Patient Information Leaflet

Latuda 18.5 mg Film-Coated Tablets

Latuda 37 mg Film-Coated Tablets

Latuda 74 mg Film-Coated Tablets

Lurasidone

Read this leaflet carefully before you start taking this medicine, because

it contains important information for you.

• Keep this leaflet, 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 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 leaflet. See section 4.

Latuda contains the active substance lurasidone and belongs to a group of medications called antipsychotics. It is used to treat the symptoms of schizophrenia in adults (18 years of age and older) andadolescents aged 13 to 17 years. Lurasidone acts by blocking the brain receptors on which 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 characterized by symptoms such as hearing, seeing, or feeling things that do not exist, holding false beliefs, excessive suspicion, withdrawal, incoherent speech and behavior, and lack of emotions. People who suffer from this disorder may feel depressed, anxious, guilty, or tense. This medication is used to improve their schizophrenia symptoms.

Do not take Latuda if:

• Antifungal medications like itraconazole, ketoconazole (except 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
• Rifampin, a medication for tuberculosis
• Anticonvulsants 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 this medication or during treatment, especially if:

• 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 decreased renal function
  • You have decreased liver function
  • You experience weight gain
  • Your blood pressure drops when standing, 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 Latuda may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Latuda").

If you meet any of these conditions, consult your doctor, as your doctor may need to adjust your dose, monitor you more closely, or discontinue Latuda treatment.

Children and adolescents

Do not administer to children under 13 years old.

Other medications and Latuda

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 Latuda 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 ergot alkaloids (used to treat migraines) and other medications 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), and bepridil (used to treat chest pain).

Inform your doctor if you are taking any of these medications, as you may need to change the dose of that medication during Latuda treatment.

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:

Inform your doctor if you are taking any of these medications, as you may need to change your Latuda dose.

Latuda with food, drinks, and alcohol

Avoid consuming alcohol while taking this medication, as it will have a negative additive 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 or plan to become 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 risk to 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 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 or operate machinery until you know that this medication does not affect you negatively.

Latuda contains sodium

Each tablet contains less than 1 mmol of sodium (23 mg), making it 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:

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 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 Latuda

Swallow the entire tablet 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 just after eating, as this helps the body absorb the medication and allows it to work better.

If You Take More Latuda 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-related dizziness, and abnormal heartbeats.

If You Forget to Take Latuda

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 after the missed dose. If you forget two or more doses, consult your doctor.

If You Stop Taking Latuda

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 using this medication, ask your doctor or pharmacist.

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

Seek medical attentionimmediately if 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 rare (may 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 may be symptoms of a condition known as malignant neuroleptic syndrome. These reactions are rare (may affect 1 in 1,000 people).

• Clots in the veins, especially in the legs (your 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 medical attention immediately.

Also, the following side effects may appear in adults:

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

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

Common (may 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 itching
  • indigestion
  • dry mouth or excessive saliva
  • abdominal pain
  • drowsiness, fatigue, agitation, and anxiety

• weight gain
• increased concentrations of creatine phosphokinase (a muscle enzyme) in blood tests
• increased concentration of creatinine (a kidney function marker) seen in blood tests
• decreased appetite.

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

blood tests

• lack of energy (lethargy)
• gas (flatulence)
• neck pain
• erectile dysfunction
• painful or absent menstrual period
• reduction in the number of red blood cells (which carry oxygen throughout the body).

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

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

muscle, tremor, drowsiness, respiratory or feeding problems

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.

In adolescents, the following side effects may appear:

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

• feeling agitated and unable to stay still
• headache
• drowsiness
• nausea.

Common (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
• 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 concentrations of creatine phosphokinase (a muscle enzyme) in blood tests
• increased prolactin (a hormone) in the blood, seen in blood tests
• weight gain or loss.

Uncommon (may 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)
• perform unnecessary and useless involuntary movements (hyperactivity psychomotor)
• muscle hyperactivity, inability to rest (restlessness)
• involuntary, uncontrollable leg movement (restless leg 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, abnormal heart rhythm
• blood pressure drops when standing, 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 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
• pain or difficulty urinating, frequent urination, kidney disorder
• sexual dysfunction
• difficulty ejaculating
• abnormal enlargement of the breasts, breast pain, milk secretion from the breasts
• irregular or absent menstrual period
• 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 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 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 national notification system included in theAppendix V.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 or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Latuda Composition

• The active ingredient is lurasidone.

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

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

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

• The other components are mannitol, pregelatinized starch, sodium croscarmellose,

hypromellose, magnesium stearate (E 470b), titanium dioxide (E171), macrogol, yellow iron oxide (E172) (present in 74 mg tablets), indigotin (E132) (present in 74 mg tablets), and carnauba wax (E903).

Appearance of the product and contents of the package

• Latuda 18.5 mg film-coated tablets are round, white or off-white tablets with “LA” engraved

• Latuda 37 mg film-coated tablets are round, white or off-white tablets with “LB” engraved

• Latuda 74 mg film-coated tablets are oval-shaped, light green tablets with “LD” engraved

Latuda film-coated tablets are available in pack sizes containing 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1, or 98 x 1 tablets in pre-cut, unit-dose blisters of aluminum/aluminum.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181

Rome - Italy

Responsible for manufacturing

Aziende Chimiche Riunite Angelini Francesco ACRAF SPA

Via Vecchia del Pinocchio, 22 60100

Ancona (AN), Italy

Millmount Healthcare Ltd.

Block-7, City North Business Campus,

Stamullen, Co. Meath, K32 YD60,

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last updated date of this leaflet:02/12/2021

For detailed information about this medicine, please visit the European Medicines Agency website:http://www.ema.europa.eu.