LURASIDONE TECNIGEN 37 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lurasidone TecniGen 18.5 mg film-coated tablets EFG

Lurasidone TecniGen 37 mg film-coated tablets EFG

Lurasidone TecniGen 74 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Keep this package leaflet, as you may need to read it again.

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

• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lurasidone TecniGen and what is it used for
2. What you need to know before taking Lurasidone TecniGen
3. How to take Lurasidone TecniGen
4. Possible side effects
5. Storage of Lurasidone TecniGen
6. Package contents and additional information

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

Lurasidone TecniGen contains the active substance lurasidone and belongs to a group of medications called antipsychotics. It is used to treat symptoms of schizophrenia in adults (18 years of age and older) and adolescents aged 13 to 17 years. Lurasidone works by blocking brain receptors that dopamine and serotonin act on. 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 lack of emotions. People with this disorder may feel depressed, anxious, guilty, or tense. This medication is used to improve their schizophrenia symptoms.

2. What you need to know before taking Lurasidone TecniGen

Do not take Lurasidone TecniGen

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

• medications for fungal infections such as itraconazole, ketoconazole (except in shampoo), posaconazole, or voriconazole
• medications for infections, such as the antibiotic clarithromycin or telithromycin
• medications for HIV infection such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir
• medications for chronic hepatitis such as boceprevir and telaprevir
• nefazodone, a medication for depression
• rifampicin, a medication for tuberculosis
• medications for seizures such as 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 questions about this medication.

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

• you have suicidal thoughts or behaviors
• you suffer from Parkinson's disease or dementia
• you have been diagnosed with a disease whose symptoms are high fever and muscle stiffness (also called malignant neuroleptic syndrome) or have ever suffered from stiffness, 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 medication
• you suffer from heart disease or are being treated 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 medications for schizophrenia have been associated with blood clot formation
• breast enlargement in men (gynecomastia), milky discharge from the nipples (galactorrhea), absence of menstruation (amenorrhea), or erectile dysfunction
• you suffer from diabetes or are prone to it
• you have reduced kidney function
• you have reduced liver function
• weight gain
• your blood pressure drops when standing up, which can cause dizziness
• you are dependent on opioids (treated with buprenorphine) or severe pain (treated with opioids) or depression or other diseases 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 TecniGen").

If you meet any of these conditions, consult your doctor, as it is possible that they may want to adjust your dose, monitor you more closely, or interrupt treatment with lurasidone.

Children and adolescents

Do not administer to children under 13 years of age.

Other medications and Lurasidone TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, 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 their effects may be negatively 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 legs syndrome (e.g., levodopa), as this medication may reduce their effects
• medications containing ergot alkaloid derivatives (used to treat migraines), and other medications such as terfenadine and astemizole (used to treat hay fever and other allergic conditions), cisapride (used to treat digestive problems), pimozide (used to treat psychiatric disorders), 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 such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with lurasidone, and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles 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.

Tell your doctor if you are taking any of these medications, as it is possible that they may need to change the dose of that medication during treatment with lurasidone.

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

• diltiazem (for hypertension)
• erythromycin (for infections)
• fluconazole (for fungal infections)
• verapamil (for hypertension 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)
• armodafinil, modafinil (for somnolence)
• bosentan (for high blood pressure or finger ulcers)
• nafcillin (for infections)
• prednisone (for inflammatory diseases)
• rufinamide (for seizures)

Tell your doctor if you are taking any of these medications, as it is possible that they may change your dose of lurasidone.

Taking Lurasidone TecniGen with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

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

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

If your doctor decides that the potential benefit of treatment during pregnancy justifies the potential risk to the unborn child, your doctor will closely monitor your child after birth. The reason is that in newborns of mothers who have used lurasidone in the last trimester (last three months) of pregnancy, the following symptoms may appear:

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

If your child develops any of these symptoms, you should consult your doctor. It is not known whether lurasidone passes into breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed.

Driving and using machines

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

Lurasidone TecniGen contains sodium

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

3. How to take Lurasidone TecniGen

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, 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 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 dose should not exceed 148 mg once a day.

Adolescents aged 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 TecniGen

Swallow the tablet whole with water to mask its bitter taste. You should take the dose regularly every day at the same time, so it is easier to remember. You should 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 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, problems standing and walking, dizziness due to low blood pressure, 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 TecniGen

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

If you stop taking Lurasidone TecniGen

If you stop taking this medication, you will lose its effects. You should not stop taking the medication unless your doctor tells you to, as the symptoms may reappear. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• a severe 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 frequent (may affect 1 in 10 people)
• severe rash with blisters that affects 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 (may affect 1 in 1000 people)
• blood clots in the veins, especially in the legs (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.

The following adverse effects may also appear in adults:

Very frequent (may affect more than 1 in 10 people):

• feeling of agitation and inability to remain still
• nausea (vomiting)
• insomnia

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

• Parkinsonism: this medical term describes numerous symptoms, including increased saliva secretion or very humid mouth, drooling, spasms when flexing the limbs, slow, reduced, or difficult body movements, facial expressiveness, muscle tension, neck stiffness, muscle stiffness, 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 called extrapyramidal symptoms (EPS) that will typically include unusual involuntary muscle movements
• rapid heart rate
• increased blood pressure
• dizziness
• muscle spasms and stiffness
• vomiting
• diarrhea
• back pain
• rash and itching
• indigestion
• dry mouth or excess saliva
• abdominal pain
• drowsiness, fatigue, agitation, and anxiety
• weight gain
• increased creatine phosphokinase (a muscle enzyme) levels in blood tests
• increased creatinine (a kidney function marker) levels in blood tests
• decreased appetite

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

• slow and difficult speech
• nightmares
• difficulty swallowing
• irritation of the stomach mucosa
• sudden feeling of anxiety
• seizures
• chest pain
• muscle pain
• temporary loss of consciousness
• feeling that everything is spinning
• abnormal nervous impulses in the heart
• slow heart rate
• joint pain
• walking difficulties
• stiff posture
• increased prolactin and glucose levels in the blood (blood sugar) or some liver enzymes in blood tests
• drop in blood pressure when standing up, which can cause fainting
• common cold
• hot flashes
• blurred vision
• sweating
• pain when urinating
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia)
• low sodium levels in the blood, which can cause fatigue and confusion, muscle spasms, seizures, and coma (hyponatremia)
• lack of energy (lethargy)
• gas (flatulence)
• neck pain
• erection problems
• painful or absent menstrual period
• reduced number of red blood cells (which carry oxygen throughout the body)

Rare (may 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, 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
• reduced number of white blood cells (which fight infection)
• breast pain, milk secretion from the breasts
• sudden death

Frequency not known (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 size increase

In elderly people with dementia, a small increase in the number of deaths has been reported in patients taking schizophrenia medications compared to those who did not take them.

The following adverse effects may appear in adolescents:

Very frequent (may affect more than 1 in 10 people):

• feeling of agitation and inability to remain still
• headache
• drowsiness
• nausea.

Frequent (may 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: this medical term describes many mental illnesses that cause abnormal thoughts and perceptions; people with psychosis lose contact with reality
• schizophrenia symptoms
• difficulty paying attention
• feeling that everything is spinning
• abnormal involuntary movements (dyskinesia)
• abnormal muscle tone, including torticollis and involuntary upward deviation of the eyes
• Parkinsonism: this medical term describes numerous symptoms, including increased saliva secretion or very humid mouth, drooling, spasms when flexing the limbs, slow, reduced, or difficult body movements, facial expressiveness, muscle tension, neck stiffness, muscle stiffness, 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 excess saliva
• vomiting
• sweating
• muscle stiffness
• erection problems
• increased creatine phosphokinase levels in blood tests
• increased prolactin levels in the blood, seen in blood tests
• weight gain or loss

Infrequent (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
• confusional state
• depressed mood
• separation from normal mental processes (dissociation)
• hallucination (auditory or visual)
• homicidal thoughts
• difficulty sleeping
• increased or decreased sexual desire
• lack of energy
• altered mental state
• obsessive thoughts
• feeling of acute and disabling anxiety (panic attack)
• performing involuntary movements that serve no purpose (psychomotor hyperactivity)
• muscle hyperactivity (hyperkinesia), inability to rest

(restlessness)

• uncontrollable urge to move the legs (restless legs syndrome), uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia)

sleep disorders

• deliberate suicidal thoughts
• abnormal thoughts
• instability (feeling that everything is spinning)
• altered sense of taste
• memory impairment
• abnormal skin sensation (paresthesia)
• feeling of having a band tightened around the head (tension headache), migraine

• difficulty focusing the eyes, blurred vision
• increased auditory sensitivity
• palpitations, heart rhythm disorders
• blood pressure drops when standing up, which can cause fainting
• increased blood pressure
• abdominal pain or discomfort
• absence or deficiency of saliva secretion
• diarrhea
• indigestion
• dry lips
• toothache
• partial or complete absence of hair, abnormal hair growth
• rash, urticaria
• muscle spasms and stiffness, 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

• pain or difficulty urinating, frequent urination, kidney disorder
• sexual dysfunction
• difficulty ejaculating
• abnormal breast size increase, breast pain, milk secretion from the breasts
• absent or irregular menstrual period
• making uncontrolled noises and movements (Tourette's syndrome)
• chills
• walking difficulties
• 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 lipoproteins,

decreased low-density lipoproteins, seen in blood tests

• increased glucose in the blood (blood sugar), increased insulin in the blood, increased 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 Adverse Effects

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

5. Conservation of Lurasidona TecniGen

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lurasidona 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), carmine indigo (E132) (present in 74 mg tablets).

Appearance of the Product and Package Contents

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

Lurasidona TecniGen film-coated tablets EFG are available in packages of 28 tablets in OPA/Alu/PVC - Aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

Date of the Last Revision of this Prospectus: March 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/