Lurasidone +pharma

Package Leaflet: Information for the Patient

Lurasidone +pharma, 18.5 mg, coated tablets

Lurasidone +pharma, 37 mg, coated tablets

Lurasidone +pharma, 74 mg, coated tablets

Lurasidone

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

Lurasidone +pharma contains the active substance lurasidone, which belongs to a group of medicines called antipsychotics. It is used to treat the symptoms of schizophrenia in adult patients (18 years and older) and adolescents (13-17 years). Lurasidone works by blocking receptors in the brain that dopamine and serotonin attach to. Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to communicate with each other) associated with the occurrence of schizophrenia symptoms. By blocking these receptors, lurasidone helps to normalize brain activity, reducing schizophrenia symptoms.

Schizophrenia is a disorder in which symptoms such as hearing, seeing, or feeling things that do not exist, mistaken beliefs, unusual suspiciousness, withdrawal, incoherent speech, and flattening of behaviors and emotions occur. People with this disorder may also experience depression, anxiety, guilt, or tension. This medicine is used to alleviate schizophrenia symptoms.

2. Important information before taking Lurasidone +pharma

When not to take Lurasidone +pharma

• medicines used to treat fungal infections, such as itraconazole, ketoconazole (except ketoconazole 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 used to treat chronic hepatitis, such as boceprevir and telaprevir
• an antidepressant - nefazodone
• a medicine for tuberculosis - rifampicin
• medicines used to treat epilepsy, 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 for this medicine to start working fully. If you have any questions about this medicine, you should contact your doctor.

Before starting to take Lurasidone +pharma or during treatment, you should discuss this with your doctor, especially if:

• you have suicidal thoughts or exhibit suicidal behavior
• you have Parkinson's disease or dementia
• you have been diagnosed with a condition characterized by high fever and muscle stiffness (called malignant neuroleptic syndrome) or have experienced muscle stiffness and tremors or had problems with movement (extrapyramidal symptoms) or abnormal movements of the tongue or face (tardive dyskinesia). Note that this medicine may cause such symptoms.
• you have heart disease or are taking medicines for heart disease that may cause low blood pressure or have a family history of heart rhythm disorders (including QT prolongation)
• you have had seizures or epilepsy
• you or a family member have had blood clots, as antipsychotic medicines are associated with the formation of blood clots
• you have enlarged breasts (in men, gynecomastia), milk secretion from the breasts (galactorrhea), absence of menstruation, or erectile dysfunction
• you have diabetes or are at risk of diabetes
• you have impaired kidney function
• you have impaired liver function
• you have gained weight
• you experience a drop in blood pressure when standing up, which may cause fainting
• you have opioid dependence (treated with buprenorphine), severe pain (treated with opioids), or depression, or other conditions treated with antidepressants. Taking these medicines with Lurasidone +pharma may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition (see "Lurasidone +pharma and other medicines").

If any of these conditions apply to you, you should tell your doctor, who may decide to change the dose of the medicine, monitor your condition more closely, or stop taking Lurasidone +pharma.

Children and adolescents

This medicine should not be given to children under 13 years of age.

Lurasidone +pharma and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or recently, and about any medicines you plan to take.

This is especially important if you are taking:

• any medicines that affect 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 migraines) 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 mental illnesses), quinidine (used to treat heart conditions), and 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, excitement, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. If you experience such symptoms, you should contact your doctor.

If you are taking any of these medicines, you should tell your doctor, who may decide to change the dose of such a medicine during treatment with Lurasidone +pharma.

The following medicines may increase the level of lurasidone in your blood:

• 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 the level of lurasidone in your 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 high blood pressure or finger ulcers)
• nafcillin (used to treat infections)
• prednisone (used to treat inflammatory diseases)
• rufinamide (used to treat epilepsy)

If you are taking any of these medicines, you should tell your doctor, who may decide to change the dose of Lurasidone +pharma.

Taking Lurasidone +pharma with food, drink, and alcohol

While taking this medicine, you should avoid drinking alcohol, as alcohol increases the negative effects of the medicine.

While taking this medicine, you should not drink grapefruit juice. Grapefruit may affect the action of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take this medicine during pregnancy unless your doctor has decided that it is necessary.

If your doctor decides that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn baby, they will closely monitor the baby's condition after birth.

This is because newborns whose mothers took lurasidone during the last trimester of pregnancy (the last 3 months) may experience symptoms such as tremors, muscle stiffness, and (or) muscle weakness, sleepiness, excitement, breathing problems, and feeding difficulties.

If your baby experiences any of these symptoms, you should contact your doctor.

It is not known whether lurasidone passes into breast milk. If you are breastfeeding or plan to breastfeed, you should discuss this with your doctor.

Driving and using machines

During treatment with this medicine, you may experience sleepiness, dizziness, or vision disturbances (see section 4 "Possible side effects"). You should not drive, ride a bike, or operate any tools or machines until you know that this medicine does not affect you negatively.

Lurasidone +pharma contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Lurasidone +pharma

You should always take this medicine exactly as your doctor or pharmacist has told you.

If you are not sure, you should ask your doctor or pharmacist.

Your doctor will determine the dose for you, taking into account:

• your response to the dose used
• any other medicines you are taking (see section 2 "Lurasidone +pharma and other medicines")
• any kidney or liver problems you may have

Adults (18 years and older)

The recommended starting dose is 37 mg once a day.

Your doctor may increase or decrease this dose within the range of 18.5 mg to 148 mg once a day.

The maximum dose should not exceed 148 mg once a day.

Adolescents (13-17 years)

The recommended starting dose is 37 mg of lurasidone once a day.

The dose may be increased or decreased by your doctor within the range of 37 to 74 mg once a day.

The maximum daily dose should not exceed 74 mg.

How to take Lurasidone +pharma

You should swallow the tablet(s) whole with water to avoid the bitter taste.

You should take your dose of this medicine regularly, every day at the same time, which will help you remember to take your medicine.

This medicine should be taken with food or immediately after a meal, which will help the medicine be absorbed by your body and allow it to work better.

If you take more Lurasidone +pharma than you should

If you take more Lurasidone +pharma than you should, you should contact your doctor immediately.

You may experience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness due to low blood pressure, and abnormal heart rhythm.

If you forget to take Lurasidone +pharma

You should not take a double dose to make up for a forgotten dose.

If you miss one dose of this medicine, you should take the next dose the following day.

If you miss two or more doses, you should contact your doctor.

Stopping treatment with Lurasidone +pharma

If you stop taking this medicine, you will lose its effects.

You should not stop taking this medicine unless your doctor tells you to, as your symptoms may return.

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should contact a doctor immediately if you experience any of the following symptoms:

• a severe allergic reaction with symptoms such as fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, rash, and sometimes a drop in blood pressure (hypersensitivity). Such reactions are common (may occur in up to 1 in 10 people).
• a severe skin rash with blisters, affecting the mouth, eyes, and genitals (Stevens-Johnson syndrome). This reaction occurs with an unknown frequency.
• fever, sweating, muscle stiffness, and changes in mental status. These may be symptoms of a condition called malignant neuroleptic syndrome. Such reactions are rare (may occur in up to 1 in 1,000 people).
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, you should contact a doctor immediately.

Adults may also experience the following side effects:

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

• feeling restless and unable to sit still
• nausea (feeling sick)
• insomnia

Common(may occur in up to 1 in 10 people)

• Parkinsonism: a general medical term that includes many symptoms, such as increased saliva production or wet mouth, drooling, muscle tremors when bending limbs, slow, limited, or disturbed body movements, lack of facial expression, muscle tension, neck stiffness, muscle stiffness, walking with small, quick steps and dragging feet, and lack of normal arm movements when walking, persistent eye blinking in response to tapping on the forehead (abnormal reflex)
• speech disorders, abnormal muscle movements, a syndrome of symptoms called extrapyramidal symptoms (EPS), which include abnormal, purposeless, involuntary muscle movements
• rapid heartbeat
• high blood pressure
• dizziness
• muscle cramps and stiffness
• vomiting
• diarrhea
• back pain
• rash and itching
• indigestion
• dry mouth or excessive salivation
• abdominal pain
• sleepiness, tiredness, excitement, and anxiety
• weight gain
• increased activity of the enzyme creatine phosphokinase (found in muscles) shown in blood tests
• increased creatinine level (a measure of kidney function) shown in blood tests
• decreased appetite

Uncommon(may occur in up to 1 in 100 people)

• slurred speech
• nightmares
• difficulty swallowing
• irritation of the stomach lining
• sudden feeling of anxiety
• seizures (fits)
• chest pain
• muscle pain
• temporary loss of consciousness
• feeling of spinning
• disturbances in the transmission of electrical impulses in the heart
• slow heart rate
• joint pain
• difficulty walking
• stiff posture
• increased prolactin level in the blood, increased glucose level in the blood (blood sugar), increased activity of certain liver enzymes (shown in blood tests)
• high blood pressure
• drop in blood pressure when standing up, which may cause fainting
• common cold
• hot flashes
• blurred vision
• sweating
• pain when urinating
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• low sodium level in the blood, which may cause fatigue and disorientation, muscle tremors, seizures, and coma (hyponatremia)
• lack of energy (lethargy)
• gas in the intestines
• neck pain
• erectile dysfunction
• painful menstrual bleeding or absence of menstruation
• decreased red blood cell count (which distributes oxygen in the body)

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

• rabdomyolysis, a breakdown of muscle fibers that releases muscle contents into the bloodstream, which may cause muscle pain, nausea, confusion, abnormal heart rhythm, and dark urine
• increased eosinophil count (a type of white blood cell)
• swelling under the skin (angioedema)
• self-inflicted injury
• stroke or transient ischemic attack
• kidney failure
• decreased white blood cell count (which fights infections)
• breast pain, milk secretion from the breast
• sudden death

Frequency not known(frequency cannot be estimated from the available data)

• decreased neutrophil count (a type of white blood cell)
• sleep disorders
• in newborns, symptoms such as excitement, increased or decreased muscle tone, tremors, sleepiness, breathing problems, or feeding difficulties may be observed
• abnormal breast enlargement
• in elderly people with dementia, a small increase in the number of deaths has been observed in patients taking antipsychotic medicines compared to those not taking these medicines

Adolescents may also experience the following side effects:

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

• feeling restless and unable to sit still
• headache
• sleepiness
• nausea (feeling sick)

Common(may occur in up to 1 in 10 people)

• increased or decreased appetite
• abnormal dreams
• difficulty sleeping, tension, excitement, anxiety, and irritability
• physical weakness, tiredness
• depression
• psychotic disorders: a medical term referring to many mental illnesses that cause disturbances in thinking and perception; patients with psychoses lose contact with reality
• schizophrenia symptoms
• difficulty concentrating
• feeling of spinning
• abnormal, involuntary movements (dyskinesia)
• abnormal muscle tension, including neck stiffness and involuntary eye movements
• Parkinsonism: a general medical term that includes many symptoms, such as increased saliva production or wet mouth, drooling, muscle tremors when bending limbs, slow, limited, or disturbed body movements, lack of facial expression, muscle tension, neck stiffness, muscle stiffness, walking with small, quick steps and dragging feet, and lack of normal arm movements when walking, persistent eye blinking in response to tapping on the forehead (abnormal reflex)
• rapid heartbeat
• constipation
• dry mouth or excessive salivation
• vomiting
• sweating
• muscle stiffness
• erectile dysfunction
• increased creatine phosphokinase level (a muscle enzyme) shown in blood tests
• increased prolactin level in the blood, shown in blood tests
• weight gain or loss

Uncommon(may occur in up to 1 in 100 people)

• hypersensitivity
• common cold, throat and nose infection
• increased thyroid activity, thyroid inflammation
• aggressive behavior, impulsive behavior
• apathy
• confusion
• depressed mood
• disruption of normal thought processes (dissociative disorders)
• hallucinations (hearing or seeing things)
• thoughts of murder
• difficulty sleeping
• increased or decreased sexual desire
• lack of energy
• changes in mental state
• obsessive thoughts
• feeling of intense and overwhelming anxiety (panic attack)
• performing involuntary, purposeless movements (psychomotor agitation)
• muscle overactivity (hyperkinesia), inability to rest (restlessness)
• uncontrolled desire to move the legs (restless legs syndrome), uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• sleep disorders
• suicidal thoughts
• thought disorders
• instability (feeling of spinning)
• changes in taste
• memory disorders
• abnormal sensations on the skin (paresthesia)
• feeling of wearing a tight band around the head (tension headache), migraines
• difficulty focusing, blurred vision
• increased sensitivity to sound
• palpitations, changes in heart rhythm
• drop in blood pressure when standing up, which may cause fainting
• high blood pressure
• abdominal pain or discomfort
• lack of saliva or excessive salivation
• 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 the urine, presence of protein in the urine - a marker of kidney function
• pain or difficulty urinating, frequent urination, kidney problems
• sexual dysfunction
• difficulty ejaculating
• abnormal breast enlargement, breast pain, milk secretion from the breast
• irregular menstrual cycles or absence of menstruation
• making uncontrolled sounds and movements (Tourette's syndrome)
• chills
• difficulty walking
• feeling unwell
• chest pain
• fever
• intentional overdose
• effect on thyroid function, shown in blood tests: increased cholesterol level, increased triglyceride level, decreased HDL level, decreased LDL level
• increased glucose level in the blood (blood sugar), increased insulin level in the blood, increased activity of certain liver enzymes (a marker of liver function) - shown in blood tests
• increased or decreased testosterone level in the blood, increased TSH level - shown in blood tests
• changes in ECG
• decreased hemoglobin level, decreased white blood cell count (which fights infections) - shown in blood tests

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder or its representative in Poland.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lurasidone +pharma

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 carton and blister after "EXP:". The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Lurasidone +pharma contains

• The active substance is lurasidone.

Lurasidone +pharma, 18.5 mg, coated tablets

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

Lurasidone +pharma, 37 mg, coated tablets

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

Lurasidone +pharma, 74 mg, coated tablets

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

• The other ingredients are: tablet core: mannitol, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose type 2910, colloidal silicon dioxide, magnesium stearate

coating (Lurasidone +pharma, 18.5 mg and 37 mg, coated tablets): hypromellose type 2910, titanium dioxide (E 171), macrogol, carnauba wax

coating (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, with the letter "L" embossed 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, with the letter "I" embossed on one side and smooth on the other.

Lurasidone +pharma, 74 mg, coated tablets

Light green to green, oval, biconvex coated tablets with dimensions of 12 x 7 mm, with the letter "I" embossed on one side and smooth on the other.

Lurasidone +pharma coated tablets are available in packs containing 28 coated tablets in aluminum/aluminum blisters.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria

Lurasidon Genericon 18.5 mg/37 mg/74 mg Filmtabletten

Czech Republic

Lurasidone +pharma

Poland

Lurasidone +pharm

Sweden

Lurasidone Genericon

For more information about this medicine, you should contact the local representative of the marketing authorization holder:

+pharma Polska sp. z o.o.

ul. Podgórska 34

31-536 Kraków, Poland

tel.: +48 12 262 32 36

e-mail: [email protected]

Date of last revision of the leaflet: