Lurasidone Teva B.v.

Leaflet accompanying the packaging: patient information

Lurasidone Teva 18.5 mg coated tablets

Lurasidone Teva 37 mg coated tablets

Lurasidone Teva 74 mg coated tablets

Lurasidone

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

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

Table of contents of the leaflet

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

1. What is Lurasidone Teva and what is it used for

Lurasidone Teva 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 (from 18 years) and adolescents aged 13-17 years. Lurasidone works by 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 to 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 Lurasidone Teva

When not to take Lurasidone Teva:

• 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:
• medicines used to treat fungal infections, such as itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole, or voriconazole
• medicines used to treat infections, such as the antibiotic clarithromycin or telithromycin
• medicines used to treat HIV infection, such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir
• medicines used to treat chronic hepatitis, such as boceprevir and telaprevir
• an antidepressant, nefazodone
• a medicine for tuberculosis, rifampicin
• medicines used to treat epilepsy, 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 to take Lurasidone Teva or during treatment, discuss it 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 (called malignant neuroleptic syndrome) or has experienced muscle stiffness and tremors or had problems with movement (extrapyramidal symptoms) or abnormal movements of the tongue or face (tardive dyskinesia). Note that this medicine may cause such symptoms
• the patient has heart disease or is taking medicines for heart disease that can cause low blood pressure, or has a family history of heart rhythm disorders (including QT interval prolongation)
• the patient has a history of epilepsy or seizures
• 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 can cause fainting
• opioid dependence (treated with buprenorphine), severe pain (treated with opioids), or depression or other conditions treated with antidepressants. Taking these medicines with Lurasidone Teva may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition (see "Lurasidone Teva and other medicines").

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

Children and adolescents

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

Lurasidone Teva and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
This is especially important if you are taking:

• any medicines that affect the brain, as they may negatively affect the action of Lurasidone Teva on the brain
• medicines that lower blood pressure, as this medicine may also lower blood pressure
• medicines used to treat Parkinson's disease and restless legs syndrome (e.g., levodopa), as this medicine may weaken their effect
• medicines containing ergot alkaloid derivatives (used to treat migraines) and other medicines, including terfenadine and astemizole (used to treat hay fever and other allergic symptoms), cisapride (used to treat digestive problems), pimozide (used to treat mental illnesses), quinidine (used to treat heart conditions), and bepridil (used to treat chest pain)
• medicines containing buprenorphine (used to treat opioid 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 Lurasidone Teva and may cause symptoms such as involuntary, rhythmic muscle contractions, including those controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, increased muscle tension, and body temperature above 38°C. If such symptoms occur, consult a 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 Lurasidone Teva.
The following medicines may increase the level of lurasidone in the blood:

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

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

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

If you are taking any of these medicines, tell your doctor, who may decide to change the dose of Lurasidone Teva.

Taking Lurasidone Teva with food, drinks, and alcohol

While taking this medicine, avoid drinking alcohol, as alcohol enhances the negative effects of the medicine.
While taking this medicine, do not drink grapefruit juice. Grapefruits 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 child, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy, unless your doctor has decided that the potential benefits of treatment during pregnancy outweigh the potential risk to the unborn child.
If your doctor decides that the potential benefits of treatment during pregnancy outweigh the potential risk to the unborn child, they will closely monitor the condition of the child 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, breathing problems, and feeding difficulties.

If the child experiences any of these symptoms, consult a 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, drowsiness, dizziness, or vision disturbances may occur (see section 4 "Possible side effects"). Do not drive vehicles, ride a bike, or operate any tools or machines until you know that this medicine does not affect you unfavorably.

Lurasidone Teva contains sodium

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

3. How to take Lurasidone Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will determine the dose for your specific condition, taking into account:

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

Adults (from 18 years)

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 to 74 mg once a day.
The maximum daily dose should not exceed 74 mg.

How to take Lurasidone Teva

Swallow the tablet(s) whole with water to avoid the bitter taste.
Take your dose of Lurasidone Teva 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 facilitate its absorption and allow it to work better.

Taking a higher dose of Lurasidone Teva than recommended

If you take a higher dose of Lurasidone Teva than recommended, contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, problems standing and walking, dizziness due to low blood pressure, and abnormal heart rhythm.

Missing a dose of Lurasidone Teva

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

Stopping treatment with Lurasidone Teva

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 doubts about taking this medicine, consult 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 immediatelyif you experience any of the following symptoms:

• severe allergic reaction characterized by fever, swelling of the lips, face, or tongue, difficulty breathing, itching, rash, and sometimes a drop in blood pressure (hypersensitivity). Such reactions are common (may occur in 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 malignant neuroleptic syndrome. These reactions are rare (may occur in 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 breathing difficulties. 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 or wet mouth; tremors when bending limbs; slow, limited, or disturbed body movements; lack of facial expression; muscle tension; neck stiffness; muscle stiffness; walking with small, quick, shuffling steps and lack of normal arm movement while walking; persistent blinking in response to tapping on the forehead (abnormal reflexes)
• speech disorders, abnormal muscle movements; a set of symptoms called extrapyramidal symptoms (EPS), which include abnormal, purposeless, involuntary muscle movements
• rapid heartbeat
• high blood pressure
• dizziness
• muscle spasms and stiffness
• vomiting
• diarrhea
• back pain
• rash and itching
• indigestion
• dry mouth or excessive salivation
• abdominal pain
• drowsiness, fatigue, agitation, and anxiety
• weight gain
• increased activity of the enzyme creatine phosphokinase (found in muscles) shown in blood tests
• increased creatinine level (a measure 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 conduction of electrical impulses in the heart
• slow heart rate
• joint pain
• walking difficulties
• 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)
• high blood pressure
• low blood pressure when standing up, which can cause fainting
• common cold
• hot flashes
• 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)
• lack of energy (lethargy)
• gas (bloating)
• 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):

• rabdomyolysis, a condition where muscle fibers break down, releasing their contents into the bloodstream, characterized by muscle pain, nausea, feeling disoriented, abnormal heart rate and rhythm, and possibly dark urine
• increased eosinophil count (a type of white blood cell)
• swelling under the skin surface (angioedema)
• self-inflicted injury
• stroke or transient ischemic attack
• kidney failure
• decreased white blood cell count (which fights infections)
• chest pain, breast discharge
• 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 restless and unable 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 tone, including neck stiffness and involuntary eye movements
• parkinsonism: a medical term that includes many symptoms, such as excessive saliva production or wet mouth; tremors when bending limbs; slow, limited, or disturbed body movements; lack of facial expression; muscle tension; neck stiffness; muscle stiffness; walking with small, quick, shuffling steps and lack of normal arm movement while walking; persistent blinking in response to tapping on the forehead (abnormal reflexes)
• 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 infection
• decreased thyroid activity, thyroid inflammation
• aggressive behavior, impulsive behavior
• apathy
• confusion
• depressed mood
• loss of contact with normal thought processes (dissociative disorders)
• hallucinations (hearing or seeing things)
• murderous thoughts
• sleep problems
• increased or decreased sexual desire
• lack of energy
• changes in mental state
• obsessive thoughts
• feeling of intense and overwhelming anxiety (panic attack)
• performing involuntary, purposeless movements (psychomotor agitation)
• muscle hyperactivity (hyperkinesia), inability to rest (restlessness)
• involuntary movement of the legs (restless legs syndrome), involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia)
• sleep disorders
• suicidal thoughts
• thought disorders
• instability (feeling of spinning)
• changes in taste perception
• memory disorders
• abnormal sensation on the skin (paresthesia)
• feeling of wearing a tight band around the head (tension headache), migraines
• difficulty focusing, blurred vision
• increased sensitivity to sound
• palpitations, changes in heart rhythm
• low blood pressure when standing up, which can cause fainting
• high blood pressure
• abdominal pain or disorders
• lack of or decreased saliva production
• 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 urine, presence of protein in urine, kidney function marker
• pain or difficulty urinating, frequent urination, kidney function disorders
• sexual dysfunction
• difficulty ejaculating
• abnormal breast enlargement, breast pain, breast discharge
• irregular menstrual cycles or absence of menstruation
• making uncontrolled sounds and movements (Tourette's syndrome)
• chills
• walking difficulties
• 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 (liver function marker), 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Lurasidone Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage precautions.
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 packaging and other information

What Lurasidone Teva contains

• The active substance is lurasidone. Each 18.5 mg tablet contains lurasidone hydrochloride equivalent to 18.6 mg of lurasidone. Each 37 mg tablet contains lurasidone hydrochloride equivalent to 37.2 mg of lurasidone. Each 74 mg tablet contains lurasidone hydrochloride equivalent to 74.5 mg of lurasidone. The other ingredients are: microcrystalline cellulose (E460), mannitol (E421), hypromellose 2910 (E464), sodium croscarmellose (E468) (see "Lurasidone Teva contains sodium"), magnesium stearate (E470b), titanium dioxide (E171), macrogol 8000 (E1521). Additionally, the 74 mg coated tablets contain: yellow iron oxide (E172), indigo carmine aluminum lake (E132).

Lurasidone Teva 18.5 mg coated tablets
White or almost white, round, coated tablets with "LL" embossed on one side and smooth on the other, 6.1 mm in diameter.
Lurasidone Teva 37 mg coated tablets
White or almost white, round, coated tablets with "LI" embossed on one side and smooth on the other, 8.1 mm in diameter.
Lurasidone Teva 74 mg coated tablets
Light green to green, oval, coated tablets with "LH" embossed on one side and smooth on the other, 12.1 x 7.1 mm in size.
Blisters made of OPA/Aluminum/PVC//Aluminum and single-dose perforated blisters, packaged in cardboard boxes.
Pack sizes: 28 or 28 x 1 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA, Haarlem
Netherlands

Manufacturer:

ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95
19009 Pikermi Attiki
Greece
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80
31-546 Kraków

For more information about this medicine, contact the marketing authorization holder's representative:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.

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

Bulgaria
Луразидон Тева 37 mg филмирани
таблетки
Lurasidone Teva 37 mg film-coated
tablets
Czech Republic
Croatia
Lurasidon Teva
Lurasidon Teva 18.5 mg filmom obložene
tablete
Lurasidon Teva 37 mg filmom obložene
tablete
Lurasidon Teva 74 mg filmom obložene
tablete
Lurasidona Teva 18.5 mg comprimidos
recubiertos con película EFG
Lurasidona Teva 37 mg comprimidos
recubiertos con película EFG
Lurasidona Teva 74 mg comprimidos
recubiertos con película EFG
Lurasidon Teva 18.5 mg, filmomhulde
tabletten
Lurasidon Teva 37 mg, filmomhulde
Tabletten
Lurasidon Teva 74 mg, filmomhulde
tabletten
Lurasidone Teva
Lurasidon Teva 18.5 mg filmsko obložene
tablete
Lurasidon Teva 37 mg filmsko obložene
tablete
Lurasidon Teva 74 mg filmsko obložene
tablete
LURASIDONE TEVA
Date of last revision of the leaflet:July 2025
Spain
Netherlands
Poland
Slovenia
Italy