Rispolit

Leaflet accompanying the packaging: patient information

Ryspolit, 1 mg, coated tablets

Ryspolit, 2 mg, coated tablets

Ryspolit, 3 mg, coated tablets

Ryspolit, 4 mg, coated tablets

Risperidone

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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. Package contents 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, irritability, enthusiasm, or be overly active. Manic episodes occur in the course of bipolar affective disorders.
• short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's disease who 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 the 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 not sure 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, you should discuss it with your doctor:

• 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 regulating 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.
• in patients with Parkinson's disease or dementia.
• in patients with diabetes.
• in patients with epilepsy.
• if the patient is a man and has experienced prolonged or painful erections. In the event of such symptoms occurring during treatment with Ryspolit, you should immediately contact your doctor.
• if the patient has body temperature regulation disorders or overheats.
• if the patient has kidney function disorders.
• if the patient has liver function disorders.
• if the patient has an abnormally high level of prolactin 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 such medicines as Ryspolit is associated with the formation of blood clots.
• 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).

You should immediately inform your doctor if you experience:

• involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Ryspolit.
• fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate treatment may be necessary. If the patient is not sure whether any of the above symptoms apply to them, they should consult a doctor or pharmacist before taking Ryspolit.

Your 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. Your doctor will regularly monitor your weight.
Your doctor should check if you have 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 monitored.
During cataract surgery, the pupil may not dilate sufficiently. The iris may also be flaccid during the procedure, which can result in eye damage. If you have scheduled eye surgery, you should tell your 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. You should seek medical help immediately if the patient or their caregiver notices a sudden change in the patient's mental state or sudden weakness or numbness of the face, arms, or legs, especially if it is one-sided, or speech disorders, even if they occur for a short time. These symptoms may indicate a stroke.

Children and adolescents

Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.
If the patient experiences fatigue during treatment, changing the time of taking risperidone may improve concentration.
Your doctor may recommend measuring body weight before treatment and regularly monitoring it during treatment.

Ryspolit and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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 can cause changes in heart electrical activity, such as malaria medicines, anti-arrhythmic medicines (e.g., quinidine), antihistamines, certain antidepressants, or other medicines used to treat mental disorders,
• medicines that slow down heart activity,
• medicines that lower blood potassium levels (e.g., certain diuretics),
• medicines used to treat high blood pressure. Ryspolit may lower blood pressure.
• medicines used to treat Parkinson's disease, such as levodopa,
• diuretics (used in patients with heart disease or to relieve swelling in areas where there is excessive fluid accumulation, e.g., furosemide or chlorthiazide). Ryspolit taken alone or together with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may weaken the effect of risperidone:

• rifampicin (a medicine used to treat certain infections),
• carbamazepine, phenytoin (antiepileptic medicines),
• phenobarbital. If you start or stop taking these medicines, you may need 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-adrenergic blockers (used to treat high blood pressure),
• phenothiazines (used to treat psychoses or to sedate),
• cimetidine, ranitidine (reducing stomach acid),

If you are not sure whether you have taken or are taking any of the above medicines, you should consult your 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, you should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Ryspolit.
• In newborns of mothers who 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 your child experiences any of these symptoms, you should contact your doctor.
• Risperidone may increase the level of prolactin in the blood - a hormone that can affect fertility (see "Possible side effects").

Driving and using machines

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

Ryspolit contains lactose

If you have been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.

3. How to take Ryspolit

This medicine should always be taken according to your doctor's recommendations. If you have any doubts, you should consult your doctor or pharmacist.

Recommended dose:

In the treatment of schizophrenia

Adults

• Usually, the 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 can be taken once or divided into two doses. Your doctor will inform you which method of taking the medicine is best for you.

Elderly patients

• The initial dose is usually 0.5 mg twice a day.
• Then, the doctor may gradually increase the dose to 1 mg to 2 mg twice a day.
• Your doctor will inform you which method of taking the medicine is best for you.

Children and adolescents

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

In the treatment of manic episodes

Adults

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

Children and adolescents

• Ryspolit should not be used in children and adolescents under 18 years of age for the treatment of mania in bipolar affective disorders.

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

Adults (including elderly patients)

• The 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.

In the treatment of behavioral disorders in children and adolescents

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

• The 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.
• Usually, the 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 initial dose is usually 0.5 mg once a day.
• The dose may be increased every other day by 0.5 mg per day.
• Usually, the 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.

Important:

You should discuss the appropriateness of a 0.25 mg dose with your doctor. Your doctor may prescribe a different medicine with the appropriate strength.

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.

How to take Ryspolit

The tablet should be swallowed, washed down with a glass of water.

Taking a higher dose of Ryspolit than recommended

You should immediately consult a doctor. You should take the packaging of the medicine with you.
In the event of an overdose, the patient may experience drowsiness or fatigue, or may have abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, or abnormal heart rhythm, or may have a seizure.

Missing a dose of Ryspolit

If you forget to take a dose, you should take the next dose as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose and take the next dose as recommended. If you forget to take two or more doses, you should consult your doctor. You should not take a double dose to make up for the missed dose.

Stopping treatment with Ryspolit

You should not stop taking Ryspolit unless it is recommended by your doctor. It is possible that the symptoms of the disease will recur. If your doctor decides to stop treatment with Ryspolit, the dose of the medicine may be gradually reduced over several days.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ryspolit can cause side effects, although not everybody gets them.

You should immediately consult your doctor:

• if blood clots occur 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 you experience such symptoms, you should immediately seek medical help.
• if a patient with dementia experiences a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially if it is one-sided, or speech disorders, even if they occur for a short time. These symptoms may indicate a stroke.
• if fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome) occur. Immediate treatment may be necessary.
• if a man experiences prolonged or painful erections. This condition is called priapism. Immediate treatment may be necessary.
• if involuntary rhythmic movements of the tongue or face occur. It may be necessary to discontinue Ryspolit.
• if a severe allergic reaction occurs, characterized by fever, swelling of the lips, face, eyelids, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure.

The following side effects may occur:
Very common(occurring in more than 1 in 10 patients)

• Difficulty sleeping or inability to sleep,
• Parkinsonism: This condition may include slow or abnormal movements, a feeling of stiffness or muscle tension (which makes the patient's movements uneven, jerky), and sometimes even a feeling of "freezing" of movements, followed by release. Other symptoms of parkinsonism include a slow, shuffling gait, tremors at rest, increased saliva production, and a face without expression,
• Drowsiness or sedation,
• Headache.

Common(occurring in 1 to 10 in 100 patients)

• Pneumonia, bronchitis, common cold symptoms,
• Flu,
• Sinus infection,
• Urinary tract infection,
• Ear infection,
• Ryspolit may increase the level of prolactin in the blood (with or without symptoms). If symptoms of high prolactin levels occur, they may include in men: breast swelling, difficulty achieving or maintaining an erection, or other sexual disorders. In women, they may include breast discomfort, milk secretion from the breasts, absence of menstruation, or other menstrual cycle disorders,

increased body weight, increased appetite, decreased appetite,

• Sleep disorders, irritability, depression, anxiety, restlessness (inability to sit still or remain motionless),
• 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 eye movements, mouth, tongue, or jaw,
• Dizziness,
• Dyskinesia: In this condition, there are involuntary muscle movements, including repetitive, spasmodic, or twisting movements, or jerks,
• Tremors,
• Blurred vision, eye infection, or conjunctivitis,
• Rapid heartbeat, high blood pressure,
• Breathing difficulties,
• Sore throat, cough,
• Nosebleeds, stuffy nose,
• Abdominal pain, discomfort in the abdomen, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache,
• Rash, skin redness,
• 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(occurring in 1 to 10 in 1,000 patients)

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, limited skin infection or body part infection, viral infection, skin rash caused by mites,
• Decreased number of a certain type of white blood cell that protects the body against bacterial infections, decreased number of white blood cells, decreased number of platelets (blood cells involved in blood clotting), 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,
• Increased cholesterol levels in the blood,
• Elevated mood (mania), confusion, decreased sex drive, nervousness, nightmares,
• Late dyskinesia (twitching or jerking uncontrolled movements of the face, tongue, or other body parts). You should immediately inform your doctor if you experience involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Ryspolit,
• Sudden cessation of blood flow to the brain (stroke or "mini-stroke"),
• Lack of response 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, impaired sensation of pain and touch on the skin, feeling of tingling, pricking, or numbness of the skin,
• Increased sensitivity to light, dry eye, increased tearing, redness of the eyes,
• Feeling of dizziness, ringing in the ears, ear pain,
• Atrial fibrillation (abnormal heart rhythm), blockage of impulse conduction between the upper and lower parts of the heart, abnormal electrical conduction in the heart, prolonged QT interval in the heart, slow heart rhythm, abnormal electrocardiogram (ECG), feeling of heartbeat (palpitations),
• Low blood pressure, low blood pressure when changing position to standing (as a result, some patients taking Ryspolit may faint, feel dizzy, or lose consciousness when standing up or getting up), flushing of the face,
• Aspiration pneumonia, pulmonary congestion, respiratory disorders, crackling in the lungs, wheezing, voice disorders,
• Difficulty swallowing, gastritis, intestinal obstruction, constipation, very hard stools, excessive gas,
• Hives, severe itching of the skin, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, flaky, itchy skin of the head and body, skin disorders, skin changes,
• Increased creatine phosphokinase activity 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, breast pain, breast discomfort, vaginal discharge, sexual disorders,
• Facial swelling, lip swelling, eye swelling, or 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 aminotransferases and gamma-glutamyltransferase in the blood, increased activity of liver enzymes in the blood,
• Pain related to medical procedures.

Rare(occurring in 1 to 10 in 10,000 patients)

• Infection,
• Abnormal hormone secretion regulating urine production,
• Sugar in urine, low blood sugar levels, increased triglyceride levels in the blood,
• Increased insulin levels in the blood (a hormone that regulates blood sugar levels),
• Lack of emotions, inability to achieve orgasm,
• Malignant neuroleptic syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness),
• Cerebrovascular disorders,
• Diabetic coma due to uncontrolled diabetes,
• Head tremors,
• Glaucoma (increased pressure in the eyeball), eye movement disorders, rotational eye movements, eyelid margin ulcers, complications related to cataract surgery may also occur. During this procedure, a condition called intraoperative floppy iris syndrome (IFIS) may occur if the patient is taking or has taken Ryspolit. If you have scheduled cataract surgery, you should tell your ophthalmologist about taking this medicine in the past or present,
• Severely low number of certain white blood cells necessary for fighting infections,
• Severe allergic reaction characterized by swelling, which may involve the throat and lead to breathing difficulties, itching, skin rash, and sometimes a drop in blood pressure,
• Life-threatening complications due to uncontrolled diabetes,
• Severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties,
• Intestinal obstruction due to lack of bowel movement.

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

• Life-threatening complications due to uncontrolled diabetes,
• Severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties,
• Intestinal obstruction due to lack of bowel movement.

A side effect observed in patients taking paliperidone, a medicine very similar to risperidone, which may also occur in patients taking Ryspolit: rapid heartbeat when changing position to standing.
Additional side effects in children and adolescents
Usually, 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, nasal congestion, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and involuntary urination.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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:
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Ryspolit

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. 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/LOT means the batch number.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ryspolit contains

• The active substance of the medicine is risperidone. Each Ryspolit coated tablet contains 1 mg, 2 mg, 3 mg, or 4 mg of risperidone.
• The other ingredients of the medicine are: lactose anhydrous, microcrystalline cellulose, corn starch, magnesium stearate, and the components of the tablet coating Opadry White 03F28470: hypromellose 6 cP, macrogol 6000, and titanium dioxide (E171).

What Ryspolit looks like and contents of the pack

1 mg tablet: white, coated, round, biconvex, with a dividing line, 8 mm x 5 mm in size, with the inscription "T1". The tablet can be divided into equal doses.
2 mg tablet: white, coated, round, biconvex, with a dividing line, 10 mm x 5 mm in size, with the inscription "T2". The tablet can be divided into equal doses.
3 mg tablet: white, coated, round, biconvex, with a dividing line, 11 mm x 6.5 mm in size, with the inscription "T3". The tablet can be divided into equal doses.
4 mg tablet: white, coated, round, biconvex, with a dividing line, 14 mm x 7.5 mm in size, with the inscription "T4". The tablet can be divided into equal doses.
The package contains 20, 28, 30, 60, or 100 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland
Actavis Ltd.,
BLB 016 Bulebel Industrial Estate
Zejtun, Malta
Balkanpharma-Dupnitsa AD,
3 Samokovsko Shosse Str.
Dupnitza 2600
Bulgaria

Date of last revision of the leaflet: