Lurasidone teva

Package leaflet: Information for the patient

Lurasidone Teva 18.5 mg film-coated tablets
Lurasidone Teva 37 mg film-coated tablets
Lurasidone Teva 74 mg film-coated tablets
Lurasidone
Please read 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Lurasidone Teva is and what it is used for

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

2. What you need to know before taking Lurasidone Teva
Do not take Lurasidone Teva:

• 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 may affect the blood levels of lurasidone, such as:
  • antifungal medicines like 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, or saquinavir
• medicines for chronic hepatitis, such as boceprevir and telaprevir
• an antidepressant medicine, nefazodone
• a medicine for tuberculosis, rifampicin
• medicines used for seizures, such as carbamazepine, phenobarbital, or phenytoin
• herbal products used for 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 or during treatment with Lurasidone Teva, discuss this with your doctor, especially if:

• you have suicidal thoughts or behaviors
• you have Parkinson’s disease or dementia
• you have ever been diagnosed with a condition characterized by high fever and muscle stiffness (called neuroleptic malignant syndrome), or if you have ever experienced muscle stiffness, tremors, difficulty moving (extrapyramidal symptoms), or involuntary movements of the tongue or face (tardive dyskinesia). Please 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 if someone in your family has heart rhythm disorders (including QT prolongation)
• you have a history of seizures or epilepsy
• you or someone in your family has had blood clots, as antipsychotic medicines are associated with an increased risk of blood clots
• you have enlarged breasts (in men, gynaecomastia), milky discharge from the breasts (galactorrhoea), absence of menstruation, or erectile dysfunction
• you have diabetes or are at risk of developing diabetes
• you have impaired kidney function
• you have impaired liver function
• your body weight has increased
• you experience low blood pressure upon standing, 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 together with Lurasidone Teva may lead to serotonin syndrome, a potentially life-threatening condition (see “Lurasidone Teva and other medicines”).

If any of the above conditions apply to you, tell your doctor, who may decide to adjust your dose, monitor you more closely, or discontinue treatment with Lurasidone Teva.
Children and adolescents
Do not give this medicine to children under 13 years of age.
Lurasidone Teva and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important if you are taking:

• any medicines that act on the brain, as they may interfere with the effects of Lurasidone Teva on the brain
• medicines that lower blood pressure, as this medicine may also lower blood pressure
• medicines for Parkinson’s disease or restless legs syndrome (e.g. levodopa), as this medicine may reduce their effectiveness
• medicines containing ergot alkaloids (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), or bepridil (used to treat chest pain)
• medicines containing buprenorphine (used to treat opioid dependence), opioids (used to treat severe pain), or antidepressants such as mirtazapine, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Lurasidone Teva and cause symptoms such as rhythmic, involuntary muscle contractions (including muscles controlling eye movement), agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. If you experience any of these symptoms, contact your doctor immediately.

If you are taking any of these medicines, tell your doctor, who may need to adjust the dose of such medicines during treatment with Lurasidone Teva.
The following medicines may increase the blood levels of lurasidone:

• 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 blood levels of lurasidone:

• 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 conditions)
• rufinamide (used to treat seizures)

If you are taking any of these medicines, tell your doctor, who may need to adjust the dose of Lurasidone Teva.
Taking Lurasidone Teva with food, drink, and alcohol
While taking this medicine, avoid drinking alcohol, as alcohol may worsen the adverse effects of this medicine.
While taking this medicine, do 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 are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless advised by your doctor.
If your doctor decides that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn child, your baby will be closely monitored after birth.
This is because newborns whose mothers took lurasidone during the third trimester (last 3 months) of pregnancy may experience the following symptoms:

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

If your baby shows any of these symptoms, contact your doctor.
It is not known whether lurasidone passes into breast milk. If you are breastfeeding or planning to breastfeed, talk to your doctor.
Driving and using machines
This medicine may cause drowsiness, dizziness, or blurred vision (see section 4 “Possible side effects”). Do not drive, ride a bicycle, or operate any tools or machinery until you know how this medicine affects you.
Lurasidone Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered “sodium-free”.

3. How to take Lurasidone Teva

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of
doubt, consult the doctor or pharmacist.
The doctor will determine the appropriate dose for each individual patient, taking into account:

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

Adults (from 18 years of age)
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 dose may be increased or decreased by the doctor within the range of 37 mg to 74 mg once daily.
The maximum daily dose should not exceed 74 mg.
How to take Lurasidone Teva
The tablet(s) should be swallowed whole with water to avoid experiencing their bitter taste.
The patient should take the medicine regularly at the same time each day, which helps remember
to take the dose. This medicine should be taken with food or immediately after a meal, as this
facilitates absorption into the body and ensures better effectiveness.
Taking more Lurasidone Teva than recommended
If an overdose of Lurasidone Teva is taken, contact the doctor immediately.
The patient may experience drowsiness, fatigue, abnormal body movements, difficulty standing or walking,
dizziness due to low blood pressure, and irregular heartbeat.
Missing a dose of Lurasidone Teva
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 the following day. If two or more doses are missed, the patient should contact
their doctor.
Stopping Lurasidone Teva treatment
If the patient stops taking this medicine, the therapeutic effects will be lost. This medicine should
not be discontinued unless advised by the doctor, as symptoms of the illness may return.
If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Medical help should be sought immediately if the patient experiences any of the
following symptoms:

• severe allergic reaction manifested by fever, swelling of the lips, face, eyelids, or tongue, breathing difficulties, itching, skin rash, and sometimes low blood pressure (hypersensitivity). Such reactions are commonly observed (may affect up to 1 in 10 patients).
• severe skin rash with blisters on the skin, inside 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 affect up to 1 in 1000 patients).
• blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If the patient experiences any of these symptoms, medical advice should be sought immediately.

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

• feeling of restlessness and inability to sit still
• nausea (feeling sick)
• insomnia

Common (may affect up to 1 in 10 people):

• Parkinsonism: a general medical term covering various symptoms such as increased salivation or wet mouth, drooling; muscle tremors when bending limbs; slowed, limited, or disturbed body movements; lack of facial expression; muscle tension, neck stiffness; muscle rigidity; walking with small, shuffling steps and lack of normal arm swing while walking; persistent blinking in response to tapping the forehead (abnormal reflex)
• speech disorders, abnormal 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
• diarrhoea
• back pain
• rash and itching
• indigestion
• dry mouth or excessive salivation
• abdominal pain
• drowsiness, fatigue, agitation, and anxiety
• weight gain
• increased creatine kinase activity (an enzyme present in muscles) shown in blood tests
• increased creatinine levels (a marker of kidney function) shown in blood tests
• decreased appetite

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

• slurred speech
• nightmares
• difficulty swallowing
• irritation of the stomach lining
• sudden anxiety
• seizures (fits)
• chest pain
• muscle pain
• temporary loss of consciousness
• sensation of spinning
• disturbances in the conduction of electrical impulses in the heart
• slow heart rate
• joint pain
• difficulty walking
• rigid posture
• increased blood prolactin levels, increased blood glucose levels (blood sugar), increased activity of certain liver enzymes (shown in blood tests)
• increased blood pressure
• low blood pressure upon standing, which may cause fainting
• cold
• hot flushes
• blurred vision
• sweating
• pain during urination
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia)
• low sodium levels in the blood, which may cause fatigue, confusion, muscle twitching, seizures, and coma (hyponatremia)
• lack of energy (lethargy)
• gas (bloating)
• neck pain
• erectile problems
• painful or absent menstrual bleeding
• decreased number of red blood cells (which carry oxygen in the body)

Rare (may affect up to 1 in 1000 people):

• rhabdomyolysis, i.e. breakdown of muscle fibres leading to the release of muscle fibre contents (myoglobin) into the bloodstream, manifesting as muscle pain, nausea, confusion, abnormal heart rate and rhythm, and possibly dark 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)
• breast pain, milk secretion from the breasts
• sudden death

Frequency unknown (frequency cannot be estimated from available data):

• decreased number of a subtype of white blood cells (neutrophils)
• sleep disorders
• in newborns, symptoms such as agitation, increased or decreased muscle tone, muscle tremors, drowsiness, breathing difficulties, or feeding problems may be observed
• abnormal breast enlargement

A slightly increased number of deaths has been observed in elderly patients with dementia who are taking antipsychotic medicines compared to patients not taking these medicines.

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

• feeling of restlessness and inability to sit still
• headache
• drowsiness
• nausea (feeling sick)

Common (may affect up to 1 in 10 people):

• 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 touch with reality
• symptoms of schizophrenia
• difficulty concentrating
• sensation of spinning
• unusual involuntary movements (dyskinesias)
• abnormal muscle tension, including neck spasms and involuntary upward rolling of the eyes
• parkinsonism: a medical term referring to a range of symptoms including excessive salivation or wet mouth, drooling, sudden jerks when bending limbs, slow, limited, or disturbed body movements, lack of facial expression, muscle tension, neck stiffness, muscle rigidity, small, shuffling, hurried steps and lack of normal arm movement while walking, persistent blinking in response to tapping the forehead (abnormal reflexes)
• rapid heartbeat
• difficulty defecating (constipation)
• dry mouth or excessive salivation
• vomiting (nausea)
• sweating
• muscle stiffness
• erectile problems
• increased creatine kinase levels (a muscle enzyme) observed in blood tests
• increased prolactin levels (a hormone) in blood observed in blood tests
• weight gain or weight loss

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

• hypersensitivity
• cold, sore throat, and nasal infection
• reduced 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)
• homicidal thoughts
• difficulty falling asleep
• increased or decreased sex drive
• lack of energy
• changes in mental state
• obsessions
• sudden and overwhelming fear (panic attack)
• performing involuntary, purposeless movements (psychomotor hyperactivity)
• excessive muscle activity (hyperkinesia), inability to rest (motor restlessness)
• uncontrollable urge to move legs (restless legs syndrome), uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia)
• sleep disorders
• suicidal thoughts
• thought disorders
• instability (sensation of spinning)
• changes in taste sensation
• memory disturbances
• abnormal skin sensations (paresthesia)
• sensation of tight band around the head (tension headache), migraines
• difficulty focusing vision, blurred vision
• increased sensitivity to sound
• palpitations, changes in heart rhythm
• low blood pressure upon standing, which may cause fainting
• elevated blood pressure
• abdominal pain or disturbances
• lack or deficiency of saliva production
• diarrhoea
• 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, kidney function marker
• pain or difficulty urinating, frequent urination, kidney function disturbances
• sexual dysfunction
• difficulty with ejaculation
• abnormal breast enlargement, breast pain, milk secretion from the breasts
• irregular or absent menstrual cycles
• making involuntary sounds and performing involuntary movements (Tourette's syndrome)
• chills
• difficulty walking
• feeling unwell
• chest pain
• fever
• intentional overdose
• effects on thyroid function, increased blood cholesterol, increased blood triglycerides, decreased HDL, decreased LDL observed in blood tests
• 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 in blood observed in blood tests
• changes in ECG
• decreased haemoglobin levels, decreased white blood cell count (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 for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lurasidone Teva

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

6. Contents of the packaging and other information

What Lurasidone Teva 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 ingredients are: microcrystalline cellulose (E460), mannitol (E421), hypromellose 2910 (E464), sodium croscarmellose (E468) (see “Lurasidone Teva contains sodium”), magnesium stearate (E470b), titanium dioxide (E171), macrogol 8000 (E1521). Additionally, the 74 mg coated tablets contain: iron oxide yellow (E172), indigo carmine aluminium lake (E132).

What Lurasidone Teva looks like and contents of the pack

Lurasidone Teva 18.5 mg film-coated tablets
White or almost white, round film-coated tablets, engraved with the code “LL” on one side and smooth on the other, with a diameter of 6.1 mm.

Lurasidone Teva 37 mg film-coated tablets
White or almost white, round film-coated tablets, engraved with the code “LI” on one side and smooth on the other, with a diameter of 8.1 mm.

Lurasidone Teva 74 mg film-coated tablets
Light green to green, oval film-coated tablets, engraved with the code “LH” on one side and smooth on the other, measuring 12.1 x 7.1 mm.

Blister packs made of OPA/Aluminium/PVC//Aluminium and single-dose perforated blisters, packed in cardboard boxes.
Pack sizes: 28 or 28 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA, Haarlem
The Netherlands

Manufacturer:
ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95
19009 Pikermi Attiki
Greece
Teva Operations Poland Sp. z o.o
ul. Mogilska 80
31-546 Kraków

For further information about this medicine, contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicinal product is authorised in the European Economic Area countries under the following names:

Bulgaria Луразидон Тева 37 mg филмирани таблетки
Lurasidone Teva 37 mg film-coated tablets

Czech Republic Lurasidon Teva

Croatia Lurasidon Teva 18,5 mg filmom obložene tablete
Lurasidon Teva 37 mg filmom obložene tablete
Lurasidon Teva 74 mg filmom obložene tablete

Spain Lurasidona Teva 18,5 mg comprimidos recubiertos con película EFG
Lurasidona Teva 37 mg comprimidos recubiertos con película EFG
Lurasidona Teva 74 mg comprimidos recubiertos con película EFG

The Netherlands Lurasidon Teva 18.5 mg, filmomhulde tabletten
Lurasidon Teva 37 mg, filmomhulde tabletten
Lurasidon Teva 74 mg, filmomhulde tabletten

Poland Lurasidone Teva

Slovenia Lurasidon Teva 18,5 mg filmsko obložene tablete
Lurasidon Teva 37 mg filmsko obložene tablete
Lurasidon Teva 74 mg filmsko obložene tablete

Italy LURASIDONE TEVA