Ryspolit

Package leaflet: Information for the user

Ryspolit, 1 mg/ml, oral solution
Risperidone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, 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.

Leaflet contents

1. What Ryspolit is and what it is used for
2. What you need to know 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 Ryspolit is and what it is used for

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

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

Ryspolit may help relieve symptoms of the illness and prevent their recurrence.

2. Information before using Ryspolit

When not to use 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 their doctor or
pharmacist before taking Ryspolit.
Warnings and precautions
Before starting treatment with Ryspolit, discuss the following with your doctor or pharmacist:

• if the patient has heart function disorders, for example irregular heartbeat; or if the patient has a tendency to low blood pressure, or if the patient is taking medicines for blood pressure regulation. Ryspolit may cause a drop in blood pressure. Dose adjustment may be necessary;
• if the patient has any risk factors for stroke, such as high blood pressure, cardiovascular disorders, or cerebral vascular disorders;
• if the patient has ever experienced involuntary rhythmic movements of the tongue, mouth or face;
• if the patient has ever had symptoms including fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called neuroleptic malignant syndrome);
• if the patient has Parkinson's disease or dementia;
• if the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines);
• if the patient has diabetes;
• if the patient has epilepsy;
• if the patient has kidney function disorders;
• if the patient is a male who has experienced prolonged or painful erection;
• if the patient has body temperature regulation disorders or is overheating;
• if the patient has liver function disorders;
• if the patient has abnormally high levels of prolactin hormone in the blood or a tumour likely to be prolactin-dependent;
• if the patient or any of their relatives have previously had blood clots, as antipsychotic medicines are associated with an increased risk of thrombosis.

If the patient is unsure whether any of the symptoms described above apply to them, they should
consult their doctor or pharmacist before taking Ryspolit.
The treating doctor may order a white blood cell count test, as very rarely, a dangerously low number of certain
white blood cells essential for fighting infections has been observed in patients taking Ryspolit.
Ryspolit may cause weight gain. Significant weight gain may adversely affect health. The treating doctor will regularly monitor the patient's body weight.
The doctor should check whether the patient has symptoms of high blood glucose levels,
as diabetes has been observed in patients taking Ryspolit, and existing diabetes may worsen. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Ryspolit often increases the level of a hormone called "prolactin". This may cause adverse effects such as: menstrual disorders, fertility problems in women, breast swelling in men (see section 4 "Possible side effects"). If such adverse effects occur, measuring prolactin levels in the blood is recommended.
During cataract surgery, the pupil may not dilate sufficiently. Also, the iris may be floppy during the procedure, which may lead to eye damage. If the patient is scheduled for eye surgery, they must inform the ophthalmologist 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. Immediate medical help should be sought if the patient or caregiver notices a sudden change in mental status or sudden weakness or numbness of facial muscles, hands or legs, especially on one side, or speech disturbances, even if they are brief. These symptoms may indicate a stroke.
Children and adolescents
Before starting treatment for behavioural disorders, other causes of aggressive behaviour should be ruled out.
If fatigue occurs during treatment, timing of risperidone administration may be adjusted to improve concentration.
The patient's body weight will 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.
Ryspolit and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients should especially inform their doctor or pharmacist if they are taking
any of the following medicines:

• medicines acting on the brain, such as medicines used to calm down (benzodiazepines) or certain painkillers (opioids), antihistamines (some antiallergic medicines), as risperidone may enhance their sedative effects,
• medicines that may cause changes in the electrical activity of the heart, such as antimalarial medicines, antiarrhythmics, antihistamines, certain antidepressants or other medicines used to treat psychiatric disorders,
• medicines that slow down heart function,
• medicines that reduce potassium levels in the blood (e.g. certain diuretics),
• medicines used for high blood pressure; risperidone may lower blood pressure,
• medicines used in Parkinson's disease (e.g. levodopa),
• medicines that increase central nervous system activity (psychostimulants, such as methylphenidate),
• diuretics (water pills), used in patients with heart disease or to relieve swelling in areas with 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 (medicines for epilepsy),
• phenobarbital. When starting or stopping these medicines, a change in risperidone dose may be necessary.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart conditions),
• antidepressants, such as paroxetine, fluoxetine, tricyclic antidepressants,
• medicines known as beta-blockers (used to treat high blood pressure),
• phenothiazines (such as medicines used to treat psychosis or for calming),
• cimetidine, ranitidine (reducing stomach acid),
• itraconazole or ketoconazole (used in fungal infections),
• some medicines used to treat HIV/AIDS, such as ritonavir,
• verapamil, used to treat high blood pressure and (or) heart rhythm disorders,
• sertraline and fluvoxamine, used to treat depression and other psychiatric disorders. When starting or stopping these medicines, a change in risperidone dose may be necessary.

If the patient is unsure whether they have taken or are taking any of the medicines described above,
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, alcohol consumption should be avoided.
Pregnancy, breastfeeding and effects on fertility

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take Ryspolit.
• Newborns whose mothers took Ryspolit during the third trimester of pregnancy (last three months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the baby, contact a doctor.
• Risperidone may increase prolactin levels in the blood – a hormone that may affect fertility (see section 4 "Possible side effects").

Driving and operating machinery
During treatment with Ryspolit, dizziness, fatigue, and vision disturbances may occur. Therefore, without consulting a doctor, the patient should not drive, use tools, or operate any machinery.
Ryspolit contains benzoic acid (E 210)
The medicine contains 1.5 mg of benzoic acid (E 210) in each ml of oral solution.
Benzoic 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 use Ryspolit

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended doses of the medicine are:

Treatment of schizophrenia
Adults

• The recommended starting dose is 2 mg once daily. This dose may be increased to 4 mg once daily on the second day.
• Depending on the patient's response to treatment, the doctor may adjust the dose.
• For most patients, the most appropriate daily dose ranges from 4 mg to 6 mg.
• This total daily dose may be taken as a single dose or divided into two doses. Your doctor will advise which dosing regimen is best for you.

Elderly patients

• The usual recommended starting dose is 0.5 mg twice daily.
• The doctor may then gradually increase the dose to 1 mg to 2 mg twice daily.
• Your doctor will advise which dosing regimen is best for you.

Treatment of manic episodes
Adults

• The usual recommended 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 most appropriate dose ranges from 1 mg to 6 mg once daily.

Elderly patients

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

Treatment of persistent aggression in patients with Alzheimer's type dementia
Adults (including elderly patients)

• The usual recommended 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 most appropriate 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 type dementia 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.

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

• The usual recommended starting dose is 0.25 mg once daily.
• The dose may be increased every other day (gradually) by 0.25 mg daily.
• The recommended maintenance dose is 0.25 mg to 0.75 mg once daily.

In children with body weight of 50 kg or more

• The usual recommended starting dose is 0.5 mg once daily.
• The dose may be increased every other day by 0.5 mg daily.
• The recommended maintenance dose is 0.5 mg to 1.5 mg once daily.

The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.
Ryspolit should not be used in children under 5 years of age for the treatment of behavioural disorders.

Patients with impaired kidney or liver function
Regardless of the disease being treated, all starting and subsequent doses should be reduced by half. Doses should be increased more slowly in these patients.
Risperidone should be used with caution in this patient group.

Method of administration
Oral use.

Ryspolit oral solution
The liquid should be drawn up using the provided pipette. To ensure accurate measurement of the prescribed amount of medicine, use the pipette as follows:

1. Remove the child-resistant cap from the bottle by pressing down on the cap while turning it counter-clockwise (Figure 1.).
2. Insert the pipette into the bottle.
3. While holding the lower ring, pull the upper ring upwards until the mark corresponding to the number of millilitres or milligrams of medicine to be taken is visible (Figure 2.).
4. While holding the lower ring, remove the entire pipette from the bottle (Figure 3.).
5. Empty the contents of the pipette into a non-alcoholic drink (except 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.

If you take more Ryspolit than you should

• Seek medical advice immediately. Take the medicine pack with you.
• In case of overdose, the patient may experience drowsiness or fatigue, or may develop abnormal body movements, difficulty standing or walking, may feel dizzy due to low blood pressure, or may have an irregular heartbeat, or a seizure may occur.

If you forget to take Ryspolit

• If the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken as prescribed. If the patient forgets two or more doses, they should contact their doctor.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Ryspolit
Do not stop taking this medicine unless instructed 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Contact your doctor immediately if any of the following uncommon adverse effects occur
(occur less frequently than in 1 out of 100 people):

• In a patient with dementia, sudden change in mental status 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.
• Development of tardive dyskinesia (involuntary, jerking or twitching movements of the face, tongue or other body parts). Inform your doctor immediately if rhythmic involuntary movements of the tongue, lips or face occur. Discontinuation of Ryspolit may be necessary.

Contact your doctor immediately if any of the following rare adverse effects occur
(occur less frequently than in 1 out of 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 called 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.

Contact your doctor immediately if any of the following rare adverse effects occur
(frequency unknown: cannot be estimated based on available data):

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

Other adverse effects that may also occur:
Very common (occur in more than 1 out of 10 people):

• Difficulty falling asleep or staying asleep,
• Parkinsonism: This condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, abrupt movements of the patient), 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/drooling, and expressionless face,
• Drowsiness or sedation,
• Headache.

Common (occur in less than 1 out of 10 people):

• Pneumonia, respiratory tract infection (bronchitis), cold-like symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms,
• Ryspolit may increase blood levels of the hormone prolactin (with or without symptoms). Symptoms of increased prolactin occur uncommonly and may include in men: breast swelling, difficulty achieving or maintaining erection, decreased libido or other sexual disturbances. In women, they may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding, other menstrual cycle disturbances or fertility problems,
• Weight gain, increased appetite, decreased appetite,
• Sleep disturbances, irritability, depression, anxiety, restlessness,
• Dystonia: This condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (possibly resulting in abnormal posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements,
• Dizziness,
• Dyskinesia: This condition involves involuntary muscle movements, including repetitive, spasmodic or twisting movements, or jerks,
• Tremor,
• Blurred vision, eye infection or conjunctivitis,
• Rapid heartbeat, high blood pressure, shallow breathing,
• Sore throat, cough, nosebleed, nasal congestion,
• Abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, constipation, diarrhoea, 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, pain,
• Fall.

Uncommon (occur in less than 1 out of 100 people):

• Respiratory tract infection, urinary bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection limited to one area of the skin or one body part, viral infection, skin inflammation caused by mites,
• Decreased number of certain white blood cells that protect the body against infection, decreased number of white blood cells, decreased number of platelets (blood cells involved in stopping bleeding), anaemia, decreased number of red blood cells, increased eosinophil count (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,
• Increased blood cholesterol levels,
• Elevated mood (mania), confusion, decreased sexual drive, nervousness, nightmares,
• Lack of response to stimuli, loss of consciousness, low level of consciousness,
• Seizures, fainting,
• Need to move body parts, balance disturbances, coordination problems, dizziness upon changing to upright position, concentration difficulties, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness of the skin,
• Light sensitivity of the eyes, dry eye, increased tearing, eye redness,
• Sensation of dizziness (of labyrinthine origin), ringing in the ears, ear pain,
• Atrial fibrillation (irregular heartbeat), conduction block between the upper and lower chambers of the heart, abnormal conduction of electrical impulses in the heart, QT interval prolongation on ECG, slow heartbeat, abnormal electrocardiogram (ECG), palpitations,
• Low blood pressure, low blood pressure upon standing (as a result of which some patients taking Ryspolit may faint, feel dizzy or lose consciousness when standing up suddenly), facial flushing,
• Aspiration pneumonia caused by food entering the airways, pulmonary congestion, respiratory tract congestion, crackles in the lungs, wheezing/whistling breathing, voice disturbances, breathing difficulties,
• Gastritis and enteritis, faecal incontinence, very hard stools, difficulty swallowing, excessive flatulence,
• Urticaria, severe skin itching, hair loss, skin thickening, eczema, dry skin, skin depigmentation, acne, itchy, scaly skin of the scalp and other body parts, skin disorders, skin changes,
• Increased blood levels of creatine phosphokinase, an enzyme sometimes released from damaged muscles,
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain,
• Frequent urination, inability to urinate, pain during urination,
• Erectile dysfunction, ejaculation disorders,
• Delayed menstruation, absence of menstruation and 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 eyelids,
• Chills, increased body temperature,
• Change in walking pattern,
• Thirst, malaise, chest discomfort, feeling "unwell", discomfort,
• Increased activity of aminotransferases and gamma-glutamyl transferase in blood, increased liver enzyme activity in blood,
• Pain related to medical procedures.

Rare (occur in less than 1 out of 1,000 people):

• Infection,
• Abnormal secretion of the hormone regulating urine production,
• Sleepwalking (somnambulism),
• Sleep-related eating disorders,
• Glucose in urine, low blood sugar levels, increased blood triglyceride levels,
• Lack of emotion, inability to achieve orgasm,
• Cerebrovascular disorders,
• Coma due to uncontrolled diabetes,
• Head tremor,
• Glaucoma (increased pressure in the eyeball), eye movement disorders, rotatory eye movements, eyelid margin ulcers,
• Eye complications may also occur during cataract surgery. During this procedure, intraoperative floppy iris syndrome (IFIS) may occur if the patient is currently or has previously taken Ryspolit. If a patient has planned cataract surgery, the ophthalmologist must be informed about current or past use of this medicine,
• Dangerously low number of certain white blood cells responsible for fighting infections,
• Dangerous, excessive water intake,
• Irregular heartbeat,
• Breathing problems during sleep, rapid, shallow breathing,
• Immobility or excessive agitation (catatonia),
• Pancreatitis, intestinal obstruction,
• Tongue swelling, lip inflammation, drug hypersensitivity (skin rash),
• Psoriasis,
• Muscle fiber breakdown and muscle pain (rhabdomyolysis),
• Delayed menstruation, enlargement of mammary glands, breast enlargement, breast discharge,
• Increased blood insulin levels (a hormone regulating blood sugar levels),
• Skin thickening,
• Low body temperature, cold hands and feet,
• Withdrawal symptoms,
• Yellowing of the skin and eyes (jaundice).

Very rare (occur in less than 1 out of 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.

An adverse effect observed during use of another medicine – paliperidone, very similar to risperidone – which may also occur during use of Ryspolit: rapid heartbeat upon standing.

Additional adverse effects in children and adolescents
Generally, adverse effects in children are similar to those observed in adults. The following adverse 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, cold-like symptoms, nasal mucosa congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhoea and involuntary urination.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ryspolit

Keep this medicine 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 specified month.
The label on the packaging shows EXP followed by the expiry date, and Lot followed by 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. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ryspolit contains

• The active substance is risperidone. 1 ml of oral solution contains 1 mg of risperidone.
• The other ingredients are: tartaric acid (E334), benzoic acid (E210), concentrated hydrochloric acid (for pH adjustment), and purified water.

What Ryspolit looks like and contents of the pack
Ryspolit is a clear, colourless oral solution.
The medicine is available in PP/LDPE bottles with child-resistant caps containing 30 ml and 100 ml of solution, packed in a cardboard carton.
A dosing pipette supplied with the 30 ml and 100 ml bottles is graduated in milligrams and millilitres from the minimum value of 0.25 ml up to the maximum value of 3 ml. The dosing pipette has markings every 0.25 ml (corresponding to 0.25 mg of oral solution) up to 3 ml (corresponding to 3 mg of oral solution).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Poland

Manufacturer
Chanelle Medical Unlimited Company
Loughrea, Co. Galway
Ireland