LURASIDONE TEVA

Patient Information Leaflet

Lurasidone Teva 18.5 mg film-coated tablets, 37 mg film-coated tablets, 74 mg film-coated tablets

lurasidone
Generic medicine
Read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 and belongs to a group of medicines called antipsychotics. It is used to treat the symptoms of schizophrenia in adults (aged 18 years and older) and adolescents aged 13–17 years. Lurasidone works by blocking brain receptors to which the substances dopamine and serotonin bind. Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to communicate with each other) involved in the symptoms of schizophrenia. By blocking their receptors, lurasidone helps normalize brain activity, thereby reducing the symptoms of schizophrenia.

Schizophrenia is a disorder characterized by symptoms such as hearing, sensing, or seeing things that are not actually present, having false beliefs, experiencing unusual suspicions, withdrawing socially, speaking and behaving incoherently, and lacking emotional expression. People affected by this disorder may also feel depressed, anxious, guilty, or tense. This medicine is used to improve the symptoms of schizophrenia.

2. What you need to know before taking Lurasidone Teva

Do not take Lurasidone 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 could affect the level of lurasidone in your blood, such as:
  • medicines used to treat fungal infections like itraconazole, ketoconazole (except in shampoo formulation), 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
• a medicine used to treat depression, nefazodone
• a medicine used to treat tuberculosis, rifampicin
• medicines used to treat seizures, such as carbamazepine, phenobarbital, and phenytoin
• a herbal medicine used to treat depression, St. John’s Wort (Hypericum perforatum).

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

• You have suicidal thoughts or behaviors
• You have Parkinson’s disease or dementia
• You have been diagnosed with a condition whose symptoms include high temperature and muscle rigidity (also known as neuroleptic malignant syndrome), or if you have ever had problems such as muscle stiffness, tremors, or movement disorders (extrapyramidal symptoms), or abnormal movements of the tongue or face (tardive dyskinesia). You should be aware that these problems 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 if you have a family history of irregular heartbeat (including QT prolongation)
• You have a history of seizures (convulsions) or epilepsy
• You have a history of blood clots, or if any of your family members have a history of blood clots, because antipsychotic medicines have been associated with blood clot formation
• You experience breast enlargement in men (gynecomastia), milky discharge from the nipples (galactorrhea), absence of menstruation (amenorrhea), or erectile dysfunction
• You have diabetes or are predisposed to developing diabetes
• You have reduced kidney function
• You have reduced liver function
• You have gained weight
• You have low blood pressure when standing up, which may cause fainting
• You have opioid dependence (treated with buprenorphine) or severe pain (treated with opioids), or suffer from depression or other conditions treated with antidepressants. Taking these medicines together with Lurasidone Teva may cause serotonin syndrome, a potentially life-threatening condition (see section “Other medicines and Lurasidone Teva”).

If you have any of these conditions, talk to your doctor, as they may need to adjust your dosage, 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.
Other medicines and Lurasidone Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

• Medicines that also act on the brain, as their effects may add to the negative effects of Lurasidone Teva on the brain
• Medicines that lower blood pressure, because this medicine may also lower blood pressure
• Medicines used to treat Parkinson’s disease and restless legs syndrome (e.g., levodopa), because this medicine may reduce their effectiveness
• Medicines containing ergot alkaloid derivatives (used to treat migraines) and other medicines, including terfenadine and astemizole (used to treat hay fever and other allergic conditions), cisapride (used to treat digestive problems), pimozide (used to treat psychiatric 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 Teva and cause symptoms such as involuntary, rhythmic muscle contractions (including muscles controlling eye movements), agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience any of these symptoms.

Inform your doctor if you are taking any of these medicines, as they may decide to adjust the dosage during treatment with Lurasidone Teva.
The following medicines may increase lurasidone levels in the blood:

• Diltiazem (used to treat high blood pressure)
• Erythromycin (used to treat infections)
• Fluconazole (used to treat fungal infections)
• Verapamil (used to treat high blood pressure or chest pain).

The following medicines may reduce lurasidone levels in the blood:

• Amprenavir, efavirenz, etravirine (used to treat HIV infection)
• Aprepitant (used to treat nausea and vomiting)
• Armodafinil, modafinil (used to treat sleepiness)
• Bosentan (used to treat pulmonary hypertension or finger ulcers)
• Nafcillin (used to treat infections)
• Prednisone (used to treat inflammatory conditions)
• Rufinamide (used to treat epileptic seizures).

Inform your doctor if you are taking any of these medicines, as they may decide to adjust the dose of Lurasidone Teva.
Lurasidone Teva with food, drinks, and alcohol
During treatment with this medicine, you should avoid alcohol. Alcohol may have an additive negative effect.
Do not drink grapefruit juice during treatment with this medicine. Grapefruit may affect how this medicine works.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not take this medicine during pregnancy unless specifically advised by your doctor.
If your doctor decides that the potential benefit of treatment during pregnancy outweighs the potential risk to the unborn child, your baby will be closely monitored after birth.
Newborns whose mothers have used lurasidone during the third trimester (last three months) of pregnancy may experience the following symptoms:

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

If your baby shows any of these symptoms, contact your doctor.
It is not known whether lurasidone is excreted in breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed.
Driving and using machines
Drowsiness, dizziness, and vision problems may occur during treatment with this medicine (see section 4, Possible side effects). Do not drive or operate bicycles, motorcycles, tools, or machinery until you know how this medicine affects you.
Lurasidone Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Lurasidone Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dose you will be prescribed will be determined by your doctor and may depend on several factors:

• How you respond to a given dose
• Whether you are taking other medicines (see section 2, “Other medicines and Lurasidone Teva”)
• Whether you have kidney or liver problems.

Adults (aged 18 years and older)
The recommended starting dose is 37 mg once daily.
Your doctor may increase or decrease this dose within the dose range of 18.5 mg to
148 mg once daily. The maximum dose must not exceed 148 mg once daily.
Adolescents (13–17 years)
The recommended starting dose is 37 mg of lurasidone once daily.
This dose may be increased or decreased by your doctor within the dose range of 37 mg to
74 mg once daily. The maximum daily dose must not exceed 74 mg.
How to take Lurasidone Teva
Swallow the tablets whole with some water to mask their bitter taste. You must take the dose regularly, every day at the same time, to make it easier to remember. You must take
this medicine during a meal or immediately after eating, as this helps your body absorb the
medicine and allows it to work effectively.
If you take more Lurasidone Teva than you should
If you take more medicine than prescribed, contact your doctor immediately. You may experience drowsiness, tiredness, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, or abnormal heartbeats.
If you forget to take Lurasidone Teva
Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose on the following day at the usual time. If you miss two or more doses, consult your doctor.
If you stop taking Lurasidone Teva
If you stop taking this medicine, you will lose its effects. Do not stop taking this medicine unless your doctor tells you to, as your symptoms may return.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• A severe allergic reaction presenting as fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash, and sometimes low blood pressure (hypersensitivity). These reactions have been commonly observed (may affect up to 1 in 10 people).
• A severe skin rash with blistering affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). The frequency of this reaction is not known.
• Fever, sweating, muscle stiffness, and reduced level of consciousness. These could 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, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult a doctor immediately.

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

• Feeling restless and unable to sit still
• Nausea (feeling unwell)
• Insomnia.

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

• Parkinsonism: a medical term grouping various symptoms, including increased salivation or watery mouth, drooling, jerking movements when bending limbs, slow, reduced, or impaired body movements, expressionless face, muscle tension, stiff neck, muscle rigidity, small, shuffling, hurried steps, and lack of normal arm swing while walking, persistent blinking in response to tapping the forehead (an abnormal reflex)
• Difficulty speaking, abnormal muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS), which generally include unusual, involuntary, and purposeless muscle movements
• Rapid heartbeat
• Increased blood pressure
• Dizziness
• Muscle spasms and stiffness
• Vomiting
• Diarrhea
• Back pain
• Skin rash and itching
• Indigestion
• Dry mouth or excessive saliva
• Abdominal pain
• Drowsiness, fatigue, agitation, and anxiety
• Weight gain
• Increased levels of creatine phosphokinase (an enzyme present in muscles), detected in blood tests
• Increased levels of creatinine (a marker of kidney function), detected in blood tests
• Loss of appetite.

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

• Difficulty articulating words
• Nightmares
• Difficulty swallowing
• Irritation of the stomach lining
• Sudden anxiety
• Seizures (epileptic fits)
• Chest pain
• Muscle pain
• Temporary loss of consciousness
• Dizziness
• Abnormal nerve impulses in the heart
• Slow heartbeat
• Joint pain
• Difficulty walking
• Stiff posture
• Increased blood levels of prolactin, increased blood glucose (blood sugar), increased levels of certain liver enzymes, detectable in blood tests
• Sudden drop in blood pressure upon standing, possibly leading to fainting
• Common cold
• Hot flushes
• Blurred vision
• Sweating
• Painful urination
• Involuntary, uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia)
• Low sodium levels in the blood, which may cause fatigue, confusion, muscle cramps, seizures, and coma (hyponatremia)
• Lack of energy (lethargy)
• Gas (flatulence)
• Neck pain
• Erectile problems
• Painful or absent menstruation
• Reduced levels of red blood cells (which carry oxygen in the body).

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

• Rhabdomyolysis, i.e., breakdown of muscle fibers leading to release of their contents (myoglobin) into the bloodstream, causing muscle pain, malaise, confusion, abnormal heart rate and rhythm, and possibly dark-colored urine
• Increased eosinophils (a type of white blood cells)
• Swelling beneath the skin (angioedema)
• Self-harm
• Stroke
• Kidney failure
• Reduced levels of white blood cells (which fight infections)
• Breast pain, milk secretion from the breasts
• Sudden death.

Not known (frequency cannot be estimated from available data):

• Reduced levels of a subgroup of white blood cells (neutrophils)
• Sleep disorder
• Newborns may experience the following symptoms: agitation, increased or decreased muscle tone, tremors, drowsiness, breathing or feeding difficulties
• Abnormal breast enlargement.

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

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

• Feeling restless and unable to sit still
• Headache
• Drowsiness
• Nausea (feeling unwell).

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

• Decreased or increased appetite
• Abnormal dreams
• Difficulty sleeping, tension, agitation, anxiety, and irritability
• Physical weakness, fatigue
• Depression
• Psychotic disorder: a medical term grouping various mental illnesses causing abnormal thoughts and perceptions; people with psychosis lose touch with reality
• Schizophrenia symptoms
• Difficulty concentrating
• Dizziness
• Abnormal involuntary movements (dyskinesia)
• Abnormal muscle tone, including torticollis and involuntary upward deviation of the eyes
• Parkinsonism: a medical term grouping various symptoms, including increased salivation or watery mouth, drooling, jerking movements when bending limbs, slow, reduced, or impaired body movements, expressionless face, muscle tension, stiff neck, muscle rigidity, small, shuffling, hurried steps, and lack of normal arm swing while walking, persistent blinking in response to tapping the forehead (an abnormal reflex)
• Rapid heartbeat
• Difficulty emptying the bowel (constipation)
• Dry mouth or excessive saliva
• Vomiting
• Sweating
• Muscle stiffness
• Erectile problems
• Increased levels of creatine phosphokinase (an enzyme present in muscles), detected in blood tests
• Increased levels of prolactin (a hormone) in the blood, detected in blood tests
• Weight gain or weight loss.

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

• Hypersensitivity
• Common cold, throat and nasal infection
• Reduced thyroid activity, thyroid inflammation
• Aggressive behavior, impulsive behavior
• Apathy
• Confusional state
• Depressed mood
• Separation of normal mental processes (dissociation)
• Hallucinations (auditory or visual)
• Homicidal thoughts
• Difficulty sleeping
• Increased or decreased sexual desire
• Lack of energy
• Changes in mental state
• Obsessive thoughts
• Acute, disabling anxiety (panic attack)
• Performing purposeless involuntary movements (psychomotor hyperactivity)
• Excessive muscle activity in the body (hyperkinesia), inability to stay still (restlessness)
• Uncontrollable urge to move the legs (restless legs syndrome), uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia)
• Sleep disorder
• Intentional suicidal thoughts
• Abnormal thinking
• Instability (sensation of spinning)
• Altered taste
• Impaired memory
• Altered skin sensation (paresthesia)
• Sensation of tightness around the head (tension-type headache), migraine
• Difficulty focusing the eyes, blurred vision
• Increased hearing sensitivity
• Palpitations, changes in heart rhythm
• Sudden drop in blood pressure upon standing, possibly leading to 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
• Skin rash, hives
• Muscle spasms and stiffness, muscle pain
• Joint pain, pain in arms and legs, jaw/mouth pain
• Presence of bilirubin in urine, presence of protein in urine, indicators of kidney function
• Pain or difficulty urinating, frequent urination, kidney disease
• Sexual dysfunction
• Difficulty ejaculating
• Abnormal breast enlargement, breast pain, milk secretion from the breasts
• Absent or irregular menstruation
• Uncontrollable noises and movements (Tourette’s syndrome)
• Chills
• Difficulty walking
• Malaise
• Chest pain
• Fever
• Intentional overdose
• Effects on thyroid function, detected in blood tests, increased cholesterol in blood, increased triglycerides in blood, reduced high-density lipoproteins, reduced low-density lipoproteins, detected in blood tests
• Increased blood glucose (blood sugar), increased insulin in blood, increased levels of certain liver enzymes (a marker of liver function), detected in blood tests
• Increased or decreased testosterone in blood, increased thyroid-stimulating hormone in blood, detected in blood tests
• Changes in electrocardiogram
• Reduced hemoglobin, reduced levels of white blood cells (which fight infections), detected in blood tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What 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 components are microcrystalline cellulose (E460), mannitol (E421), hypromellose 2910 (E464), sodium croscarmellose (E468) (see section 2, “Lurasidone Teva contains sodium”), magnesium stearate (E470b), titanium dioxide (E171), macrogol 8000 (E1521). Also present only in the 74 mg film-coated tablets: yellow iron oxide (E172), indigo carmine aluminium lake (E132).

Description of the appearance of Lurasidone Teva and package contents
Lurasidone Teva 18.5 mg film-coated tablets
Round, white to off-white film-coated tablets, with the inscription “LO” on one side and smooth on the other, with a diameter of 6.1 mm.
Lurasidone Teva 37 mg film-coated tablets
Round, white to off-white film-coated tablets, with the inscription “LI” on one side and smooth on the other, with a diameter of 8.1 mm.
Lurasidone Teva 74 mg film-coated tablets
Oval, light green to green film-coated tablets, with the inscription “LH” on one side and smooth on the other, measuring 12.1 x 7.1 mm.
Unit dose blister packs and perforated divisible blisters in OPA/Al/PVC//Al, packaged in cardboard boxes.
Pack sizes: 28 or 28 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva B.V., Swensweg 5, 2031 GA Haarlem, the Netherlands

Manufacturer
ELPEN Pharmaceutical Co. Inc., Marathonos Avenue 95, Pikermi, Attiki, 190 09, Greece
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, 31-546 Krakow, Poland