Latuda: detailed information

Package leaflet: Information for the patient

Latuda 18.5 mg, film-coated tablets, 37 mg, film-coated tablets, 74 mg, film-coated tablets

lurasidone
Please read all of this leaflet carefully before 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 their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Latuda is and what it is used for
What you need to know before taking Latuda
How to take Latuda
Possible side effects
How to store Latuda
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 (aged 18 years and older) and
adolescents aged 13–17 years. Lurasidone works by blocking brain receptors to which the
substances dopamine and serotonin bind. Dopamine and serotonin are neurotransmitters (substances that
enable nerve cells to communicate with each other) involved in the symptoms of
schizophrenia. By blocking their receptors, lurasidone helps normalize brain activity, reducing the
symptoms of schizophrenia.
Schizophrenia is a disorder characterized by symptoms such as hearing, sensing, or seeing things that
are not actually present, having false beliefs, experiencing unusual suspicions, withdrawing socially, speaking and behaving incoherently, and lacking emotional expression. People affected by this disorder may also feel
depressed, anxious, guilty, or tense. This medicine is used to improve the symptoms of
schizophrenia.

2. What you should 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)
if you are taking medicines that may affect the level of lurasidone in your blood, such as:
- medicines for fungal infections like itraconazole, ketoconazole (except in shampoo formulation), posaconazole, or voriconazole
- medicines for infections, such as the antibiotic clarithromycin or telithromycin
- medicines for HIV infection, such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir
- medicines for chronic hepatitis, such as boceprevir and telaprevir
- a medicine for depression, nefazodone
- a medicine for tuberculosis, rifampicin
medicines for seizures, such as carbamazepine, phenobarbital, and phenytoin
a herbal medicine for depression, St. John’s wort (Hypericum perforatum).

Warnings and precautions
It may take days or even weeks before this medicine has a full effect. Contact your doctor if you have any questions about this medicine.
Contact your doctor or pharmacist before taking Latuda, or during treatment, especially if:

You have suicidal thoughts or behaviors
You have Parkinson’s disease or dementia
You have been diagnosed with a condition whose symptoms include high temperature and muscle rigidity (also known as neuroleptic malignant syndrome), or if you have ever had muscle stiffness, tremors, or movement problems (extrapyramidal symptoms), or abnormal movements of the tongue or face (tardive dyskinesia). Be aware that these problems 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 if you have a family history of irregular heartbeat (including QT prolongation)
You have a history of seizures (convulsions) or epilepsy
You have a history of blood clots, or if any of your family members have a history of blood clots, because medicines for schizophrenia have been associated with blood clot formation
You experience breast enlargement if you are a man (gynecomastia), milky discharge from the nipples (galactorrhea), absence of menstruation (amenorrhea), or erectile dysfunction
You have diabetes or are prone to developing diabetes
You have reduced kidney function
You have reduced liver function
You have gained weight
You experience low blood pressure when standing up, which may cause fainting
You have opioid dependence (treated with buprenorphine) or severe pain (treated with opioids), or suffer from depression or other conditions treated with antidepressants. Using these medicines together with Latuda may cause serotonin syndrome, a potentially life-threatening condition (see section “Other medicines and Latuda”).

If you have any of these conditions, contact your doctor, as they may need to adjust your dosage, monitor you more closely, or discontinue treatment with Latuda.
Children and adolescents
Do not give this medicine to children and adolescents under 13 years of age.
Other medicines and Latuda
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

Medicines that also act on the brain, as their effects may add negatively to the effects of Latuda on the brain
Medicines that lower blood pressure, because this medicine may also lower it
Medicines for Parkinson’s disease and restless legs syndrome (e.g., levodopa), because this medicine may reduce their effects
Medicines containing ergot alkaloid derivatives (used to treat migraines) and other medicines, including terfenadine and astemizole (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), 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 Latuda and symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Contact your doctor if you experience any of these symptoms.

Tell your doctor if you are taking any of these medicines, as they may decide to adjust the dose during treatment with Latuda.
The following medicines may increase lurasidone levels in the blood:

Diltiazem (used to treat high blood pressure)
Erythromycin (used to treat infections)
Fluconazole (used to treat fungal infections)
Verapamil (used to treat high blood pressure or chest pain).

The following medicines may reduce lurasidone levels in the blood:

Amprenavir, efavirenz, etravirine (used to treat HIV infection)
Aprepitant (used to treat nausea and vomiting)
Armodafinil, modafinil (used to treat sleepiness)
Bosentan (used to treat pulmonary hypertension or finger ulcers)
Nafcillin (used to treat infections)
Prednisone (used to treat inflammatory conditions)
Rufinamide (used to treat seizures).

Tell your doctor if you are taking any of these medicines, as they may decide to adjust the dose of Latuda.
Latuda with food, drinks, and alcohol
During treatment with this medicine, you should avoid alcohol. Alcohol may have an additive negative effect.
Do not drink grapefruit juice during treatment with this medicine. Grapefruit may affect how this medicine works.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking 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 the baby after birth.
Newborns whose mothers have used lurasidone during the third trimester (last three months) of pregnancy may experience the following symptoms:

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

If your baby shows any of these symptoms, contact your doctor.
It is not known whether lurasidone is excreted in human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed.
Driving and using machines
Drowsiness, dizziness, and vision problems may occur during treatment with this medicine (see section 4, Possible side effects). Do not drive or operate bicycles, motorcycles, tools, or machinery until you know how this medicine affects you.
Latuda contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

3. How to take Latuda

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose you will be given will be determined by your doctor and may depend on several factors:

How you respond to a given dose
Whether you are taking other medicines (see section 2, Other medicines and Latuda)
Whether you have kidney or liver problems.

Adults (aged 18 years and older)
The recommended starting dose is 37 mg once daily.
Your doctor may increase or decrease this dose within the dose range of 18.5–
148 mg once daily. The maximum dose must not exceed 148 mg once daily.
Adolescents (13–17 years)
The recommended starting dose is 37 mg of lurasidone once daily.
This dose may be increased or decreased by your doctor within the dose range of 37–74 mg
once daily. The maximum daily dose must not exceed 74 mg.
How to take Latuda
The tablets must be swallowed whole with water to mask their bitter taste.
You should take the dose regularly every day at the same time, as this makes it easier to remember. You
must take this medicine with food or immediately after a meal, as this helps your body absorb the medicine and allows it to work properly.
If you take more Latuda than you should
If you take more medicine than you should, contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty standing or 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 a forgotten dose. If you miss a dose, take the next dose on the following day after 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. Do not stop taking this medicine unless your doctor tells you to, as your symptoms may return.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following symptoms, seek immediate medical advice:

A severe allergic reaction presenting as fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes low blood pressure (hypersensitivity). These reactions have been commonly observed (may affect up to 1 in 10 people)
A severe rash with blistering affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). This reaction has been reported with unknown frequency
Fever, sweating, muscle stiffness and reduced 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 swelling, pain and redness in the leg), which may travel through blood vessels and reach the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, seek immediate medical advice.

The following side effects may also occur in adults:
Very common (may affect more than 1 in 10 people)

Feeling restless and unable to sit still
Nausea
Insomnia.

Common (may affect up to 1 in 10 people)

Parkinsonism: a medical term grouping various symptoms, including increased salivation or watery mouth, drooling, jerking when bending limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, stiff neck, muscle rigidity, small, shuffling, hurried steps and lack of normal arm movements while walking, persistent blinking in response to tapping on the forehead (an abnormal reflex)
Difficulty speaking, abnormal muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS), which generally include unusual, unprovoked and involuntary muscle movements
Fast heartbeat
Increased blood pressure
Dizziness
Muscle spasms and stiffness
Vomiting
Diarrhoea
Back pain
Rash and itching
Indigestion
Dry mouth or excessive salivation
Abdominal pain
Drowsiness, fatigue, agitation and anxiety
Weight gain
Increased levels of creatine phosphokinase (an enzyme present in muscles) detected in blood tests
Increased levels of creatinine (a marker of kidney function) detected in blood tests
Loss of appetite.

Uncommon (may affect up to 1 in 100 people)

Difficulty articulating words
Nightmares
Difficulty swallowing
Irritation of the stomach lining
Sudden anxiety
Seizures (epileptic fits)
Chest pain
Muscle pain
Temporary loss of consciousness
Dizzy sensation
Abnormal nerve impulses in the heart
Slow heartbeat
Joint pain
Difficulty walking
Stiff posture
Increased levels of prolactin in the blood, increased blood glucose (sugar), increased levels of certain liver enzymes, detectable in blood tests
Sudden drop in blood pressure upon standing, possibly leading to fainting
Common cold
Hot flushes
Blurred vision
Sweating
Pain when urinating
Uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia)
Low sodium levels in the blood which may cause fatigue, confusion, muscle cramps, seizures and coma (hyponatraemia)
Lack of energy (lethargy)
Gas (flatulence)
Neck pain
Erectile problems
Painful or absent menstruation
Reduced levels of red blood cells (which carry oxygen in the body).

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

Rhabdomyolysis, i.e. breakdown of muscle fibres leading to release of their contents (myoglobin) into the bloodstream, causing muscle pain, malaise, confusion, abnormal heartbeat 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 levels of white blood cells (which fight infections)
Breast pain, milk secretion from the breasts
Sudden death.

Not known (frequency cannot be estimated from available data)

Reduced levels of a subgroup of white blood cells (neutrophils)
Sleep disorders
Newborns may experience the following symptoms: agitation, increased or decreased muscle tone, tremor, drowsiness, breathing or feeding difficulties
Abnormal breast enlargement.

In elderly patients with dementia, a small increase in mortality has been reported in patients treated with antipsychotic medicines compared to those not treated with these medicines.

The following side effects may occur in adolescents:
Very common (may affect more than 1 in 10 people)

Feeling restless and unable to sit 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: a medical term grouping various mental illnesses causing abnormal thoughts and perceptions; people with psychosis lose touch with reality
Symptoms of schizophrenia
Difficulty concentrating
Dizzy sensation
Abnormal involuntary movements (dyskinesia)
Abnormal muscle tone, including torticollis and involuntary upward deviation of the eyes
Parkinsonism: a medical term grouping various symptoms, including increased salivation or watery mouth, drooling, jerking when bending limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, stiff neck, muscle rigidity, small, shuffling, hurried steps and lack of normal arm movements while walking, persistent blinking in response to tapping on the forehead (an abnormal reflex)
Fast heartbeat
Difficulty emptying the bowel (constipation)
Dry mouth or excessive salivation
Vomiting
Sweating
Muscle stiffness
Erectile problems
Increased levels of creatine phosphokinase (an enzyme present in muscles), detected in blood tests
Increased levels of prolactin (an enzyme) in the blood, detected in blood tests
Weight gain or weight loss.

Uncommon (may affect up to 1 in 100 people)

Hypersensitivity
Common cold, throat and nasal infection
Reduced thyroid activity, thyroid inflammation
Aggressive behaviour, impulsive behaviour
Apathy
Confusional state
Depressed mood
Separation of normal mental processes (dissociation)
Hallucinations (auditory or visual)
Homicidal thoughts
Difficulty sleeping
Increased or decreased sexual desire
Lack of energy
Changes in mental state
Obsessive thoughts
Sudden, disabling anxiety (panic attack)
Performing purposeless involuntary movements (psychomotor hyperactivity)
Excessive muscle activity (hyperkinesia), inability to stay still (restlessness)
Uncontrollable urge to move legs (restless legs syndrome), uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
Sleep disorders
Intentional suicidal thoughts
Abnormal thinking
Instability (dizzy sensation), altered taste
Impaired memory
Altered skin sensation (paraesthesia)
Sensation of a tight band around the head (tension-type headache), migraine
Difficulty focusing eyes, blurred vision
Increased hearing sensitivity
Palpitations, changes in heart rhythm
Sudden drop in blood pressure upon standing, possibly leading to fainting
Increased blood pressure
Abdominal pain or discomfort
Partial or complete absence of saliva secretion
Diarrhoea
Indigestion
Dry lip
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/mouth pain
Presence of bilirubin in urine, presence of protein in urine, indicators of kidney function
Pain or difficulty urinating, frequent urination, kidney disease
Sexual dysfunction
Ejaculation difficulties
Abnormal breast enlargement, breast pain, milk secretion from the breasts
Absent or irregular menstruation
Making involuntary noises and movements (Tourette syndrome)
Chills
Difficulty walking
Malaise
Chest pain
Fever
Intentional overdose
Effects on thyroid function, detected in blood tests: increased cholesterol in blood, increased triglycerides in blood, reduced high-density lipoproteins, reduced low-density lipoproteins, detected in blood tests
Increased blood glucose (sugar), increased insulin in blood, increased levels of certain liver enzymes (an indicator of liver function), detected in blood tests
Increased or decreased testosterone in blood, increased thyroid-stimulating hormone in blood, detected in blood tests
Changes in electrocardiogram
Reduced haemoglobin, reduced levels of white blood cells (which fight infections), detected in blood tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Latuda

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Latuda contains

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 2910, magnesium stearate (E 470b), titanium dioxide (E171), macrogol, iron oxide yellow (E172) (present in the 74 mg tablets), indigo carmine (E132) (present in the 74 mg tablets), and carnauba wax (E903).

Description of the appearance of Latuda and contents of the pack

Latuda 18.5 mg film-coated tablets are film-coated, white to off-white, round tablets, marked with the code ‘LA’
Latuda 37 mg film-coated tablets are film-coated, white to off-white, round tablets, marked with the code ‘LB’
Latuda 74 mg film-coated tablets are film-coated, light green, oval tablets, marked with the code ‘LD’

Latuda film-coated tablets are available in packs containing 14 x 1, 28 x 1, 30 x 1,
56 x 1, 60 x 1, 90 x 1 or 98 x 1 film-coated tablets in perforated aluminum/aluminum blisters
divided into single-dose units.
Not all 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

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

Belgium/Belgique/Belgien Lithuania/Lietuva
CNX Therapeutics Netherlands B.V. CNX Therapeutics Netherlands B.V.
[email protected] [email protected]

Bulgaria/България Luxembourg/Luxemburg
Andelini Pharma Bulgaria EOOD CNX Therapeutics Netherlands B.V.
[email protected] [email protected]

Czech Republic/Česká republika Hungary/Magyarország
Angelini Pharma Česká republika s.r.o. Angelini Pharma Magyarország Kft
[email protected] [email protected]

Denmark/Danmark Malta
CNX Therapeutics Netherlands B.V. CNX Therapeutics Netherlands B.V.
[email protected] [email protected]

Germany/Deutschland Netherlands/Nederland
CNX Therapeutics Netherlands B.V. CNX Therapeutics Netherlands B.V.
[email protected] [email protected]

Estonia/Eesti Norway/Norge
CNX Therapeutics Netherlands B.V. CNX Therapeutics Netherlands B.V.
[email protected] [email protected]

Greece/Ελλάδα Austria/Österreich
Angelini Pharma Hellas Monoprosopi EPE Angelini Pharma Österreich GmbH
[email protected] [email protected]

Spain/España Poland/Polska
ANGELINI PHARMA ESPAÑA, S.L. Angelini Pharma Polska Sp. z o.o.
Tel: +34 93 253 45 00 [email protected]

France Portugal
CNX Therapeutics Netherlands B.V. Angelini Pharma Portugal, Unipessoal Lda
[email protected] [email protected]

Croatia/Hrvatska Romania/România
Aziende Chimiche Riunite Angelini Francesco Angelini Pharmaceuticals România SRL
A.C.R.A.F. S.p.A. [email protected] Tel: +39 06 78 0531

Ireland Slovenia/Slovenija
CNX Therapeutics Netherlands B.V. Bonifar d.o.o.
[email protected] Tel: +386 1 235 0490

Iceland/Ísland Slovakia/Slovenská republika
CNX Therapeutics Netherlands B.V. Angelini Pharma Slovenská republika s.r.o.
[email protected] [email protected]

Italy/Italia Finland/Suomi
Angelini S.p.A. CNX Therapeutics Netherlands B.V.
Tel: +39 06 78 0531 [email protected]

Cyprus/Κύπρος Sweden/Sverige
Angelini Pharma Hellas Monoprosopi EPE CNX Therapeutics Netherlands B.V.
[email protected] [email protected]

Latvia/Latvija Northern Ireland
CNX Therapeutics Netherlands B.V. CNX Therapeutics Netherlands B.V.
[email protected] [email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.