Lurasidone g.l. pharma

Package leaflet: Information for the patient

Lurasidone G.L. Pharma, 18.5 mg, coated tablets
Lurasidone G.L. Pharma, 37 mg, coated tablets
Lurasidone G.L. Pharma, 74 mg, coated tablets
Lurasidonum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on 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, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Lurasidone G.L. Pharma is and what it is used for

Lurasidone G.L. Pharma 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 to 17 years. Lurasidone works by blocking receptors in the brain to which dopamine and serotonin attach. Dopamine and serotonin are neurotransmitters (chemicals that allow nerve cells to communicate with each other) associated with the symptoms of schizophrenia. By blocking these receptors, lurasidone helps normalize brain activity and reduce schizophrenia symptoms.

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. Important information before taking Lurasidone G.L. Pharma

When not to take Lurasidone G.L. Pharma:

• 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 the blood concentration of lurasidone, such as:
  • antifungal medicines, such as itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole or voriconazole
  • antibiotics used to treat infections, such as clarithromycin or telithromycin
  • antiviral medicines used to treat HIV infection, such as cobicistat, indinavir, nelfinavir, ritonavir and saquinavir
• medicines used to treat chronic hepatitis C, such as boceprevir and telaprevir
• an antidepressant medicine, nefazodone
• a medicine used to treat tuberculosis, rifampicin
• medicines used to treat epilepsy, such as carbamazepine, phenobarbital and phenytoin
• herbal products used to treat depression, St John’s wort (Hypericum perforatum).

Warnings and precautions
It may take several days before this medicine starts to work fully. If you have any questions about this medicine, please contact your doctor.
Before starting treatment with Lurasidone G.L. Pharma 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 characterised by high fever and muscle stiffness (called neuroleptic malignant syndrome), or has ever experienced muscle stiffness and tremors or had problems with movement (extrapyramidal symptoms), or has abnormal movements of the tongue or face (tardive dyskinesia). Please remember that this medicine may cause such symptoms
• the patient has heart disease or is taking medicines used for heart disease that may cause low blood pressure, or if a family member has heart rhythm disorders (including QT prolongation)
• the patient has previously had 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 (gynaecomastia in men), has milk discharge from the breasts (galactorrhoea), absence of menstruation or erectile dysfunction
• the patient has diabetes or is prone to diabetes
• the patient has impaired kidney function
• the patient has impaired liver function
• the patient’s body weight has increased
• the patient experiences a drop in blood pressure upon standing, which may cause fainting
• opioid dependence (treated with buprenorphine), severe pain (treated with opioids), depression or other conditions treated with antidepressants. Taking these medicines together with Lurasidone G.L. Pharma may lead to serotonin syndrome, a potentially life-threatening condition (see “Lurasidone G.L. Pharma 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 of the medicine, monitor the patient more closely, or discontinue treatment with Lurasidone G.L. Pharma.
Children and adolescents
Do not give this medicine to children under 13 years of age.
Lurasidone G.L. Pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has 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 the action of Lurasidone G.L. Pharma on the brain
• medicines that lower blood pressure, as Lurasidone G.L. Pharma 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 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), 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 Lurasidone G.L. Pharma and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, drowsiness, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, contact your doctor.

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 Lurasidone G.L. Pharma.
The following medicines may increase the blood concentration 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 concentration of lurasidone:

• 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 conditions)
• rufinamide (used to treat epileptic seizures)

If the patient is taking any of these medicines, inform the doctor, who may consider it necessary to adjust the dose of Lurasidone G.L. Pharma.
Taking Lurasidone G.L. Pharma with food, drink and alcohol
While taking this medicine, avoid drinking alcohol, as alcohol may worsen the adverse effects of the medicine.
While taking this medicine, do not drink grapefruit juice. 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy unless agreed with the doctor.
If the doctor considers that the potential benefits of treatment during pregnancy outweigh the potential risks to the unborn child, the baby 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:

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

If the baby shows any of these symptoms, contact the doctor. 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
During treatment with this medicine, drowsiness, dizziness or visual disturbances may occur (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.
Lurasidone G.L. Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. this medicine is considered “sodium-free”

3. How to take Lurasidone G.L. Pharma

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for the 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 G.L. Pharma and other medicines”)
• any kidney or liver problems the patient may have.

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 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 G.L. Pharma
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 with remembering to take it. This medicine must be taken with food or immediately after a meal, as this facilitates absorption into the body and ensures better effectiveness.
Taking more Lurasidone G.L. Pharma than recommended
If you take more Lurasidone G.L. Pharma than recommended, contact your doctor immediately.
Symptoms may include drowsiness, fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, and irregular heartbeat.
Missed dose of Lurasidone G.L. Pharma
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 treatment with Lurasidone G.L. Pharma
If the patient stops taking this medicine, the therapeutic effects will be lost. Do not discontinue treatment with this medicine unless advised by your doctor, as symptoms of the illness may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You should seek immediate medical help if the patient experiences any of the following symptoms:

• Severe allergic reaction with fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (hypersensitivity). Such reactions are observed frequently (may affect up to 1 in 10 patients).
• Severe skin rash with blisters around the mouth, eyes or genital organs (Stevens-Johnson syndrome). This type of reaction occurs with unknown frequency.
• Fever, sweating, muscle stiffness and altered consciousness. These may be symptoms of a condition known as neuroleptic malignant syndrome. These reactions occur rarely (may affect up to 1 in 1000 patients).
• Blood clots in the 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 breathing difficulties. If the patient experiences any of these symptoms, immediate medical advice should be sought.

The following side 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 many symptoms such as increased salivation; drooling; muscle tremor when bending limbs; slowed, limited or impaired body movements; lack of facial expression; muscle tension, neck stiffness; muscle rigidity; walking with small, quick steps and shuffling gait, lack of normal arm swing when 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 unusual, purposeless involuntary muscle movements
• Fast 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 activity of creatine kinase (an enzyme present in muscles) shown in blood tests
• Increased concentration of creatinine (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
• Stomach mucosa irritation
• Sudden feeling of fear
• Convulsions (seizures)
• Chest pain
• Muscle pain
• Brief loss of consciousness
• Sensation of spinning
• Disturbances in electrical impulse conduction in the heart
• Slow heart rate
• Joint pain
• Problems with walking
• Stiff posture
• Increased concentration of prolactin in blood, increased concentration of glucose in blood (blood sugar), increased activity of certain liver enzymes (shown in blood tests)
• Drop in blood pressure upon standing, which may cause fainting
• Chills
• Hot flushes
• Blurred vision
• Sweating
• Pain during urination
• Uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia)
• Low sodium levels in blood, which may cause fatigue and disorientation, muscle tremors, convulsions and seizures (hyponatremia)
• Lack of energy (lethargy)
• Intestinal gas
• Neck pain
• Problems with erection
• Painful menstrual bleeding or absence of periods
• Decreased number of red blood cells (which carry oxygen throughout the body)

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

• 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 urine

• Increased number of eosinophils (a type of white blood cells)

• Swelling beneath the skin surface (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 unknown (frequency cannot be estimated from available data):

• Decreased number of a subgroup of white blood cells (neutrophils)

• Sleep disorders

• In newborns, symptoms may include agitation, increased or decreased muscle tone, muscle tremors, drowsiness, breathing or feeding difficulties

• Abnormal breast enlargement

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

The following side 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 unwell)

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

• Increased or decreased appetite
• Unusual dreams
• Problems 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 contact with reality
• Schizophrenia symptoms
• 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, drooling, sudden jerks when bending limbs, slow, limited or impaired body movements, lack of facial expression, muscle tension, neck stiffness, muscle rigidity, small, shuffling steps with dragging of legs and lack of normal arm movement during walking, persistent blinking in response to tapping the forehead (abnormal reflexes)
• Fast heartbeat
• Difficulty in defecation (constipation)
• Dry mouth or excessive saliva production
• Vomiting
• Sweating
• Muscle stiffness
• Problems with erection
• Increased concentration of creatine kinase (a muscle enzyme) observed in blood tests
• Increased concentration of prolactin (a hormone) in blood observed in blood tests
• Weight gain or weight loss

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

• Hypersensitivity
• Chills, throat and nasal infections
• Increased thyroid activity, thyroid inflammation
• Aggressive behaviour, impulsive behaviour
• Apathy
• Confusion state
• Depressed mood
• Loss of contact with normal thought processes (dissociative disorders)
• Hallucinations (auditory or visual)
• Thoughts of murder
• 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 hyperactivity)
• Excessive muscle activity of the body (hyperkinesia), inability to rest (motor restlessness)
• Uncontrollable urge to move legs (restless legs syndrome), uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
• Sleep disorders
• Suicidal thoughts
• Thought disturbances
• Instability (sensation of spinning)
• Changes in taste sensation
• Memory disturbances
• Abnormal skin sensations (paresthesia)
• Feeling of wearing a tight band around the head (tension headache), migraines
• Difficulty focusing vision, blurred vision
• Increased sensitivity to sound
• Palpitations, changes in heart rhythm
• Decreased blood pressure on standing, which may cause fainting
• Elevated blood pressure
• Pain or disturbances in the abdominal area
• Absence or deficiency of saliva secretion
• Diarrhoea
• Indigestion
• Dry lips
• Toothache
• Partial or complete hair loss, abnormal hair growth
• Rash, hives
• Muscle cramps and stiffness, muscle pain
• Joint pain, shoulder and leg pain, jaw pain
• Presence of bilirubin in urine, presence of protein in urine, kidney function marker
• Pain or difficulty during urination, frequent urination, kidney function disturbances
• Sexual dysfunction
• Difficulty during ejaculation
• Abnormal breast enlargement, breast pain, milk secretion from breasts
• Irregular menstrual cycles or absence of periods
• Uncontrolled sounds and involuntary movements (Tourette's syndrome)
• Shivering
• Difficulty walking
• Wasting (marasmus)
• Chest pain
• Fever
• Intentional overdose
• Effects on thyroid function, visible in blood tests: increased concentration of cholesterol in blood, increased concentration of triglycerides in blood, decreased concentration of HDL, decreased concentration of LDL
• Increased concentration of glucose in blood (blood sugar), increased concentration of insulin in blood, increased activity of certain liver enzymes (liver function marker), observed in blood tests
• Increased or decreased concentration of testosterone in blood, increased concentration of TSH in blood observed in blood tests
• Changes in ECG
• Decreased haemoglobin concentration, decreased number of white blood cells (which fight infections) observed in blood tests

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 authorisation holder.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Lurasidone G.L. Pharma

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

6. Contents of the packaging and other information

What Lurasidone G.L. Pharma contains

• The active substance is lurasidone.

18.5 mg film-coated tablets
Each tablet contains lurasidone hydrochloride equivalent to 18.6 mg of lurasidone.
37 mg film-coated tablets
Each tablet contains lurasidone hydrochloride equivalent to 37.2 mg of lurasidone.
74 mg film-coated tablets
Each tablet contains lurasidone hydrochloride equivalent to 74.5 mg of lurasidone.

• Other ingredients are:

Tablet core
mannitol, maize starch, microcrystalline cellulose, sodium croscarmellose, hypromellose type 2910, colloidal anhydrous silica, magnesium stearate
Tablet coating (18.5 mg and 37 mg)
hypromellose type 2910 (E 464), titanium dioxide (E 171), macrogol (E 1521), carnauba wax
Tablet coating (74 mg)
hypromellose type 2910 (E 464), titanium dioxide (E 171), macrogol (E 1521), iron oxide yellow (E 172), indigo carmine (E 132), carnauba wax

What Lurasidone G.L. Pharma looks like and contents of the pack

• Lurasidone G.L. Pharma 18.5 mg film-coated tablets are white to off-white, round (6 mm in diameter), biconvex, with the imprint "L" on one side and smooth on the other.
• Lurasidone G.L. Pharma 37 mg film-coated tablets are white to off-white, round (8 mm in diameter), biconvex, with the imprint "I" on one side and smooth on the other.
• Lurasidone G.L. Pharma 74 mg film-coated tablets are pale green to green, oval (12 x 7 mm), biconvex, with the imprint "I" on one side and smooth on the other.

Packaging contains 10, 14, 28, 30, 56, or 60 film-coated tablets in aluminium/aluminium blisters.
HDPE bottle containing 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer/Importer
Laboratorios Liconsa S.A.
Avda. Miralcampo, 7
Pol. Ind. Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Sweden: Lurasidone G.L. Pharma
Austria: Lurasidon G.L. 18.5/37/74 mg-Filmtabletten
Czech Republic: Lurasidone G.L. Pharma
Poland: Lurasidone G.L. Pharma

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]