Package Insert: Information for the Patient

Lurasidone Hydrochloride 18.5 mg Film-Coated Tablets

Lurasidone Hydrochloride 37 mg Film-Coated Tablets

Lurasidone Hydrochloride 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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.

Lurasidone cinfa 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 the 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) that are 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 who suffer from this disorder may feel depressed, anxious, guilty or tense. This medicine is used to improve their schizophrenia symptoms.

Do not take Lurasidone cinfa

• 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 concentration of lurasidone in your blood, such as:
• • antifungal medicines like itraconazole, ketoconazole (except in shampoo), posaconazole or voriconazole
  • infectious disease medicines like the antibiotic clarithromycin or telithromycin
  • medicines for HIV infection like cobicistat, indinavir, nelfinavir, ritonavir and saquinavir
  • medicines for chronic hepatitis like boceprevir and telaprevir
  • nefazodone, a medicine for depression
  • rifampicin, a medicine for tuberculosis
  • medicines for seizures like carbamazepine, phenobarbital and phenytoin
  • St. John's Wort (Hypericum perforatum), a medicinal plant used to treat depression.

Warnings and precautions

The full effect of this medicine may take several days or even weeks to appear. Consult your doctor if you have any doubts about this medicine.

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

• you have thoughts or behaviors of suicide
• you have Parkinson's disease or dementia
• you have ever been diagnosed with a condition whose symptoms are high fever and muscle rigidity (also known as neuroleptic malignant syndrome) or have ever experienced rigidity, tremors or mobility problems (extrapyramidal symptoms) or abnormal movements of the tongue or face (tardive dyskinesia). You should be aware that these conditions may be caused by this medicine
• 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 any other family member has a history of blood clots, as antipsychotic medicines 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 gain weight
• your blood pressure drops when you stand up, which may cause you to faint.
• you have dependence on opioids (treated with buprenorphine) or severe pain (treated with opioids) or depression or other conditions treated with antidepressants. The use of these medicines in combination with lurasidone may cause serotonin syndrome, a potentially fatal condition (see "Other medicines and Lurasidone cinfa").

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 treatment with lurasidone.

Children and adolescents

Do not administer to children under 13 years.

Other medicines and Lurasidone cinfa

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

• any medicine that also acts on the brain, as its effects may be additive to those of lurasidone in your brain
• medicines that lower blood pressure, as this medicine may also lower blood pressure
• medicines for Parkinson's disease and restless legs syndrome (e.g., levodopa), as this medicine may reduce their effects
• medicines containing derivatives of ergot alkaloids (used to treat migraines), and other medicines like terfenadine and astemizol (used to treat hay fever 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)
• medicines containing buprenorphine (used to treat opioid dependence) or opioids (used to treat severe pain) or antidepressants like moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines 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, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C. If you experience these symptoms, consult your doctor.

Inform your doctor if you are taking any of these medicines, as it may be necessary to change the dose of that medicine during treatment with lurasidone.

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

• diltiazem (to treat hypertension)
• erythromycin (to treat infections)
• fluconazole (to treat fungal infections)
• verapamil (to treat hypertension or chest pain).

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

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

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

Taking Lurasidone cinfa with food, drinks and alcohol

Alcohol consumption should be avoided when taking this medicine, as it will have an additive negative effect.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be taken during pregnancy unless agreed with your doctor.

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 your child or intend to do so.

Driving and operating machinery

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

Lurasidone cinfa contains sodium

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

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

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

• how you respond to a dose
• if you are taking other medications (see section 2, Other medications and Lurasidone cinfa)
• 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 cinfa

Swallow the tablet whole with water to mask its 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 take more Lurasidone cinfa than you should

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

You may experience drowsiness, fatigue, abnormal body movements, difficulty staying upright and walking, low blood pressure-related dizziness, and abnormal heartbeats.

If you forget to take Lurasidone cinfa

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 cinfa

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 rigidity, 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 stay 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 very moist mouth, drooling, spasms when flexing the limbs, slow, reduced, or difficult body movements, facial expressionlessness, muscle tension, neck stiffness, muscle rigidity, short, dragged, 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 usually include unnecessary and unusual involuntary muscle movements
• rapid heart rate
• increased blood pressure
• dizziness
• muscle spasms and rigidity
• vomiting
• diarrhea
• back pain
• skin rash and pruritus
• indigestion
• dry mouth or excessive saliva
• abdominal pain
• drowsiness, fatigue, agitation, and anxiety
• weight gain
• increased levels of creatine phosphokinase (a muscle enzyme) 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
• stomach mucosa irritation
• sudden feeling of anxiety
• convulsions
• 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 or some liver enzymes in blood tests
• drop in blood pressure when standing, which can cause dizziness
• common cold
• headaches
• blurred vision
• sweating
• painful urination
• 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 menstruation or absence of menstruation
• reduction in the number of red blood cells (which carry oxygen throughout the body).

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

• Rhabdomyolysis, which is the breakdown of muscle fibers, releasing the contents of muscle fibers (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 surface (angioedema)
• deliberate self-harm
• stroke
• kidney failure
• reduction in the 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):

• reduction in the 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 enlargement of the breast.

In elderly people 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 stay still
• headache
• drowsiness
• nausea.

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

• decreased 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 upwards of the eyes,
• Parkinsonism: this medical term describes numerous symptoms, including increased saliva secretion or very moist mouth, drooling, spasms when flexing the limbs, slow, reduced, or difficult body movements, facial expressionlessness, muscle tension, neck stiffness, muscle rigidity, short, dragged, 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
• sweating
• muscle rigidity
• erectile dysfunction
• increased levels of creatine phosphokinase (a muscle enzyme) 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, incapacitating anxiety (panic attack)
• performing unnecessary and useless movements (hyperactivity)
• muscle hyperactivity, inability to rest (restlessness)
• involuntary leg movement (restless legs syndrome), involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia)
• sleep disorders
• deliberate suicidal thoughts
• abnormal thoughts
• instability (sensation of spinning)
• abnormal sense 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, heart rhythm alterations
• 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, arm and leg pain, jaw pain
• bilirubin presence in urine, protein presence in urine, a kidney function marker
• painful or difficult urination, frequent urination, kidney disorder
• sexual dysfunction
• difficulty ejaculating
• abnormal breast enlargement, breast pain, milk secretion from the breasts
• irregular or absent menstruation
• making unnecessary and useless sounds and movements (Tourette's syndrome)
• chills
• difficulty walking
• uncomfortable feeling
• chest pain
• fever
• intentional overdose
• effects on thyroid function, seen in blood tests, increased cholesterol in blood, increased triglycerides in 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 some liver enzymes (a liver function marker), 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 after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Lurasidone Hydrochloride Composition

• The active ingredient is lurasidone.

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

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

Each 74 mg tablet contains hydrochloride of lurasidone equivalent to 74.5 mg of lurasidone.

• The other components are:
• • Core: microcrystalline cellulose, mannitol (E-421), hypromellose, croscarmellose sodium, and magnesium stearate.
  • Coating: hypromellose, titanium dioxide (E-171), macrogol, yellow iron oxide (E-172) (present in 74 mg tablets) and indigo carmine (E-132) (present in 74 mg tablets).

Appearance of the product and contents of the package

Lurasidone Hydrochloride 18.5 mg film-coated tablets

Round, white or off-white, film-coated tablets, engraved with "LL" on one side and plain on the other, with a diameter of 6.1 mm.

Lurasidone Hydrochloride 37 mg film-coated tablets

Round, white or off-white, film-coated tablets, engraved with "LI" on one side and plain on the other, with a diameter of 8.1 mm.

Lurasidone Hydrochloride 74 mg film-coated tablets

Oval, pale green to green, film-coated tablets, engraved with "LH" on one side and plain on the other, with dimensions 12.1 mm x 7.1 mm.

Available in package sizes containing 28 tablets in unit dose blisters of OPA/Al/PVC//Al.

Marketing Authorization Holder

Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

ELPEN Pharmaceutical Co Inc

Marathonos Ave. 95, Pikermi Attiki,

19009, Greece

or

Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: September 2024

The detailed information of this medicine 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 with your smartphone the QR code included in the leaflet and packaging. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/89812/P_89812.html

QR code to:https://cima.aemps.es/cima/dochtml/p/89812/P_89812.html