are commonly observed (may affect up to 1 in 10 people).
• Severe skin rash with blisters on the skin, inside the mouth, eyes, and genital organs (Stevens-Johnson syndrome). This reaction occurs with unknown frequency.
• Fever, sweating, muscle stiffness and disturbances in consciousness. These may be symptoms of a condition called neuroleptic malignant syndrome. These reactions occur rarely (may affect up to 1 in 1000 people).
• Blood clots in veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, seek immediate medical advice.

The following adverse reactions may also occur in adults:
Very common (may affect more than 1 in 10 people):

• Feeling of restlessness and inability to sit still
• Nausea
• Insomnia.

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

• Parkinsonism: a general medical term encompassing various symptoms such as increased salivation; drooling; muscle tremor when bending limbs; slowed, limited or disturbed body movements; lack of facial expression; muscle tension, neck stiffness; muscle rigidity; walking with small, quick steps, dragging the feet, and absence of normal arm movements while walking; persistent blinking in response to tapping on the forehead (abnormal reflex)
• Speech disorders, unusual muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS), including unusual, aimless involuntary muscle movements
• Rapid heartbeat
• Increased blood pressure
• Dizziness
• Muscle cramps 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 creatine phosphokinase activity (an enzyme present in muscles), observed in blood tests
• Increased creatinine levels (a marker of kidney function), observed in blood tests
• Decreased appetite.

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

• Slurred speech
• Nightmares
• Difficulty swallowing
• Stomach mucosa irritation
• Sudden anxiety
• Seizures (seizure attacks)
• Chest pain
• Muscle pain
• Brief loss of consciousness
• Sensation of spinning
• Impaired conduction of electrical impulses in the heart
• Slow heart rate
• Joint pain
• Difficulty walking
• Stiff posture
• Increased prolactin levels in blood, increased blood glucose levels (blood sugar), increased activity of certain liver enzymes (observed in blood tests)
• Drop in blood pressure upon standing, which may cause fainting
• Cold
• Hot flushes
• Blurred vision
• Excessive sweating
• Pain during urination
• Uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia)
• Low sodium levels in blood, which may cause fatigue, disorientation, muscle tremors, seizures and coma (hyponatremia)
• Lack of energy (lethargy)
• Intestinal gas (flatulence with gas release)
• Neck pain
• Erectile problems
• Painful menstruation or absence of menstruation
• Decreased number of red blood cells (which carry oxygen throughout the body).

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

• Rhabdomyolysis, i.e. breakdown of muscle fibers leading to release of muscle fiber contents (myoglobin) into the bloodstream, manifesting as muscle pain, nausea, confusion, abnormal heart rate and rhythm, and possibly dark urine
• Increased number of eosinophils (a type of white blood cells)
• Subcutaneous swelling (angioedema)
• Intentional self-harm
• Cerebrovascular event
• Kidney failure
• Decreased number of white blood cells (which fight infections)
• Breast pain, milk secretion from the breasts
• Sudden death.

Frequency unknown (frequency cannot be estimated from available data):

• Decreased number of a subgroup of white blood cells (neutrophils)
• Sleep disorders
• In newborns, symptoms such as agitation, increased or decreased muscle tone, muscle tremors, drowsiness, breathing or feeding difficulties may be observed
• Abnormal breast enlargement
• In elderly patients with dementia, a slight increase in mortality has been observed among patients taking antipsychotic medicines compared to those not taking these medicines.

The following adverse reactions may occur in adolescents:
Very common (may affect more than 1 in 10 people):

• Feeling of restlessness and inability to sit still
• Headache
• Drowsiness
• Nausea (feeling unwell).

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

• Increased or decreased appetite
• Unusual dreams
• Difficulty falling asleep, tension, agitation, anxiety and irritability
• Physical weakness, fatigue
• Depression
• Psychotic disorders: a medical term referring to various mental illnesses causing disturbances in thinking and perception; patients with psychosis lose contact with reality
• Symptoms of schizophrenia
• Difficulty concentrating
• Sensation of spinning
• Unusual involuntary movements (dyskinesias)
• Abnormal muscle tone, including neck spasm and involuntary upward rolling of the eyes
• Parkinsonism: a medical term referring to a range of symptoms including excessive salivation; drooling; muscle tremor when bending limbs; slowed, limited or disturbed body movements; lack of facial expression; muscle tension; neck stiffness; muscle rigidity; walking with small, quick steps, dragging the feet, and absence of normal arm movements while walking; persistent blinking in response to tapping on the forehead (abnormal reflexes)
• Rapid heartbeat
• Difficulty defecating (constipation)
• Dry mouth or excessive salivation
• Vomiting
• Excessive sweating
• Muscle stiffness
• Erectile problems
• Increased creatine phosphokinase activity (a muscle enzyme), observed in blood tests
• Increased prolactin (hormone) levels in blood, observed in blood tests
• Weight gain or weight loss.

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

• Hypersensitivity
• Cold, throat and nasal infection
• Increased thyroid activity, thyroid inflammation
• Aggressive behavior, impulsive behavior
• Apathy
• Confusion
• Depressed mood
• Loss of contact with normal thought processes (dissociative disorders)
• Hallucinations (auditory or visual)
• Thoughts of murder
• Difficulty falling asleep
• Increased or decreased sexual desire
• Lack of energy
• Changes in mental state
• Obsessive thoughts
• Sudden, intense and disabling anxiety (panic attack)
• Performing involuntary, aimless movements (psychomotor agitation)
• Increased body muscle activity (hyperkinesia), inability to rest (motor restlessness)
• Uncontrollable urge to move legs (restless legs syndrome), uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
• Sleep disorders
• Suicidal thoughts
• Thought disorders
• Instability (sensation of spinning)
• Changes in taste sensation
• Memory disturbances
• Abnormal skin sensations (paresthesia)
• Feeling of wearing a tight band around the head (tension headache), migraines
• Difficulty focusing, blurred vision
• Increased hearing sensitivity
• Palpitations, changes in heart rhythm
• Drop in blood pressure upon standing, which may cause fainting
• Increased blood pressure
• Pain or disturbances in the abdominal area
• Absence or deficiency of saliva secretion
• Diarrhea
• Indigestion
• Dry mouth
• Toothache
• Partial or complete hair loss, abnormal hair growth
• Rash, urticaria
• Muscle cramps and stiffness, muscle pain
• Joint pain, shoulder and limb pain, jaw pain
• Presence of bilirubin in urine, presence of protein in urine, markers of kidney function
• Pain or difficulty urinating, frequent urination, kidney function disorders
• Sexual dysfunction
• Difficulty with ejaculation
• Abnormal breast enlargement, breast pain, milk secretion from the breasts
• Absence of menstruation or irregular menstruation
• Uncontrolled vocalizations and involuntary movements (Tourette's syndrome)
• Chills
• Difficulty walking
• Feeling unwell
• Chest pain
• Fever
• Intentional overdose
• Effect on thyroid function, increased blood cholesterol levels, increased blood triglyceride levels, decreased high-density lipoprotein (HDL) levels, decreased low-density lipoprotein (LDL) levels observed in blood tests
• Increased blood glucose (sugar) levels, increased blood insulin levels, increased activity of certain liver enzymes (liver function markers), observed in blood tests
• Increased or decreased blood testosterone levels, increased blood thyroid-stimulating hormone (TSH) levels, observed in blood tests
• Changes in electrocardiogram (EKG)
• Decreased hemoglobin levels, decreased white blood cell count (which fight infections), observed in blood tests.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Lurobran

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lurobran contains

• The active substance is lurazidon.

18.5 mg, film-coated tablets:
Each film-coated tablet contains lurazidon hydrochloride equivalent to 18.6 mg
of lurazidon.
37 mg, film-coated tablets:
Each film-coated tablet contains lurazidon hydrochloride equivalent to 37.2 mg
of lurazidon.
74 mg, film-coated tablets:
Each film-coated tablet contains lurazidon hydrochloride equivalent to 74.5 mg
of lurazidon.
111 mg, film-coated tablets:
Each film-coated tablet contains lurazidon hydrochloride equivalent to 111.75 mg
of lurazidon.
148 mg, film-coated tablets:
Each film-coated tablet contains lurazidon hydrochloride equivalent to 149 mg
of lurazidon.

• Other ingredients are:

Tablet core:
Mannitol; maize starch; microcrystalline cellulose; sodium croscarmellose; hypromellose
type 2910; colloidal anhydrous silica; magnesium stearate.
Tablet coating (18.5 mg, 37 mg and 111 mg tablets):
Hypromellose type 2910; titanium dioxide (E 171); macrogol; carnauba wax.
Tablet coating (74 mg and 148 mg tablets):
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 round, biconvex, film-coated tablets, white to off-white in colour, 6 mm in diameter, with an embossed mark “L” on one side and smooth on the other side.
• Lurobran 37 mg tablets are round, biconvex, film-coated tablets, white to off-white in colour, 8 mm in diameter, with an embossed mark “I” on one side and smooth on the other side.
• Lurobran 74 mg tablets are oval, biconvex, film-coated tablets, light green to green in colour, 12 x 7 mm in size, with an embossed mark “I” on one side and smooth on the other side.
• Lurobran 111 mg tablets are oval, biconvex, film-coated tablets, white to off-white in colour, 15 x 8 mm in size, with an embossed mark “C” on one side and smooth on the other side.
• Lurobran 148 mg tablets are oval, biconvex, film-coated tablets, light green to green in colour, 16 x 9 mm in size, with an embossed mark “L” on one side and smooth on the other side.

Lurobran film-coated tablets are available in packs containing 28 tablets in aluminium/aluminium foil blisters.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]
Manufacturer/Importer
Laboratorios Liconsa S.A.
Avda. Miralcampo, 7
Pol. Ind. Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
This medicinal product is authorised in the following European Economic Area countries
under the following names:
Czech Republic: Isaq
Spain: Lurobran
Poland: Lurobran
Sweden: Lurobran