Latuda 18.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Latuda 18.5 mg film-coated tablets

Latuda 37 mg film-coated tablets

Latuda 74 mg film-coated tablets

lurasidone

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Latuda is and what it is used for

Latuda 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 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, lurasidona 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 Latuda

Do not take Latuda if:

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

• you are taking medicines that may affect the concentration of lurasidone in your blood, such as:

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

• medicines for infections, such as the antibiotics clarithromycin or telithromycin

• medicines for HIV infection such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir

• medicines for chronic hepatitis such as 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 questions about this medicine.

Talk to your doctor or pharmacist before taking this medicine 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 causing 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). 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 family member has a history of blood clots, as antipsychotic medicines have been associated with blood clot formation
• you experience 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 fainting
• 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 Latuda may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Latuda”).

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

Children and adolescents

Do not give to children under 13 years of age.

Other medicines and Latuda

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 Latuda in your brain
• medicines that lower blood pressure, as this medicine may 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).

Tell your doctor if you are taking any of these medicines, as you may need to adjust the dose of that medicine during treatment with Latuda.

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 Latuda may need to be changed.

Taking Latuda 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 are planning 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 outweighs the possible risk to the unborn child, your doctor will closely monitor your baby after birth. This is because babies born to mothers who have taken lurasidone during the last trimester (last three months) of pregnancy may develop 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 intend to breastfeed.

Driving and using machines

This medicine may cause drowsiness, dizziness, and vision problems (see section 4, Possible side effects). Do not drive or operate tools or machinery until you know how this medicine affects you.

Latuda contains sodium

Each tablet contains less than 1 mmol of sodium (23 mg), i.e., essentially “sodium-free”.

3. How to take Latuda

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 decided 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 Latuda)
• whether 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 your 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 your dose within the range of 37 mg to 74 mg once daily. The maximum daily dose must not exceed 74 mg.

How to take Latuda

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 Latuda than you should

If you take more of this medicine than you should, contact your doctor immediately.

You may experience drowsiness, tiredness, abnormal body movements, difficulty 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 miss a dose, take the next dose on the day following the missed dose. If you miss two or more doses, consult your doctor.

If you stop taking Latuda

If you stop taking this medicine, you will lose its effects. You must 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 with 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 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 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 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 a number of symptoms, including increased salivary secretion 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
• Fast heart rate
• Increased blood pressure
• Dizziness
• Muscle spasms and stiffness
• Vomiting
• Diarrhoea
• Back pain
• Rash and itching
• Indigestion
• Dry mouth or excess saliva
• Abdominal pain
• Drowsiness, tiredness, agitation and anxiety
• Weight gain
• Increased levels of creatine phosphokinase (an enzyme from muscles) in blood tests
• Increased levels of creatinine (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
• Stomach lining irritation
• Sudden feeling of anxiety
• Seizures
• Chest pain
• Muscle pain
• Temporary loss of consciousness
• Feeling of spinning (vertigo)
• Abnormal nerve impulses in the heart
• Low heart rate
• Joint pain
• Difficulty walking
• Stiff posture
• Increases in prolactin and glucose in the blood 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 tiredness and confusion, muscle spasms, seizures and coma (hyponatraemia)
• Lack of energy (lethargy)
• Gas (flatulence)
• Neck pain
• Erectile dysfunction
• 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 fibres, leading to the release of muscle fibre contents (myoglobin) into the bloodstream and causing muscle pain, nausea, confusion, abnormal heart rate and rhythm, and possibly dark urine
• Increase in 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):

• Reduction in 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 problems
• Abnormal enlargement of the breast

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):

• Decreased or increased appetite
• Abnormal dreams
• Difficulty sleeping, tension, agitation, anxiety and irritability
• Physical weakness, tiredness
• Depression
• Psychotic disorder: a medical term describing various mental illnesses causing abnormal thoughts and perceptions; people with psychosis lose touch with reality
• Schizophrenia symptoms
• Difficulty concentrating
• Feeling of spinning (vertigo)
• 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 salivary secretion 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
• 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 weight loss.

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

• Hypersensitivity
• Common cold, throat and nose infection
• Decreased thyroid activity, thyroid inflammation
• Aggressive behaviour, impulsive behaviour
• 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
• Sudden, severe and disabling anxiety (panic attack)
• Performing involuntary, purposeless movements (psychomotor hyperactivity)
• Excessive muscle activity (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 of spinning)
• Altered sense of taste
• Memory impairment
• Abnormal skin sensation (paraesthesia)
• Feeling of a tight band around the head (tension headache), migraine
• Difficulty focusing the eyes, blurred vision
• Increased sensitivity to sound
• Palpitations, changes in heart rhythm
• Drop in blood pressure upon standing, which may cause fainting
• Increased blood pressure
• Abdominal pain or discomfort
• Partial or complete absence of saliva secretion
• Diarrhoea
• 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 enlargement of the breasts, breast pain, milk secretion from the breasts
• Absent or irregular menstruation
• Uncontrolled 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
• Increase or decrease in blood testosterone, increased thyroid-stimulating hormone in blood, seen in blood tests
• Electrocardiogram abnormalities
• Decreased haemoglobin, reduced number of white blood cells (which fight infection), seen in blood tests.

Reporting of adverse effects

If you experience any adverse effect, consult 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 national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging and blister after EXP or CAD. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Latuda

• The active substance 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 components 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 contents of the pack

• Latuda 18.5 mg film-coated tablets are film-coated, round, white or almost white tablets with "LA" engraved.
• Latuda 37 mg film-coated tablets are film-coated, round, white or almost white tablets with "LB" engraved.
• Latuda 74 mg film-coated tablets are film-coated, 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-scored single-dose aluminum/aluminum blisters.

Only some pack 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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