Package leaflet: Information for the patient

Rispolept, 1 mg, film-coated tablets
Rispolept, 2 mg, film-coated tablets
Rispolept, 3 mg, film-coated tablets
Rispolept, 4 mg, film-coated tablets
Risperidone
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

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

Leaflet contents

What Rispolept is and what it is used for
Important information before taking Rispolept
How to take Rispolept
Possible side effects
How to store Rispolept
Contents of the pack and other information

1. What Rispolept is and what it is used for

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

schizophrenia – a condition in which the patient may see, hear, or feel things that do not exist, believe things that are not true, or experience unusual suspiciousness or disorientation
manic episodes – a condition in which the patient may experience intense excitement, agitation, enthusiasm, or excessive activity. Manic episodes occur in bipolar affective disorders
short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who are a danger to themselves or others. Before initiating treatment, non-pharmacological alternative approaches should be considered
short-term treatment (up to 6 weeks) of severe aggression in intellectually disabled children (over 5 years of age) and adolescents with behavioral disorders.

Rispolept helps to alleviate 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 to 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 treatment with Rispolept, discuss the following with your doctor or pharmacist:

If the patient has heart problems, such as irregular heartbeat, or if the patient is prone to low blood pressure, or is taking medications that regulate blood pressure. Rispolept may cause a drop in blood pressure. A dose adjustment may be necessary.
If the patient has any risk factors for stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disease.
If the patient has ever experienced involuntary movements of the tongue, mouth, or face.
If the patient has ever had a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as neuroleptic malignant syndrome).
If the patient has Parkinson's disease or dementia.
If the patient has previously had a low white blood cell count (which may or may not have been caused by other medications).
If the patient has diabetes.
If the patient has epilepsy.
If the patient is a male who has experienced prolonged or painful erection.
If the patient has problems regulating body temperature or is prone to overheating.
If the patient has kidney function disorders.
If the patient has liver function disorders.
If the patient has abnormally high levels of the hormone prolactin in the blood or suspicion of a prolactin-dependent tumor.
If the patient or a family member has a history of blood clots, as use of medicines like Rispolept has been associated with blood clot formation.

If the patient is unsure whether any of the symptoms described above apply to them, they should consult their
doctor or pharmacist before taking Rispolept.
The treating doctor may order a white blood cell count test, as very rarely, a dangerously low number of certain
types of white blood cells necessary to fight infections has been observed in patients taking Rispolept.
Rispolept may cause weight gain. Significant weight gain may negatively affect health. The treating doctor
will regularly monitor the patient's body weight.
The doctor should check for symptoms of high blood glucose levels, as diabetes has been reported in patients
taking Rispolept, and pre-existing diabetes may worsen. In patients with pre-existing diabetes, blood glucose
levels should be monitored regularly.
Rispolept often increases the level of a hormone called prolactin. This may cause adverse effects such as:
menstrual disorders, fertility problems in women, breast enlargement in men (see Possible side effects). If such
adverse effects occur, a blood test to measure prolactin levels is recommended.
During cataract surgery, the pupil may not dilate sufficiently. Also, the iris may be floppy during the procedure,
which may lead to eye damage. If the patient is scheduled for eye surgery, they must inform the ophthalmologist
that they are 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 treatment with risperidone, the patient should have regular consultations with their doctor.
Seek immediate medical help if the patient or caregiver notices a sudden change in mental status, sudden
weakness or numbness in facial muscles or limbs—especially on one side—or speech disturbances, even if
they are brief. These symptoms may indicate a stroke.
Children and adolescents
Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.
If fatigue occurs during treatment, timing of risperidone administration may be adjusted to improve
concentration.
Before starting treatment and regularly during treatment, the patient's body weight may be measured.
In a small study, increased growth was observed in children taking risperidone, but it is not known whether
this is due to the medicine or other factors.
Rispolept 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 they plan to take.
Patients should especially inform their doctor or pharmacist if they are taking any of the following
medicines:

Sedatives acting on the brain (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect.
Medicines that may cause changes in the electrical activity of the heart, such as antimalarial drugs, antiarrhythmics, antihistamines, certain antidepressants, or other medicines used to treat psychiatric disorders.
Medicines that slow heart rate.
Medicines that reduce potassium levels in the blood (e.g., certain diuretics).
Medicines used for high blood pressure. Rispolept may lower blood pressure.
Medicines used to treat Parkinson’s disease (e.g., levodopa).
Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
Diuretics (water tablets), used in patients with heart disease or to reduce swelling due to fluid accumulation (e.g., furosemide or chlorothiazide). Rispolept, taken alone or together with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

Rifampicin (used to treat certain infections).
Carbamazepine, phenytoin (used for epilepsy).
Phenobarbital. When starting or stopping these medicines, a change in risperidone dose may be needed.

The following medicines may increase the effect of risperidone:

Quinidine (used in certain heart conditions).
Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.
Beta-blockers (used to treat high blood pressure).
Phenothiazines (e.g., used to treat psychosis or for sedation).
Cimetidine, ranitidine (reduce stomach acid).
Itraconazole and ketoconazole (used for 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 psychiatric disorders.

When starting or stopping these medicines, a change in risperidone dose may be needed.
If the patient is unsure whether they have taken or are taking any of the medicines listed above,
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 treatment with Rispolept, alcohol should be avoided.
Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take Rispolept.
Newborns whose mothers took Rispolept during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the baby, contact a doctor.
Rispolept may increase the level of prolactin in the blood—a hormone that may affect fertility (see section “Possible side effects”).

Driving and using machines
Dizziness, tiredness, and vision disturbances may occur while taking Rispolept. Therefore, do not drive, use tools,
or operate machinery without first consulting your doctor.
Rispolept coated tablets contain lactose and sodium
Coated tablets contain lactose—a type of sugar. If the patient has previously been diagnosed with intolerance
to certain sugars, they should consult their doctor before taking this medicine.
Coated tablets contain less than 1 mmol of sodium (23 mg) per dose and are therefore essentially “sodium-free.”
Rispolept 2 mg coated tablets also contain Sunset Yellow FCF (E 110) and may cause allergic reactions.

3. How to take Rispolept

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Rispolept is not available as an 0.5 mg coated tablet.
Other medicines are available for use at this dose. Please consult your doctor.
The recommended doses are given below:
In the treatment of schizophrenia
Adults

the usual starting dose is 2 mg per day; this dose may be increased on the second day to 4 mg per day
depending on the patient's response to treatment, the doctor may adjust the dose
for most patients, the daily dose ranges from 4 mg to 6 mg
this total daily dose may be taken once daily or divided into two doses. Your doctor will advise which dosing schedule is best for you.

Elderly patients

the usual starting dose is 0.5 mg twice daily
the doctor may then gradually increase the dose to 1 mg to 2 mg twice daily
your doctor will advise which dosing schedule is best for you.

In the treatment of manic episodes
Adults

the usual starting dose is 2 mg once daily
depending on the patient's response to treatment, the doctor may gradually adjust the dose
for most patients, the dose ranges from 1 mg to 6 mg once daily.

Elderly patients

the usual starting dose is 0.5 mg twice daily
the doctor may then gradually adjust the dose to 1 mg to 2 mg twice daily, depending on the patient's response to treatment.

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

the usual starting dose is 0.25 mg (0.25 ml of Rispolept oral solution 1 mg/ml) twice daily
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 daily. Some patients may require a dose of 1 mg twice daily
the duration of treatment in patients with dementia in Alzheimer's disease should not exceed 6 weeks.

Use 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 behavioural disorders
The dose depends on the child's body weight:
In children weighing less than 50 kg

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

In children weighing 50 kg or more

the usual starting dose is 0.5 mg once daily
the dose may be increased every other day by 0.5 mg per day
the usual maintenance dose is 0.5 mg to 1.5 mg once daily.

The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.
Rispolept should not be used in children under 5 years of age for the treatment of behavioural disorders.
Patients with impaired kidney or liver function
Regardless of the condition being treated, all initial and subsequent doses of risperidone should be
reduced by half. Doses should be increased more slowly in these patients.
Risperidone should be used with caution in this patient group.
Method of administration
Oral administration
Rispolept coated tablets

Swallow the tablet with water.
The score line on the tablet is only intended to facilitate breaking the tablet for ease of swallowing.

If you take more Rispolept than you should

seek medical advice immediately. Take the medicine pack with you.
after an overdose, the patient may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, abnormal heart function, or a seizure may occur.

If you forget to take 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, the missed dose should be skipped and the next dose taken as prescribed. If the patient forgets two or more doses, they should contact their doctor
do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Rispolept
Do not stop taking this medicine unless instructed by your doctor. Symptoms of the illness may recur. If your doctor decides to discontinue treatment, the dose may be gradually reduced over several days.
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.
You should immediately inform the doctor if the patient experiences any of the following
uncommon adverse reactions (may occur in less than 1 in 100 people):

sudden change in mental state or sudden weakness or numbness of the face or limbs, particularly on one side, or speech disturbances, even if brief, in a patient with dementia. These symptoms may indicate a stroke
tardive dyskinesia (twitching or jerking involuntary movements of the face, tongue or other body parts). Immediately inform the doctor if rhythmic involuntary movements of the tongue, mouth or face occur. Discontinuation of Rispolept may be necessary.

You should immediately inform the doctor if the patient experiences any of the following
rare adverse reactions (may occur in less than 1 in 1000 people):

blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help
fever, muscle stiffness, sweating or decreased level of consciousness (a condition called neuroleptic malignant syndrome). Immediate treatment may be required
prolonged or painful erection in men. This condition is known as priapism. Immediate treatment may be required
severe allergic reaction characterized by fever, swelling of the lips, face, tongue or throat, breathing difficulties, skin itching, rash or drop in blood pressure.

Other adverse reactions may also occur:
Very common adverse reactions (may occur in more than 1 in 10 people):

difficulty falling asleep or waking up
parkinsonism: this condition may involve slow or abnormal movements, feeling of stiffness or muscle tension (causing uneven movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face
feeling of drowsiness or reduced alertness
headache.

Common adverse reactions (may occur in less than 1 in 10 people):

pneumonia, respiratory tract infection (bronchitis), cold symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms
increased blood levels of prolactin hormone (with or without symptoms). Symptoms of increased prolactin levels are uncommon and may include in men: breast swelling, difficulty achieving or maintaining erection, decreased sexual drive or other sexual disorders. In women, they may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding or other menstrual cycle disorders, or fertility problems
weight gain, increased appetite, decreased appetite
sleep disturbances, irritability, depression, anxiety, restlessness
dystonia: in this condition, slow or sustained involuntary muscle contractions occur. They may affect any part of the body (possibly resulting in abnormal posture), but dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
dizziness
dyskinesia: in this condition, involuntary muscle movements occur, including repetitive, spasmodic or twisting movements or jerks
tremor
blurred vision, eye infection or conjunctivitis
rapid heartbeat, high blood pressure, shortness of breath (dyspnea)
sore throat, cough, nosebleed, nasal congestion
abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
rash, skin redness
muscle cramps, bone or muscle pain, back pain, joint pain
urinary incontinence
swelling of the body, upper or lower limbs, fever, chest pain, weakness, fatigue (tiredness), pain
fall.

Uncommon adverse reactions (may occur in less than 1 in 100 people):

respiratory tract infection, urinary bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection affecting one area or one part of the body, viral infection, skin inflammation caused by mites
decreased number of white blood cells (including those that help protect against infections), decreased number of platelets (blood cells that help stop bleeding)
anemia, decreased number of red blood cells, increased number of eosinophils (a type of white blood cell) in 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 blood cholesterol levels
elevated mood (mania), confusion, decreased libido, nervousness, nightmares
lack of response to stimuli, loss of consciousness, low level of consciousness
seizures, fainting
urge to move body parts, balance disorders, abnormal coordination, dizziness upon changing to upright position, concentration difficulties, speech difficulties, loss or abnormal sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness of the skin
light sensitivity of the eyes, dry eye, increased tearing, eye redness
sensation of dizziness, ringing in the ears, ear pain
atrial fibrillation (irregular heartbeat), conduction block between heart chambers, abnormal conduction of electrical impulses in the heart, QT interval prolongation in the heart, slow heartbeat, abnormal electrocardiogram (ECG), palpitations
low blood pressure, low blood pressure upon changing to upright position (as a result, some patients taking Rispolept may faint, feel dizzy or lose consciousness when standing up suddenly or rising quickly), sudden flushing
aspiration pneumonia (caused by food entering the airways), pulmonary congestion, respiratory tract congestion, crackles, rales, speech difficulties, respiratory disorders
stomach or intestinal infection, fecal incontinence, very hard stool, difficulty swallowing, excessive flatulence
urticaria, itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, scaly and itchy scalp or other body parts, skin disorders, skin lesions
increased CPK (creatine phosphokinase) activity in blood – an enzyme sometimes released from damaged muscles
abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
frequent urination, inability to urinate, painful urination
erectile dysfunction, ejaculation disorders
absence of menstruation, missed periods or other menstrual cycle disorders (in women)
breast enlargement in men, milk discharge from the breasts, sexual disorders, breast pain, breast discomfort, vaginal discharge
swelling of the face, lips, eyes or mouth
chills, increased body temperature
change in gait
thirst, malaise, chest discomfort, feeling "unwell", discomfort
increased aminotransferase activity in blood, increased GGT enzyme activity (liver enzyme – gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
pain related to medical procedures.

Rare adverse reactions (may occur in less than 1 in 1000 people):

infection
abnormal secretion of the hormone regulating urine output
sleepwalking (somnambulism)
eating disorders related to sleep
reduced motor activity and lack of response in a patient with preserved consciousness (catatonia)
glucose in urine, low blood sugar, high triglyceride (fat) levels in blood
lack of emotion, inability to achieve orgasm
cerebral vascular disorders
coma due to uncontrolled diabetes
tremulous, nodding head movements
glaucoma (increased intraocular pressure), eye movement disorders, rotational eye movements, eyelid margin ulcers (with crust formation)
eye complications during cataract surgery. During this procedure, Intraoperative Floppy Iris Syndrome (IFIS) may occur if the patient is currently or has previously taken Rispolept. If the patient has planned cataract surgery, inform the ophthalmologist about current or past use of this medicine
dangerously low number of specific white blood cells responsible for fighting infections
dangerously excessive water intake
irregular heartbeat
breathing disorders during sleep (sleep apnea), rapid shallow breathing
pancreatitis, intestinal obstruction
tongue swelling, chapped lips, drug rash
psoriasis
muscle fiber breakdown and muscle pain (rhabdomyolysis)
delayed menstruation, enlargement of mammary glands, breast enlargement, breast discharge
increased insulin levels in blood (hormone regulating blood sugar levels)
skin hardening
low body temperature, cold hands and feet
withdrawal symptoms
yellowing of the skin and eyes (jaundice).

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

life-threatening complications related to uncontrolled diabetes
severe allergic reaction with swelling which may involve the throat and lead to breathing difficulties
lack of intestinal function leading to obstruction.

Adverse reactions with unknown frequency: frequency cannot be estimated from available data

severe or life-threatening rash with blisters and peeling skin, which may appear in the mouth, nose, eyes and genital areas and around these sites, and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Adverse reactions observed during use of another medicine – paliperidone, very similar to risperidone – which may also occur during use of Rispolept: rapid heartbeat upon changing to upright position.
Additional adverse reactions in children and adolescents
In general, adverse reactions in children will be similar to those in adults.
The following adverse reactions have been reported more frequently in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or reduced alertness, fatigue (tiredness), headache, increased appetite, vomiting, frequent cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhea and urinary incontinence.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rispolept

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister.
The expiry date refers to the last day of the specified month.
Do not store above 30ºC.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rispolept contains
The active substance is risperidone.
Each coated tablet contains 1 mg, 2 mg, 3 mg or 4 mg of risperidone.
The other ingredients (excipients) are:
Rispolept 1 mg
Tablet core
Monohydrate lactose
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Tablet coating
Hypromellose
Propylene glycol
Rispolept 2 mg:
Tablet core
Monohydrate lactose
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Tablet coating
Hypromellose
Propylene glycol
Titanium dioxide
Talc
Orange Yellow S (E 110) - aluminium lake
Rispolept 3 mg:
Tablet core
Monohydrate lactose
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Tablet coating
Hypromellose
Propylene glycol
Titanium dioxide
Talc
Quinoline Yellow (E 104)
Rispolept 4 mg:
Tablet core
Monohydrate lactose
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Tablet coating
Hypromellose
Propylene glycol
Titanium dioxide
Talc
Quinoline Yellow (E 104)
Indigo carmine - aluminium lake

What Rispolept looks like and contents of the pack
Rispolept is a coated tablet, packed in blisters made of Aluminium/PVC-LDPE-PVDC foil.
Rispolept 1 mg: white, elongated, biconvex tablet with a score line, 10.5 mm x 5 mm in size;
Rispolept 2 mg: orange, elongated, biconvex tablet with a score line, 10.5 mm x 5 mm in size;
Rispolept 3 mg: yellow, elongated, biconvex tablet with a score line, 13.5 mm x 6.5 mm in size;
Rispolept 4 mg: green, elongated, biconvex tablet with a score line, 15 mm x 6.5 mm in size.
The coated tablets have an embossed mark on one side: RIS 1, RIS 2, RIS 3 or RIS 4, respectively.
Additionally, the mark JANSSEN may be embossed on the other side.

Pack sizes contain:

20 coated tablets, placed in a cardboard box,
60 coated tablets, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer:
Janssen-Cilag S.p.A.
Borgo S. Michele (LT)
Italy

For further information, contact the local representative of the Marketing Authorisation Holder:
Janssen-Cilag Polska sp. z o.o.
tel. +48 22 237 60 00

This medicinal product is authorised for marketing in 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