Asil

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• 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 Asil is and what it is used for
2. Important information before taking Asil
3. How to take Asil
4. Possible side effects
5. How to store Asil
6. Contents of the package and other information

1. What Asil is and what it is used for

Asil contains the active substance lurasidone, which belongs to a group of medicines called antipsychotics. It is used to treat symptoms of schizophrenia in adult patients (aged 18 years and older) and 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 allow nerve cells to communicate with each other) involved in the development of schizophrenia symptoms. By blocking these receptors, lurasidone helps normalize brain activity and reduce symptoms of schizophrenia.

Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or sensing things that do not exist, false beliefs, extreme suspiciousness, social withdrawal, disorganized speech, and blunted emotions and behaviors. 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 Asil

When not to take Asil:

• 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 medicines, such as itraconazole, ketoconazole (except ketoconazole in shampoo), posaconazole or voriconazole;
• medicines for infections, such as the antibiotic clarithromycin or telithromycin;
• medicines for HIV infection, such as cobicistat, indinavir, nelfinavir, ritonavir and saquinavir;
• medicines for chronic hepatitis, such as boceprevir and telaprevir;
• the antidepressant medicine nefazodone;
• the medicine for tuberculosis, rifampicin;
• medicines used for epileptic 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 before this medicine starts to work fully. If you have any questions about this medicine, please contact your doctor.
Before starting treatment with Asil 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 the patient has ever experienced muscle stiffness and tremors or had problems with movement (extrapyramidal symptoms), or involuntary 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 used in heart disease that cause a tendency to low blood pressure, or if a family member of the patient 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 treatment with antipsychotic medicines is associated with blood clot formation;
• the patient has enlarged breasts (in men, gynaecomastia), has milky discharge from the breasts (galactorrhoea), 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 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 Asil may lead to serotonin syndrome, a potentially life-threatening condition (see “Asil with other medicines”).

If any of the above conditions apply to the patient, inform the doctor, who may consider it appropriate to adjust the dose of the medicine, monitor the patient more closely, or discontinue treatment with Asil.
Children and adolescents
This medicine should not be given to children under 13 years of age.
Asil with 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 Asil on the brain;

• medicines that lower blood pressure, as Asil 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 Asil 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 tension, 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 Asil.
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 sleepiness);
• bosentan (used to treat high blood pressure or finger ulcers);
• nafcillin (used to treat infections);
• prednisone (used to treat inflammatory diseases);
• 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 Asil.
Asil with food, drink and alcohol
During treatment with this medicine, avoid drinking alcohol, as alcohol may worsen the negative effects of the medicine.
During treatment with 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 if she is planning to have a baby, 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:

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

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, discuss this with the doctor.
Driving and using machines
During treatment with this medicine, drowsiness, dizziness or vision 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 in an unfavourable way.
Asil 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 Asil

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, "Asil and other medicines");
• any kidney or liver problems the patient may have.

Adults (age 18 years and older)
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 lurasidone 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 Asil
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 doses. This medicine should be taken with food or immediately after a meal, as this helps the body absorb the medicine and allows it to work more effectively.
Taking more Asil than recommended
If more Asil has been taken than recommended, 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 heartbeat.
Missing a dose of Asil
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 the following day. If the patient misses two or more doses, they should contact their doctor.
Stopping Asil
If the patient stops taking this medicine, they will lose its therapeutic effects. Do not discontinue treatment with this medicine unless advised by a 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 adverse reactions

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

• Severe allergic reaction characterized by fever, swelling of the lips, face, tongue or throat, breathing difficulties, 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 and genital organs (Stevens-Johnson syndrome). This type of reaction occurs with unknown frequency.
• Fever, sweating, muscle stiffness and disturbances in consciousness. These may be symptoms of a condition called neuroleptic malignant syndrome. These reactions are rare (may occur in up to 1 in 1000 patients).
• Blood clots in veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, immediate medical advice should be sought.

The following adverse reactions 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 various symptoms such as increased salivation; drooling; muscle tremors when bending limbs; slowed, limited or disturbed body movements; lack of facial expression; muscle tension, neck stiffness; muscle rigidity; walking with small, shuffling steps and lack of normal arm swing while walking; persistent blinking in response to tapping on the forehead (abnormal reflex);
• Speech disorders, unusual muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS), which include unusual, 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 phosphokinase activity (an enzyme present in muscles) shown in blood tests;
• Increased creatinine levels (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;
• Irritation of the stomach lining;
• Sudden anxiety;
• Seizures (fits);
• Chest pain;
• Muscle pain;
• Brief loss of consciousness;
• Sensation of spinning;
• Disturbances in electrical impulse conduction in the heart;
• Slow heart rate;
• Joint pain;
• Walking difficulties;
• Stiff posture;
• Increased prolactin levels in blood, increased blood glucose levels (blood sugar), increased activity of certain liver enzymes (shown in blood tests);
• Increased blood pressure;
• Drop in blood pressure upon standing, which may lead to fainting;
• Cold-like symptoms;
• 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, disorientation, muscle twitching, seizures and coma (hyponatremia);
• Lack of energy (lethargy);
• Intestinal gas (bloating);
• Neck pain;
• Erectile problems;
• 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 fibers leading to release of muscle fiber contents (myoglobin) into the bloodstream, manifesting as muscle pain, nausea, disorientation, abnormal heart rate and rhythm, and possibly dark urine;
• Increased number of eosinophils (a type of white blood cells);
• Subcutaneous swelling (angioedema);
• Deliberate self-harm;
• Cerebrovascular event;
• Kidney failure;
• Decreased number of white blood cells (which fight infections);
• Breast pain, milk discharge from breasts;
• Sudden death.

Frequency unknown (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, muscle 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 patients taking antipsychotic medicines compared to those not taking these medicines.

The following adverse reactions may occur in young people:
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):

• 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 a range of mental illnesses causing disturbances in thinking and perception; patients with psychosis lose touch with reality;
• Symptoms of schizophrenia;
• Difficulty concentrating;
• Sensation of spinning;
• Unusual involuntary movements (dyskinesias);
• Abnormal muscle tone, including neck spasms and involuntary upward eye deviation;
• Parkinsonism: a medical term referring to a range of symptoms including excessive salivation, drooling, sudden jerks when bending limbs, slow, limited or disturbed body movements, lack of facial expression, muscle tension, neck stiffness, muscle rigidity, small, shuffling, hurried steps and lack of normal arm swing while walking, persistent blinking in response to tapping on the forehead (abnormal reflexes);
• Rapid heartbeat;
• Difficulty passing stools (constipation);
• Dry mouth or excessive salivation;
• Vomiting;
• Sweating;
• Muscle stiffness;
• Erectile problems;
• Elevated creatine phosphokinase levels (a muscle enzyme) observed in blood tests;
• Increased prolactin levels (a hormone) in blood observed in blood tests;
• Weight gain or weight loss.

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

• Hypersensitivity;
• Cold-like symptoms, throat and nose infection;
• Increased thyroid activity, thyroid inflammation;
• Aggressive behavior, impulsive behavior;
• Apathy;
• Disorientation;
• 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, intense and disabling fear (panic attack);
• Performing involuntary, purposeless movements (psychomotor agitation);
• Excessive muscle activity (hyperkinesia), inability to rest (restlessness);
• Uncontrollable urge to move legs (restless legs syndrome), uncontrolled 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 sensitivity to sound;
• Palpitations, changes in heart rhythm;
• Drop in blood pressure upon standing, which may lead to fainting;
• Increased blood pressure;
• Abdominal pain or discomfort;
• Absence or deficiency of saliva secretion;
• Diarrhea;
• 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, marker of kidney function;
• Pain or difficulty urinating, frequent urination, kidney function disturbances;
• Sexual dysfunction;
• Ejaculation difficulties;
• Abnormal breast enlargement, breast pain, milk discharge from breasts;
• Irregular menstrual cycles or absence of periods;
• Involuntary sounds and movements (Tourette’s syndrome);
• Chills;
• Walking difficulties;
• Malaise;
• Chest pain;
• Fever;
• Intentional overdose;
• Effect on thyroid function, increased blood cholesterol, increased blood triglyceride levels, decreased HDL, decreased LDL observed in blood tests;
• 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 white blood cell count (fighting infections);
• Observed in blood tests.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Asil

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 stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Asil contains

• The active substance is lurazidon. Each 18.5 mg tablet contains lurazidon hydrochloride equivalent to 18.6 mg of lurazidon. Each 37 mg tablet contains lurazidon hydrochloride equivalent to 37.2 mg of lurazidon. Each 74 mg tablet contains lurazidon hydrochloride equivalent to 74.5 mg of lurazidon.
• The other ingredients are: mannitol, sodium croscarmellose, hypromellose 2910, magnesium stearate, titanium dioxide (E 171), polyethylene glycol 6000, yellow iron oxide (E 172) (in 74 mg tablets), indigo carmine (E 132) (in 74 mg tablets).

What Asil looks like and contents of the pack

• Asil 18.5 mg film-coated tablets are white, round, biconvex film-coated tablets with a diameter of 6 mm +/- 0.2 mm, embossed with a „-”.
• Asil 37 mg film-coated tablets are white, round, biconvex film-coated tablets with a diameter of 6 mm +/- 0.2 mm, embossed with the number „40”.
• Asil 74 mg film-coated tablets are light green, oblong, biconvex film-coated tablets with a length of 12.75 mm +/- 0.2 mm and a width of 6.38 mm +/- 0.2 mm.

Asil film-coated tablets are available in packs containing 28 or 56 tablets in
opaque blisters OPA/Aluminium/PVC/Aluminium.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65
00-667 Warsaw
[email protected]
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira, 2710-228 Sintra, Portugal