LURASIDONE 18.5 mg Film-coated tablets

Зміст інструкції

1. Lurasidone Liconsa 18.5 mg, film-coated tablets, 37 mg, film-coated tablets, 74 mg, film-coated tablets
   1. What is Lurasidone Liconsa and what is it used for
   2. What you need to know before taking Lurasidone Liconsa
   3. How to take Lurasidone Liconsa
   4. Possible side effects
   5. How to store Lurasidone Liconsa
   6. Contents of the pack and other information

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

Lurasidone

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Lurasidone Liconsa 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 over
) 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) that are involved in the symptoms of
schizophrenia. By blocking their receptors, lurasidone helps to normalize brain activity, reducing
the symptoms of schizophrenia.
Schizophrenia is a disorder characterized by symptoms such as hearing, perceiving or seeing things that
are not actually there, having false beliefs, harboring unusual suspicions, isolating oneself, speaking and behaving in
an incoherent way and not feeling emotions. 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 Liconsa

Do not take Lurasidone Liconsa

• if you are allergic to lurasidone or any of the other ingredients of this medicine (listed in section 6)
• if you are taking medicines that could affect the level of lurasidone in your blood, such as:
• medicines to treat fungal infections such as itraconazole, ketoconazole (except in shampoo formulation), posaconazole or voriconazole
• medicines to treat an infection, such as the antibiotic clarithromycin or telithromycin
• medicines to treat HIV infection, such as cobicistat, indinavir, nelfinavir, ritonavir and saquinavir
• medicines to treat chronic hepatitis, such as boceprevir and telaprevir
• a medicine to treat depression, nefazodone
• a medicine to treat tuberculosis, rifampicin
• medicines to treat convulsions, such as carbamazepine, phenobarbital and phenytoin
• a herbal medicine to treat depression, St John's Wort ( Hypericum perforatum).

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

• You have thoughts or behaviours of suicide
• You have Parkinson's disease or dementia
• You have been diagnosed with an illness whose symptoms include high temperature and muscle rigidity (also known as neuroleptic malignant syndrome) or if you have ever had problems with muscle rigidity, tremors or movement problems (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 heart disease 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 someone in your family has a history of blood clots, because medicines for schizophrenia have been associated with the formation of blood clots
• You experience enlargement of the breasts and you are a man (gynecomastia), milky nipple discharge (galactorrhea), absence of menstruation (amenorrhea) or erectile dysfunction
• You have diabetes or are prone to developing diabetes
• You have reduced kidney function
• You have reduced liver function
• You have weight gain
• You have low blood pressure when standing up which can cause fainting
• You have an opioid dependence (treated with buprenorphine) or severe pain (treated with opioids) or suffer from depression or other conditions that are treated with antidepressants. The use of these medicines together with Lurasidone Liconsa can cause serotonin syndrome, a potentially life-threatening condition (see section “Other medicines and Lurasidone Liconsa”).

If you have any of these conditions, talk to your doctor, because they are likely to want to change your
dosage, monitor you more closely or stop your treatment with Lurasidone Liconsa.

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

Other medicines and Lurasidone Liconsa
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 could add up negatively to the effects of Lurasidone Liconsa on the brain

Medicines that lower blood pressure, because this medicine can lower it too

• Medicines to treat Parkinson's disease and restless legs syndrome (e.g. levodopa) because this medicine can reduce their effects
• Medicines containing ergot alkaloids (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 conditions), quinidine (used to treat heart conditions), bepridil (used to treat chest pain)
• Medicines that contain buprenorphine (used to treat opioid dependence) or opioids (used to treat severe pain) or antidepressants such as moclobemide, tranylcipromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines can interact with Lurasidone Liconsa and symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, a body temperature above 38 °C may occur. Contact your doctor if you experience these symptoms.

Tell your doctor if you take any of these medicines because they may decide to change their
dose during treatment with Lurasidone Liconsa.
The following medicines can increase the levels of lurasidone 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 can reduce the levels of lurasidone 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 arterial hypertension or finger ulcers)
• Nafcillin (used to treat infections)
• Prednisone (used to treat inflammatory conditions)
• Rufinamide (used to treat seizures).

Tell your doctor if you take any of these medicines because they may decide to change the
dose of Lurasidone Liconsa.

Lurasidone Liconsa with food, drinks and alcohol
You should avoid alcohol while taking this medicine. In fact, alcohol has an additive
negative effect.
Do not drink grapefruit juice while taking this medicine. Grapefruit can affect
how this medicine works.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine during pregnancy unless this has been
agreed with your doctor.
If your doctor decides that the potential benefit of treatment during pregnancy justifies the
potential risk to the unborn child, your doctor will closely monitor the baby after birth.
Indeed, newborns whose mothers have used lurasidone in the last trimester (the last three months) of
pregnancy may experience the following symptoms:

• tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding.

If the baby develops any of these symptoms, seek medical attention.
It is not known whether lurasidone is excreted in breast milk. Tell your doctor if you are breastfeeding or
intend to do so.

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, ride bicycles, operate
tools or machinery until you have found out how this medicine affects you.

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

3. How to take Lurasidone Liconsa

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose you will need to take will be established by your doctor and may depend on several factors:

• How you respond to a dose
• If you are taking other medicines (see section 2, Other medicines and Lurasidone Liconsa)
• If you have kidney or liver problems.

Adults (aged 18 years or over)
The recommended starting dose is 37 mg once a day.
This dose may be increased or decreased by your doctor, within the dose range of 18.5-
148 mg once a day. The maximum dose should not exceed 148 mg once a day.

Adolescents (13-17 years)
The recommended starting dose is 37 mg of lurasidone once a day.
This dose may be increased or decreased by your doctor, within the dose range of 37-74 mg
once a day. The maximum daily dose should not exceed 74 mg.

How to take Lurasidone Liconsa
The tablets must be swallowed whole with water to mask the bitter taste.
You should take the dose regularly, every day at the same time, so it is easier to remember. You should
take this medicine during or immediately after meals, as this helps the body to
absorb the medicine and allows it to work best.

If you take more Lurasidone Liconsa than you should
If you take a quantity of medicine higher than you should, contact your
doctor immediately. You may experience drowsiness, fatigue, abnormal body movements, problems
staying upright and walking, dizziness due to low blood pressure, and abnormal
heartbeats.

If you forget to take Lurasidone Liconsa
Do not take a double dose to make up for a missed dose. If you miss a dose, take the
next dose the day following the missed dose. If you miss two or more doses, contact your doctor.

If you stop taking Lurasidone Liconsa
If you stop taking this medicine, you will lose its effects. Do not stop this
medicine unless your doctor tells you to, as your symptoms may return.
If you have any doubts about the use of this medicine, ask 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 medical attention immediately:

• a severe allergic reaction manifesting 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 observed commonly (may affect up to 1 in 10 people)
• a severe rash with blistering affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). This reaction has been observed with unknown frequency
• fever, sweating, muscle rigidity and decreased level of consciousness. These could be symptoms of a condition known as neuroleptic malignant syndrome. These reactions are rarely observed (may affect up to 1 in 1,000 people)
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may move along the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.

In adults, the following side effects may also occur:

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

• Feeling of restlessness and inability to remain seated quietly
• Nausea
• Insomnia.

Common (may affect up to 1 in 10 people)

• Parkinsonism: this is a medical term that groups many symptoms, including increased saliva production or watery mouth, loss of saliva, jerks when bending the limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, stiff neck, muscle rigidity, small, shuffling, hurried steps and lack of normal arm movements during walking, persistent blinking in response to taps on the forehead (an abnormal reflex)
• Problems articulating words, abnormal muscle movements; a series of symptoms

known as extrapyramidal symptoms (EPS), which generally include
unusual, involuntary muscle movements

• Fast heartbeat
• Increased blood pressure
• Dizziness
• Spasms and muscle rigidity
• Vomiting
• Diarrhea
• Back pain
• Rash and itching
• Indigestion
• Dry mouth or excessive saliva
• Abdominal pain
• Sleepiness, 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 feeling of anxiety
• Convulsions (seizures)
• Chest pain
• Muscle pain
• Temporary loss of consciousness
• Feeling of lightheadedness
• Abnormal heart impulses
• Slow heartbeat
• Joint pain
• Problems walking
• Rigid posture
• Increased levels of prolactin in the blood, increased blood sugar (glucose), increased levels of some liver enzymes, detectable in blood tests
• Sudden drop in blood pressure when getting up, with possible fainting
• Common cold
• Hot flashes
• Blurred vision
• Sweating
• Pain when urinating
• Involuntary movements of the mouth, tongue and limbs (tardive dyskinesia)
• Low levels of sodium in the blood, which can cause fatigue, confusion, muscle contractions, seizures and coma (hyponatremia)
• Lack of energy (lethargy)
• Gas (flatulence)
• Neck pain
• Erectile dysfunction
• Painful or absent menstruation
• Decreased levels of red blood cells (which carry oxygen throughout the body).

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

• Rhabdomyolysis, i.e. breakdown of muscle fibers with subsequent release of

their contents (myoglobin) into the bloodstream, which causes muscle pain,
illness, confusion, abnormal heart rate and rhythm, and possibly dark urine

• Increased eosinophils (a type of white blood cell)
• Swelling under the surface of the skin (angioedema)
• Self-inflicted injuries
• Stroke
• Kidney failure
• Decreased levels of white blood cells (which fight infections)
• Breast pain, nipple discharge
• Sudden death.

Not known (frequency cannot be estimated based on available data)

• Decreased levels of a subgroup of white blood cells (neutrophils)
• Sleep disorders
• Newborns may experience the following symptoms: agitation, increased or decreased muscle tone, tremor, drowsiness, breathing or feeding problems
• Abnormal breast enlargement.
• In elderly people with dementia, a small increase in the number of deaths has been reported in patients treated with schizophrenia medications compared to patients not treated with these medications.

Adolescents may experience the following side effects:

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

• Feeling of restlessness and inability to remain seated quietly
• Headache
• Sleepiness
• Nausea.

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: this is a medical term that groups many mental illnesses that cause abnormal thoughts and perceptions; people with psychosis lose touch with reality
• Symptoms of schizophrenia
• Difficulty concentrating
• Feeling dizzy
• Involuntary abnormal movements (dyskinesia)
• Abnormalities in muscle tone, including torticollis and involuntary upward deviation of the eyes
• Parkinsonism: this is a medical term that groups many symptoms, including increased saliva production or watery mouth, loss of saliva, jerks when bending the limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, stiff neck, muscle rigidity, small, shuffling, hurried steps and lack of normal arm movements during walking, persistent blinking in response to taps on the forehead (an abnormal reflex)
• Fast heartbeat
• Difficulty emptying the bowels (constipation)
• Dry mouth or excessive saliva
• Vomiting
• Sweating
• Muscle rigidity
• Erectile dysfunction
• Increased levels of creatine phosphokinase (an enzyme present in muscles), detected in blood tests
• Increased levels of prolactin (an enzyme) in the blood, detected in blood tests
• Weight gain or loss.

Uncommon (may affect up to 1 in 100 people)

• Hypersensitivity
• Common cold, throat and nose infection
• Decreased thyroid activity, inflammation of the thyroid
• Aggressive behavior, impulsive behavior
• Apathy
• Confused state
• Depressed mood
• Separation of normal mental processes (dissociation)
• Hallucination (auditory or visual)
• Thoughts of homicide
• Difficulty sleeping
• Increased or decreased sexual desire
• Lack of energy
• Mental state alterations
• Obsessive thoughts
• Feeling of acute and debilitating anxiety (panic attack)
• Performing involuntary movements without purpose (psychomotor hyperactivity)
• Hyperactivity of body muscles (hyperkinesia), inability to stay still (restlessness)
• Uncontrollable urge to move legs (restless legs syndrome), involuntary movements of mouth, tongue and limbs (tardive dyskinesia)
• Sleep disorders
• Intentional suicidal thoughts
• Abnormal thinking
• Instability (feeling dizzy)
• Alteration of taste
• Impaired memory
• Alteration of skin sensitivity (paresthesia)
• Feeling of a tight band around the head (muscle tension headache), migraine
• Difficulty focusing eyes, blurred vision
• Increased sensitivity to hearing
• Palpitations, alterations in heart rhythm
• Sudden drop in blood pressure when getting up, with possible fainting
• Increased blood pressure
• Pain or discomfort in the abdomen
• Absence or significant decrease in salivary secretion
• Diarrhea
• Indigestion
• Dry lip
• Toothache
• Partial or total loss of hair, abnormal hair growth
• Rash, hives
• Muscle spasms and rigidity, muscle pain
• Joint pain, pain in arms and legs, pain in jaw/mandible
• Presence of bilirubin in urine, presence of protein in urine, an indicator of kidney function
• Pain or difficulty urinating, frequent urination, kidney disease
• Sexual dysfunction
• Difficulty ejaculating
• Abnormal breast enlargement, breast pain, nipple discharge
• Absent or irregular menstruation
• Performing uncontrolled noises and movements (Tourette's syndrome)
• Chills
• Problems walking
• Illness
• Chest pain
• Fever
• Intentional overdose
• Effects on thyroid function, detected in blood tests increased cholesterol in the blood, increased triglycerides in the blood, decreased high-density lipoproteins, decreased low-density lipoproteins, detected in blood tests
• Increased blood sugar (glucose), increased insulin in the blood, increased levels of some liver enzymes (an indicator of liver function), detected in blood tests
• Increased or decreased testosterone in the blood, increased thyroid-stimulating hormone in the blood, detected in blood tests
• Changes in electrocardiogram
• Decreased hemoglobin, decreased levels of white blood cells (which fight infections), detected in blood tests.

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

5. How to store Lurasidone Liconsa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister after
Expiry Date/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lurasidone Liconsa contains

• The active ingredient is lurasidone.

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

Tablet core:
Mannitol, corn starch, microcrystalline cellulose, sodium croscarmellose, hypromellose, colloidal anhydrous
silica, magnesium stearate.

Tablet coating (18.5 mg and 37 mg tablets):
Hypromellose (E464), titanium dioxide (E171), macrogol (E1521), carnauba wax.

Tablet coating (74 mg tablets):
Hypromellose (E464), titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172), lacquer
containing indigo carmine aluminium (E132), carnauba wax.

Description of the appearance of Lurasidone Liconsa and contents of the pack

• Lurasidone Liconsa 18.5 mg tablets are film-coated tablets, round in shape, biconvex, from white to off-white in colour, with a diameter of 6 mm. They are imprinted with ‘L’ on one side and smooth on the other.
• Lurasidone Liconsa 37 mg tablets are film-coated tablets, round in shape, biconvex, from white to off-white in colour, with a diameter of 8 mm. They are imprinted with ‘I’ on one side and smooth on the other.
• Lurasidone Liconsa 74 mg tablets are film-coated tablets, oval in shape, biconvex, from light green to green in colour, with dimensions 12 x 7 mm. They are imprinted with ‘I’ on one side and smooth on the other.

Lurasidone Liconsa tablets are available in packs containing 28 film-coated tablets in aluminium-aluminium
blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Laboratorios Liconsa, S.A.
C/Dulcinea s/n, 28805,
Alcalá de Henares,
Madrid (Spain)

Manufacturer
Laboratorios Liconsa S.A.
Avda. Miralcampo, Nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara) Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Sweden – Lurasidone Liconsa
Italy – Lurasidone Liconsa