Lurasidone Teva 74 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lurasidona Teva 18.5 mg film-coated tablets EFG

Lurasidona Teva 37 mg film-coated tablets EFG

Lurasidona Teva 74 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Lurasidona Teva contains the active substance lurasidona and belongs to a group of medicines called antipsychotics. It is used to treat the symptoms of schizophrenia in adults (18 years of age and older) and adolescents aged 13 to 17 years. Lurasidona works by blocking brain receptors acted upon by the substances dopamine and serotonin. Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to communicate with each other) involved in the symptoms of schizophrenia. By blocking these receptors, lurasidona helps normalize brain activity, thereby reducing the symptoms of schizophrenia.

Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or feeling things that do not exist, having false beliefs, excessive suspiciousness, social withdrawal, disorganized speech and behavior, and lack of emotional expression. People with this disorder may feel depressed, distressed, guilty, or tense. This medicine is used to improve their schizophrenia symptoms.

2. What you need to know before starting to take Lurasidona Teva

Do not take Lurasidona Teva

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

Warnings and precautions

The full effect of this medicine may take several days or even weeks to appear.

Consult your doctor if you have any doubts about this medicine.

Talk to your doctor or pharmacist before taking lurasidone or during treatment, especially if:

• you have suicidal thoughts or behaviors
• you suffer from Parkinson’s disease or dementia
• you have ever been diagnosed with a condition whose symptoms include high fever and muscle stiffness (also known as neuroleptic malignant syndrome), or have previously experienced stiffness, tremors, or movement problems (extrapyramidal symptoms), or abnormal movements of the tongue or face (tardive dyskinesia). You should be aware that these conditions may be caused by this medicine
• you have heart disease or are being treated for a heart condition that makes you prone to low blood pressure, or have a family history of irregular heartbeats (including QT prolongation)
• you have a history of seizures (fits) or epilepsy
• you have a history of blood clots, or another member of your family has a history of blood clots, as antipsychotic medicines have been associated with blood clot formation
• you experience breast enlargement in men (gynaecomastia), milky discharge from the nipples (galactorrhoea), absence of menstruation (amenorrhoea), or erectile dysfunction
• you have diabetes or are prone to it
• you have reduced kidney function
• you have reduced liver function
• you gain weight
• your blood pressure drops when you stand up, which may cause fainting
• you are dependent on opioids (treated with buprenorphine) or have severe pain (treated with opioids), or have depression or other conditions treated with antidepressants. Using these medicines together with lurasidone may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Lurasidona Teva”).

If any of these apply to you, consult your doctor, as they may need to adjust your dose, monitor you more closely, or discontinue treatment with lurasidone.

Children and adolescents

Do not give this medicine to children under 13 years of age.

Other medicines and Lurasidona Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking:

• any medicine that also acts on the brain, as their effects could add negatively to those of lurasidone in your brain
• medicines that lower blood pressure, as this medicine may also reduce blood pressure
• medicines for Parkinson’s disease and restless legs syndrome (e.g., levodopa), as this medicine may reduce their effectiveness
• medicines containing ergot alkaloid derivatives (used to treat migraines), and other medicines such as terfenadine and astemizole (used to treat hay fever or allergic rhinitis and other allergic conditions), 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) or opioids (used to treat severe pain), or antidepressants such as moclobemide, tranilcipromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with lurasidone, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, body temperature above 38 °C. If you experience these symptoms, consult your doctor.

Inform your doctor if you are taking any of these medicines, as your dose of this medicine may need to be adjusted during treatment with lurasidone.

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

• diltiazem (for treating hypertension)
• erythromycin (for treating infections)
• fluconazole (for treating fungal infections)
• verapamil (for treating hypertension or chest pain)

The following medicines may decrease the concentration of lurasidone in your blood:

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

Inform your doctor if you are taking any of these medicines, as your dose of lurasidone may need to be changed.

Taking Lurasidona Teva with food, drinks, and alcohol

You should avoid consuming alcohol while taking this medicine, as it may have an additive negative effect.

Do not drink grapefruit juice while taking this medicine. 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 become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine during pregnancy unless your doctor has specifically advised you to do so.

If your doctor decides that the potential benefit of treatment during pregnancy justifies the potential risk to the unborn child, your doctor will monitor your baby closely after birth. This is because newborns of mothers who have taken lurasidone during the third trimester (last three months) of pregnancy may develop the following symptoms:

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

If your baby develops any of these symptoms, you should consult your doctor.

It is unknown whether lurasidone passes into breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed.

Driving and using machines

During treatment with this medicine, drowsiness, dizziness, and vision problems may occur (see section 4, Possible side effects). Do not drive, ride a bicycle, or operate tools or machinery until you know that this medicine does not affect you negatively.

Lurasidona Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Lurasidona Teva

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your dose will be determined by your doctor and may depend on:

• how well you respond to a dose
• whether you are taking other medicines (see section 2 “Other medicines and Lurasidona Teva”)
• whether you have kidney or liver problems

Adults (18 years and older)

The recommended starting dose is 37 mg once daily.

Your doctor may increase or decrease your dose within the range of 18.5 mg to 148 mg once daily. The maximum dose should not exceed 148 mg once daily.

Adolescents (13 to 17 years of age)

The recommended starting dose is 37 mg of lurasidone once daily.

Your doctor may increase or decrease your dose within the range of 37 mg to 74 mg once daily. The maximum daily dose should not exceed 74 mg.

How to take Lurasidona Teva

Swallow the tablet(s) whole with water to mask their bitter taste. You should take your dose regularly every day at the same time, to make it easier to remember. This medicine must be taken with food or immediately after eating, as this helps your body absorb the medicine and allows it to work better.

If you take more Lurasidona Teva than you should

If you take more of this medicine than you should, contact your doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, and abnormal heartbeats.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lurasidona Teva

Do not take a double dose to make up for forgotten doses. If you miss a dose, take the next dose on the day following the missed dose. If you miss two or more doses, consult your doctor.

If you stop taking Lurasidona Teva

If you stop taking this medicine, you will lose its effects. Do not stop taking the medicine unless instructed by your doctor, as symptoms may return.

If you have any further questions about the use of this medicine, ask 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 attention if you notice any of the following symptoms:

• severe allergic reaction including fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash and sometimes a drop in blood pressure (hypotension) (hypersensitivity). These reactions are common (may affect up to 1 in 10 people)
• severe blistering rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). The frequency of this reaction is unknown
• fever, sweating, muscle stiffness and decreased level of consciousness. These may be symptoms of a condition known as neuroleptic malignant syndrome. These reactions are rare (may affect up to 1 in 1,000 people)
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the bloodstream to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.

The following adverse effects may also occur in adults:

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

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

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

• Parkinsonism: this medical term describes various symptoms including increased salivary secretion or very wet mouth, drooling, spasms when flexing limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, neck stiffness, muscle rigidity, short, shuffling and hurried steps, lack of normal arm movements when walking, persistent blinking when tapping the forehead (abnormal reflex)
• speech problems, unusual muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS), which usually include unusual, unnecessary involuntary muscle movements
• fast heart rate
• increased blood pressure
• dizziness
• muscle spasms and stiffness
• vomiting (nausea)
• diarrhea
• back pain
• rash and itching
• indigestion
• dry mouth or excess saliva
• abdominal pain
• drowsiness, tiredness, restlessness and anxiety
• weight gain
• increased levels of creatine phosphokinase (an enzyme in muscles) seen in blood tests
• increased levels of creatinine (a marker of kidney function) seen in blood tests
• decreased appetite

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

• slow and difficult speech
• nightmares
• difficulty swallowing
• irritation of the stomach lining
• sudden feeling of anxiety
• seizures (fits)
• chest pain
• muscle pain
• temporary loss of consciousness
• sensation of spinning (vertigo)
• abnormal nerve impulses in the heart
• slow heart rate
• joint pain
• difficulty walking
• rigid posture
• increased levels of prolactin and glucose in the blood (blood sugar), increased levels of certain liver enzymes, observed in blood tests
• drop in blood pressure upon standing, which may cause fainting
• common cold
• hot flushes
• blurred vision
• sweating
• pain when urinating
• involuntary movements of the mouth, tongue and limbs (tardive dyskinesia)
• low sodium levels in the blood, which may cause tiredness and confusion, muscle spasms, seizures and coma (hyponatremia)
• lack of energy (lethargy)
• gas (flatulence)
• neck pain
• erection problems
• painful or absent menstrual periods
• reduced number of red blood cells (which carry oxygen throughout the body)

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

• rhabdomyolysis, which is the breakdown of muscle fibers, leading to the release of muscle contents (myoglobin) into the bloodstream, causing muscle pain, nausea, confusion, abnormal heart rate and rhythm, and possibly dark urine
• increased eosinophils (a type of white blood cell)
• swelling beneath the skin surface (angioedema)
• deliberate self-harm
• stroke
• kidney failure
• reduced number of white blood cells (which fight infection)
• breast pain, milk secretion from the breasts
• sudden unexpected death

Frequency not known (cannot be estimated from available data):

• reduced number of a subgroup of white blood cells (neutrophils)
• sleep disorder
• newborns may present with the following: restlessness, increased or decreased muscle tone, tremor, drowsiness, breathing or feeding difficulties
• abnormal enlargement of the breast

In elderly patients with dementia, a small increase in the number of deaths has been reported in patients taking antipsychotic medicines compared to those not taking them.

The following adverse effects may occur in adolescents:

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

• feeling restless and unable to stay still
• headache
• drowsiness
• nausea (feeling sick)

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

• decreased or increased appetite
• abnormal dreams
• difficulty sleeping, tension, restlessness, anxiety and irritability
• physical weakness, tiredness
• depression
• psychotic disorder: a medical term describing various mental illnesses causing abnormal thoughts and perceptions; people with psychosis lose touch with reality
• symptoms of schizophrenia
• difficulty concentrating
• sensation of spinning (vertigo)
• abnormal involuntary movements (dyskinesia)
• abnormal muscle tone, including torticollis and involuntary upward deviation of the eyes
• Parkinsonism: this medical term describes various symptoms including increased salivary secretion or very wet mouth, drooling, spasms when flexing limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, neck stiffness, muscle rigidity, short, shuffling and hurried steps, lack of normal arm movements when walking, persistent blinking when tapping the forehead (abnormal reflex)
• rapid heartbeat
• difficulty emptying the bowels (constipation)
• dry mouth or excess saliva
• vomiting (nausea)
• sweating
• muscle stiffness
• erection problems
• increased levels of creatine phosphokinase (a muscle enzyme) seen in blood tests
• increased levels of prolactin (a hormone) in the blood, seen in blood tests
• weight gain or weight loss

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

• hypersensitivity
• common cold, throat and nose infections
• decreased thyroid activity, thyroid inflammation
• aggressive behavior, impulsive behavior
• apathy
• confusion
• depressed mood
• separation from normal mental processes (dissociation)
• hallucination (auditory or visual)
• homicidal thoughts
• difficulty sleeping
• increased or decreased sex drive
• lack of energy
• altered mental state
• obsessive thoughts
• acute, disabling anxiety (panic attack)
• performing involuntary, purposeless movements (psychomotor hyperactivity)
• hyperactivity of body muscles (hyperkinesia), inability to rest (restlessness)
• uncontrollable urge to move legs (restless legs syndrome), uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia)
• sleep disorder
• deliberate suicidal thoughts
• abnormal thoughts
• instability (sensation of spinning)
• altered sense of taste
• memory impairment
• abnormal skin sensation (paresthesia)
• sensation of a tight band around the head (tension headache), migraine
• difficulty focusing eyes, blurred vision
• increased sensitivity to sound
• palpitations, heart rhythm disturbances
• drop in blood pressure upon standing, which may cause fainting
• increased blood pressure
• abdominal pain or discomfort
• partial or complete absence of saliva secretion
• diarrhea
• indigestion
• dry lips
• toothache
• partial or complete hair loss, abnormal hair growth
• rash, hives
• muscle spasms and stiffness, muscle pain
• joint pain, pain in arms and legs, jaw pain
• presence of bilirubin in urine, presence of protein in urine, a marker of kidney function
• pain or difficulty urinating, frequent urination, kidney disorder
• sexual dysfunction
• difficulty with ejaculation
• abnormal enlargement of the breasts, breast pain, milk secretion from the breasts
• absent or irregular menstruation
• uncontrollable noises and movements (Tourette’s disorder)
• chills
• difficulty walking
• malaise
• chest pain
• fever
• intentional overdose
• effects on thyroid function seen in blood tests, increased blood cholesterol, increased blood triglycerides, decreased high-density lipoproteins, decreased low-density lipoproteins, seen in blood tests
• increased blood glucose (blood sugar), increased blood insulin, increased levels of certain liver enzymes (a marker of liver function), seen in blood tests
• increased or decreased blood testosterone, increased thyroid-stimulating hormone in blood, seen in blood tests
• electrocardiogram abnormalities
• decreased hemoglobin, reduced number of white blood cells (which fight infection), seen in blood tests

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lurasidone Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lurasidona Teva

• The active substance is lurasidone.

Lurasidona Teva 18.5 mg:

Each tablet contains 18.5 mg of lurasidone hydrochloride equivalent to 18.6 mg of lurasidone.

Lurasidona Teva 37 mg:

Each tablet contains 37 mg of lurasidone hydrochloride equivalent to 37.2 mg of lurasidone.

Lurasidona Teva 74 mg:

Each tablet contains 74 mg of 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 section 2, “Lurasidona Teva contains sodium”). Additionally, present only in the 74 mg tablet: yellow iron oxide (E172), indigo carmine (E132).

Appearance of the product and contents of the pack

Lurasidona Teva 18.5 mg film-coated tablets

Round, white to off-white film-coated tablets, marked with “LL” on one side, plain on the other, with a diameter of 6.1 mm.

Lurasidona Teva 37 mg film-coated tablets

Round, white to off-white film-coated tablets, marked with “LI” on one side, plain on the other, with a diameter of 8.1 mm.

Lurasidona Teva 74 mg film-coated tablets

Oval, green to light green film-coated tablets, marked with “LH” on one side, plain on the other, with dimensions of 12.1 x 7.1 mm.

Blister packs made of OPA/Al/PVC//Al and single-dose perforated blisters, packed in cardboard boxes.

Pack sizes of 28 or 28 x 1 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95, Pikermi,

Attiki, 190 09, Greece

or

Teva Operations Poland Sp. z.o.o,

ul. Mogilska 80

31-546, Krakow, Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Bulgaria Lurasidone Teva 37 mg film-coated tablets
Czech Republic Lurasidon Teva

Spain Lurasidona Teva 18.5 mg film-coated tablets EFG
Lurasidona Teva 37 mg film-coated tablets EFG
Lurasidona Teva 74 mg film-coated tablets EFG

Croatia Lurasidon Teva 18.5 mg filmom obložene tablete
Lurasidon Teva 37 mg filmom obložene tablete
Lurasidon Teva 74 mg filmom obložene tablete

Italy LURASIDONE TEVA

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

Poland Lurasidone Teva B.V.

Slovenia Lurasidon Teva 18.5 mg filmsko obložene tablete
Lurasidon Teva 37 mg filmsko obložene tablete
Lurasidon Teva 74 mg filmsko obložene tablete

Date of the most recent review of this summary: May 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and up-to-date information on this medicinal product by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html