LATUDA 74 mg FILM-COATED TABLETS

2. What you need to know before taking Latuda

Do not take Latuda if:

• you are allergic to lurasidone or any of the other components of this medication (listed in section 6)

• 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 herbal remedy for 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 this medication 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 neuroleptic malignant syndrome) or have ever experienced 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
• enlargement of the breasts in men (gynecomastia), milky secretion 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
  • you gain weight
  • your blood pressure drops when standing up, which can cause you to faint
  • you are dependent on opioids (treated with buprenorphine) or have 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 it is possible that they will want to adjust your dose, monitor you more closely, or interrupt treatment with Latuda.

Children and adolescents

Do not administer to children under 13 years of age.

Other medications and Latuda

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 Latuda in your brain
• medications that lower blood pressure, as this medication can 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), and bepridil (used to treat chest pain)

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

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:

• amprenavir, efavirenz, etravirine (for HIV infection)
• aprepitant (for nausea and vomiting)
• armodafinil, modafinil (for sleepiness)
• 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 will change your dose of Latuda.

Taking Latuda 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 agreed with your doctor.

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, breathing 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. Tell your doctor if you are breastfeeding or plan to breastfeed.

Driving and using machines

During treatment with this medication, drowsiness, dizziness, and vision problems (see section 4, Possible side effects) may occur. Do not drive or operate tools or 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), i.e., it is essentially "sodium-free".

3. How to take Latuda

Follow the administration instructions for this medication exactly 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 Latuda)
• 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 from 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 tablet whole with water, in order 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 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, problems standing and walking, dizziness due to low blood pressure, and abnormal heartbeats.

If you forget to take Latuda

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take the next dose the day after the forgotten 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. You should not stop taking the medication unless your doctor tells you to, as the symptoms may recur.

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 medical attentionimmediately if 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 rare (may affect 1 in 10 people).

• Severe rash with blisters 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 1 in 1,000 people).

• Blood clots in the veins, especially in the legs (symptoms are swelling, pain, and redness of the leg), which can travel through the bloodstream 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 appear in adults:

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

• Feeling of agitation and inability to remain still
• Nausea (vomiting)
• 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 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
• Fast 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
  • Somnolence, fatigue, agitation, and anxiety

• Weight gain
• Increased creatine phosphokinase (a muscle enzyme) levels in blood tests
• Increased creatinine (a kidney function marker) levels 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 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
• Difficulty walking
• Stiff posture
• Increases in prolactin and glucose in the blood 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 that can cause fatigue and confusion, muscle spasms, seizures, and coma (hyponatremia).

• Lack of energy (lethargy)
• Gas (flatulence)
• Neck pain
• Erectile dysfunction
• Painful or absent menstrual period
• Decreased 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, 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
• Decreased 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):

• Decreased number of a subgroup of white blood cells (neutrophils)
• • Sleep disorder
  • Newborns may show the following: agitation, increased or decreased muscle tone

muscle tremors, somnolence, respiratory or feeding problems

• Abnormal increase in breast size

In elderly patients 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 common (may affect more than 1 in 10 people):

• Feeling of agitation and inability to remain still
• Headache
• Somnolence
• 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: 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
• 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 moist 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)
• Fast heart rate
• Difficulty emptying the intestines (constipation)
• Dry mouth or excess saliva
• Vomiting
• Sweating
• Muscle stiffness
• Erectile dysfunction
• Increased creatine phosphokinase (a muscle enzyme) levels in blood tests
• Increased prolactin (a hormone) levels 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 nose infection
• Decreased thyroid activity, thyroid inflammation
• Aggressive behavior, impulsive behavior
• Apathy
• Confusion
• 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)
• Hyperactivity of the body muscles (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
• Drop in blood pressure 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
• Absence or partial loss of hair, abnormal hair growth
• Rash, hives
• 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 kidney function marker
• Pain or difficulty urinating, frequent urination, kidney disorder
• Sexual dysfunction
• Difficulty ejaculating
• Abnormal increase in breast size, breast pain, milk secretion from the breasts
• Absent or irregular menstrual period
• Making uncontrolled noises and movements (Tourette's syndrome)
• Chills
• Difficulty walking
• 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 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, decreased 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 is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Latuda

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

Do not use this medicine after the expiration date that appears on the packaging and the 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.

Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Latuda

• The active ingredient is lurasidone.

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

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

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

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

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

Appearance of the product and package contents

• Latuda 18.5 mg film-coated tablets are round, white or almost white, with "LA" engraved

• Latuda 37 mg film-coated tablets are round, white or almost white, with "LB" engraved

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

Latuda film-coated tablets are available in package 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 single-dose aluminum/aluminum blisters.

Not all package sizes may be marketed.

Marketing authorization holder

Angelini Pharma S.p.A. Viale Amelia 70, 00181

Rome - Italy

Manufacturer

Aziende Chimiche Riunite Angelini Francesco ACRAF SPA

Via Vecchia del Pinocchio, 22 60100

Ancona (AN), Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.