Polur

Package Leaflet: Information for the Patient

POLUR, 18.5 mg, coated tablets

POLUR, 37 mg, coated tablets

POLUR, 74 mg, coated tablets

Lurasidone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Polur and what is it used for
• 2. Important information 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 is Polur and what is it used for

Polur 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 (18 years and older) and adolescents (13-17 years). The action of lurasidone involves blocking receptors in the brain that dopamine and serotonin bind 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 normalize brain activity, reducing schizophrenia symptoms.
Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or feeling non-existent things, false beliefs, unusual suspiciousness, withdrawal, incoherent speech, and flattening of behaviors 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 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 the level of lurasidone in the blood, namely:
• antifungal medicines, such as itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole, or voriconazole
• antibiotics, such as clarithromycin or telithromycin,
• HIV medicines, such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir,
• medicines for chronic hepatitis, such as boceprevir and telaprevir,
• antidepressant nefazodone,
• tuberculosis medicine rifampicin,
• seizure medicines, 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 for this medicine to start working fully. If you have any questions about this medicine, consult your doctor.
Before starting or during treatment with Polur, discuss with your doctor, especially if:

• the patient has suicidal thoughts or exhibits 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 (neuroleptic malignant 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 seizures or epilepsy,
• the patient or a family member has had blood clots, as antipsychotic medicines are associated with the formation of 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 impaired kidney function,
• the patient has impaired liver function,
• the patient's weight has increased,
• the patient experiences a drop in blood pressure when standing up, which may cause fainting,
• opioid dependence (treated with buprenorphine), severe pain (treated with opioids), depression, or other conditions treated with antidepressants. Taking these medicines with Polur may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Polur and other medicines").

If any of these conditions apply to the patient, inform the doctor, who may decide to change the dose of the medicine, monitor the patient's condition more closely, or stop the use of Polur.

Children and adolescents

Do not give this medicine to children under 13 years of age.

Polur and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. This is especially important if the patient is taking:

• any medicines that act on the brain, as their effects may add up negatively with the effects of Polur on the brain,
• blood pressure-lowering medicines, as Polur 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), bepridil (used to treat chest pain),

and

• 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 cause symptoms such as involuntary, rhythmic muscle contractions, including those controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, consult a doctor.

If the patient is taking any of these medicines, inform the doctor, who may decide to change the dose of such a medicine during treatment with Polur.
The following medicines may increase the level of lurasidone in the blood:

• 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 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 seizures).

If the patient is taking any of these medicines, inform the doctor, who may decide to change the dose of Polur.

Polur with food and drink

While taking this medicine, avoid drinking alcohol, as it may enhance the negative effects of the medicine.
While taking this medicine, do not drink grapefruit juice. Grapefruit may affect the action of this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy, unless advised by a doctor.
If the doctor decides that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn child, the doctor will closely monitor the child's condition after birth.
This is because newborns whose mothers took lurasidone during the last trimester of pregnancy (the last 3 months) may experience symptoms such as:

• tremors, muscle stiffness, and/or muscle weakness, sleepiness, agitation, problems with breathing, and difficulties with feeding.

If the child experiences any of these symptoms, consult a doctor.
It is not known 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

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

Polur contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Polur

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The doctor will determine the dose for the individual patient, taking into account:

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

Adults (18 years and older)

The recommended starting 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.

Adolescents (13-17 years)

The recommended starting 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.

How to take Polur

Swallow the tablet(s) whole with water to avoid the bitter taste.
The patient should take the dose regularly, every day at the same time, which helps remember to take the medicine. This medicine should be taken with food or immediately after a meal, which facilitates its absorption by the body and allows for better action.

Taking more than the recommended dose of Polur

If a higher dose than recommended is taken, consult a doctor immediately. The patient may experience drowsiness, fatigue, abnormal body movements, problems with standing and walking, dizziness due to low blood pressure, and abnormal heart function.

Missing a dose of Polur

Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose the following day. If two or more doses are missed, consult a doctor.

Stopping treatment with Polur

If the patient stops taking this medicine, the effects of the treatment will be lost. Do not stop taking this medicine unless advised by a doctor, as the symptoms of the disease may return.
If you have any further questions on the use of 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.
Seek medical help immediately if the patient experiences any of the following symptoms:

• severe allergic reaction with symptoms such as fever, swelling of the mouth, face, lips, or tongue, 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 genitals (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 neuroleptic malignant syndrome. Such reactions are rare (may affect up to 1 in 1,000 people).
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If the patient experiences any of these symptoms, seek medical help immediately.

The following side effects may also occur in adults:

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 general medical term that includes many symptoms, such as increased saliva production; drooling; sudden jerks when bending limbs; slow, limited, or disturbed body movements; lack of facial expression; muscle tension; neck stiffness; muscle stiffness; walking with small, quick steps, shuffling feet, and lack of normal arm movements when walking; persistent blinking in response to tapping on the forehead (abnormal reflex),
• speech disorders, abnormal muscle movements; a syndrome of symptoms known as 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) shown in blood tests,
• increased creatinine level (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 stomach lining,
• sudden feeling of anxiety,
• seizures (fits),
• chest pain,
• muscle pain,
• temporary loss of consciousness,
• feeling of spinning,
• disturbances in the transmission of electrical impulses in the heart,
• slow heart rate,
• joint pain,
• problems with walking,
• stiffened body posture,
• increased prolactin level in the blood, increased glucose level in the blood (blood sugar), increased activity of certain liver enzymes (shown in blood tests),
• drop in blood pressure when standing up, which may cause fainting,
• common cold,
• hot flushes,
• blurred vision,
• sweating,
• pain when urinating,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• low sodium level in the blood, which may cause fatigue and disorientation, muscle tremors, seizures, and coma (hyponatremia),
• lack of energy (lethargy),
• gas in the intestines,
• neck pain,
• problems with erection,
• painful menstrual bleeding or absence of menstruation,
• decreased red blood cell count (which distributes oxygen in the body).

Rare (may affect up to 1 in 1,000 people):

• rabdomyolysis, a breakdown of muscle fibers that releases muscle contents into the bloodstream, which may cause muscle pain, nausea, confusion, abnormal heart rhythm, and possibly dark urine,
• increased eosinophil count (a type of white blood cell),
• swelling under the skin (angioedema),
• intentional self-injury,
• stroke or mini-stroke,
• kidney failure,
• decreased white blood cell count (which fights infections),
• breast pain, breast swelling, or milk secretion from the breasts,
• sudden death.

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

• decreased neutrophil count (a type of white blood cell),
• sleep disorders,
• in newborns, symptoms such as agitation, increased or decreased muscle tone, tremors, sleepiness, 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.

The following side effects 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 sick).

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

• increased or decreased appetite,
• abnormal dreams,
• sleep problems, 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; sudden jerks when bending limbs; slow, limited, or disturbed body movements; lack of facial expression; muscle tension; neck stiffness; muscle stiffness; walking with small, quick steps, shuffling feet, and lack of normal arm movements when walking; persistent blinking in response to tapping on the forehead (abnormal reflex),
• rapid heartbeat,
• constipation,
• dry mouth or excessive salivation,
• vomiting,
• sweating,
• muscle stiffness,
• problems with erection,
• increased creatine phosphokinase level in the blood (a muscle enzyme), increased prolactin level in the blood,
• weight gain or loss.

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

• hypersensitivity,
• common cold, throat infection,
• increased thyroid activity, thyroid inflammation,
• aggressive behavior, impulsive behavior,
• apathy,
• confusion,
• depressed mood,
• dissociative disorders: a medical term referring to many mental illnesses that cause a disconnection from normal thought processes,
• hallucinations (hearing or seeing things),
• thoughts of murder,
• sleep problems,
• increased or decreased sexual desire,
• lack of energy,
• mood changes,
• obsessive thoughts,
• feeling of intense and overwhelming anxiety (panic attack),
• performing uncontrolled, purposeless movements (psychomotor agitation),
• muscle overactivity (hyperkinesia), inability to rest (restlessness),
• uncontrolled urge 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 perception,
• memory problems,
• 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,
• 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 saliva or excessive salivation,
• diarrhea,
• indigestion,
• dry lips,
• toothache,
• partial or complete hair loss, abnormal hair growth,
• rash, hives,
• muscle spasms and stiffness, muscle pain,
• joint pain, arm and leg pain, jaw pain,
• presence of bilirubin in the urine, presence of protein in the urine (a marker of kidney function),
• pain or difficulty urinating, frequent urination, kidney problems,
• sexual function disorders,
• difficulty with ejaculation,
• abnormal breast enlargement, breast pain, milk secretion from the breasts,
• irregular menstrual cycles or absence of menstruation,
• making uncontrolled sounds and movements (Tourette's syndrome),
• chills,
• difficulty walking,
• feeling unwell,
• chest pain,
• fever,
• intentional overdose,
• effect on thyroid function; increased cholesterol level in the blood, increased triglyceride level in the blood, decreased HDL level, decreased LDL level,
• increased glucose level in the blood (blood sugar), increased insulin level in the blood, increased activity of certain liver enzymes (a marker of liver function), shown in blood tests,
• increased or decreased testosterone level in the blood, increased TSH level in the blood, shown in blood tests,
• changes in ECG,
• decreased hemoglobin level, decreased white blood cell count (which fights infections), shown in blood tests.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 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 after "EXP". The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
There are no special precautions for storing this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Polur contains

• The active substance of Polur is lurasidone. Each Polur 18.5 mg coated tablet contains lurasidone hydrochloride equivalent to 18.6 mg of lurasidone. Each Polur 37 mg coated tablet contains lurasidone hydrochloride equivalent to 37.2 mg of lurasidone. Each Polur 74 mg coated tablet contains lurasidone hydrochloride equivalent to 74.5 mg of lurasidone.
• Other ingredients are: Tablet core:mannitol, cornstarch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, hypromellose type 2910, magnesium stearate. Coating of 18.5 mg and 37 mg tablets:hypromellose type 2910, titanium dioxide (E 171), macrogol, carnauba wax. Coating of 74 mg tablets: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, 6 mm in diameter, with "L" embossed on one side and smooth on the other.
• Polur, 37 mg, tablets are white to almost white, round, biconvex, 8 mm in diameter, with "I" embossed on one side and smooth on the other.
• Polur, 74 mg, tablets are light green to green, oval, biconvex, 12x7 mm in size, with "I" embossed on one side and smooth on the other.

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

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer/Importer

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:

Poland, Sweden
POLUR

Date of last revision of the leaflet: