Prospect: information for the patient

Lurasidone TecniGen 18.5 mg film-coated tablets

Lurasidone TecniGen 37 mg film-coated tablets

Lurasidone TecniGen 74 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, because

it contains important information for you.

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

- This medicine has been prescribed to you alone, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Lurasidona TecniGen 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 dopamine and serotonin substances 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 Lurasidona TecniGen

• if you are allergic to lurasidona or any of the other ingredients of this medication (listed in section 6)
• if you are taking medications that may affect the concentration of lurasidona in your blood, such as:

• antifungal medications like itraconazol, ketoconazol (except in shampoo), posaconazol, or voriconazol
• antibiotics like claritromicina or telitromicina
• medications for HIV infection like cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir
• medications for chronic hepatitis like boceprevir and telaprevir
• nefazodona, a medication for depression
• rifampicina, a medication for tuberculosis
• medications for seizures like carbamazepina, fenobarbital, and fenitoína
• St. John's Wort (Hypericum perforatum), a medicinal plant used to treat 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 lurasidona 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 whose symptoms are high fever and muscle rigidity (also known as neuroleptic malignant syndrome) or have experienced 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 another family member has 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 lurasidona may cause serotonin syndrome, a potentially fatal condition (see "Other medications and Lurasidona TecniGen").

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 lurasidona treatment.

Children and adolescents

Do not administer to children under 13 years old.

Other medications and Lurasidona TecniGen

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 lurasidona 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 and other allergic conditions), cisaprida (used to treat digestive problems), pimozida (used to treat psychiatric conditions), quinidina (used to treat heart conditions), bepridilo (used to treat chest pain)
• medications containing buprenorphine (used to treat opioid dependence) or opioids (used to treat severe pain) or antidepressants like moclobemida, tranilcipromina, citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, duloxetina, venlafaxina, amitriptilina, doxepina, or trimipramina. These medications may interact with lurasidona 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, body temperature above 38 °C. 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 the dose of that medication during lurasidona treatment.

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

• diltiazem (for high blood pressure)
• erythromycin (for infections)
• fluconazol (for fungal infections)
• verapamilo (for high blood pressure or chest pain)

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

• amprenavir, efavirenz, etravirina (for HIV infection)
• aprepitant (for nausea and vomiting)
• armodafinilo, modafinilo (for somnolence)
• bosentan (for high blood pressure or ulcers on the fingers)
• nafcilina (for infections)
• prednisona (for inflammatory diseases)
• rufinamida (for seizures)

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

Lurasidona TecniGen 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 lactation

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 lurasidona in the last trimester (last three months) of pregnancy may experience the following symptoms:

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

If your child develops any of these symptoms, consult your doctor. It is unknown whether lurasidona passes into breast milk. Inform your doctor if you are breastfeeding your child 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.

Lurasidona TecniGen contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 Lurasidona (TecniGen)

TecniGen)

• 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 once a day.

Adolescents 13 to 17 years old

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 Lurasidona TecniGen

Swallow the tablet whole with water to mask its bitter taste. You should take the dose regularly every day at the same time to make it easier to remember. You should take this medication with food or just after eating, as this helps your body absorb the medication and allows it to work better.

If you takemore Lurasidona TecniGen 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeLurasidona TecniGen

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 Lurasidona TecniGen

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 doubts 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 is unknown in 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 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, dragging, 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 called extrapyramidal symptoms (EPS) that will include, as a rule, 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
• fatigue, drowsiness, 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
• gastric mucosa irritation
• sudden feeling of anxiety
• convulsions
• chest pain
• muscle pain
• temporary loss of consciousness
• sensation of spinning
• abnormal nervous impulses in the heart
• slow heart rate
• joint pain
• difficulty walking
• rigid posture
• increased levels of prolactin and glucose in the blood (blood sugar) 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 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 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 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 stay still
• headache
• drowsiness
• nausea

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 very moist mouth, drooling, spasms when flexing the limbs, slow, reduced, or difficult body movements, facial expressionlessness, muscle tension, neck stiffness, muscle rigidity, short, dragging, 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)
• auditory or visual hallucination
• 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 involuntary movements (hyperactivity)
• hyperactivity of the body's muscles (hyperkinesia), inability to rest

(restlessness)

• involuntary and uncontrollable movements of the legs (restless leg syndrome), movements

involuntary and uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia)

• sleep disorders
• deliberate suicidal thoughts
• abnormal thoughts
• instability (sensation of spinning)
• alteration of the sense of taste
• memory deterioration
• abnormal sensation of the skin (paresthesia)
• sensation of having 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
• presence of bilirubin in the urine, presence of proteins in the urine, a marker of kidney function

• painful or difficult urination, frequent urination, kidney disorder
• sexual dysfunction
• difficulty ejaculating
• abnormal enlargement of the breasts, breast pain, milk secretion from the breasts
• irregular or absent menstruation
• making unnecessary and useless movements and sounds (Tourette's syndrome)
• chills
• difficulty walking
• unwellness
• 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 lipoproteins,

  decreased low-density lipoproteins, seen in blood tests

  • increased glucose in the blood (blood sugar), increased insulin in the blood, increased 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 the Pharmacovigilance of Medicines for Human Usehttps://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.

No special storage conditions are required.

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 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 TecniGen

• The active ingredient is lurasidone

Each 18.5 mg tablet contains 20 mg of lurasidone hydrochloride equivalent

to 18.6 mg of lurasidone.

Each 37 mg tablet contains 40 mg of lurasidone hydrochloride equivalent to

37.2 mg of lurasidone.

Each 74 mg tablet contains 80 mg of lurasidone hydrochloride equivalent to

74.5 mg of lurasidone.

• The other components are mannitol, sodium croscarmellose, hypromellose, magnesium stearate, titanium dioxide (E171), macrogol, yellow iron oxide (E172) (present in 74 mg tablets), and indigo carmine (E132) (present in 74 mg tablets).

Appearance of the product and contents of the packaging

• Lurasidone TecniGen 18.5 mg film-coated tablets, EFG, are white, circular, and convex tablets of 6 mm ± 0.2 mm in diameter, engraved with a minus sign “-“.
• Lurasidone TecniGen 37 mg film-coated tablets, EFG, are white, circular, and convex tablets of 8 mm ± 0.2 mm in diameter.
• Lurasidone TecniGen 74 mg film-coated tablets, EFG, are pale green, oval, and convex tablets of 12.75 mm ± 0.2 mm in length and 6.38 mm ± 0.2 mm in width.

Lurasidone TecniGen film-coated tablets are available in blister packs of 28 tablets in OPA/Alu/PVC – Aluminum.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor.

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet: March 2024

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/