Rispolept

Leaflet accompanying the packaging: patient information

Rispolept, 1 mg, coated tablets

Rispolept, 2 mg, coated tablets

Rispolept, 3 mg, coated tablets

Rispolept, 4 mg, coated tablets

Risperidone

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, 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 feel unusual suspicion or disorientation
• treatment of manic episodes - a condition where the patient may feel strong excitement, agitation, irritability, 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 not sure whether the above information applies to them, they should consult a doctor or pharmacist before taking Rispolept.

Warnings and precautions

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

• if the patient has heart rhythm disorders, such as 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 their risk of 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 a prolonged or painful erection
• 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 hormone 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 not sure whether any of the above conditions apply to them, they should consult a doctor or pharmacist before taking Rispolept.
The doctor may order a white blood cell count test, as very rarely, patients taking Rispolept have been observed to have a dangerously low number of a certain type of white blood cells necessary for fighting infections.
Rispolept may cause weight gain. Significant weight gain can have a negative impact on health. The doctor will regularly check the patient's weight.
The doctor should check if the patient has symptoms of high blood sugar levels, as patients taking Rispolept have been observed to develop diabetes and exacerbate existing diabetes. 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 is scheduled for eye surgery, they should tell 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 taking risperidone may improve concentration.
The patient's weight may be measured before starting treatment and regularly during treatment.
In a small study, it was found that children taking risperidone had increased growth, 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:

• sedatives acting on the brain (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect
• medicines that can cause changes in heart rhythm, such as malaria medicines, anti-arrhythmic medicines, antihistamines, certain antidepressants or other medicines used to treat mental disorders
• 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 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 (a medicine used to treat certain infections)
• carbamazepine, phenytoin (anti-epileptic medicines)
• phenobarbital. When starting or stopping these medicines, it may be necessary to adjust 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-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 adjust the dose of risperidone.
If the patient is not sure 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

• 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, sleepiness, 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 hormone in the blood - a hormone that can affect fertility (see Possible side effects).

Driving and using machines

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

Rispolept, coated tablets, contains lactose and sodium

The coated tablets contain lactose - a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The coated tablets contain less than 1 mmol of sodium (23 mg) per dose, which means they are essentially "sodium-free".
The 2 mg Rispolept coated tablets also contain orange yellow S (E 110) and may cause allergic reactions.

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.
Rispolept is not available in 0.5 mg coated tablets.
Other medicines are available for use in this dose. The patient should ask their doctor.

Recommended doses are given below: In the treatment of schizophreniaAdults

• the usual starting 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 starting 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 starting 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 starting 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 starting 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.

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

• the starting 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 starting 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 starting doses of risperidone, as well as subsequent doses, 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 coated tablets

• The tablet should be swallowed with water.
• The score line on the tablet only makes it easier to break, in order to facilitate swallowing.

Taking a higher dose of Rispolept than recommended

• the patient should immediately consult a doctor. They should take the medicine packaging with them.
• after an overdose of the medicine, the patient may feel drowsy or tired, or they may experience abnormal body movements, 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

• the patient should not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Rispolept treatment

The patient should not stop taking the medicine unless it is in agreement with their doctor. It is possible that the symptoms of the disease will recur. If the doctor decides to stop the medicine, the dose of the medicine 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, not very common side effects (may occur in less than 1 in 100 people):

• 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 (trembling or twitching uncontrolled 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), these clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, the patient should immediately seek medical help
• fever, muscle stiffness, sweating or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary
• a man experiences a prolonged or painful erection. This condition is called priapism. Immediate treatment may be necessary
• a severe allergic reaction characterized by fever, swelling of the lips, face, tongue or throat, difficulty breathing, itching of the skin, 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 make the patient's movements uneven), and sometimes even a feeling of "freezing" of movements, followed by a release. Other symptoms of parkinsonism include: slow, shuffling gait, tremors, increased salivation and/or drooling and a mask-like face
• 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, sinusitis, urinary tract infection, ear infection, flu-like symptoms
• increased level of prolactin hormone in the blood (with or without symptoms). Symptoms of increased prolactin levels occur infrequently and may include in men: breast swelling, difficulty in 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 cycle disorders, or fertility disorders
• weight gain, increased appetite, decreased appetite
• sleep disorders, irritability, depression, anxiety, restlessness
• dystonia: in this condition, there are slow or persistent involuntary muscle contractions. They can affect any part of the body (which can result in an abnormal posture), but dystonia most often affects the facial muscles, 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 jerks
• tremors
• blurred vision, eye infection or conjunctivitis
• rapid heartbeat, high blood pressure, shortness of breath (dyspnea)
• sore throat, 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, pain in bones or muscles, back pain, joint pain
• urinary incontinence
• swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• fall.

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 one part of the body, viral infection, allergic reaction
• 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 the blood

• allergic reaction
• development of diabetes or exacerbation 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 emotions, inability to achieve orgasm
• cerebrovascular disorders
• diabetic coma due to uncontrolled diabetes
• shaking or nodding movements of the head
• glaucoma (increased pressure in the eye), 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 called intraoperative floppy iris syndrome (IFIS) may occur if the patient is taking or has taken Rispolept. If the patient is scheduled for cataract surgery, they should tell their ophthalmologist about taking this medicine in the past or present
• a dangerously low number of certain white blood cells responsible for fighting infections
• excessive water drinking
• irregular heartbeat
• sleep apnea (breathing pauses during sleep), rapid, shallow breathing
• pancreatitis, intestinal obstruction
• swelling of the tongue, swollen 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 thickening
• low body temperature, cold hands and feet
• withdrawal symptoms
• jaundice (yellowing of the skin and eyes).

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

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

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

• a severe or life-threatening rash with blisters and peeling skin, which can occur 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 (tiredness), headache, increased appetite, vomiting, common cold symptoms, stuffy 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 Drug Monitoring of the Office for Registration 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 blister.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from light.
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.
One coated tablet contains 1 mg, 2 mg, 3 mg or 4 mg of risperidone.
The other ingredients (excipients) are:
Rispolept 1 mg
Tablet core
Lactose monohydrate
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Coating
Hypromellose
Propylene glycol
Rispolept 2 mg:
Tablet core
Lactose monohydrate
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Coating
Hypromellose
Propylene glycol
Titanium dioxide
Talc
Orange yellow S (E 110) - aluminum lake
Rispolept 3 mg:
Tablet core
Lactose monohydrate
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Coating
Hypromellose
Propylene glycol
Titanium dioxide
Talc
Quinoline yellow (E 104)
Rispolept 4 mg:
Tablet core
Lactose monohydrate
Corn starch
Microcrystalline cellulose
Hypromellose
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Coating
Hypromellose
Propylene glycol
Titanium dioxide
Talc
Quinoline yellow (E 104)
Indigo carmine - aluminum lake

What Rispolept looks like and contents of the pack

Rispolept is a coated tablet packaged in aluminum/PVC-LDPE-PVDC blisters.
Rispolept, 1 mg: white, oval, biconvex tablet with a score line, measuring 10.5 mm x 5 mm;
Rispolept, 2 mg: orange, oval, biconvex tablet with a score line, measuring 10.5 mm x 5 mm;
Rispolept, 3 mg: yellow, oval, biconvex tablet with a score line, measuring 13.5 mm x 6.5 mm;
Rispolept, 4 mg: green, oval, biconvex tablet with a score line, measuring 15 mm x 6.5 mm.
The coated tablets have the inscription "RIS 1", "RIS 2", "RIS 3", "RIS 4" on one side.
On the other side, they may have the inscription "JANSSEN".

Packaging

• 20 coated tablets, packaged in a cardboard box,
• 60 coated tablets, packaged in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer:

Janssen-Cilag S.p.A.
Borgo S. Michele (LT)
Italy
To obtain more detailed information, the patient should contact the 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: 08/2022.