Lurasidone Tecnigen 37 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lurasidona TecniGen 18.5 mg film-coated tablets EFG

Lurasidona TecniGen 37 mg film-coated tablets EFG

Lurasidona TecniGen 74 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

1. What Lurasidona TecniGen is and what it is used for
2. What you need to know before taking Lurasidona TecniGen
3. How to take Lurasidona TecniGen
4. Possible side effects
5. How to store Lurasidona TecniGen
6. Contents of the pack and other information

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

Lurasidona TecniGen contains the active substance lurasidona and belongs to a group of medicines called antipsychotics. It is used to treat the symptoms of schizophrenia in adults (aged 18 years and older) and adolescents aged 13 to 17 years. Lurasidone works by blocking brain receptors that are acted upon by the substances dopamine and serotonin. 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 normalize brain activity, thereby reducing the symptoms of schizophrenia.

Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or feeling things that do not exist, having false beliefs, excessive suspiciousness, social withdrawal, incoherent speech and behavior, and lack of emotional expression. People with this disorder may feel depressed, distressed, guilty, or tense. This medicine is used to improve their symptoms of schizophrenia.

2. What you need to know before taking TecniGen

Do not take Lurasidone TecniGen

• if you are allergic to lurasidone or to 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 the blood, such as:

• antifungal medicines like itraconazole, ketoconazole (except in shampoo), posaconazole, or voriconazole

• medicines for infections, such as the antibiotics 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 such as carbamazepine, phenobarbital, and phenytoin

• St. John’s wort (Hypericum perforatum), a herbal remedy 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 suicidal thoughts or behaviors
• you suffer from Parkinson’s disease or dementia
• you have ever been diagnosed with a condition whose symptoms include high fever and muscle stiffness (also known as neuroleptic malignant syndrome), or have previously experienced stiffness, tremors, or movement 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 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 another member of your family has a history of blood clots, as antipsychotic medicines have been associated with blood clot formation
• breast enlargement in men (gynaecomastia), milky discharge from the nipples (galactorrhoea), absence of menstruation (amenorrhoea), or erectile dysfunction
• you have diabetes or are prone to it
• you have reduced kidney function
• you have reduced liver function
• you are gaining weight
• your blood pressure drops when you stand up, which may cause you to faint
• you are dependent on opioids (treated with buprenorphine) or have severe pain (treated with opioids), or have depression or other conditions treated with antidepressants. Using these medicines together with lurasidone may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Lurasidona TecniGen”).

If any of these conditions apply to you, consult your doctor, as they may wish to adjust your dose, monitor you more closely, or discontinue treatment with lurasidone.

Children and adolescents

Do not administer to children under 13 years of age.

Other medicines and Lurasidona TecniGen

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

• any medicine that also acts on the brain, as their effects could negatively add to those of lurasidone in your brain
• medicines that lower blood pressure, as this medicine can also reduce blood pressure
• medicines for Parkinson’s disease and restless legs syndrome (e.g., levodopa), as this medicine may reduce their effectiveness
• medicines containing ergot alkaloid derivatives (used to treat migraines), and other medicines 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)
• medicines 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 medicines may interact with lurasidone and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling 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 your dose of that medicine may need to be changed during treatment with lurasidone.

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

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

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

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

Inform your doctor if you are taking any of these medicines, as your dose of lurasidone may need to be changed.

Taking Lurasidona TecniGen with food, drinks, and alcohol

Alcohol consumption should be avoided when taking this medicine, as it may 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine during pregnancy unless your doctor has specifically advised you to do so.

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 baby after birth. This is because newborns of mothers who have used lurasidone during the third trimester (last three months) of pregnancy may experience the following symptoms:

• tremors, muscle stiffness or weakness, drowsiness, agitation, breathing problems, and feeding difficulties.

If your baby develops any of these symptoms, you should consult your doctor. It is unknown whether lurasidone passes into breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed.

Driving and using machines

This medicine may cause drowsiness, dizziness, and vision problems (see section 4, Possible side effects). Do not drive, ride a bicycle, or operate tools or machinery until you know that this medicine does not affect you negatively.

Lurasidona TecniGen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”

3. How to take Lurasidona TecniGen

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

• how you respond to a dose
• whether you are taking other medicines (see section 2, Other medicines and Lurasidona TecniGen)
• if you have kidney or liver problems

Adults (18 years and over)

The recommended starting dose is 37 mg once daily.

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

Adolescents aged 13 to 17 years

The recommended starting dose is 37 mg of lurasidone once daily. Your doctor may increase or decrease the dose within the range of 37 mg to 74 mg once daily. The maximum daily dose must 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 must take this medicine with food or immediately after eating, as this helps your body absorb the medicine and allows it to work better.

If you take more Lurasidona TecniGen than you should

If you take more of this medicine than you should, consult your doctor immediately. You may experience drowsiness, tiredness, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, and abnormal heartbeats.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lurasidona TecniGen

Do not take a double dose to make up for missed doses. If you forget to take a dose, take the next dose on the following day at the usual time. If you miss two or more doses, consult your doctor.

If you stop taking Lurasidona TecniGen

If you stop taking this medicine, you will lose its effects. You should not stop taking the medicine unless instructed by your doctor, as symptoms may return. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Seek immediate medical attention if you notice any of the following symptoms:

• severe allergic reaction including 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 (may affect up to 1 in 10 people)
• severe blistering rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). The frequency of this reaction is unknown
• fever, sweating, muscle stiffness and decreased level of consciousness. These could be symptoms of a condition known as neuroleptic malignant syndrome. These reactions are rare (may affect up to 1 in 1,000 people)
• blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness), which may travel through blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.

The following adverse effects may also occur in adults:

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

• feeling of restlessness and inability to stay still
• nausea (feeling sick)
• insomnia

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

• Parkinsonism: this medical term describes various symptoms, including increased salivation or very wet mouth, drooling, spasms when bending limbs, slow, reduced or difficult body movements, expressionless face, muscle tension, neck stiffness, muscle rigidity, short, shuffling and hurried steps, lack of normal arm movements when walking, persistent blinking when tapping the forehead (abnormal reflex)
• speech problems, unusual muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS), which usually include unnecessary 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 concentrations of creatine phosphokinase (an enzyme in muscles) in blood tests
• increased creatinine concentration (a marker of kidney function) seen in blood tests
• decreased appetite

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

• slow and difficult speech
• nightmares
• difficulty swallowing
• irritation of the stomach lining
• sudden feeling of anxiety
• seizures
• chest pain
• muscle pain
• temporary loss of consciousness
• sensation of spinning (vertigo)
• abnormal nerve impulses in the heart
• low heart rate
• joint pain
• difficulty walking
• rigid posture
• increases in blood prolactin and glucose (blood sugar) levels, or certain liver enzymes seen in blood tests
• drop in blood pressure upon standing, which may cause fainting
• common cold
• hot flushes
• blurred vision
• sweating
• pain when urinating
• involuntary movements of the mouth, tongue and limbs (tardive dyskinesia)
• low sodium levels in the blood, which may cause fatigue, confusion, muscle spasms, seizures and coma (hyponatremia)
• lack of energy (lethargy)
• gas (flatulence)
• neck pain
• erection problems
• painful or absent menstrual periods
• reduced number of red blood cells (which carry oxygen throughout the body)

Rare (may affect up to 1 in 1,000 people):

• Rhabdomyolysis, which is the breakdown of muscle fibers, leading to the release of muscle fiber contents (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 beneath 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

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: restlessness, increased or decreased muscle tone, tremor, drowsiness, breathing or feeding difficulties
• abnormal breast enlargement

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

The following adverse effects may occur in adolescents:

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

• feeling of restlessness and inability to stay still
• headache
• drowsiness
• nausea

Common (may 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 describing various mental illnesses causing abnormal thoughts and perceptions; people with psychosis lose touch with reality
• symptoms of schizophrenia
• difficulty concentrating
• sensation of spinning (vertigo)
• abnormal involuntary movements (dyskinesia)
• abnormal muscle tone, including torticollis and involuntary upward deviation of the eyes
• Parkinsonism: this medical term describes various symptoms, including increased salivation or very wet mouth, drooling, spasms when bending limbs, slow, reduced or difficult body movements, expressionless face, muscle tension, neck stiffness, muscle rigidity, short, shuffling and hurried steps, lack of normal arm movements when walking, persistent blinking when tapping the forehead (abnormal reflex)
• rapid heartbeat
• difficulty emptying the bowels (constipation)
• dry mouth or excess saliva
• vomiting
• sweating
• muscle stiffness
• erection problems
• increased concentrations of creatine phosphokinase (a muscle enzyme) in blood tests
• increased blood prolactin levels (a hormone), seen in blood tests
• weight gain or weight loss

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

• hypersensitivity
• common cold, throat and nose infections
• decreased thyroid activity, thyroid inflammation
• aggressive behavior, impulsive behavior
• apathy
• confusion
• depressed mood
• separation from normal mental processes (dissociation)
• hallucinations (auditory or visual)
• homicidal thoughts
• difficulty sleeping
• increased or decreased sex drive
• lack of energy
• altered mental state
• obsessive thoughts
• sudden, severe and disabling anxiety (panic attack)
• performing unnecessary involuntary movements (psychomotor hyperactivity)
• excessive muscle activity in the body (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 (sensation of spinning)
• altered sense of taste
• memory impairment
• 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 disturbances
• blood pressure drops upon standing, which may cause fainting
• increased blood pressure
• abdominal pain or discomfort
• partial or complete lack of saliva secretion
• diarrhea
• indigestion
• dry lips
• toothache
• partial or complete hair loss, abnormal hair growth
• rash, hives
• muscle spasms and stiffness, muscle pain
• joint pain, pain in arms and legs, jaw pain
• presence of bilirubin in urine, presence of protein in urine, a marker of kidney function
• pain or difficulty urinating, frequent urination, kidney disorder
• sexual dysfunction
• difficulty with ejaculation
• abnormal breast enlargement, breast pain, milk secretion from the breasts
• absent or irregular menstruation
• uncontrollable noises and movements (Tourette's disorder)
• chills
• difficulty walking
• malaise
• chest pain
• fever
• intentional overdose
• effects on thyroid function seen in blood tests, increased blood cholesterol, increased blood triglycerides, decreased high-density lipoproteins, decreased low-density lipoproteins, seen in blood tests
• increased blood glucose (blood sugar), increased blood insulin, increased levels of certain liver enzymes (a marker of liver function), seen in blood tests
• increased or decreased blood testosterone, increased thyroid-stimulating hormone in blood, seen in blood tests
• electrocardiogram abnormalities
• decreased hemoglobin, reduced number of white blood cells (which fight infection), seen in blood tests.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lurasidone TecniGen

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Lurasidona TecniGen

• The active substance 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, iron oxide yellow (E172) (present in the 74 mg tablets), indigo carmine (E132) (present in the 74 mg tablets).

Appearance of the product and contents of the pack

• Lurasidona TecniGen 18.5 mg film-coated tablets EFG are white, circular, convex tablets, 6 mm ± 0.2 mm in diameter, marked with a minus sign “-”.
• Lurasidona TecniGen 37 mg film-coated tablets EFG are white, circular, convex tablets, 8 mm ± 0.2 mm in diameter, marked with an "L" on one side.
• Lurasidona TecniGen 74 mg film-coated tablets EFG are pale green, oblong, convex tablets, 12.75 mm ± 0.2 mm in length and 6.38 mm ± 0.2 mm in width.

Lurasidona TecniGen film-coated tablets EFG are available in packs of 28 tablets in OPA/Alu/PVC – Aluminium 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 most recent revision of this leaflet: March 2024

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