Rispolept

Leaflet accompanying the packaging: patient information

Rispolept, 1 mg/ml, oral solution

Risperidone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Rispolept and what is it used for

Rispolept belongs to a group of medicines called antipsychotics.
Rispolept is used in:

• treatment of schizophrenia - a condition where the patient may see, hear, or feel things that do not exist, believe in untrue things, or experience unusual suspicion or disorientation
• treatment of manic episodes - a condition where the patient may feel strong excitement, agitation, irritation, enthusiasm, or be overly active. Manic episodes occur in the course of bipolar affective disorders
• short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's disease, who harm themselves or others. Before taking the medicine, alternative non-pharmacological treatment methods should be used
• short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (over 5 years old) and adolescents with behavioral disorders.

Rispolept helps to alleviate the symptoms of the disease and prevent their recurrence.

2. Important information before taking Rispolept

When not to take Rispolept

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

If the patient is unsure whether the above information applies to them, they should consult their doctor or pharmacist before taking Rispolept.

Warnings and precautions

Before starting to take Rispolept, the patient should discuss the following with their doctor or pharmacist:

• if the patient has heart rhythm disorders, such as an irregular heartbeat, or if the patient has a tendency to low blood pressure, or is taking blood pressure regulating medicines. Rispolept may cause a decrease in blood pressure. It may be necessary to adjust the dose of the medicine
• if the patient knows of any factors that may contribute to the occurrence of a stroke, such as high blood pressure, cardiovascular disorders, or cerebral vessel disorders
• if the patient has ever experienced involuntary movements of the tongue, lips, or face
• if the patient has ever experienced a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as malignant neuroleptic syndrome)
• if the patient has Parkinson's disease or dementia
• if the patient has had a low white blood cell count in the past (which may or may not have been caused by the action of other medicines)
• if the patient has diabetes
• if the patient has epilepsy
• if the patient is a man and has experienced prolonged or painful erections
• if the patient has disorders of body temperature regulation or overheats
• if the patient has kidney function disorders
• if the patient has liver function disorders
• if the patient has an abnormally high level of prolactin in the blood or a suspected prolactin-dependent tumor
• if the patient or any of their relatives have had blood clots in the past, as the use of such medicines as Rispolept is associated with the formation of blood clots.

If the patient is unsure whether any of the above conditions apply to them, they should consult their doctor or pharmacist before taking Rispolept.
The attending doctor may order a white blood cell count test, as very rare cases of a dangerously low number of a certain type of white blood cell necessary for fighting infections have been observed in patients taking Rispolept.
Rispolept may cause weight gain. Significant weight gain can have a negative impact on health. The attending doctor will regularly monitor the patient's weight.
The doctor should check if the patient has symptoms of high blood sugar levels, as diabetes and worsening of existing diabetes have been observed in patients taking Rispolept.
In patients with existing diabetes, blood sugar levels should be regularly monitored.
Rispolept often increases the level of a hormone called prolactin. This can cause side effects such as: menstrual disorders, fertility problems in women, breast swelling in men (see: Possible side effects). If such side effects occur, it is recommended to have a blood prolactin level test.
During cataract surgery, the pupil may not dilate sufficiently.
The iris may also be flaccid during the procedure, which can result in eye damage.
If the patient has a scheduled eye surgery, they should inform their ophthalmologist about taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke.
Patients with dementia caused by stroke should not take risperidone.
During risperidone treatment, the patient should frequently consult their doctor.
Medical help should be sought immediately if the patient or their caregiver notices a sudden change in the patient's mental state or sudden weakness or numbness of the face, limbs, especially one-sided, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke.

Children and adolescents

Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.
If the patient experiences fatigue during treatment, changing the time of risperidone administration may improve concentration.
Before starting treatment and regularly during treatment, the patient's weight may be measured.
In a small study, an increase in growth was found in children taking risperidone, but it is not known whether this is due to the action of the medicine or other factors.

Rispolept and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Patients should especially inform their doctor or pharmacist if they are taking any of the following medicines:

• central nervous system depressants (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect
• medicines that may cause changes in heart rhythm, such as malaria medicines, anti-arrhythmic medicines, antihistamines, or certain antidepressants
• medicines that slow down the heart rate
• medicines that lower potassium levels in the blood (e.g., certain diuretics)
• medicines used to treat high blood pressure. Rispolept may lower blood pressure
• medicines used to treat Parkinson's disease (e.g., levodopa)
• medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)
• diuretics, used in patients with heart disease or to relieve swelling in areas where there is excessive fluid accumulation (e.g., furosemide or chlorthiazide). Rispolept taken alone or in combination with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may weaken the effect of risperidone:

• rifampicin (a medicine used to treat certain infections)
• carbamazepine, phenytoin (anti-epileptic medicines)
• phenobarbital. When starting or stopping these medicines, it may be necessary to change the dose of risperidone.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart diseases)
• antidepressants, such as paroxetine, fluoxetine, tricyclic antidepressants
• beta-adrenergic blockers (used to treat high blood pressure)
• phenothiazines (e.g., used to treat psychoses or to sedate)
• cimetidine, ranitidine (reducing stomach acid)
• itraconazole and ketoconazole (used in fungal infections)
• certain medicines used to treat HIV/AIDS, such as ritonavir
• verapamil, used to treat high blood pressure and/or heart rhythm disorders
• sertraline and fluvoxamine, used to treat depression and other mental disorders. When starting or stopping these medicines, it may be necessary to change the dose of risperidone.

If the patient is unsure whether they have taken or are taking any of the above medicines, they should consult their doctor or pharmacist before taking Rispolept.

Rispolept with food, drink, and alcohol

This medicine can be taken with or without food.
During Rispolept treatment, the patient should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

• if the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take Rispolept
• in newborns whose mothers took Rispolept in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If such symptoms are observed in the child, the patient should contact their doctor
• Rispolept may increase the level of prolactin in the blood - a hormone that can affect fertility (see: Possible side effects).

Driving and using machines

During Rispolept treatment, dizziness, fatigue, and vision disturbances may occur. Therefore, without consulting their doctor, the patient should not drive vehicles, use any tools, or operate any machines.

Rispolept, oral solution, contains benzoeic acid (E 210) and sodium

This medicine contains 2 mg of benzoeic acid in 1 ml of oral solution. Benzoeic acid may exacerbate jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to take Rispolept

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended doses are given below: In the treatment of schizophreniaAdults

• the usual initial dose is 2 mg per day, which may be increased to 4 mg per day on the second day
• depending on the patient's response to treatment, the doctor may adjust the dose
• for most patients, the daily dose is between 4 mg and 6 mg
• this total daily dose may be taken once or divided into two doses. The doctor will inform the patient which method of taking the medicine is best for them.

Elderly patients

• the initial dose is usually 0.5 mg twice a day
• then the doctor may gradually increase the dose to 1 mg to 2 mg twice a day
• the doctor will inform the patient which method of taking the medicine is best for them.

In the treatment of manic episodes
Adults

• the initial dose is usually 2 mg once a day
• depending on the patient's response to treatment, the doctor may gradually adjust the dose
• for most patients, the dose is between 1 mg and 6 mg once a day.

Elderly patients

• the initial dose is usually 0.5 mg twice a day
• then the doctor may gradually adjust the dose to 1 mg to 2 mg twice a day, depending on the patient's response to treatment.

In the treatment of persistent aggression in patients with Alzheimer's disease
Adults (including elderly patients)

• the initial dose is usually 0.25 mg (0.25 ml of Rispolept 1 mg/ml oral solution) twice a day
• depending on the patient's response to treatment, the doctor may gradually adjust the dose
• for most patients, the daily dose is 0.5 mg twice a day. Some patients may need a dose of 1 mg twice a day
• the duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

Administration in children and adolescents

• Rispolept should not be used in children and adolescents under 18 years of age for the treatment of schizophrenia or mania.

In the treatment of behavioral disorders
The dose depends on the child's weight:
In children with a body weight of less than 50 kg

• the initial dose is usually 0.25 mg (0.25 ml of Rispolept 1 mg/ml oral solution) once a day
• the dose may be increased every other day (gradually) by 0.25 mg per day
• the usual maintenance dose is between 0.25 mg and 0.75 mg (0.25 ml to 0.75 ml of Rispolept 1 mg/ml oral solution) once a day.

In children with a body weight of 50 kg or more

• the initial dose is usually 0.5 mg once a day
• the dose may be increased every other day by 0.5 mg per day
• the usual maintenance dose is between 0.5 mg and 1.5 mg once a day.

The duration of treatment in patients with behavioral disorders should not exceed 6 weeks.
Rispolept should not be used in children under 5 years of age for the treatment of behavioral disorders.

Patients with kidney or liver function disorders

Regardless of the disease being treated, all initial and subsequent doses of risperidone should be reduced by half. In these patients, doses should be increased more slowly.
Risperidone should be used with caution in this group of patients.

Method of administration

Oral administration.
Rispolept oral solution
A dosing pipette is included with the packaging. This allows for accurate measurement of the amount of medicine the patient needs.
The patient should follow these steps:

• 1. remove the child-resistant cap from the medicine by pressing the plastic cap and turning it in the opposite direction of the arrow (Figure 1)

• 2. place the pipette in the bottle (Figure 2)

• 3. holding the pipette by the collar, pull the plunger up to the mark on the pipette corresponding to the number of milliliters or milligrams to be taken (Figure 3)

• 4. holding the pipette by the collar of the body, remove it from the bottle (Figure 4)

• 5. pressing the plunger, empty the pipette by expelling its contents into any non-alcoholic beverage
• 6. close the bottle
• 7. rinse the pipette with a small amount of water.

Taking a higher dose of Rispolept than recommended

• the patient should immediately consult their doctor. They should take the packaging of the medicine with them
• after an overdose of the medicine, the patient may feel drowsy or tired, or they may experience involuntary movements of the body, difficulty standing and walking, dizziness due to low blood pressure, or irregular heart rhythm, or they may have a seizure.

Missing a dose of Rispolept

• if the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose and take the next dose as recommended. If the patient forgets to take two or more doses, they should consult their doctor
• the patient should not take a double dose (two doses at the same time) to make up for the missed dose.

Stopping Rispolept treatment

The patient should not stop taking the medicine unless it is recommended by their doctor. It is possible that the symptoms of the disease will recur. If the doctor decides to stop the medicine, the dose may be gradually reduced over several days.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor if they experience any of the following uncommon side effects (may occur in less than 1 in 100 people):

• the following:
• in patients with dementia, a sudden change in mental state or sudden weakness or numbness of the face, limbs, especially one-sided, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke
• late dyskinesia (involuntary, repetitive, or twitching movements of the face, tongue, or other parts of the body). The patient should immediately inform their doctor if they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue Rispolept.

The patient should immediately inform their doctor if they experience any of the following rare side effects (may occur in less than 1 in 1,000 people):

• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, the patient should seek medical help immediately
• fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary
• in men, prolonged or painful erections. This condition is known as priapism. Immediate treatment may be necessary
• a severe allergic reaction characterized by fever, swelling of the lips, face, or tongue, difficulty breathing, itching, rash, or low blood pressure.

Other side effects may also occur:

Very common side effects (may occur in more than 1 in 10 people):

• difficulty sleeping or waking up
• parkinsonism: this condition may include slow or abnormal movements, a feeling of stiffness or tension in the muscles (which can cause the patient's movements to be uneven), and sometimes even a feeling of "freezing" of movements, followed by a release. Other symptoms of parkinsonism include: a slow, shuffling gait, tremors, increased saliva production, and a face without expression
• feeling drowsy or less alert
• headache.

Common side effects (may occur in less than 1 in 10 people):

• pneumonia, respiratory tract infection (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms
• increased prolactin levels in the blood (with or without symptoms). Symptoms of increased prolactin levels occur infrequently and may include in men: breast swelling, difficulty achieving or maintaining an erection, decreased sex drive, or other sexual disorders. In women, they may include discomfort in the breasts, milk secretion from the breasts, absence of menstrual bleeding, or other menstrual disorders, or fertility disorders
• weight gain, increased appetite, decreased appetite
• sleep disturbances, irritability, depression, anxiety, restlessness
• dystonia: in this condition, there are slow or sustained involuntary muscle contractions. They can affect any part of the body (which can result in an abnormal posture), but dystonia most commonly affects the muscles of the face, including abnormal movements of the eyes, lips, tongue, or jaw
• dizziness
• dyskinesia: in this condition, there are involuntary muscle movements, including repetitive, spasmodic, or twisting movements or twitches
• tremors
• blurred vision, eye infection, or conjunctivitis
• rapid heartbeat, high blood pressure, shortness of breath
• throat pain, cough, nosebleeds, stuffy nose
• abdominal pain, discomfort in the abdomen, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• rash, redness of the skin
• muscle spasms, muscle pain, back pain, joint pain
• urinary incontinence
• erection disorders, ejaculation disorders
• absence of menstrual bleeding, menstrual disorders, or other menstrual disorders (in women)
• breast swelling in men, milk secretion from the breasts, sexual disorders, breast pain, discomfort in the breasts, vaginal discharge
• facial swelling, lip swelling, eye swelling, or tongue swelling
• chills, increased body temperature
• change in gait
• thirst, malaise, chest discomfort, feeling unwell, discomfort
• increased liver enzyme activity in the blood, increased activity of the enzyme GGT (liver enzyme - gamma-glutamyltransferase) in the blood, increased liver enzyme activity in the blood
• pain associated with medical procedures.

Uncommon side effects (may occur in less than 1 in 100 people):

• respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, skin infection limited to one area or part of the body, viral infection, skin rash caused by mites
• decreased white blood cell count (including those that help protect against infections), decreased platelet count (blood cells that help stop bleeding), anemia, decreased red blood cell count, increased eosinophil count (a type of white blood cell) in the blood
• allergic reaction
• onset of diabetes or worsening of existing diabetes, high blood sugar levels, excessive thirst
• weight loss, loss of appetite leading to malnutrition and low body weight
• increased cholesterol levels in the blood
• elevated mood (mania), confusion, decreased libido, nervousness, nightmares
• lack of reaction to stimuli, loss of consciousness, low level of consciousness
• seizures, fainting
• involuntary movements, balance disorders, coordination disorders, dizziness when changing position to standing, concentration disorders, speech difficulties, loss of taste, or impaired taste, numbness or tingling of the skin
• eye sensitivity to light, dry eye, increased tearing, redness of the eyes
• vertigo, ringing in the ears, ear pain
• atrial fibrillation (irregular heart rhythm), conduction disorders between the heart chambers, abnormal conduction of electrical impulses in the heart, prolonged QT interval in the heart, slow heartbeat, abnormal electrocardiogram, palpitations
• low blood pressure, low blood pressure when changing position to standing (which may cause some patients taking Rispolept to faint, feel dizzy, or lose consciousness when standing up or getting up), flushing
• aspiration pneumonia (caused by food entering the airways), pulmonary congestion, respiratory distress, speech difficulties, respiratory disorders
• gastrointestinal infection, diarrhea, very hard stools, difficulty swallowing, excessive gas
• hives, itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, flaky, itchy skin of the scalp or body, skin disorders, skin damage
• increased CPK (creatine phosphokinase) activity in the blood - an enzyme that is sometimes released from damaged muscles
• abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• frequent urination, inability to urinate, painful urination
• erection disorders, ejaculation disorders
• absence of menstrual bleeding, menstrual disorders, or other menstrual disorders (in women)
• breast swelling in men, milk secretion from the breasts, sexual disorders, breast pain, discomfort in the breasts, vaginal discharge
• facial swelling, lip swelling, eye swelling, or tongue swelling
• chills, increased body temperature
• change in gait
• thirst, malaise, chest discomfort, feeling unwell, discomfort
• increased liver enzyme activity in the blood, increased activity of the enzyme GGT (liver enzyme - gamma-glutamyltransferase) in the blood, increased liver enzyme activity in the blood

Rare side effects (may occur in less than 1 in 1,000 people):

• infection
• abnormal secretion of the hormone regulating urine production
• sleepwalking (sleepwalking)
• eating disorders related to sleep
• sugar in the urine, low blood sugar levels, high triglyceride levels (fats) in the blood
• lack of emotions, inability to achieve orgasm
• decreased motor activity and lack of reaction in a patient with preserved consciousness (catatonia)
• cerebrovascular disorders
• coma due to uncontrolled diabetes
• tremors, nodding movements of the head
• glaucoma (increased pressure in the eyeball), eye movement disorders, rotational eye movements, ulcers on the edges of the eyelids (with crust formation)
• complications during cataract surgery. During this procedure, a condition known as intraoperative floppy iris syndrome (IFIS) may occur if the patient is taking or has taken Rispolept. If the patient has a scheduled cataract surgery, they should inform their ophthalmologist about taking this medicine in the past or present
• a dangerously low number of certain white blood cells responsible for fighting infections
• life-threatening excessive water intake
• irregular heartbeat
• sleep apnea (breathing difficulties during sleep), rapid, shallow breathing
• pancreatitis, intestinal obstruction
• swelling of the tongue, dry lips, allergic rash
• dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• delayed menstrual bleeding, breast swelling, breast enlargement, milk secretion from the breasts
• increased insulin levels in the blood (a hormone that regulates blood sugar levels)
• skin hardening
• low body temperature, cooling of the hands and feet
• withdrawal symptoms
• jaundice (yellowing of the skin and eyes).

Very rare side effects (may occur in less than 1 in 10,000 people):

• life-threatening complications associated with uncontrolled diabetes
• a severe allergic reaction with swelling that can affect the throat and lead to breathing difficulties
• lack of bowel movement leading to obstruction.

Side effects with unknown frequency: frequency cannot be estimated from available data

• a severe or life-threatening rash with blisters and flaky skin, which can appear in the mouth, nose, eyes, and genitals, as well as around these areas, and can also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Side effects observed during the use of another medicine - paliperidone, which is very similar to risperidone, which may also occur during the use of Rispolept: rapid heartbeat when changing position to standing.

Additional side effects in children and adolescents

Generally, side effects in children will be similar to those in adults.
The following side effects were more common in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or decreased alertness, fatigue, headache, increased appetite, vomiting, common cold symptoms, runny nose, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and urinary incontinence.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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, more information can be collected on the safety of the medicine.

5. How to store Rispolept

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not store in the refrigerator or freeze.
Shelf life after opening the bottle: 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rispolept contains

• The active substance of the medicine is risperidone. 1 ml of oral solution contains 1 mg of risperidone.
• The other ingredients (excipients) are: tartaric acid, benzoeic acid (E 210), sodium hydroxide, purified water.

What Rispolept looks like and contents of the packaging

Rispolept, oral solution, is supplied in a brown glass bottle with a PP/LDPE cap with a tamper-evident seal and a child-resistant closure, in a cardboard box. The bottles contain 30 ml or 100 ml of clear, colorless liquid.
A dosing pipette is included with the bottle.
The pipette included with the bottle has a scale in milligrams and milliliters with a minimum volume of 0.25 ml and a maximum volume of 3 ml. The pipette is marked with a scale every 0.25 ml (which corresponds to 0.25 mg of oral solution) up to a volume of 3 ml (which corresponds to 3 mg of oral solution).
Not all pack sizes may be marketed.

Marketing authorization holder:

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Lusomedicamenta Sociedade Técnica Farmacêutica S.A.
Estrada Consiglieri Pedroso 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal
To obtain more detailed information, the patient should contact their local representative of the marketing authorization holder:
Janssen-Cilag Polska sp. z o.o.
phone: +48 22 237 60 00

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Risperdal
Belgium/Cyprus/Czech Republic/Denmark/Finland/France/Greece/Spain/Netherlands/Ireland/Iceland/Luxembourg/Malta/Germany/Norway/Portugal/Slovenia/Sweden/Hungary/United Kingdom (Northern Ireland)/Italy: RISPERDAL
Estonia/Lithuania/Latvia/Poland/Romania: RISPOLEPT

Date of last revision of the leaflet: 04/2025