Alurazen

Package leaflet: Information for the patient

Alurazen, 18.5 mg, coated tablets
Alurazen, 37 mg, coated tablets
Alurazen, 74 mg, coated tablets
Lurasidone
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Alurazen is and what it is used for

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

Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, social withdrawal, disorganized speech, and blunted behaviors and emotions. People with this disorder may also experience depression, anxiety, guilt, or tension. This medicine is used to alleviate the symptoms of schizophrenia.

2. Important Information Before Taking Alurazen

When not to take Alurazen:

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

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

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

If any of the above conditions apply to the patient, inform the doctor, who may consider it appropriate to change the dose, monitor the patient more closely, or discontinue treatment with Alurazen.

Children and adolescents
Alurazen should not be given to children under 13 years of age.

Alurazen and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This is particularly important if the patient is taking:

• any medicines acting on the brain, as they may negatively affect Alurazen’s action on the brain
• medicines that lower blood pressure, as Alurazen 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 psychiatric disorders), quinidine (used to treat heart conditions), bepridil (used to treat chest pain)
• medicines containing buprenorphine (used to treat opioid dependence), 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 Alurazen and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, body temperature above 38°C. If such symptoms occur, contact your doctor immediately.

If the patient is taking any of these medicines, inform the doctor, who may consider it necessary to adjust the dose of such medicine during treatment with Alurazen.

The following medicines may increase lurasidone blood levels:

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

The following medicines may decrease lurasidone blood levels:

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

If the patient is taking any of these medicines, inform the doctor, who may consider it necessary to adjust the dose of Alurazen.

Taking Alurazen with food, drink, and alcohol
While taking this medicine, avoid drinking alcohol, as alcohol may worsen the adverse effects of the medicine.
Do not drink grapefruit juice while taking this medicine. Grapefruit may affect the action of this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless specifically advised by a doctor.
If the doctor considers that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn child, the newborn will be closely monitored after birth. This is because newborns whose mothers took lurasidone during the third trimester of pregnancy (last 3 months) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If the baby shows any of these symptoms, contact a doctor immediately.
It is not known whether lurasidone passes into breast milk. If the patient is breastfeeding or planning to breastfeed, she should discuss this with her doctor.

Driving and operating machinery
This medicine may cause drowsiness, dizziness, or vision disturbances (see section 4 “Possible side effects”). Do not drive, ride a bicycle, or operate any tools or machinery until it is known whether this medicine affects the patient adversely.

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

3. How to take Alurazen

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

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

Adults (aged 18 years and above)
The recommended starting dose is 37 mg once daily.
The doctor may increase or decrease this 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 lurazidone once daily.
The doctor may increase or decrease the dose within the range of 37 mg to 74 mg once daily.
The maximum daily dose should not exceed 74 mg.
How to take Alurazen
The tablet(s) should be swallowed whole with water to avoid experiencing their bitter taste.
The patient should take the medicine regularly every day at the same time, which helps with remembering
to take the dose. This medicine should be taken with food or immediately after a meal, as this facilitates
absorption of the medicine into the body and allows for better effectiveness.
Overdose of Alurazen
If an overdose of Alurazen is taken, contact your doctor immediately.
The patient may experience drowsiness, fatigue, abnormal body movements, difficulty standing or walking,
dizziness due to low blood pressure, and irregular heart rhythm.
Missed dose of Alurazen
Do not take a double dose to make up for a missed dose. If the patient misses one dose, they should take the
next dose at the usual time the following day. If the patient misses two or more doses, they should contact
their doctor.
Stopping Alurazen
If the patient stops taking this medicine, they will lose its therapeutic effects. This medicine should not be
discontinued unless advised by the doctor, as symptoms of the illness may return.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediate medical help should be sought if the patient experiences any of the following symptoms:

• Severe allergic reaction, manifesting as fever, swelling of the lips, face, tongue or throat, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (hypersensitivity). Such reactions are commonly observed (may occur in up to 1 in 10 patients).
• Severe skin rash with blisters on the skin, inside the mouth, eyes or genital organs (Stevens-Johnson syndrome). This type of 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 occur rarely (may occur in up to 1 in 1000 patients).
• Blood clots in veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing.
• Low sodium levels in the blood, which may cause fatigue and disorientation, muscle tremors, seizures and coma (hyponatremia). These reactions occur uncommonly (may occur in up to 1 in 100 patients).
• Uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia). These reactions are observed uncommonly (may occur in up to 1 in 100 patients). If any of the symptoms listed above occur, immediate medical advice should be sought.

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

• Feeling of restlessness and inability to sit still
• Nausea
• Insomnia

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

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

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

• Slurred speech
• Nightmares
• Difficulty swallowing
• Stomach mucosa irritation
• Sudden anxiety
• Seizures (fits)
• Chest pain
• Muscle pain
• Transient loss of consciousness
• Sensation of spinning
• Impaired conduction of electrical impulses in the heart
• Slow heart rate
• Joint pain
• Difficulty walking
• Stiff posture
• Increased blood prolactin levels, increased blood glucose (blood sugar), increased activity of certain liver enzymes (detected in blood tests)
• Increased blood pressure
• Drop in blood pressure upon standing, which may lead to fainting
• Common cold
• Hot flushes
• Blurred vision
• Loss of appetite
• Sweating
• Pain during urination
• Lack of energy (lethargy)
• Intestinal gas
• Neck pain
• Problems with erection
• Painful or absent menstrual bleeding
• Decreased number of red blood cells (which carry oxygen throughout the body)

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

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

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

• Decreased number of neutrophils (a subgroup of white blood cells)
• Sleep disturbances
• In newborns, symptoms such as agitation, increased or decreased muscle tone, tremors, drowsiness, breathing or feeding difficulties may be observed
• Abnormal breast enlargement

In elderly patients with dementia, a slightly increased number of deaths has been observed among those taking antipsychotic medicines compared to patients not taking these medicines.

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

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

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

• 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
• Abnormal involuntary movements (dyskinesias)
• Abnormal muscle tension, including neck spasm and involuntary upward rolling of the eyes
• Parkinsonism: a medical term referring to a range of symptoms including excessive salivation, drooling, sudden jerks when bending limbs, slow, limited or abnormal body movements, lack of facial expression, muscle tension, neck stiffness, muscle rigidity, shuffling gait with small, quick steps and lack of normal arm swing while walking, persistent blinking in response to tapping the forehead (abnormal reflexes)
• Rapid heartbeat
• Difficulty passing stools (constipation)
• Dry mouth or excessive saliva production
• Vomiting
• Sweating
• Muscle stiffness
• Problems with erection
• Increased creatine kinase activity (a muscle enzyme) observed in blood tests
• Increased prolactin (hormone) levels in blood observed in blood tests
• Weight gain or weight loss

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

• Hypersensitivity
• Common cold, throat and nose infections
• Reduced thyroid activity, thyroid inflammation
• Aggressive behaviour, impulsive behaviour
• Apathy
• Confusion
• Depressive mood
• Loss of connection with normal thought processes (dissociative disorders)
• Hallucinations (auditory or visual)
• Homicidal thoughts
• Difficulty falling asleep
• Increased or decreased sexual desire
• Lack of energy
• Changes in mental state
• Obsessions
• Sudden and overwhelming fear (panic attack)
• Performing involuntary, purposeless movements (psychomotor agitation)
• Excessive muscle activity (hyperkinesia), inability to rest (motor restlessness)
• Uncontrollable urge to move legs (restless legs syndrome), uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
• Sleep disturbances
• Suicidal thoughts
• Thought disturbances
• Instability (sensation of spinning)
• Changes in taste sensation
• Memory disturbances
• Abnormal skin sensations (paresthesia)
• Feeling of tight band around head (tension headache), migraines
• Difficulty focusing vision, blurred vision
• Increased hearing sensitivity
• Palpitations, changes in heart rhythm
• Drop in blood pressure upon standing, which may lead to fainting
• Increased blood pressure
• Abdominal pain or abdominal disturbances
• Absence or deficiency of saliva production
• Diarrhea
• Indigestion
• Dry lips
• Toothache
• Partial or complete hair loss, abnormal hair growth
• Rash, hives
• Muscle cramps and stiffness, muscle pain
• Joint pain, pain in arms and legs, jaw pain
• Presence of bilirubin in urine, presence of protein in urine, marker of kidney function
• Pain or difficulty urinating, frequent urination, kidney function disturbances
• Sexual dysfunction
• Difficulty with ejaculation
• Abnormal breast enlargement, breast pain, milk secretion from breasts
• Irregular menstrual cycles or absence of menstruation
• Making involuntary sounds and movements (Tourette's syndrome)
• Chills
• Difficulty walking
• Malaise
• Chest pain
• Fever
• Intentional overdose
• Effects on thyroid function, increased blood cholesterol levels observed in blood tests, increased blood triglyceride levels, decreased HDL levels, decreased LDL levels
• Increased blood glucose (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 hemoglobin levels, decreased number of white blood cells (which fight infections) observed in blood tests.

Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
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.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Alurazen

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 after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via the sewage system 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 does Alurazen contain?

• The active substance is lurazodon. Each 18.5 mg tablet contains lurazodon hydrochloride equivalent to 18.6 mg of lurazodon. Each 37 mg tablet contains lurazodon hydrochloride equivalent to 37.2 mg of lurazodon. Each 74 mg tablet contains lurazodon hydrochloride equivalent to 74.5 mg of lurazodon.

The other ingredients are: microcrystalline cellulose type 101, microcrystalline celluline type 102, mannitol,
hypromellose, sodium croscarmellose, magnesium stearate, hypromellose 2910 (E464), titanium dioxide
(E171), macrogol 8000 (E1521), and in 74 mg tablets: iron oxide yellow (E172), indigo carmine
(E132).
What Alurazen looks like and contents of the pack
Alurazen, 18.5 mg
White to off-white, round coated tablets with a diameter of 6.1 mm, embossed with the code "LL" on one side, smooth on the other side.
Alurazen, 37 mg
White to off-white, round coated tablets with a diameter of 8.1 mm, embossed with the code "LI" on one side, smooth on the other side.
Alurazen, 74 mg
Oval-shaped, light green to green coated tablets measuring 12.1 x 7.1 mm, embossed with the code "LH" on one side, smooth on the other side.
Packaging: 28 film-coated tablets in blisters, packed in a cardboard box.
Marketing Authorisation Holder
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Phone number: 22 811-18-14
Manufacturer
ELPEN Pharmaceutical Co., Inc.
Marathonos Ave. 95
19009 Pikermi Attiki
Greece
For further information about this medicinal product, please contact the Marketing Authorisation Holder.