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, tell 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). Lurasidone works by blocking receptors in the brain that dopamine and serotonin attach to. 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 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 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 you are allergic to lurasidone or any of the other ingredients of this medicine (listed in section 6),
• if you are taking medicines that may affect the level of lurasidone in your blood, such as:
• 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,
• hepatitis C medicines, 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, contact your doctor.
Before starting to take Polur or during treatment, discuss this with your doctor, especially if:

• you have suicidal thoughts or exhibit suicidal behavior,
• you have Parkinson's disease or dementia,
• you have been diagnosed with a condition characterized by high fever and muscle stiffness (neuroleptic malignant syndrome) or have 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.
• you have heart disease or are taking medicines for heart disease that may cause low blood pressure, or if a family member has had heart rhythm disorders (including QT interval prolongation),
• you have a history of seizures or epilepsy,
• you or a family member have had blood clots, as antipsychotic medicines are associated with the formation of blood clots,
• you have enlarged breasts (in men, gynecomastia), milk secretion from the breasts (galactorrhea), absence of menstruation, or erectile dysfunction,
• you have diabetes or are prone to diabetes,
• you have impaired kidney function,
• you have impaired liver function,
• your weight has increased,
• you experience a drop in blood pressure when standing up, which can 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 you, tell your doctor, who may decide to change the dose of the medicine, monitor your condition more closely, or stop taking 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 you are taking now or recently, and about any medicines you plan to take. This is especially important if you are taking:

• any medicines that affect 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,
• Parkinson's disease and restless legs syndrome medicines (e.g., levodopa), as this medicine may weaken their effects,
• 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, and body temperature above 38°C. If you experience such symptoms, contact your doctor.

If you are taking any of these medicines, tell your 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 your 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 your 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 you are taking any of these medicines, tell your 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy, unless your doctor has decided that it is necessary.
If your doctor decides that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn baby, they will closely monitor the baby'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, stiffness, and/or muscle weakness, sleepiness, agitation, breathing problems, and feeding difficulties.

If your baby experiences any of these symptoms, contact your doctor.
It is not known whether lurasidone passes into breast milk. If you are breastfeeding or plan to breastfeed, discuss this with your doctor.

Driving and using machines

While taking this medicine, you may experience sleepiness, dizziness, or vision disturbances (see section 4 "Possible side effects"). Do not drive, ride a bike, or operate any tools or machines until you know that this medicine does not affect you negatively.

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.
Your doctor will determine the dose for you, taking into account:

• your response to the dose used,
• any other medicines you are taking (see section 2, "Polur and other medicines"),
• any kidney or liver problems you may have.

Adults (18 years and older)

The recommended starting dose is 37 mg once a day.
Your 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 your doctor within the range of 37 mg 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.
You should take your dose regularly, every day at the same time, which will help you remember to take your medicine. This medicine should be taken with food or immediately after a meal, which will help the body absorb the medicine and allow it to work better.

Taking a higher dose of Polur than recommended

If you take more Polur than you should, contact your doctor immediately. You may experience sleepiness, fatigue, abnormal body movements, problems with standing and walking, dizziness due to low blood pressure, and abnormal heart rhythm.

Missing a dose of Polur

Do not take a double dose to make up for a forgotten dose. If you miss one dose, take the next dose the next day. If you miss two or more doses, contact your doctor.

Stopping treatment with Polur

If you stop taking this medicine, you will lose its effects. Do not stop taking this medicine unless your doctor tells you to, as your symptoms may return.
If you have any further questions about taking 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 you experience 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. 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 bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience 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 restless and unable 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; 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,
• sleepiness, 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,
• gastritis,
• panic attacks,
• seizures (fits),
• chest pain,
• muscle pain,
• loss of consciousness,
• dizziness,
• heart rhythm disturbances,
• slow heart rate,
• joint pain,
• difficulty walking,
• stiff 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 can 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 can cause fatigue and disorientation, muscle tremors, seizures, and coma (hyponatremia),
• lethargy,
• gas in the intestines,
• neck pain,
• erectile dysfunction,
• 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 1000 people):

• rhabdomyolysis, a condition that causes muscle fibers to break down, releasing their contents into the bloodstream, which can cause muscle pain, nausea, confusion, abnormal heart rhythm, and dark urine,
• increased eosinophil count (a type of white blood cell),
• angioedema (swelling under the skin),
• self-inflicted injury,
• 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 (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 growth,
• 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 restless and unable to sit still,
• headache,
• sleepiness,
• nausea (feeling sick).

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

• increased or decreased appetite,
• abnormal dreams,
• sleep disturbances, 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 touch with reality,
• schizophrenia symptoms,
• difficulty concentrating,
• dizziness,
• abnormal involuntary movements (dyskinesia),
• abnormal muscle tone, including neck and 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,
• erectile dysfunction,
• increased creatine phosphokinase level (a muscle enzyme) shown in blood tests,
• increased prolactin level in the blood shown in blood tests,
• weight gain or loss.

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

• hypersensitivity,
• common cold, throat and nose infections,
• increased thyroid activity, thyroiditis,
• aggressive behavior, impulsive behavior,
• apathy,
• confusion,
• depressed mood,
• dissociative disorders: a condition that causes a person to feel detached from their thoughts, feelings, or experiences,
• hallucinations (hearing or seeing things that are not there),
• thoughts of murder,
• sleep disturbances,
• increased or decreased sexual desire,
• lethargy,
• mood changes,
• obsessive thoughts,
• panic attacks,
• involuntary, purposeless movements (akathisia),
• muscle stiffness (hyperkinesia), restlessness (akathisia),
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• sleep disorders,
• suicidal thoughts,
• thought disorders,
• dizziness,
• changes in taste,
• memory disorders,
• abnormal sensations on the skin (paresthesia),
• headache with a feeling of wearing a tight band around the head, migraines,
• difficulty focusing, blurred vision,
• increased sensitivity to sound,
• palpitations, changes in heart rhythm,
• drop in blood pressure when standing up, which can cause fainting,
• high blood pressure,
• abdominal pain or disturbances,
• dry mouth,
• 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 function disturbances,
• sexual function disorders,
• difficulty ejaculating,
• abnormal breast growth, breast pain, milk secretion from the breasts,
• irregular menstrual cycles or absence of menstruation,
• Tourette's syndrome (a condition characterized by involuntary movements and sounds),
• chills,
• difficulty walking,
• malaise,
• 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, tell your doctor or pharmacist. You can also report side effects 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide 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 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.
• The 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

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 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: