Polur

Package leaflet: Information for the patient

POLUR, 18.5 mg, film-coated tablets
POLUR, 37 mg, film-coated tablets
POLUR, 74 mg, film-coated tablets
Lurasidonum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• 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 Polur is and what it is used for
2. What you need to know before taking Polur
3. How to take Polur
4. Possible side effects
5. How to store Polur
6. Contents of the pack and other information

1. What Polur is and what it is used for

Polur 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 older) and adolescents aged 13–17 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) involved in the occurrence of symptoms of schizophrenia. By blocking these receptors, lurasidone helps normalize brain activity and reduce symptoms of schizophrenia.
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 emotional expression and behavior. People 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 Polur

When not to take Polur:

• 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 lurasidone blood levels, such as:
• antifungal medicines, such as itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole or voriconazole,
• medicines for infections, 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,
• herbal products used to treat depression – St John’s wort ( Hypericum perforatum ).

Warnings and precautions
It may take several days or even weeks before this medicine starts to work fully. If you have any
questions about this medicine, please contact your doctor.
Before starting to take Polur 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 difficulty moving (extrapyramidal symptoms), or abnormal movements of the tongue or face (tardive dyskinesia). Please 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 if a family member 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 are associated with blood clot formation,
• the patient has enlarged breasts (in men, gynaecomastia), milky discharge from the breasts (galactorrhoea), absence of menstruation or erectile dysfunction,
• the patient has diabetes or a tendency to develop diabetes,
• the patient has impaired kidney function,
• the patient has impaired liver function,
• the patient has experienced weight gain,
• the patient experiences a drop in blood pressure upon standing, which may lead to fainting,
• opioid dependence (treated with buprenorphine), severe pain (treated with opioids), depression or other conditions treated with antidepressants. Taking these medicines together with Polur may lead to serotonin syndrome, a potentially life-threatening condition (see “Polur with other medicines”).

If any of the above conditions apply to the patient, inform the doctor, who may decide to adjust the
dose, monitor the patient more closely, or discontinue treatment with Polur.
Children and adolescents
Polur must not be given to children under 13 years of age.
Polur with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take. This is particularly important if the patient is
taking:

• any medicines acting on the brain, as their effects may add up negatively with the effects of Polur on the brain,

• medicines that lower blood pressure, as Polur may also lower blood pressure,

• medicines for Parkinson’s disease and restless legs syndrome (e.g. levodopa), as this medicine may reduce their effectiveness,

• 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 Polur and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C. If any of these symptoms occur, contact your doctor.

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 Polur.
The following medicines may increase lurasidone blood levels:

• diltiazem (used to treat high blood pressure),
• erythromycin (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 lurasidone blood levels:

• 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 epileptic seizures).

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

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

If the baby shows any of these symptoms, contact the doctor.
It is unknown whether lurasidone passes into breast milk. If the patient is breastfeeding or plans to
breastfeed, she should discuss this with her doctor.
Driving and using machines
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 clear
whether this medicine affects the patient adversely.
Polur contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered
“sodium-free”.

3. How to take Polur

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

• the patient's response to the administered dose,
• any other medicines the patient may be taking (see section 2, "Polur 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.
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.
How to take Polur
The tablet(s) should be swallowed whole with water to avoid experiencing their bitter taste.
The patient should take the medicine regularly at the same time each day, which helps with remembering to take the dose. This medicine should be taken with food or immediately after a meal, as this facilitates absorption and enables better effectiveness.
Taking more Polur than recommended
If an overdose of Polur is taken, contact the doctor immediately. The patient may experience drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, and irregular heart function.
Missing a dose of Polur
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 at the usual time the following day. If the patient misses two or more doses, they should contact their doctor.
Stopping Polur treatment
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 there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

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

• Severe allergic reaction presenting with fever, swelling of the mouth, 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 patients).
• Severe skin rash with blisters on the skin, inside the mouth, eyes, or genital organs (Stevens-Johnson syndrome). This reaction occurs at an unknown frequency.
• Fever, sweating, muscle stiffness, and disturbances of consciousness. These may be symptoms of a condition called neuroleptic malignant syndrome. These reactions are rare (may affect up to 1 in 1000 patients).
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If the patient experiences any of these symptoms, seek immediate medical advice.

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

• Feelings of restlessness and inability to sit still,
• Nausea (feeling sick),
• Insomnia.

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

• Parkinsonism: a general medical term covering various symptoms such as increased salivation; drooling; muscle tremors when bending limbs; slowed, limited, or abnormal body movements; lack of facial expression; muscle tension, neck stiffness; muscle rigidity; walking with small, rapid steps with shuffling gait and absence of normal arm swing during walking; persistent blinking in response to tapping the forehead (abnormal reflex),
• Speech disorders, abnormal muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS), including unusual, purposeless 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) shown in blood tests,
• Increased creatinine levels (a marker of kidney function) shown in blood tests,
• Decreased appetite.

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

• Slurred speech,
• Nightmares,
• Difficulty swallowing,
• Irritation of the gastric mucosa,
• Sudden anxiety,
• Seizures (fits),
• Chest pain,
• Muscle pain,
• Transient loss of consciousness,
• Sensation of spinning,
• Conduction disturbances of electrical impulses in the heart,
• Slow heart rate,
• Joint pain,
• Difficulty walking,
• Stiff posture,
• Increased blood prolactin levels, increased blood glucose levels (blood sugar), increased activity of certain liver enzymes (shown in blood tests),
• Drop in blood pressure upon standing, which may cause fainting,
• Common cold,
• Hot flushes,
• Blurred vision,
• Sweating,
• Pain during urination,
• Uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• Low sodium levels in the blood, which may cause fatigue and disorientation, muscle twitching, seizures, and coma (hyponatremia),
• Lack of energy (lethargy),
• Flatulence,
• Neck pain,
• Erectile problems,
• Painful or absent menstrual bleeding,
• 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 fibres leading to release of muscle fibre contents (myoglobin) into the bloodstream, presenting with 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),
• Deliberate 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 neutrophils (a subgroup of white blood cells),
• Sleep disorders,
• In newborns, symptoms such as agitation, increased or decreased muscle tone, muscle twitching, drowsiness, breathing difficulties, or feeding problems may be observed,
• Abnormal breast enlargement,
• In elderly patients with dementia, a slight increase in the number of deaths has been observed among patients taking antipsychotic medicines compared to those not taking these medicines.

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

• Feelings 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,
• 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 touch with reality,
• Schizophrenia symptoms,
• Difficulty concentrating,
• Sensation of spinning,
• Unusual involuntary movements (dyskinesias),
• Abnormal muscle tension, including neck spasm and involuntary upward rolling of the eyes,
• Parkinsonism: a medical term referring to a range of symptoms including excessive salivation, drooling, sudden jerks when bending limbs, slow, limited, or abnormal body movements, lack of facial expression, muscle tension, neck stiffness, muscle rigidity, small, hurried steps with shuffling gait and absence of normal arm swing during walking, persistent blinking in response to tapping the forehead (abnormal reflexes),
• Rapid heartbeat,
• Difficulty passing stools (constipation),
• Dry mouth or excessive salivation,
• Vomiting,
• Sweating,
• Muscle stiffness,
• Erectile problems,
• Increased creatine phosphokinase levels (a muscle enzyme) observed in blood tests,
• Increased prolactin levels (a hormone) in blood observed in blood tests,
• Weight gain or weight loss.

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

• Hypersensitivity,
• Common cold, throat and nasal infection,
• Increased thyroid activity, thyroid inflammation,
• Aggressive behaviour, impulsive behaviour,
• Apathy,
• Confusional state,
• Depressed mood,
• Loss of connection 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,
• Obsessions,
• Sudden, overwhelming fear (panic attack),
• Performing involuntary, purposeless movements (psychomotor agitation),
• Excessive body muscle activity (hyperkinesia), inability to rest (restlessness),
• Uncontrollable urge to move legs (restless legs syndrome), uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• Sleep disorders,
• Suicidal thoughts,
• Thought disturbances,
• Instability (sensation of spinning),
• Changes in taste perception,
• Memory disturbances,
• Abnormal skin sensations (paresthesia),
• Feeling of tight band around the head (tension headache), migraines,
• Difficulty focusing vision, blurred vision,
• Increased hearing sensitivity,
• Palpitations, changes in heart rhythm,
• Decreased blood pressure on standing, which may cause fainting,
• Increased blood pressure,
• Pain or disturbances in the abdominal area,
• Absence or deficiency of saliva secretion,
• Diarrhea,
• Indigestion,
• Dry lips,
• Toothache,
• Partial or complete hair loss, abnormal hair growth,
• Rash, hives,
• Muscle cramps and stiffness, muscle pain,
• Joint pain, arm and leg pain, jaw pain,
• Presence of bilirubin in urine, presence of protein in urine (marker of kidney function),
• Pain or difficulty urinating, frequent urination, kidney function disturbances,
• Sexual dysfunction,
• Difficulty with ejaculation,
• Abnormal breast enlargement, breast pain, milk secretion from the breasts,
• Irregular or absent menstrual cycles,
• Emitting uncontrollable sounds and performing uncontrollable movements (Tourette's syndrome),
• Chills,
• Difficulty walking,
• Malaise,
• Chest pain,
• Fever,
• Intentional overdose,
• Effect on thyroid function; increased blood cholesterol, increased blood triglycerides, decreased HDL, decreased LDL observed in blood tests,
• Increased blood glucose (blood sugar), increased blood insulin, increased activity of certain liver enzymes (liver function marker) observed in blood tests,
• Increased or decreased blood testosterone levels, increased TSH levels in blood observed in blood tests,
• Changes in ECG,
• Decreased hemoglobin levels, decreased white blood cell count (fighting infections) observed in blood tests.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store POLUR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the specified month.
The marking on the packaging following EXP indicates the expiry date, and following Lot indicates the batch number.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Polur contains

• The active substance is lurazepine. Each Polur 18.5 mg coated tablet contains lurazepine hydrochloride equivalent to 18.6 mg of lurazepine. Each Polur 37 mg coated tablet contains lurazepine hydrochloride equivalent to 37.2 mg of lurazepine. Each Polur 74 mg coated tablet contains lurazepine hydrochloride equivalent to 74.5 mg of lurazepine.
• Other ingredients are: Tablet core: mannitol, corn starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, hypromellose type 2910, magnesium stearate. Coating of the 18.5 mg and 37 mg tablets: hypromellose type 2910, titanium dioxide (E 171), macrogol, carnauba wax. Coating of the 74 mg tablet: hypromellose type 2910, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172), indigo carmine (E 132), carnauba wax.

What Polur looks like and contents of the pack

• Polur 18.5 mg tablets are white to almost white, round, biconvex, film-coated tablets with a diameter of 6 mm, embossed with an "L" on one side and smooth on the other.
• Polur 37 mg tablets are white to almost white, round, biconvex, film-coated tablets with a diameter of 8 mm, embossed with an "I" on one side and smooth on the other.
• Polur 74 mg tablets are light green to green, oval, biconvex, film-coated tablets measuring 12x7 mm, embossed with an "I" on one side and smooth on the other.

Polur film-coated tablets are available in packs containing 28 film-coated tablets in aluminium/aluminium blisters.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
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 European Economic Area countries under the following names:
Poland, Sweden: POLUR