Risperon

Package Leaflet: Information for the Patient

Risperon, 1 mg, coated tablets

Risperon, 2 mg, coated tablets

Risperon, 3 mg, coated tablets

Risperon, 4 mg, coated tablets

Risperidone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

1.
What Risperon is and what it is used for

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

Risperon belongs to a group of medicines called antipsychotics.
Risperon is used in the treatment of:
schizophrenia - a condition where the patient may see, hear, or feel things that do not exist, believe in things that are not true, or experience unusual suspiciousness or disorientation;
treatment of manic episodes - a condition where the patient may feel strongly excited, elated, agitated, enthusiastic, or 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 mentally retarded children (over 5 years) and adolescents with behavioral disorders.
Risperon alleviates the symptoms of the disease and prevents their recurrence.

2. Important information before taking Risperon

When not to take Risperon

If the patient is not sure whether the above information applies to them, they should consult their doctor or pharmacist before taking Risperon.

Warnings and precautions

Before starting treatment with Risperon, the patient should discuss the following with their doctor or pharmacist:in patients with Parkinson's disease or dementia;in patients with diabetes;
in patients with epilepsy;If the patient is not sure whether any of the above conditions apply to them, they should consult their doctor or pharmacist before taking Risperon.
The doctor may order a white blood cell count test, as very rarely, patients taking risperidone have had a dangerously low number of a certain type of white blood cell needed to fight infections.
Risperon 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 a high blood sugar level, as patients taking risperidone have been reported to develop diabetes or worsening of existing diabetes. In patients with existing diabetes, blood sugar levels should be regularly monitored.
Risperon 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 test for prolactin levels.
During cataract surgery, the pupil may not dilate sufficiently. The iris may also be floppy during the procedure, which can result in eye damage.
If the patient is scheduled for 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 treatment with Risperon, 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, numbness, or paralysis of the face, arms, or legs, especially if it occurs on one side, 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 will be measured.
In a small study, an increase in growth was observed in children taking risperidone, but it is not known whether this is due to the action of the medicine or other factors.

Risperon and other medicines

The patient should inform 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:

medicines that act on the brain, such as sedatives (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect,
medicines that may cause changes in heart rhythm, such as anti-malarial medicines, anti-arrhythmic medicines, antihistamines, or certain antidepressants,
medicines that slow down heart rate,
medicines that lower blood potassium levels (e.g., certain diuretics),
medicines used to treat high blood pressure; Risperon may lower blood pressure,
medicines used to treat Parkinson's disease, such as levodopa,
diuretics (used in heart disease or to reduce swelling due to excess fluid accumulation). Risperon taken alone or 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.
If the patient starts or stops taking 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 (used to treat psychoses or to sedate),
cimetidine, ranitidine (reducing stomach acid),
itraconazole or 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.
If the patient starts or stops taking 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 Risperon.

Risperon with food, drink, and alcohol

Risperon can be taken with or without food.
The patient should avoid drinking alcohol while taking Risperon.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take Risperon.
• In newborns whose mothers took Risperon during the last trimester (last three 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 baby, the patient should contact their doctor.
• Risperon may increase the level of prolactin in the blood - a hormone that can affect fertility (see "Possible side effects").

Driving and using machines

While taking Risperon, the patient may experience dizziness, fatigue, and vision disturbances. Therefore, without consulting their doctor, the patient should not drive vehicles or operate any machines.

Risperon contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Risperon.

3. How to take Risperon

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 schizophrenia

Adult administration

• Usual initial dose is 2 mg per day; this dose may be increased to 4 mg per day.
• Depending on the patient's response to treatment, the doctor may adjust the dose.
• For most patients, the optimal 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 administration is best for them.

Administration in elderly patients

• Initial dose is usually 0.5 mg twice a day.
• Then the doctor may gradually increase the dose to 1 mg - 2 mg twice a day.
• The doctor will inform the patient which method of administration is best for them.

Administration in children and adolescents

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

In the treatment of manic episodes

Adult administration

• 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 optimal dose is between 1 mg and 6 mg once a day.

Administration in elderly patients

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

Administration in children and adolescents
Risperon should not be used in children and adolescents under 18 years of age for the treatment of mania.

In the treatment of persistent aggression in patients with Alzheimer's disease

Administration in adults (including elderly patients)
Initial dose is usually 0.25 mg twice a day.
Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
For most patients, the optimal daily dose is 0.5 mg twice a day. Some patients may need a dose of 1 mg twice a day.
Treatment duration in patients with Alzheimer's disease should not exceed 6 weeks.

In the treatment of behavioral disorders

Dose depends on the child's weight:
In children with a body weight of less than 50 kg
Initial dose is usually 0.25 mg once a day.
Dose may be increased every other day (gradually) by 0.25 mg per day.
Usual maintenance dose is between 0.25 mg and 0.75 mg once a day.
In children with a body weight of 50 kg or more
Initial dose is usually 0.5 mg once a day.
Dose may be increased every other day by 0.5 mg per day.
Usual maintenance dose is between 0.5 mg and 1.5 mg once a day.
Treatment duration in patients with behavioral disorders should not exceed 6 weeks.
Risperon should not be used in children under 5 years of age for the treatment of behavioral disorders.

Patients with kidney or liver disorders

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

Method of administration

Oral administration.
The tablet should be swallowed with water.
The score line on the tablet allows it to be divided into two halves.

Overdose of Risperon

In case of overdose, the patient should immediately consult their doctor. The patient should take the medicine packaging with them.
In case of overdose, the patient may experience drowsiness or fatigue, or abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, or abnormal heart rhythm, or seizures.

Missed dose of Risperon

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 patient should skip the missed dose and take the next dose as directed. If the patient forgets to take two or more doses, they should consult their doctor.

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

Stopping treatment with Risperon

The patient should not stop taking Risperon 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 treatment, 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, Risperon can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor if:

• they experience blood clots in the veins, especially in the legs (symptoms include pain and redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, the patient should seek medical help immediately;
• they have dementia and experience a sudden change in mental state or sudden weakness, numbness, or paralysis of the face, arms, or legs, especially if it occurs on one side, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke;
• they experience fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary;
• they are a man and experience prolonged or painful erections. This condition is called priapism. Immediate treatment may be necessary;
• they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to stop taking Risperon;
• they experience a severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, or a drop in blood pressure.

The following side effects may occur.

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

Difficulty sleeping or waking up.
Parkinsonism. This condition may include slow or abnormal movements, feeling of stiffness or muscle tension (which makes movements uneven, jerky), and sometimes even a feeling of "freezing" of movements, followed by release. Other symptoms of parkinsonism include: slow, shuffling gait, tremors, increased salivation, and a mask-like face.
Feeling of drowsiness or decreased alertness.
Headache.

Common side effects (may affect up to 1 in 10 people)

Pneumonia, respiratory tract infection (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms.
Increased level of the hormone prolactin in the blood (with or without symptoms). Symptoms of increased prolactin levels occur not very often 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 breast discomfort, milk secretion from the breasts, absence of menstrual periods or menstrual disorders, or fertility disorders.
Weight gain, increased appetite, decreased appetite.
Sleep disorders, irritability, depression, anxiety, restlessness.
Dystonia: in this condition, there are slow or sustained involuntary muscle contractions. Although it can affect any part of the body (which can result in an abnormal posture), dystonia most commonly affects 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 and jerks.
Tremors.
Blurred vision, eye infection, or conjunctivitis.
Fast 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, bone or muscle pain, back pain, joint pain.
Urinary incontinence.
Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue, pain.
Falls.

Uncommon side effects (may affect up to 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 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).
Allergic reaction.
Development of diabetes or worsening of existing diabetes, high blood sugar, excessive thirst.
Weight loss, loss of appetite leading to malnutrition and low body weight.
Increased cholesterol levels in the blood.
Mania (elevated mood), confusion, decreased libido, nervousness, agitation.
Late dyskinesia (involuntary, uncontrolled movements of the face, tongue, or other parts of the body). The patient should immediately consult their doctor if they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to stop taking Risperon.
Sudden lack of blood supply to the brain (stroke or "mini" stroke).
Loss of consciousness, decreased level of consciousness, coma.
Seizures, fainting.
Need to move body parts, balance disorders, coordination disorders, dizziness when standing up, concentration disorders, speech difficulties, loss of taste, decreased sensation of pain and touch on the skin, feeling of tingling, pricking, or numbness of the skin.
Increased sensitivity of the eyes to light, dry eye, increased tearing, redness of the eyes.
Feeling of dizziness, ringing in the ears, ear pain.
Atrial fibrillation (abnormal heart rhythm), conduction disorder between the heart chambers, abnormal conduction of electrical impulses in the heart, prolonged QT interval in the heart, slow heartbeat, abnormal electrocardiogram (ECG), feeling of palpitations.
Low blood pressure, low blood pressure when standing up (which may cause some patients taking Risperon to faint, feel dizzy, or lose consciousness when standing up suddenly), sudden flushing.
Aspiration pneumonia (caused by food entering the airways), pulmonary congestion, bronchitis, wheezing, speech disorders, respiratory disorders.
Gastrointestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excessive gas.
Hives, itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, peeling skin, and itchy skin on the head and rest of the body, skin disorders, skin damage.
Increased activity of the enzyme CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released from damaged muscles.
Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
Frequent urination, urinary incontinence, painful urination.
Erectile dysfunction, ejaculation disorders.
Menstrual disorders, absence of menstrual periods, and other menstrual disorders (in women).
Breast enlargement in men, milk secretion from the breasts, sexual disorders, breast pain, breast discomfort, vaginal discharge.
Facial swelling, lip swelling, eye swelling, tongue swelling.
Chills, increased body temperature.
Change in gait.
Feeling of thirst, malaise, feeling of discomfort in the chest, feeling unwell, discomfort.
Increased activity of liver enzymes in the blood, increased activity of the enzyme GGTP (liver enzyme - gamma-glutamyltransferase) in the blood, increased activity of liver enzymes in the blood.
Pain related to medical procedures.

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

Infection.
Abnormal secretion of the hormone regulating urine volume.
Sugar in urine, low blood sugar, high triglyceride levels in the blood.
Lack of emotions, inability to achieve orgasm.
Malignant neuroleptic syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness).
Cerebrovascular disorders.
Coma due to uncontrolled diabetes.
Shaking movements, nodding movements of the head.
Glaucoma (increased pressure in the eye), eye movement disorders, rotational eye movements, ulcers on the eyelid margins.
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 Risperon. If the patient is scheduled for cataract surgery, they should inform their ophthalmologist about taking this medicine in the past or present.
Severely low number of certain white blood cells, which are necessary to fight infections.
Severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure.
Excessive thirst.
Irregular heartbeat.
Blood clots in the legs, blood clots in the lungs.
Respiratory disorders during sleep (sleep apnea), rapid, shallow breathing.
Pancreatitis, intestinal obstruction.
Tongue swelling, lip swelling, rash.
Dandruff.
Muscle breakdown and muscle pain (rhabdomyolysis).
Delayed menstrual periods, breast enlargement, breast swelling, milk secretion from the breasts.
Increased insulin levels in the blood (a hormone that regulates blood sugar levels).
Priapism (prolonged erection, which may require surgical intervention).
Skin thickening.
Low body temperature, cooling of the hands and feet.
Withdrawal symptoms.
Jaundice (yellowing of the skin and eyes).

Very rare side effects (may affect up to 1 in 10,000 people)

Life-threatening complications due to uncontrolled diabetes.
Severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties.
Intestinal obstruction leading to bowel obstruction.
The following side effects have been observed with the use of another medicine, paliperidone, which is very similar to risperidone and may also occur with the use of Risperon: rapid heartbeat when standing up.

Additional side effects in children and adolescents

It is assumed that the side effects in children will be similar to those in adults.
The following side effects occurred more frequently in children and adolescents (aged 5 to 17 years) than in adults: feeling of drowsiness or decreased alertness, fatigue, headache, increased appetite, vomiting, common cold symptoms, stuffy nose, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and urinary incontinence.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Risperon

The medicine should be stored in a place inaccessible to children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 pack and other information

What Risperon contains

• The active substance of the medicine is risperidone, in a quantity of 1 mg, 2 mg, 3 mg, or 4 mg.
• Other ingredients are: tablet core: microcrystalline cellulose, anhydrous colloidal silica, lactose monohydrate, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate; tablet coating: talc, polyvinyl alcohol, titanium dioxide, soybean lecithin, xanthan gum.

What Risperon looks like and contents of the pack

Risperon 1 mg and 2 mg coated tablets are white, round, with a score line to facilitate breaking the tablet into two halves.
Risperon 3 mg coated tablets are white, oval, with a score line to facilitate breaking the tablet into two halves.
Risperon 4 mg coated tablets are white, oblong, with a score line to facilitate breaking the tablet into two halves.
Packaging:
Blister packs of OPA/Aluminum/PVC/Aluminum foil in a cardboard box.
The pack contains 20 or 60 tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14 A
05-170 Zakroczym
Poland
tel.: +48 22 785 27 60
fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet:

• 18.09.2023