Lurasidone +pharma

Package leaflet: Information for the patient

Lurasidone +pharma, 18.5 mg, film-coated tablets
Lurasidone +pharma, 37 mg, film-coated tablets
Lurasidone +pharma, 74 mg, film-coated tablets
Lurasidonum
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Lurasidone +pharma is and what it is used for
2. Important information before taking Lurasidone +pharma
3. How to take Lurasidone +pharma
4. Possible side effects
5. How to store Lurasidone +pharma
6. Contents of the pack and other information

1. What Lurasidone +pharma is and what it is used for

Lurasidone +pharma contains an active substance called lurasidone, which belongs to a group of medicines known as antipsychotics. It is used to treat symptoms of schizophrenia in adult patients (aged 18 years and above) and in adolescents aged 13–17 years. Lurasidone works by blocking receptors in the brain to which dopamine and serotonin bind. Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to communicate with each other) involved in the occurrence of symptoms of schizophrenia. By blocking these receptors, lurasidone helps normalize brain activity and reduce schizophrenia symptoms.
Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or sensing things that do not exist, false beliefs, extreme suspiciousness, social withdrawal, disorganized speech, and blunted emotions and behaviors. Individuals with this disorder may also experience depression, anxiety, guilt, or tension. This medicine is used to alleviate the symptoms of schizophrenia.

2. Important information before using Lurasidone +pharma

When not to take Lurasidone +pharma

• if the patient is allergic to lurasidone or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking medicines that may affect lurasidone blood levels, such as:
  • medicines used to treat fungal infections, such as: itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole or voriconazole
  • medicines used to treat infections, such as: the antibiotic clarithromycin or telithromycin
  • medicines used to treat HIV infection, such as: cobicistat, indinavir, nelfinavir, ritonavir and saquinavir
• medicines for chronic hepatitis, such as: boceprevir and telaprevir
• the antidepressant medicine – nefazodone
• the medicine for tuberculosis – rifampicin
• medicines used for epileptic seizures, such as: carbamazepine, phenobarbital and phenytoin
• herbal products used to treat depression – St. John’s wort ( Hypericum perforatum ).

Warnings and precautions
It may take several days or even weeks before this medicine starts to work fully. If you have any
questions about this medicine, please contact your doctor.
Before starting treatment with Lurasidone +pharma or during treatment, discuss this with your
doctor, especially if:

• the patient has suicidal thoughts or exhibits suicidal behaviour
• the patient has Parkinson’s disease or dementia
• the patient has ever been diagnosed with a condition characterised by high fever and muscle stiffness (called neuroleptic malignant syndrome), or the patient has ever experienced muscle stiffness and tremors, or had movement problems (extrapyramidal symptoms), or abnormal movements of the tongue or face (tardive dyskinesia). Please note that this medicine may cause such side effects.
• the patient has heart disease or is taking medicines for heart disease that may cause low blood pressure, or if a family member has heart rhythm disorders (including QT prolongation)
• the patient has had seizures or epilepsy in the past
• the patient or someone in their family has had blood clots, as antipsychotic medicines are associated with blood clot formation
• the patient has enlarged breasts (in men, gynaecomastia), milky discharge from the breasts (galactorrhoea), absence of menstruation or erectile dysfunction
• the patient has diabetes or a tendency to diabetes
• the patient has impaired kidney function
• the patient has impaired liver function
• the patient’s body weight has increased
• the patient experiences a drop in blood pressure upon standing, which may lead to fainting
• the patient has opioid dependence (treated with buprenorphine), severe pain (treated with opioids), or depression, or other conditions treated with antidepressant medicines. Taking these medicines together with Lurasidone +pharma may lead to serotonin syndrome, a potentially life-threatening condition (see “Lurasidone +pharma and other medicines”).

If any of the above conditions apply to the patient, inform the doctor, who may consider it necessary to adjust the dose, monitor the patient more closely, or discontinue treatment with Lurasidone +pharma.
Children and adolescents
Lurasidone +pharma should not be given to children under 13 years of age.
Lurasidone +pharma and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is particularly important if the patient is taking:

• any medicines acting on the brain, as they may negatively affect the action of Lurasidone +pharma on the brain
• medicines that lower blood pressure, as this medicine may also lower blood pressure
• medicines for Parkinson’s disease and restless legs syndrome (e.g. levodopa), as this medicine may weaken their effect
• medicines containing ergot alkaloid derivatives (used to treat migraine) and other medicines, including terfenadine and astemizole (used to treat hay fever and other allergic symptoms), cisapride (used to treat digestive problems), pimozide (used to treat psychiatric disorders), 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 Lurasidone +pharma and may cause symptoms such as: involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, contact your doctor immediately.

If the patient is taking any of these medicines, inform the doctor, who may consider it necessary to adjust the dose of such medicines during treatment with Lurasidone +pharma.
The following medicines may increase lurasidone blood levels:

• diltiazem (used to treat high blood pressure)
• erythromycin (an antibiotic used to treat infections)
• fluconazole (used to treat fungal infections)
• verapamil (used to treat high blood pressure or chest pain)

The following medicines may decrease lurasidone blood levels:

• amprenavir, efavirenz, etravirine (used to treat HIV infection)
• aprepitant (used to treat nausea and vomiting)
• armodafinil, modafinil (used to treat excessive sleepiness)
• bosentan (used to treat high blood pressure or finger ulcers)
• nafcillin (used to treat infections)
• prednisone (used to treat inflammatory diseases)
• rufinamide (used to treat epileptic seizures)

If the patient is taking any of these medicines, inform the doctor, who may consider it necessary to adjust the dose of Lurasidone +pharma.
Taking Lurasidone +pharma with food, drink and alcohol
During treatment with this medicine, avoid drinking alcohol, as alcohol may worsen the adverse effects of the medicine.
Do not drink grapefruit juice while taking this medicine. Grapefruit may affect the action of this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy unless agreed with the doctor.
If the doctor considers that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn child, the newborn will be closely monitored after birth.
This is because newborns whose mothers took lurasidone during the third trimester of pregnancy (last 3 months) may experience the following symptoms:

• tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems

If the baby shows any of these symptoms, contact the doctor.
It is not known whether lurasidone passes into breast milk. If the patient is breastfeeding or planning to breastfeed, she should discuss this with her doctor.
Driving and using machines
During treatment with this medicine, drowsiness, dizziness or visual disturbances may occur (see section 4 “Possible side effects”). Do not drive, ride a bicycle, or operate any tools or machinery until it is known whether this medicine affects the patient adversely.
Lurasidone +pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to use Lurasidone +pharma

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The doctor will determine the appropriate dose for each individual patient, taking into account:

• the patient's response to the administered dose
• any other medicines the patient may be taking (see section 2 "Lurasidone +pharma and other medicines")
• any kidney or liver problems the patient may have

Adults (aged 18 years and above)
The recommended starting dose is 37 mg once daily.
The doctor may increase or decrease the dose within the range of 18.5 mg to 148 mg once daily.
The maximum dose should not exceed 148 mg once daily.
Adolescents aged 13–17 years
The recommended starting dose is 37 mg of lurasidone once daily.
The doctor may increase or decrease the dose within the range of 37 mg to 74 mg once daily.
The maximum daily dose should not exceed 74 mg.
How to take Lurasidone +pharma
The tablet(s) should be swallowed whole with water to avoid experiencing their bitter taste.
The patient should take the medicine regularly every day at the same time, which helps with remembering to take it.
This medicine should be taken with food or immediately after a meal, as this facilitates absorption and ensures better effectiveness.
Taking more Lurasidone +pharma than recommended
If more Lurasidone +pharma has been taken than recommended, contact your doctor immediately.
The patient may experience drowsiness, fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, and irregular heart rhythm.
Missing a dose of Lurasidone +pharma
Do not take a double dose to make up for a missed dose. If the patient misses one dose, they should take the next dose at the usual time the following day. If the patient misses two or more doses, they should contact their doctor.
Stopping Lurasidone +pharma
If the patient stops taking this medicine, the therapeutic effects will be lost. Do not discontinue use of this medicine unless advised by the doctor, as symptoms of the illness may return.
If you have any further questions about the use of this medicine, consult 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 help if any of the following symptoms occur in the patient:

• Severe allergic reaction presenting with fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes low blood pressure (hypersensitivity). Such reactions are commonly observed (may occur in up to 1 in 10 patients).
• Severe skin rash with blisters on the skin, in the mouth, eyes or genital organs (Stevens-Johnson syndrome). This reaction occurs with unknown frequency.
• Fever, sweating, muscle stiffness and altered mental status. These may be symptoms of a condition called neuroleptic malignant syndrome. These reactions are rare (may occur in up to 1 in 1000 patients).
• Blood clots in veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If any of these symptoms occur, seek immediate medical advice.

The following adverse effects may also occur in adults:
Very common (may occur in more than 1 in 10 patients)

• Feeling of restlessness and inability to sit still
• Nausea (feeling sick)
• Insomnia

Common (may occur in less than 1 in 10 patients)

• Parkinsonism: a general medical term covering various symptoms such as increased salivation or moist mouth, drooling, muscle tremor when bending limbs, slowed, limited or disturbed body movements, lack of facial expression, muscle tension, neck stiffness, muscle rigidity, walking with small, quick steps with shuffling gait, absence of normal arm swing when walking, persistent blinking in response to tapping the forehead (abnormal reflex)
• Speech disorders, unusual muscle movements, a group of symptoms known as extrapyramidal symptoms (EPS), including unusual, purposeless involuntary muscle movements
• Rapid heartbeat
• Increased blood pressure
• Dizziness
• Muscle cramps and stiffness
• Vomiting
• Diarrhea
• Back pain
• Rash and itching
• Indigestion
• Dry mouth or excessive salivation
• Abdominal pain
• Drowsiness, fatigue, agitation and anxiety
• Weight gain
• Increased creatine phosphokinase activity (an enzyme present in muscles) detected in blood tests
• Increased creatinine levels (a marker of kidney function) detected in blood tests
• Decreased appetite

Uncommon (may occur in less than 1 in 100 patients)

• Slurred speech
• Nightmares
• Difficulty swallowing
• Gastric mucosal irritation
• Sudden anxiety
• Seizures (fits)
• Chest pain
• Muscle pain
• Transient loss of consciousness
• Sensation of spinning
• Impaired conduction of electrical impulses in the heart
• Slow heart rate
• Joint pain
• Difficulty walking
• Stiff posture
• Increased blood prolactin levels, increased blood glucose levels (blood sugar), increased activity of certain liver enzymes (detected in blood tests)
• Increased blood pressure
• Drop in blood pressure upon standing, which may lead to fainting
• Cold-like symptoms
• Hot flushes
• Blurred vision
• Sweating
• Pain during urination
• Uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia)
• Low sodium levels in the blood, which may cause fatigue and disorientation, muscle twitching, seizures and coma (hyponatremia)
• Lack of energy (lethargy)
• Abdominal gas
• Neck pain
• Erectile problems
• Painful menstrual bleeding or absence of periods
• Decreased number of red blood cells (which carry oxygen throughout the body)

Rare (may occur in less than 1 in 1000 patients)

• Rhabdomyolysis, i.e. breakdown of muscle fibres leading to release of muscle fibre contents (myoglobin) into the bloodstream, causing muscle pain, nausea, confusion, abnormal heart rate and rhythm, and possibly dark-coloured urine
• Increased number of eosinophils (a type of white blood cell)
• Subcutaneous swelling (angioedema)
• Deliberate self-harm
• Cerebrovascular event
• Kidney failure
• Decreased number of white blood cells (which fight infections)
• Chest pain, milk discharge from the breasts
• Sudden death

Frequency unknown (frequency cannot be estimated from available data)

• Decreased number of a subgroup of white blood cells (neutrophils)
• Sleep disorders
• In newborns, symptoms such as agitation, increased or decreased muscle tone, muscle tremor, drowsiness, breathing or feeding difficulties may be observed
• Abnormal breast enlargement
• In elderly patients with dementia, a slight increase in mortality has been observed among patients taking antipsychotic medicines compared to those not taking such medicines

The following adverse effects may occur in adolescents:
Very common (may occur in more than 1 in 10 patients)

• Feeling of restlessness and inability to sit still
• Headache
• Drowsiness
• Nausea (feeling sick)

Common (may occur in less than 1 in 10 patients)

• Increased or decreased appetite
• Unusual dreams
• Difficulty falling asleep, tension, agitation, anxiety and irritability
• Physical weakness, fatigue
• Depression
• Psychotic disorders: a medical term referring to various mental illnesses causing disturbances in thinking and perception; patients with psychosis lose contact with reality
• Schizophrenia symptoms
• Difficulty concentrating
• Sensation of spinning
• Unusual involuntary movements (dyskinesias)
• Abnormal muscle tension, including neck spasm and involuntary upward rolling of the eyes
• Parkinsonism: a general medical term covering various symptoms such as increased salivation or moist mouth, drooling, muscle tremor when bending limbs, slowed, limited or disturbed body movements, lack of facial expression, muscle tension, neck stiffness, muscle rigidity, walking with small, quick steps with shuffling gait, absence of normal arm swing when walking, persistent blinking in response to tapping the forehead (abnormal reflexes)
• Rapid heartbeat
• Difficulty defecating (constipation)
• Dry mouth or excessive salivation
• Vomiting
• Sweating
• Muscle stiffness
• Erectile problems
• Increased creatine phosphokinase levels (a muscle enzyme) observed in blood tests
• Increased prolactin levels (a hormone) in serum, observed in blood tests
• Weight gain or weight loss

Uncommon (may affect up to 1 in 100 patients)

• Hypersensitivity
• Cold-like symptoms, throat and nose infection
• Increased thyroid activity, thyroid inflammation
• Aggressive behaviour, impulsive behaviour
• Apathy
• Confusion
• Depressed mood
• Loss of contact with normal thought processes (dissociative disorders)
• Hallucinations (auditory or visual)
• Thoughts of murder
• Difficulty falling asleep
• Increased or decreased sexual desire
• Lack of energy
• Changes in mental state
• Obsessive thoughts
• Sudden and overwhelming fear (panic attack)
• Performing involuntary, purposeless movements (psychomotor agitation)
• Excessive body muscle activity (hyperkinesia), inability to rest (restlessness)
• Uncontrollable urge to move legs (restless legs syndrome), uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
• Sleep disorders
• Suicidal thoughts
• Thinking disturbances
• Instability (sensation of spinning)
• Changes in taste perception
• Memory disturbances
• Abnormal skin sensations (paresthesia)
• Feeling of tight band around the head (tension headache), migraines
• Difficulty focusing, blurred vision
• Increased sensitivity to sound
• Palpitations, changes in heart rhythm
• Decreased blood pressure upon standing, which may cause fainting
• Elevated blood pressure
• Pain or disturbances in the abdominal area
• Absence or deficiency of saliva secretion
• Diarrhea
• Indigestion
• Dry lips
• Toothache
• Partial or complete hair loss, abnormal hair growth
• Rash, hives
• Muscle cramps and stiffness, muscle pain
• Joint pain, arm and leg pain, jaw pain
• Presence of bilirubin in urine, presence of protein in urine – markers of kidney function
• Pain or difficulty urinating, frequent urination, kidney function disturbances
• Sexual dysfunction
• Difficulty with ejaculation
• Abnormal breast enlargement, breast pain, milk discharge from the breasts
• Irregular menstrual cycles or absence of periods
• Making uncontrolled sounds and performing uncontrolled movements (Tourette's syndrome)
• Chills
• Difficulty walking
• Malaise
• Chest pain
• Fever
• Intentional overdose
• Effect on thyroid function, observed in blood tests: increased blood cholesterol levels, increased blood triglyceride levels, decreased HDL levels, decreased LDL levels
• Increased blood glucose levels (blood sugar), increased blood insulin levels, increased activity of certain liver enzymes (liver function marker) – observed in blood tests
• Increased or decreased blood testosterone levels, increased TSH levels – observed in blood tests
• Changes in ECG
• Decreased haemoglobin levels, decreased number of white blood cells (which fight infections)
  • observed in blood tests.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lurasidone +pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after "EXP:". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Lurasidone +pharma contains

• The active substance is lurazidone.

Lurasidone +pharma, 18.5 mg, coated tablets
Each coated tablet contains lurazidone hydrochloride equivalent to 18.6 mg of lurazidone.
Lurasidone +pharma, 37 mg, coated tablets
Each coated tablet contains lurazidone hydrochloride equivalent to 37.2 mg of lurazidone.
Lurasidone +pharma, 74 mg, coated tablets
Each coated tablet contains lurazidone hydrochloride equivalent to 74.5 mg of lurazidone.

• Other components are: tablet core: mannitol, maize starch, microcrystalline cellulose, sodium croscarmellose, hypromellose type 2910, colloidal anhydrous silica, magnesium stearate

coating of the tablet (Lurasidone +pharma, 18.5 mg and 37 mg, coated tablets): hypromellose type 2910,
titanium dioxide (E 171), macrogol, carnauba wax
coating of the tablet (Lurasidone +pharma, 74 mg, coated tablets): hypromellose type 2910, titanium
dioxide (E 171), macrogol, yellow iron oxide (E 172), indigo carmine (E 132), carnauba wax

What Lurasidone +pharma looks like and contents of the pack
Lurasidone +pharma, 18.5 mg, coated tablets
White or almost white, round, biconvex coated tablets with a diameter of 6 mm, embossed with the letter "L" on one side and smooth on the other.
Lurasidone +pharma, 37 mg, coated tablets
White or almost white, round, biconvex coated tablets with a diameter of 8 mm, embossed with the letter "I" on one side and smooth on the other.
Lurasidone +pharma, 74 mg, coated tablets
Light green to green, oval, biconvex coated tablets measuring 12 x 7 mm, embossed with the letter "I" on one side and smooth on the other.

Lurasidone +pharma coated tablets are available in packages containing 28 coated tablets in aluminium/aluminium blisters.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, 7
Pol. Ind. Miralcampo
19200 Azuqueca De Henares (Guadalajara)
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria Lurasidon Genericon 18.5 mg/37 mg/74 mg Film Tablets
Czech Republic Lurasidone +pharma
Poland Lurasidone +pharma
Sweden Lurasidone Genericon

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]