Rispolit

Leaflet attached to the packaging: information for the user

Ryspolit, 1 mg/ml, oral solution

Risperidone

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

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

Table of contents of the leaflet

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

1. What is Ryspolit and what is it used for

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

• treatment of schizophrenia - a disease that makes the patient see, hear, or feel things that do not exist, believe in untrue things, or experience unusual suspicion or disorientation.
• treatment of manic episodes - a state in which the patient may feel strong excitement, agitation, irritation, enthusiasm, or be overly active. Manic episodes occur in the course of bipolar affective disorders.
• short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease who pose a threat to 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 old) and adolescents with behavioral disorders.

Ryspolit can help alleviate symptoms of the disease and prevent their recurrence.

2. Important information before taking Ryspolit

When not to take Ryspolit

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

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

Warnings and precautions

Before starting treatment with Ryspolit, the patient should discuss the following with their doctor or pharmacist:

• if the patient has heart rhythm disorders, such as an irregular heartbeat; or if the patient has a tendency to low blood pressure, or if the patient is taking blood pressure-lowering medicines. Ryspolit may cause a decrease in blood pressure. It may be necessary to adjust the dose of the medicine;
• if the patient knows of any factors that may contribute to the occurrence of a stroke, such as high blood pressure, cardiovascular disorders, or cerebral vessel disorders;
• if the patient has ever experienced involuntary rhythmic movements of the tongue, lips, or face;
• if the patient has ever experienced symptoms including fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called 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 has kidney function disorders;
• if the patient is a man and has experienced prolonged or painful erections;
• if the patient has body temperature regulation disorders or overheats;
• if the patient has liver function disorders;
• if the patient has an abnormally high level of the hormone prolactin in the blood or a prolactin-dependent tumor;
• if the patient or any of their relatives have had blood clots in the past, as the use of antipsychotic medicines is associated with the formation of blood clots.

If the patient is unsure whether any of the above conditions apply to them, they should consult a doctor or pharmacist before taking Ryspolit.
The doctor may order a white blood cell count test, as very rarely, patients taking Ryspolit have been observed to have a dangerously low number of a certain type of white blood cell necessary for fighting infections.
Ryspolit 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 Ryspolit have been observed to develop diabetes and worsening of existing diabetes. In patients with existing diabetes, blood sugar levels should be regularly checked.
Ryspolit 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 section 4 "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 floppy during the procedure, which can result in eye damage. If the patient is scheduled for eye surgery, they should tell their eye doctor 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 Ryspolit, the patient should frequently consult their doctor. If the patient or their caregiver notices a sudden change in the patient's mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or speech disorders, even if they occur for a short time, they should seek medical help immediately. 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, it was found that children who took risperidone had increased growth, but it is not known whether this is due to the action of the medicine or other factors.

Ryspolit 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:

• 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 malaria medicines, anti-arrhythmic medicines, antihistamines, or certain antidepressants or other medicines used to treat mental disorders,
• medicines that slow down heart rate,
• medicines that lower blood potassium levels (e.g., certain diuretics),
• medicines used to treat high blood pressure; risperidone 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 heart disease or to relieve swelling in areas where there is excessive fluid accumulation, e.g., furosemide or chlorothiazide). Ryspolit 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. If the patient starts or stops taking these medicines, the dose of risperidone may need to be changed.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart diseases),
• antidepressants, such as paroxetine, fluoxetine, tricyclic antidepressants,
• beta-adrenergic blocking agents (used to treat high blood pressure),
• phenothiazines (such as medicines used to treat psychosis 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, the dose of risperidone may need to be changed.

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

Ryspolit with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take Ryspolit.
• In newborns whose mothers took Ryspolit in the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the child experiences any of these symptoms, the patient should contact their doctor.
• Risperidone may increase the level of the hormone prolactin in the blood - a hormone that can affect fertility (see section 4 "Possible side effects").

Driving and using machines

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

Ryspolit contains benzonic acid (E 210)

The medicine contains 1.5 mg of benzonic acid (E 210) per 1 ml of oral solution.
Benzonic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

3. How to take Ryspolit

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended doses of the medicine are:

In the treatment of schizophrenia

Adults

• The recommended initial dose is 2 mg per day, which may be increased to 4 mg per day on the second day.
• Depending on the patient's response to treatment, the doctor may adjust the dose.
• For most patients, the 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 taking the medicine is best for them.

Elderly patients

• The recommended initial dose is usually 0.5 mg twice a day.
• The doctor may then 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 recommended 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.

Elderly patients

• The recommended initial dose is usually 0.5 mg twice a day.
• The doctor may then 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 recommended 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.
• The duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

Use in children and adolescents

• Ryspolit 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 recommended initial dose is usually 0.25 mg once a day.
• The dose may be increased every other day (gradually) by 0.25 mg per day.
• The recommended 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

• The recommended initial dose is usually 0.5 mg once a day.
• The dose may be increased every other day by 0.5 mg per day.
• The recommended 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.
Ryspolit should not be used in children under 5 years of age for the treatment of behavioral disorders.

Patients with kidney or liver function disorders

Regardless of the disease being treated, all initial and subsequent doses 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 use.

Ryspolit oral solution

The liquid should be drawn up using a pipette. To facilitate accurate measurement of the correct amount of medicine, a pipette should be used.
To do this, the following steps should be performed:

• 1. Remove the child-resistant cap from the bottle by pressing the cap down and turning it counterclockwise (Figure 1).
• 2. Place the pipette in the bottle.

• 3. Holding the lower ring, pull the upper ring up to the mark corresponding to the number of milliliters or milligrams of medicine to be taken (Figure 2).
• 4. Holding the lower ring, remove the entire pipette from the bottle (Figure 3).
• 5. Empty the pipette into a non-alcoholic drink, except for tea, by pushing the upper ring down.
• 6. Close the bottle.
• 7. Rinse the pipette with a small amount of water.

Figure 1.
Figure 2.
Figure 3.

What to do if too much Ryspolit is taken

• The patient should go to the doctor immediately. They should take the medicine packaging with them.
• In case of overdose, the patient may experience drowsiness or fatigue, or they may have abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, or abnormal heart rhythm, or they may have a seizure.

What to do if a dose of Ryspolit 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, they should skip the missed dose and take the next dose as scheduled. If the patient forgets to take two or more doses, they should contact their doctor.
• The patient should not take a double dose (two doses at the same time) to make up for a missed dose.

What to do if treatment with Ryspolit is stopped

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

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

• In a patient with dementia, a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke.
• The patient experiences late dyskinesia (involuntary, repetitive, and rhythmic 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 Ryspolit,

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

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

The patient should immediately inform their doctor if they experience any of the following rare side effects (frequency not known: cannot be estimated from the available data).

• A severe skin rash with blisters and peeling skin, which may initially occur in the mouth, nose, eyes, and genitals, and may spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following other side effects may also occur:

Very common (occurring in more than 1 in 10 people):

• Difficulty sleeping or staying asleep,
• 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, jerky), and sometimes even a feeling of "freezing" of movements, followed by a release. Other symptoms of parkinsonism include: a slow, shuffling gait, tremors, increased salivation, and a mask-like face,
• Feeling drowsy or sedated,
• Headache.

Common (occurring in less than 1 in 10 people):

• Pneumonia, respiratory tract infection (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms,
• Ryspolit may increase the level of the hormone prolactin in the blood (with or without symptoms). Symptoms of high prolactin levels 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 menstruation, or other menstrual cycle disorders or fertility disorders,
• Weight gain, increased appetite, decreased appetite,
• Sleep disturbances, irritability, depression, anxiety, restlessness,
• Dystonia: In this condition, there are slow or sustained involuntary muscle contractions. Although it can affect any part of the body (which can result in an abnormal posture), dystonia most commonly affects the muscles of the face, including abnormal movements of the eyes, lips, tongue, or jaw,
• Dizziness,
• Dyskinesia: In this condition, there are involuntary muscle movements, including repetitive, spasmodic, or twisting movements, or jerks,
• Tremors,
• Blurred vision, eye infection or conjunctivitis,
• Fast heartbeat, high blood pressure, shallow breathing,
• 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, pain,
• Falls.

Uncommon (occurring in less than 1 in 100 people):

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal infection of the nails, skin infection limited to one area of the skin or one part of the body, viral infection, skin rash caused by mites,
• Decreased number of a certain type of white blood cell that protects the body against infection, decreased number of white blood cells, decreased number of platelets (blood cells involved in stopping bleeding), anemia (low red blood cell count), decreased number of red blood cells, increased number of eosinophils (a type of white blood cell),
• Allergic reaction,
• Diabetes or worsening of existing diabetes, high blood sugar levels, excessive thirst,
• Weight loss, decreased appetite leading to malnutrition and low body weight,
• High cholesterol levels in the blood,
• Elevated mood (mania), confusion, decreased sex drive, nervousness, nightmares,
• Lack of reaction to stimuli, loss of consciousness, decreased level of consciousness,
• Seizures, fainting,
• Need to move body parts, balance disorders, coordination disorders, dizziness when changing position to standing, 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,
• Vertigo (dizziness of inner ear origin), ringing in the ears, ear pain,
• Atrial fibrillation (irregular heart rhythm), blockage of impulse conduction between the upper and lower chambers of the heart, 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 changing position to standing (which may cause some patients taking Ryspolit to faint, feel dizzy, or lose consciousness when standing up or getting up), flushing of the face,
• Aspiration pneumonia caused by food entering the airways, pulmonary congestion, respiratory tract congestion, crackling in the lungs, wheezing, voice disorders, breathing difficulties,
• Gastritis, diarrhea, very hard stools, difficulty swallowing, excessive gas,
• Hives, severe itching of the skin, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, peeling skin, itching scalp and body, skin disorders, skin changes,
• Increased activity of creatine phosphokinase in the blood, an enzyme that is sometimes released from damaged muscles,
• Abnormal posture, stiff joints, swollen joints, muscle weakness, neck pain,
• Frequent urination, inability to urinate, pain when urinating,
• Erectile dysfunction, ejaculation disorders,
• Delayed menstruation, absence of menstruation, and other menstrual cycle disorders (in women),
• Breast enlargement in men, milk secretion from the breasts, sexual disorders, breast pain, discomfort in the breasts, vaginal discharge,
• Swelling of the face, lips, eyes, or tongue,
• Chills, increased body temperature,
• Change in gait,
• Feeling of thirst, malaise, discomfort in the chest, feeling unwell, discomfort,
• Increased activity of aminotransferases and gamma-glutamyltransferase in the blood, increased activity of liver enzymes in the blood,
• Pain related to medical procedures.

Rare (occurring in less than 1 in 1,000 people):

• Infection,
• Abnormal secretion of the hormone that regulates urine production,
• Sleepwalking (sleepwalking),
• Eating disorders related to sleep,
• Sugar in the urine, low blood sugar levels, high triglyceride levels in the blood,
• Lack of emotions, inability to achieve orgasm,
• Cerebrovascular disorders,
• Coma due to uncontrolled diabetes,
• Head tremors,
• Glaucoma (increased pressure in the eyeball), disorders of eye movements, rotational eye movements, ulcers on the edges of the eyelids,
• Additionally, complications related to the eye may occur during cataract surgery. During this procedure, a condition called intraoperative floppy iris syndrome (IFIS) may occur if the patient is taking or has taken Ryspolit. If the patient is scheduled for cataract surgery, they should tell their eye doctor about taking this medicine in the past or present,
• A dangerously low number of certain white blood cells that fight infection,
• Dangerously excessive thirst,
• Irregular heartbeat,
• Breathing difficulties during sleep, rapid, shallow breathing,
• Immobility or excessive restlessness (catatonia),
• Pancreatitis, intestinal obstruction,
• Swelling of the tongue, inflammation of the lips, hypersensitivity to the medicine (skin rash),
• Dandruff,
• Muscle fiber breakdown and muscle pain (rhabdomyolysis),
• Delayed menstruation, breast enlargement, breast swelling, milk secretion from the breasts,
• Increased insulin levels in the blood (a hormone that regulates blood sugar levels),
• Thickening of the skin,
• Low body temperature, cooling of the hands and feet,
• Withdrawal symptoms,
• Yellowing of the skin and eyes (jaundice).

Very rare (occurring in less than 1 in 10,000 people):

• Life-threatening complications related to uncontrolled diabetes,
• A severe allergic reaction with swelling that can involve the throat and lead to breathing difficulties,
• Lack of bowel movement leading to intestinal obstruction.

A side effect observed during the use of another medicine - paliperidone, which is very similar to risperidone, and which may also occur during the use of Ryspolit: rapid heartbeat when changing position to standing.
Additional side effects in children and adolescents
Generally, the side effects that occur in children are similar to those observed in adults. The following side effects occur more frequently in children and adolescents (aged 5 to 17 years) than in adults: drowsiness and/or sedation, fatigue, headache, increased appetite, vomiting, common cold symptoms, runny nose, abdominal pain, dizziness, cough, fever, tremors, and involuntary urination.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 Ryspolit

This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Do not freeze.
Store in the original packaging.
Shelf life after first opening the bottle: 4 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ryspolit contains

• The active substance of the medicine is risperidone. 1 ml of oral solution contains 1 mg of risperidone.
• The other ingredients are: tartaric acid (E334), benzonic acid (E 210), concentrated hydrochloric acid (to adjust pH) and purified water.

What Ryspolit looks like and contents of the pack

Ryspolit is a clear, colorless oral solution.
The medicine is available in bottles with a child-resistant cap made of PP/LDPE, containing 30 ml and 100 ml of solution, packed in a cardboard box.
The dosing pipette provided with the 30 ml and 100 ml bottles is calibrated in milligrams and milliliters from the smallest value of 0.25 ml to the maximum value of 3 ml. The dosing pipette has a scale every 0.25 ml (which corresponds to 0.25 mg of oral solution) up to 3 ml (which corresponds to 3 mg of oral solution).
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Poland

Manufacturer

Chanelle Medical Unlimited Company
Loughrea, Co. Galway
Ireland
Date of last revision of the leaflet:December 2022