LATUDA 18.5 mg Tabletki powlekane

Treść ulotki

1. Latuda 18.5 mg, film-coated tablets, 37 mg, film-coated tablets, 74 mg, film-coated tablets
   1. What is Latuda and what is it 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. Package Contents and Other Information

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

lurasidone

Read this leaflet carefully before you start taking this medicine as 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Latuda is and what it is used for
• 2. What you need to know before you take 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 is Latuda and what is it 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 over) 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
allow nerve cells to communicate with each other) that are involved in the symptoms of
schizophrenia. By blocking their receptors, lurasidone helps to normalize brain activity, reducing the
symptoms of schizophrenia.
Schizophrenia is a disorder characterized by symptoms such as hearing, perceiving, or seeing things that are not
actually there, having false beliefs, harboring unusual suspicions, isolating oneself, speaking and behaving in
an incoherent manner, and not experiencing emotions. 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 need to know before taking Latuda

Do not take Latuda:

• if you are allergic to lurasidone or any of the other ingredients of this medicine (listed in section 6)
• if you are taking medicines that could affect the level of lurasidone in the blood, such as:
• medicines to treat fungal infections such as itraconazole, ketoconazole (except in shampoo formulation), posaconazole or voriconazole
• medicines to treat an infection, such as the antibiotic clarithromycin or telithromycin
• medicines to treat HIV infection, such as cobicistat, indinavir, nelfinavir, ritonavir and saquinavir
• medicines to treat chronic hepatitis, such as boceprevir and telaprevir
• a medicine to treat depression, nefazodone
• a medicine to treat tuberculosis, rifampicin
• medicines to treat convulsions, such as carbamazepine, phenobarbital and phenytoin
• an herbal medicine to treat depression, St John's Wort ( Hypericum perforatum).

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

• You have thoughts or behaviours of harming yourself
• You have Parkinson’s disease or dementia
• You have been diagnosed with an illness whose symptoms include high temperature and muscle rigidity (also known as neuroleptic malignant syndrome) or if you have ever had problems with muscle rigidity, tremors or movement problems (extrapyramidal symptoms) or unusual movements of the tongue or face (tardive dyskinesia). You should be aware that these problems can be caused by this medicine
• You have heart disease or are being treated for heart disease 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 someone in your family has a history of blood clots, because medicines for schizophrenia have been associated with the formation of blood clots
• You experience enlargement of the breasts and you are a man (gynecomastia), milky nipple discharge (galactorrhea), absence of menstrual periods (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 weight gain
• You have low blood pressure when standing up which can cause fainting
• You have an opioid dependence (treated with buprenorphine) or severe pain (treated with opioids) or suffer from depression or other conditions that are treated with antidepressants. The use of these medicines together with Latuda can cause serotonin syndrome, a potentially life-threatening condition (see section “Other medicines and Latuda”).

If you have any of these conditions, talk to your doctor, as they may need to adjust your
dosage, monitor you more closely or stop your 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 could add negatively to the effects of Latuda on the brain
• Medicines that lower blood pressure, as this medicine can also lower it
• Medicines to treat Parkinson’s disease and restless legs syndrome (e.g. levodopa) because this medicine can reduce their effects
• Medicines containing ergot alkaloids (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 that contain buprenorphine (used to treat opioid dependence) or opioids (used to treat severe pain) or antidepressants such as moclobemide, tranylcipromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines can interact with Latuda and symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38 °C may occur. Contact your doctor if you experience these symptoms.

Tell your doctor if you take any of these medicines because they may decide to change their
dose during your treatment with Latuda.
The following medicines can increase the levels of lurasidone 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 can reduce the levels of lurasidone 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 take any of these medicines because they may decide to change the
dose of Latuda.

Latuda with food, drinks and alcohol
You should avoid alcohol while taking this medicine. In fact, alcohol has an additive
negative effect.
Do not drink grapefruit juice while taking this medicine. Grapefruit can affect how
this medicine works.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine during pregnancy unless this has been
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 the baby after birth.
Indeed, newborns whose mothers have used lurasidone in the last trimester (the last three months) of
pregnancy may experience the following symptoms:

• tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding.

If the baby should experience any of these symptoms, contact your doctor.
It is not known whether lurasidone is excreted in breast milk. Tell your doctor if you are breastfeeding or
intend to do so.

Driving and using machines
Drowsiness, dizziness and vision problems can occur during treatment with this
medicine (see section 4, Possible side effects). Do not drive, ride a bicycle, operate
tools or machinery until you have found out that this medicine does not affect you
negatively.

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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose you will need to take will be established by your doctor and may depend on several factors:

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

Adults (aged 18 years and over)
The recommended starting dose is 37 mg once a day.
This dose may be increased or decreased by your doctor, within the dose range of 18.5-
148 mg once a day. The maximum dose should not exceed 148 mg once a day.

Adolescents (13-17 years)
The recommended starting dose is 37 mg of lurasidone once a day.
This dose may be increased or decreased by your doctor, within the dose range of 37-74 mg
once a day. The maximum daily dose should not exceed 74 mg.

How to take Latuda
The tablets must be swallowed whole with water to mask the bitter taste.
You should take the dose regularly, every day at the same time, so it is easier to remember. You should
take this medicine during or immediately after meals, as this helps the body to
absorb the medicine and allows it to work best.

If you take more Latuda than you should
If you take a quantity of medicine higher than you should, contact your
doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty
staying upright 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 a missed dose. If you miss a dose, take the
next dose 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 should not stop this
medicine unless your doctor tells you to, as your symptoms may return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• a severe allergic reaction manifesting 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 observed commonly (may affect up to 1 in 10 people)
• a severe rash with blistering that affects the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). This reaction has been observed with unknown frequency
• fever, sweating, muscle rigidity and decreased level of consciousness. These could be symptoms of a condition known as neuroleptic malignant syndrome. These reactions are rarely observed (may affect up to 1 in 1,000 people)
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may move along the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.

In adults, the following side effects may also occur:

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

• Feeling of restlessness and inability to remain seated quietly
• Nausea
• Insomnia.

Common (may affect up to 1 in 10 people)

• Parkinsonism: this is a medical term that groups many symptoms, including increased saliva production or watery mouth, loss of saliva, jerks when bending the limbs, slow, reduced or impaired body movements, a blank facial expression, muscle tension, stiff neck, muscle rigidity, small, shuffling steps, and lack of normal arm movements during walking, persistent blinking in response to taps on the forehead (an abnormal reflex)
• Difficulty articulating words, abnormal muscle movements; a set of symptoms known as extrapyramidal symptoms (EPS), which generally include unusual, involuntary muscle movements
• Fast heartbeat
• Increased blood pressure
• Dizziness
• Spasms and muscle rigidity
• Vomiting
• Diarrhea
• Back pain
• Rash and itching
• Indigestion
• Dry mouth or excessive saliva
• 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 feeling of anxiety
• Convulsions (seizures)
• Chest pain
• Muscle pain
• Temporary loss of consciousness
• Feeling of lightheadedness
• Abnormal heart impulses
• Slow heartbeat
• Joint pain
• Problems walking
• Rigid posture
• Increased levels of prolactin in the blood, increased blood sugar (glucose), increased levels of certain liver enzymes, detectable in blood tests
• Sudden drop in blood pressure when getting up, with possible fainting
• Common cold
• Hot flashes
• Blurred vision
• Sweating
• Pain when urinating
• Involuntary movements of the mouth, tongue and limbs (tardive dyskinesia)
• Low levels of sodium in the blood, which can cause fatigue, confusion, muscle contractions, seizures and coma (hyponatremia)
• Lack of energy (lethargy)
• Gas (flatulence)
• Neck pain
• Erectile dysfunction
• Painful or absent menstruation
• Reduced levels of red blood cells (which carry oxygen throughout the body).

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

• Rhabdomyolysis, i.e. breakdown of muscle fibers with subsequent release of their contents (myoglobin) into the bloodstream, which causes muscle pain, malaise, confusion, abnormal heart rate and rhythm, and possibly dark urine
• Increased eosinophils (a type of white blood cell)
• Swelling under the skin surface (angioedema)
• Self-inflicted injuries
• 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 based on 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, difficulty breathing or feeding
• Abnormal breast enlargement.

In elderly people with dementia, a small increase in the number of deaths has been reported in patients receiving medicines for schizophrenia compared to patients not receiving these medicines.
Adolescents may experience the following side effects:

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

• Feeling of restlessness and inability to remain seated quietly
• 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 is a medical term that groups many mental illnesses that cause abnormal thoughts and perceptions; people with psychosis lose contact with reality
• Symptoms of schizophrenia
• Difficulty concentrating
• Feeling dizzy
• Involuntary abnormal movements (dyskinesia)
• Abnormalities in muscle tone, including torticollis and involuntary upward deviation of the eyes
• Parkinsonism: this is a medical term that groups many symptoms, including increased saliva production or watery mouth, loss of saliva, jerks when bending the limbs, slow, reduced or impaired body movements, a blank facial expression, muscle tension, stiff neck, muscle rigidity, small, shuffling steps, and lack of normal arm movements during walking, persistent blinking in response to taps on the forehead (an abnormal reflex)
• Fast heartbeat
• Difficulty emptying the bowels (constipation)
• Dry mouth or excessive saliva
• Vomiting
• Sweating
• Muscle rigidity
• Erectile dysfunction
• 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 loss.

Uncommon (may affect up to 1 in 100 people)

• Hypersensitivity
• Common cold, throat and nose infection
• Reduced thyroid activity, thyroid inflammation
• Aggressive behavior, impulsive behavior
• Apathy
• Confused state
• Depressed mood
• Separation of normal mental processes (dissociation)
• Hallucination (auditory or visual)
• Thoughts of homicide
• Difficulty sleeping
• Decreased or increased sexual desire
• Lack of energy
• Changes in mental state
• Obsessive thoughts
• Feeling of acute and debilitating anxiety (panic attack)
• Performing involuntary movements without purpose (psychomotor hyperactivity)
• Hyperactivity of the body's muscles (hyperkinesia), inability to stand still (restlessness)
• Uncontrollable urge to move legs (restless legs syndrome), involuntary movements of mouth, tongue and limbs (tardive dyskinesia)
• Sleep disorders
• Intentional suicidal thoughts
• Abnormal thinking
• Instability (feeling dizzy) Alteration of taste
• Impaired memory
• Alteration of skin sensation (paresthesia)
• Feeling of having a tight band around the head (muscle tension headache), migraine
• Difficulty focusing eyes, blurred vision
• Increased sensitivity to hearing
• Palpitations, changes in heart rhythm
• Sudden drop in blood pressure when getting up, with possible fainting
• Increased blood pressure
• Pain or discomfort in the abdomen
• Absence or significant decrease in salivary secretion
• Diarrhea
• Indigestion
• Dry lip
• Toothache
• Partial or total loss of hair, abnormal hair growth
• Rash, hives Muscle spasms and rigidity, muscle pain
• Joint pain, pain in arms and legs, pain in jaw/jawbone
• Presence of bilirubin in urine, presence of protein in urine, an indicator of kidney function
• Pain or difficulty urinating, frequent urination, kidney disease
• Sexual dysfunction
• Difficulty ejaculating
• Abnormal breast enlargement, breast pain, milk secretion from the breasts
• Absent or irregular menstruation
• Performing involuntary noises and movements (Tourette's syndrome)
• Chills
• Feeling unwell
• Chest pain
• Fever
• Intentional overdose
• Effects on thyroid function, detected in blood tests increased cholesterol in the blood, increased triglycerides in the blood, reduced high-density lipoproteins, reduced low-density lipoproteins, detected in blood tests
• Increased blood sugar (glucose), increased insulin in the blood, increased levels of certain liver enzymes (an indicator of liver function), detected in blood tests
• Increased or decreased testosterone in the blood, increased thyroid-stimulating hormone in the blood, detected in blood tests
• Changes in electrocardiogram
• Reduced hemoglobin, reduced levels of white blood cells (which fight infections), detected in blood tests.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
detailed in Appendix V. By reporting side effects you 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 which is stated on the package and on the blister after
Expiry/EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water 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 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 2910, magnesium stearate (E 470b), titanium dioxide (E171), macrogol, yellow iron oxide (E172) (present in 74 mg tablets), indigotine (E132) (present in 74 mg tablets) and carnauba wax (E903).

Description of Latuda and package contents

• Latuda 18.5 mg film-coated tablets are film-coated tablets of white to off-white color, round in shape, with the inscription ‘LA’
• Latuda 37 mg film-coated tablets are film-coated tablets of white to off-white color, round in shape, with the inscription ‘LB’
• Latuda 74 mg film-coated tablets are film-coated tablets of light green color, oval in shape, with the inscription ‘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 blister packs
divisible for single dose.
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 on this medicinal product, contact the local representative of the marketing
authorization holder:

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

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

Bulgaria/ България
Анджелини Фарма България ЕООД
[email protected]

Luxembourg/ Luxemburg
CNX Therapeutics Netherlands B.V.
[email protected]

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

Hungary/ Magyarország
Angelini Pharma Magyarország Kft
[email protected]

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

Malta
CNX Therapeutics Netherlands B.V.
[email protected]

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

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

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

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

Greece/ Ελλάδα
Angelini Pharma Hellas Μονοπρόσωπη ABEE
[email protected]

Austria/ Österreich
Angelini Pharma Österreich GmbH
[email protected]

Spain/ España
ANGELINI PHARMA ESPAÑA, S.L.
Tel: + 34 93 253 45 00

Poland/ Polska
Angelini Pharma Polska Sp. z o.o.
[email protected]

France
CNX Therapeutics Netherlands B.V.
[email protected]

Portugal
Angelini Pharma Portugal, Unipessoal Lda
[email protected]

Croatia/ Hrvatska
Aziende Chimiche Riunite Angelini Francesco

• A.C.R.A.F. S.p.A. Tel: + 39 06 78 0531 Romania/ RomâniaAngelini Pharmaceuticals România SRL [email protected]

Ireland
CNX Therapeutics Netherlands B.V.
[email protected]

Slovenia/ Slovenija
Bonifar d.o.o.
Tel: + 386 1 235 0490

Iceland/ Ísland
CNX Therapeutics Netherlands B.V.
[email protected]

Slovak republic/ Slovenská republika
Angelini Pharma Slovenská republika s.r.o.
[email protected]

Italy/ Italia
Angelini S.p.A.
Tel: + 39 06 78 0531

Suomi/ Finland
CNX Therapeutics Netherlands B.V.
[email protected]

Cyprus/Κύπρος
Angelini Pharma Hellas Μονοπρόσωπη ABEE
[email protected]

Sweden/ Sverige
CNX Therapeutics Netherlands B.V.
[email protected] m

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

Northern Ireland
CNX Therapeutics Netherlands B.V.
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .