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

Please read this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the 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 for:
treatment of schizophrenia – a condition in which patients may see, hear or feel things that do not exist, believe things that are not true, or experience unusual suspicion or confusion;
treatment of manic episodes – a condition in which patients may feel extremely excited, agitated, enthusiastic, or overly active. Manic episodes occur in bipolar affective disorders;
short-term treatment (up to 6 weeks) of persistent aggression in patients with dementia due to Alzheimer's disease who are a danger to themselves or others. Alternative non-pharmacological treatment methods should be tried before using this medicine;
short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (over 5 years of age) and adolescents with behavioural disorders.
Risperon helps relieve symptoms of illness and prevent their recurrence.

2. Important information before taking Risperon

When not to take Risperon

• if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

If you are unsure whether the above applies to you, speak to your doctor or pharmacist before taking Risperon.

Warnings and precautions
Before starting treatment with Risperon, discuss with your doctor or pharmacist if:
you have heart problems, such as irregular heartbeat, or if you have a tendency towards low blood pressure, or if you are taking medicines for blood pressure. Risperon may cause low blood pressure. Dose adjustment may be necessary;
you have any risk factors for stroke, such as high blood pressure, cardiovascular disease, or cerebrovascular disorders;
you have ever experienced involuntary movements of the tongue, mouth or face;
you have ever had a condition with symptoms such as fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as neuroleptic malignant syndrome);
in patients with Parkinson's disease or dementia;
if you have previously had a low white blood cell count (which may or may not have been caused by other medicines);
in patients with diabetes;
in patients with epilepsy;
if you are a man and have experienced prolonged or painful erection;
if you have problems regulating body temperature or are overheating;
if you have kidney function disorders;
if you have liver function disorders;
if you have abnormally high levels of the hormone prolactin in the blood or suspicion of a prolactin-dependent tumour;
if you or any of your family members have previously had blood clots, as use of medicines like Risperon may increase the risk of thrombosis.
If you are unsure whether any of the above symptoms apply to you, speak to your doctor or pharmacist before taking Risperon.
Your doctor may order a white blood cell count test, as very rarely, dangerously low levels of certain white blood cells essential for fighting infections have been observed in patients taking risperidone.
Risperon may cause weight gain. Significant weight gain may adversely affect health. Your doctor will regularly monitor your body weight.
Your doctor should check whether you have high blood glucose (sugar) levels, as diabetes has been reported in patients taking risperidone, and pre-existing diabetes may worsen. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Risperon often increases levels of a hormone called prolactin in the blood. This may cause side effects such as menstrual disorders, fertility problems in women, or breast enlargement in men (see section “Possible side effects”). If such side effects occur, measurement of blood prolactin levels is recommended.
During cataract surgery, the pupil may not dilate sufficiently. Also, the iris of the eye may be flaccid during surgery, which may lead to eye damage. If you have planned eye surgery, inform your ophthalmologist that you 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 Risperon, patients should have regular medical check-ups.
Seek immediate medical help if you or a caregiver notice sudden changes in mental status, sudden muscle weakness or numbness, especially on one side of the body, or speech disturbances, even if they are brief. These symptoms may indicate a stroke.

Children and adolescents
Before starting treatment for behavioural disorders, other causes of aggressive behaviour should be ruled out.
If fatigue occurs during treatment, changing the time of risperidone administration may improve concentration.
Body weight may be measured before starting treatment and regularly during treatment. 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.

Risperon and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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 (antiallergic medicines), as risperidone may enhance their sedative effect;
medicines that may affect 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 down heart rate;
medicines that reduce potassium levels in the blood (e.g. certain diuretics);
medicines used for high blood pressure; Risperon may lower blood pressure;
medicines used for Parkinson's disease (e.g. levodopa);
medicines that stimulate the central nervous system (psychostimulants, such as methylphenidate);
diuretics (water tablets), used in patients with heart disease or to reduce fluid accumulation (e.g. furosemide or hydrochlorothiazide). Risperon, 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 (antiepileptic medicines);
phenobarbital.
Dose adjustment of risperidone may be necessary when starting or stopping these medicines.

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 (reducing 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.
Dose adjustment of risperidone may be necessary when starting or stopping these medicines.
If you are unsure whether you are taking or have taken any of the medicines listed above, speak to your doctor or pharmacist before taking Risperon.

Risperon with food, drink and alcohol
Risperon can be taken with or without food. During treatment with Risperon, alcohol should be avoided.

Pregnancy, breastfeeding and fertility

• If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Risperon.
• Newborns whose mothers took Risperon during the third trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If you notice such symptoms in the baby, contact your doctor.
• Risperon may increase blood levels of prolactin – a hormone that may affect fertility (see section “Possible side effects”).

Driving and using machines
Dizziness, tiredness, and visual disturbances may occur during treatment with Risperon. Therefore, do not drive, use tools, or operate machinery without consulting your doctor.

Risperon contains lactose monohydrate and sodium (applies to all strengths)
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Risperon contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Risperon

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
To achieve doses that cannot be obtained with this medicine, consult your doctor and use other available formulations or dosage forms of medicines containing risperidone.
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 method of administration 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 – 2 mg twice daily.
• Your doctor will advise which method of administration 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 – 2 mg twice daily, depending on the patient's response to treatment.

In the treatment of persistent aggression in patients with Alzheimer's dementia
Adults (including elderly patients)
The usual starting dose is 0.25 mg 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 Alzheimer's dementia should not exceed 6 weeks.
Use in children and adolescents

• Risperon 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 once daily.
The dose may be increased every other day (gradually) by 0.25 mg per day.
The usual maintenance dose is typically between 0.25 mg and 0.75 mg 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 typically between 0.5 mg and 1.5 mg once daily.
The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.
Risperon should not be used in children under 5 years of age for the treatment of behavioural disorders.
Patients with renal or hepatic impairment
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.
Risperon should be used with caution in this patient group.
Method of administration
For oral use.
Swallow the tablet with water.
The score line on the tablet allows for splitting into halves.
Taking more Risperon than recommended

• Seek immediate medical advice. 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, irregular heartbeat, or seizures.

If a dose of Risperon is missed

• 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 at the usual time. If the patient misses 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 Risperon
Do not stop taking this medicine unless advised by your doctor. Symptoms of the illness may return. 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Contact the doctor immediately if the patient experiences any of the following
uncommon side effects (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 they occur briefly. These symptoms may indicate a stroke;
• tardive dyskinesia (involuntary, jerking or writhing movements of the face, tongue or other parts of the body). Inform the doctor immediately if there are involuntary, rhythmic movements of the tongue, lips or face. Discontinuation of Risperon may be necessary.

Contact the doctor immediately if the patient experiences 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 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 known as neuroleptic malignant syndrome). Immediate treatment may be required;
• in men, prolonged or painful erection. This condition is known as priapism. Immediate treatment may be necessary;
• severe allergic reaction, characterized by fever, swelling of the lips, face, tongue or throat, difficulty breathing, skin itching, rash or drop in blood pressure.

Other side effects may also occur:

Very common side effects (may occur in more than 1 in 10 people)
difficulty falling asleep or waking up;
parkinsonism: this condition may involve slow or abnormal movements, feelings of stiffness or muscle tension (causing movements to be uneven), 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;
drowsiness or reduced alertness;
headache.

Common side effects (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, reduced sexual drive, or other sexual disturbances. In women, they may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding or other menstrual cycle disturbances, 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 and jerking;
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 side effects (may occur in less than 1 in 100 people)
respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection affecting one area or part of the body, viral infection, skin inflammation caused by mites;
reduced number of white blood cells (including those that help protect against infections), reduced number of platelets (blood cells that help stop bleeding), anaemia, reduced number of red blood cells, increased number of eosinophils (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, reduced libido, nervousness, nightmares;
lack of response to stimuli, loss of consciousness, low level of consciousness;
seizures, fainting;
compulsion to move body parts, balance disturbances, poor coordination, dizziness upon standing, concentration difficulties, speech difficulties, loss or altered sense of taste, reduced sensitivity to pain and touch on the skin, tingling, pricking or numbness sensations;
light sensitivity of the eyes, dry eyes, excessive tearing, eye redness;
dizziness, ringing in the ears, ear pain;
atrial fibrillation (irregular heartbeat), conduction block between heart chambers, abnormal electrical conduction in the heart, QT interval prolongation on ECG, slow heartbeat, abnormal electrical activity of the heart on ECG, palpitations;
low blood pressure, low blood pressure upon standing (as a result, some patients taking Risperon may faint, feel dizzy or lose consciousness when standing up suddenly); sudden flushing;
aspiration pneumonia (caused by food entering the airways), pulmonary congestion, respiratory tract congestion, crackles, rales, speech difficulties, respiratory disturbances;
stomach or intestinal infection, fecal incontinence, very hard stools, 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 the 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 menstrual bleeding, missed periods or other menstrual cycle disturbances (in women);
breast enlargement in men, milk discharge from the breasts, sexual disturbances, breast pain, breast discomfort, vaginal discharge;
swelling of the face, lips, eyes or mouth;
chills, increased body temperature;
change in walking pattern;
thirst, malaise, chest discomfort, feeling "unwell", general discomfort;
increased aminotransferase activity in the blood, increased GGT enzyme activity (liver enzyme – gamma-glutamyl transferase) in the blood, increased liver enzyme activity in the blood;
pain related to medical procedures.

Rare side effects (may occur in less than 1 in 1,000 people)
infection;
abnormal secretion of the hormone regulating urine production;
sleepwalking (somnambulism);
eating disorders related to sleep;
reduced motor activity and unresponsiveness in a patient with preserved consciousness (catatonia);
sugar in urine, low blood sugar, high triglyceride (fat) levels in the blood;
lack of emotion, inability to achieve orgasm;
cerebrovascular disorders;
coma due to uncontrolled diabetes;
trembling, head-nodding movements;
glaucoma (increased pressure in the eye), eye movement disorders, rotary eye movements, eyelid margin ulcers (with crust formation);
eye complications during cataract surgery. During this procedure, floppy iris syndrome (Intraoperative Floppy Iris Syndrome, IFIS) may occur if the patient is currently taking or has previously taken Risperon. If the patient has cataract surgery planned, 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 disturbances during sleep (sleep apnoea), rapid, shallow breathing;
pancreatitis, intestinal obstruction;
tongue swelling, chapped lips, drug rash;
pityriasis;
muscle fiber breakdown and muscle pain (rhabdomyolysis);
delayed menstruation, enlargement of mammary glands, breast enlargement, breast discharge;
increased insulin levels in the blood (hormone regulating blood sugar);
skin hardening;
low body temperature, cold hands and feet;
withdrawal symptoms;
yellowing of the skin and eyes (jaundice).

Very rare side effects (may occur in less than 1 in 10,000 people)
life-threatening complications associated with uncontrolled diabetes;
severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties;
loss of intestinal function leading to obstruction.

Side effects with unknown frequency (frequency cannot be determined from available data)
severe or life-threatening rash with blisters and peeling skin, which may appear in the mouth, nose, eyes, genital organs and around these areas, and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Side effects observed during use of another medicine – paliperidone, very similar to risperidone – which may also occur during Risperon use:
rapid heartbeat upon standing.

Additional side effects in children and adolescents
Generally, side effects in children are similar to those in adults. The following side effects occurred 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 side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects 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 effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Risperon

Keep this medicine out of sight and reach of children.
Store below 25°C.
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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Risperon contains

• The active substance is risperidone. Each 1 mg coated tablet contains 1 mg of risperidone. Each 2 mg coated tablet contains 2 mg of risperidone. Each 3 mg coated tablet contains 3 mg of risperidone. Each 4 mg coated tablet contains 4 mg of risperidone.
• Other ingredients are: tablet core: microcrystalline cellulose, colloidal anhydrous 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 coated tablets, 1 mg are white, round, biconvex, with a score line facilitating division into two equal parts.
Risperon coated tablets, 2 mg are white, round, biconvex, with a score line facilitating division into two equal parts.
Risperon coated tablets, 3 mg are white, oval, biconvex, with a score line facilitating division into two equal parts.
Risperon coated tablets, 4 mg are white, elongated, biconvex, with a score line facilitating division into two equal parts.
Packaging:
Aluminum/OPA/PVC/Aluminum foil blisters in a cardboard box.
Pack contains 20 or 60 tablets.

Marketing Authorisation Holder and Manufacturer
LEK-AM Pharmaceutical Company Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60