Package Insert: Information for the Patient

Lurasidone Teva 18.5 mg Film-Coated Tablets

Lurasidone Teva 37 mg Film-Coated Tablets

Lurasidone Teva 74 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Lurasidona Teva contains the active substance lurasidone and belongs to a group of medicines called antipsychotics. It is used to treat the symptoms of schizophrenia in adults (18 years of age and older) and adolescents 13 to 17 years old. Lurasidone acts by blocking brain receptors on which the substances dopamine and serotonin act. Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to communicate with each other) involved in the symptoms of schizophrenia. By blocking these receptors, lurasidone helps to normalize brain activity, reducing the symptoms of schizophrenia.

Schizophrenia is a disorder with symptoms such as hearing, seeing, or feeling things that do not exist, having false beliefs, excessive suspicion, withdrawal, incoherent speech and behavior, and absence of emotions. People suffering from this disorder may feel depressed, anxious, guilty, or tense. This medicine is used to improve their schizophrenia symptoms.

Do not take Lurasidone Teva

• if you are allergic to lurasidone or any of the other ingredients of this medication (listed in section 6).
• if you are taking medications that may affect the concentration of lurasidone in the blood, such as:
• • antifungal medications like itraconazole, ketoconazole (except in shampoo), posaconazole, or voriconazole
  • antibiotics like clarithromycin or telithromycin
  • medications for HIV like cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir
  • medications for chronic hepatitis like boceprevir and telaprevir
  • nefazodone, a medication for depression
  • rifampicin, a medication for tuberculosis
  • medications for seizures like carbamazepine, phenobarbital, and phenytoin
  • St. John's Wort (Hypericum perforatum), a medicinal plant for treating depression

Warnings and precautions

The full effect of this medication may take several days or even weeks to appear.

Consult your doctor if you have any doubts about this medication.

Consult your doctor or pharmacist before taking lurasidone or during treatment, especially if:

• you have suicidal thoughts or behaviors
• you have Parkinson's disease or dementia
• you have been diagnosed with a condition characterized by high fever and muscle rigidity (also known as neuroleptic malignant syndrome) or have experienced muscle rigidity, tremors, or mobility problems (extrapyramidal symptoms) or abnormal movements of the tongue or face (tardive dyskinesia). Be aware that these conditions may be caused by this medication
• you have heart disease or are receiving treatment for a heart condition that makes you prone to low blood pressure or have a family history of irregular heartbeats (including QT prolongation)
• you have a history of seizures or epilepsy
• you have a history of blood clots or have a family member with a history of blood clots, as antipsychotic medications have been associated with blood clot formation
• you experience breast enlargement in men (gynecomastia), milk secretion from the nipples (galactorrhea), absence of menstruation (amenorrhea), or erectile dysfunction
• you have diabetes or are prone to it
• you have reduced kidney function
• you have reduced liver function
• you experience weight gain
• your blood pressure drops when you stand up, which may cause dizziness
• you have opioid dependence (treated with buprenorphine) or severe pain (treated with opioids) or depression or other conditions treated with antidepressants. The use of these medications in combination with lurasidone may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Lurasidone Teva").

If you meet any of these conditions, consult your doctor, as it may be necessary to adjust your dose, monitor you more closely, or discontinue lurasidone treatment.

Children and adolescents

Do not administer this medication to children under 13 years old.

Other medications and Lurasidone Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is especially important if you are taking:

• any medication that also acts on the brain, as its effects may be additive to those of lurasidone in your brain
• medications that lower blood pressure, as this medication may also lower blood pressure
• medications for Parkinson's disease and restless leg syndrome (e.g., levodopa), as this medication may reduce their effects
• medications containing derivatives of ergot alkaloids (used to treat migraines), and other medications like terfenadine and astemizol (used to treat hay fever or allergic rhinitis and other allergic conditions), cisapride (used to treat digestive problems), pimozide (used to treat psychiatric conditions), quinidine (used to treat heart conditions), bepridil (used to treat chest pain)
• medications containing buprenorphine (used to treat opioid dependence) or opioids (used to treat severe pain) or antidepressants like moclobemide, tranilcipromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with lurasidone and you may experience symptoms like involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, elevated body temperature above 38 ?, etc. If you experience these symptoms, consult your doctor.

Inform your doctor if you are taking any of these medications, as it may be necessary to change your dose of this medication during treatment with lurasidone.

The following medications may increase the concentration of lurasidone in your blood:

• diltiazem (for high blood pressure)
• erythromycin (for infections)
• fluconazole (for fungal infections)
• verapamil (for high blood pressure or chest pain)

The following medications may decrease the concentration of lurasidone in your blood:

• amprenavir, efavirenz, etravirine (for HIV infection)
• aprepitant (for nausea and vomiting)
• armodafinilo, modafinilo (for sleepiness)
• bosentan (for high blood pressure or ulcers on the fingers)
• nafcillin (for infections)
• prednisone (for inflammatory diseases)
• rufinamide (for seizures)

Inform your doctor if you are taking any of these medications, as it may be necessary to change your dose of lurasidone.

Lurasidone Teva with food, drinks, and alcohol

Avoid consuming alcohol while taking this medication, as it will have an additive negative effect.

Do not drink grapefruit juice while taking this medication. Grapefruit may affect the action of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication during pregnancy unless your doctor has agreed to it.

If your doctor decides that the potential benefits of treatment during pregnancy outweigh the potential risks for the unborn child, your doctor will closely monitor your child after birth. This is because newborns of mothers who have used lurasidone in the last trimester (last three months) of pregnancy may experience the following symptoms:

• tremors, rigidity, or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding.

If your child develops any of these symptoms, consult your doctor.

The passage of lurasidone into breast milk is unknown. Inform your doctor if you are breastfeeding or plan to do so.

Driving and operating machinery

During treatment with this medication, you may experience drowsiness, dizziness, and vision problems (see section 4, Possible side effects). Do not drive, ride a bike, or operate tools or machinery until you know that this medication does not affect you negatively.

Lurasidone Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, making it essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your dose will be decided by your doctor and may depend on:

• how well you respond to a dose
• if you are taking other medications (see section 2 “Other Medications and Lurasidone Teva”)
• if you have kidney or liver problems

Adults (18 years or older)

The recommended initial dose is 37 mg once a day.

Your doctor may increase or decrease the dose within the range of 18.5 mg to 148 mg once a day. The maximum daily dose should not exceed 148 mg.

Adolescents (13 to 17 years)

The recommended initial dose is 37 mg of lurasidone once a day.

The dose may be increased or decreased by your doctor within the dose 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 entire tablets with water to mask their bitter taste. Take the dose regularly every day at the same time to make it easier to remember. Take this medication with food or immediately after eating, as this helps the body absorb the medication and allows it to work better.

If you takemore Lurasidone Teva than you should

If you take more of this medication than you should, consult your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty staying upright and walking, low blood pressure dizziness, and abnormal heartbeats.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lurasidone Teva

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, take the next dose on the following day after the missed dose. If you forget two or more doses, consult your doctor.

If you interrupt treatment with Lurasidone Teva

If you stop taking this medication, you will lose its effects. Do not stop taking the medication unless your doctor tells you to, as symptoms may reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek immediate medical attentionif you notice any of the following symptoms:

• intense allergic reaction consisting of fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and, sometimes, a drop in blood pressure (hypersensitivity). These reactions are common (can affect 1 in 10 people)
• severe rash with blisters affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). This reaction has an unknown frequency
• fever, sweating, muscle stiffness, and decreased level of consciousness. These could be symptoms of a condition known as malignant neuroleptic syndrome. These reactions are rare (can affect 1 in 1000 people)
• blood clots in the veins, especially in the legs (their symptoms are swelling, pain, and redness of the leg), which can move through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.

Also, the following side effects may appear in adults:

Very common (can affect more than 1 in 10 people):

• feeling agitated and unable to remain still
• nausea (urge to vomit)
• insomnia

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

• Parkinsonism: this medical term describes numerous symptoms, including increased saliva secretion or a very moist mouth, drooling, spasms when flexing the limbs, slow, reduced, or impaired body movements, facial expressionlessness, muscle tension, neck stiffness, muscle rigidity, short, shuffling, and hurried steps, and lack of normal arm movements when walking, persistent eye blinking when hitting the forehead (abnormal reflex)
• speech problems, unusual muscle movements; a series of symptoms known as extrapyramidal symptoms (EPS) that will typically include unusual and unnecessary involuntary muscle movements
• rapid heart rate
• increased blood pressure
• dizziness
• muscle spasms and rigidity
• vomiting (nausea)
• diarrhea
• back pain
• skin rash and pruritus
• indigestion
• dry mouth or excessive saliva
• abdominal pain
• fatigue, drowsiness, agitation, and anxiety
• weight gain
• increased levels of creatine phosphokinase (a muscle enzyme) seen in blood tests
• increased levels of creatinine (a kidney function marker) seen in blood tests
• decreased appetite

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

• slow and difficult speech
• nightmares
• difficulty swallowing
• gastritis
• sudden onset of anxiety
• convulsions (seizures)
• chest pain
• muscle pain
• temporary loss of consciousness
• sensation of spinning
• abnormal heart impulses
• low heart rate
• joint pain
• difficulty walking
• rigid posture
• increased levels of prolactin and glucose in the blood (blood sugar), increased levels of some liver enzymes, seen in blood tests
• drop in blood pressure when standing, which can cause dizziness
• common cold
• headaches
• blurred vision
• sweating
• pain when urinating
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia)
• low sodium levels in the blood that can cause fatigue and confusion, muscle spasms, convulsions, and coma (hyponatremia)
• lack of energy (lethargy)
• gas (flatulence)
• neck pain
• erectile dysfunction
• painful or absent menstruation
• reduced number of red blood cells (which carry oxygen throughout the body)

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

• myoglobinuria, which is the breakdown of muscle fibers, releasing muscle content (myoglobin) into the bloodstream and causing muscle pain, nausea, confusion, abnormal heart rate and rhythm, and, possibly, dark urine
• increased eosinophils (a type of white blood cell)
• swelling under the skin (angioedema)
• deliberate self-harm
• stroke
• kidney failure
• reduced number of white blood cells (which fight infection)
• breast pain, milk secretion from the breasts
• sudden death

Unknown frequency (cannot be estimated from available data):

• reduced number of a subgroup of white blood cells (neutrophils)
• sleep disorder
• newborns may show the following: agitation, increased or decreased muscle tone, tremors, drowsiness, respiratory or feeding problems
• abnormal breast enlargement

In elderly patients with dementia, there has been a small increase in the number of deaths in patients taking antipsychotic medications compared to those not taking them.

Adolescents may experience the following side effects:

Very common (can affect more than 1 in 10 people):

• feeling agitated and unable to remain still
• headache
• drowsiness
• nausea (discomfort)

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

• reduced or increased appetite
• abnormal dreams
• difficulty sleeping, tension, agitation, anxiety, and irritability
• physical weakness, fatigue
• depression
• psychotic disorder: a medical term that describes many mental illnesses that cause abnormal thoughts and perceptions; people with psychosis lose contact with reality
• schizophrenia symptoms
• difficulty paying attention
• sensation of spinning
• abnormal involuntary movements (dyskinesia)
• abnormal muscle tone, including torticollis and involuntary deviation of the eyes upwards
• Parkinsonism: this medical term describes numerous symptoms, including increased saliva secretion or a very moist mouth, drooling, spasms when flexing the limbs, slow, reduced, or impaired body movements, facial expressionlessness, muscle tension, neck stiffness, muscle rigidity, short, shuffling, and hurried steps, and lack of normal arm movements when walking, persistent eye blinking when hitting the forehead (abnormal reflex)
• rapid heart rate
• difficulty emptying the intestines (constipation)
• dry mouth or excessive saliva
• vomiting (nausea)
• sweating
• muscle rigidity
• erectile dysfunction
• increased levels of creatine phosphokinase (a muscle enzyme) seen in blood tests
• increased levels of prolactin (a hormone) in the blood, seen in blood tests
• weight gain or loss

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

• hypersensitivity
• common cold, throat and nasal infection
• decreased thyroid activity, thyroid inflammation
• aggressive behavior, impulsive behavior
• apathy
• confusion state
• depressed mood
• disconnection of normal mental processes (dissociation)
• hallucination (auditory or visual)
• homicidal thoughts
• difficulty sleeping
• increased or decreased libido
• lack of energy
• mental state alteration
• obsessive thoughts
• sudden onset of incapacitating anxiety (panic attack)
• performing unnecessary and involuntary movements (hyperactivity)
• muscle hyperactivity, inability to rest (restlessness)
• involuntary leg movement (restless leg syndrome), involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia)
• sleep disorder
• deliberate suicidal thoughts
• abnormal thoughts
• instability (sensation of spinning)
• alteration of taste
• memory deterioration
• abnormal skin sensation (paresthesia)
• sensation of a tight band around the head (tension headache), migraine
• difficulty focusing the eyes, blurred vision
• increased sensitivity to sound
• palpitations, abnormal heart rhythm
• blood pressure drops when standing, which can cause dizziness
• increased blood pressure
• abdominal pain or discomfort
• absence or deficiency of saliva secretion
• diarrhea
• indigestion
• dry lips
• toothache
• partial or complete hair loss, abnormal hair growth
• skin rash, urticaria
• muscle spasms and rigidity, muscle pain
• joint pain, pain in arms and legs, jaw pain
• bilirubin in the urine, protein in the urine, a marker of kidney function
• pain or difficulty urinating, frequent urination, kidney disorder
• sexual dysfunction
• difficulty ejaculating
• abnormal breast enlargement, breast pain, milk secretion from the breasts
• absent or irregular menstruation
• making involuntary noises and movements (Tourette's syndrome)
• chills
• difficulty walking
• discomfort
• chest pain
• fever
• intentional overdose
• effects on thyroid function, seen in blood tests, increased cholesterol in the blood, increased triglycerides in the blood, decreased high-density lipoprotein, decreased low-density lipoprotein, seen in blood tests
• increased glucose in the blood (blood sugar), increased insulin in the blood, increased levels of some liver enzymes (a marker of liver function), seen in blood tests
• increased or decreased testosterone in the blood, increased thyroid-stimulating hormone in the blood, seen in blood tests
• electrocardiogram alterations
• decreased hemoglobin, reduced number of white blood cells (which fight infection), seen in blood tests

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lurasidone Teva

• The active ingredient is lurasidone.

Lurasidone Teva 18.5 mg:

Each tablet contains 18.5 mg of lurasidone hydrochloride equivalent to 18.6 mg of lurasidone.

Lurasidone Teva 37 mg:

Each tablet contains 37 mg of lurasidone hydrochloride equivalent to 37.2 mg of lurasidone.

Lurasidone Teva 74 mg:

Each tablet contains 74 mg of 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 section 2, “Lurasidone Teva contains sodium”). Additionally, present only in the 74 mg tablet: yellow iron oxide (E172), indigo carmine (E132).

Appearance of the product and contents of the package

Lurasidone Teva 18.5 mg film-coated tablets

Round tablets, white to off-white in color, marked with “LL” on one side, flat on the other, with a diameter of 6.1 mm.

Lurasidone Teva 37 mg film-coated tablets

Round tablets, white to off-white in color, marked with “LI” on one side, flat on the other, with a diameter of 8.1 mm.

Lurasidone Teva 74 mg film-coated tablets

Oval tablets, green to light green in color, marked with “LH” on one side, flat on the other, and with dimensions of 12.1 x 7.1 mm.

OPA/Al/PVC//Al blisters and perforated single-dose blisters conditioned inside cardboard boxes.

Package sizes of 28 or 28 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer responsible

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95, Pikermi,

Attiki, 190 09, Greece

or

Teva Operations Poland Sp. z.o.o,

ul. Mogilska 80

31-546, Krakow, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

BulgariaLurasidone Teva 37 mg film-coated tablets
Czech RepublicLurasidon Teva

SpainLurasidone Teva 18.5 mg film-coated tablets EFG

Lurasidona Teva 37 mg film-coated tablets EFG

Lurasidone Teva 74 mg film-coated tablets EFG

CroatiaLurasidon Teva 18.5 mg filmom obložene tablete

Lurasidon Teva 37 mg filmom obložene tablete

Lurasidon Teva 74 mg filmom obložene tablete
ItalyLURASIDONE TEVA

NetherlandsLurasidon Teva 18.5 mg, filmomhulde tabletten

Lurasidon Teva 37 mg, filmomhulde tabletten

Lurasidon Teva 74 mg, filmomhulde tabletten

PolandLurasidone Teva B.V.

SloveniaLurasidon Teva 18.5 mg filmsko obložene tablete

Lurasidon Teva 37 mg filmsko obložene tablete

Lurasidon Teva 74 mg filmsko obložene tablete

Last review date of this leaflet:May 2024

Other sources of information

The detailed information about thismedicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html