Rispolit

Package Leaflet: Information for the Patient

Ryspolit, 1 mg, coated tablets

Ryspolit, 2 mg, coated tablets

Ryspolit, 3 mg, coated tablets

Ryspolit, 4 mg, coated tablets

Risperidone

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

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

Table of Contents of the 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 can cause the patient to 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 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 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:

• 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 is aware of any factors that may increase the risk of stroke, such as high blood pressure, cardiovascular disease, or cerebral vascular 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. If such symptoms occur during treatment with Ryspolit, the patient should immediately contact their doctor.
• if the patient has disorders of body temperature regulation or overheating.
• 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).

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.
• 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 unsure whether any of the above symptoms 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 developed a potentially life-threatening decrease in the number of certain white blood cells needed to fight infections.
Ryspolit may cause weight gain. Significant weight gain can have a negative impact on health. The doctor will regularly monitor the patient's weight.
The doctor should check for symptoms of high blood sugar levels, as patients taking Ryspolit have developed 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 floppy during the procedure, which can result in eye damage. If the patient is scheduled for eye surgery, they should inform their ophthalmologist about taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. Patients with dementia caused by stroke should not take risperidone. During treatment with Ryspolit, the patient should frequently consult their doctor. The patient or their caregiver should immediately seek medical attention if they notice 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 disturbances, 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.
The doctor may recommend measuring the patient's weight before treatment and regularly monitoring it during treatment.

Ryspolit and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Patients should especially inform their doctor or pharmacist if they are taking any of the following medicines:

• medicines that act on the brain, such as sedatives (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect,
• medicines that can cause changes in heart rhythm, 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 rate,
• medicines that lower potassium levels in the blood (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 heart disease or to reduce swelling in areas where there is excessive fluid accumulation, e.g., furosemide or chlorthiazide). Ryspolit taken alone or in combination 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 (medicines for epilepsy),
• phenobarbital. If the patient starts or stops taking these medicines, the dose of risperidone may need to be adjusted.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart diseases),
• antidepressants, such as paroxetine, fluoxetine, tricyclic antidepressants,
• beta-blockers (used to treat high blood pressure),
• phenothiazines (used to treat psychoses or to sedate),
• cimetidine, ranitidine (reducing stomach acid),

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, drinks, 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 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 the baby experiences any of these symptoms, the patient should contact their 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, the patient may experience dizziness, fatigue, and vision disturbances. Therefore, the patient should not drive, use tools, or operate any machines without consulting their doctor.

Ryspolit contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Ryspolit

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended dose:

In the treatment of schizophrenia

Adults

• Typically, 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. The doctor will inform the patient which method of taking the medicine is best for them.

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.
• The doctor will inform the patient which method of taking the medicine is best for them.

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 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.
• Typically, 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.
• Typically, 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:

The patient should discuss the appropriateness of a 0.25 mg dose with their doctor. The 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 with a glass of water.

Taking a higher dose of Ryspolit than recommended

The patient should immediately consult their doctor. The patient should take the medicine packaging with them.
In case of an overdose, the patient may experience drowsiness or fatigue, or 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 the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose as recommended. If the patient misses two or more doses, they should contact their doctor. The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Ryspolit

The patient should not stop taking Ryspolit unless it is recommended by their doctor. It is possible that the symptoms of the disease will recur. If the doctor decides to stop treatment, the dose of Ryspolit 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 consult their doctor:

• if blood clots form 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 immediately seek medical attention.
• if the 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 disturbances, even if they occur for a short time. These symptoms may indicate a stroke.
• if the patient experiences 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 a man and experiences a prolonged or painful erection. This condition is called priapism. Immediate treatment may be necessary.
• if the patient experiences involuntary rhythmic movements of the tongue or face. It may be necessary to discontinue Ryspolit.
• if the patient experiences a severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, or a drop in blood pressure.

The following side effects may occur:
Very common(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 can cause the patient's movements to be 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 saliva production, and a mask-like face,
• Drowsiness or sedation,
• Headache.

Common(occurring in 1 to 10 in 100 patients)

• Pneumonia, bronchitis, symptoms of a cold,
• 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 leakage from the breasts, absence of menstruation, or other menstrual cycle disorders,

seksualne. U kobiet mogą one obejmować uczucie dyskomfortu dotyczące piersi, wyciek mleka
z piersi, brak krwawienia miesiączkowego lub inne zaburzenia cyklu miesiączkowego,

• Weight gain, increased appetite, decreased appetite,
• Sleep disturbances, irritability, depression, anxiety, restlessness (inability to sit still or remain motionless),
• Dystonia: This condition involves 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: This condition involves involuntary muscle movements, including repetitive, spasmodic, or twisting movements, or jerks,
• Tremors,
• Blurred vision, eye infection, or conjunctivitis,
• Fast 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, severe itching of the skin, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, flaky, itchy skin on 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,
• 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 certain white blood cells that protect 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, nightmares,
• Late dyskinesia (involuntary, repetitive, or jerky movements of the face, tongue, or other body parts). 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,
• 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 disturbances, coordination disturbances, dizziness when changing position to standing, concentration disturbances, speech difficulties, loss of taste, impaired sensation of pain and touch on the skin, tingling, numbness, or prickling sensation on 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 conduction of electrical impulses in the heart, prolonged QT interval in the heart, slow heart rate, abnormal electrocardiogram (ECG), feeling of heart palpitations (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 (inhalation of food into the airways), pulmonary congestion, respiratory distress, wheezing/whistling breath, voice disturbances,
• 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 on the head and body, skin disorders, skin changes,
• Increased activity of liver enzymes in the blood,
• Muscle spasms, muscle pain, back pain, joint 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 leakage 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,
• Thirst, malaise, chest discomfort, feeling unwell, discomfort,
• 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 secretion of the hormone that regulates urine production,
• Sugar in the 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 (a life-threatening condition caused by uncontrolled diabetes),
• Head tremors,
• Glaucoma (increased pressure in the eye), eye movement disorders, rotational eye movements, eyelid margin inflammation, and other eye complications. Complications related to the eye may also 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 inform their ophthalmologist about taking this medicine.
• A potentially life-threatening decrease in the number of certain white blood cells needed to fight infections,
• Severe allergic reaction characterized by swelling, which can involve the throat and lead to breathing difficulties,
• Life-threatening complication of uncontrolled diabetes,
• Severe allergic reaction with swelling, which can involve the throat and lead to breathing difficulties,
• Intestinal obstruction due to decreased bowel movement.

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

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

A side effect observed in patients taking paliperidone, a medicine very similar to risperidone, which may also occur in patients taking Ryspolit: fast 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, symptoms of a cold, runny nose, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and involuntary urination.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will 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. 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 Ryspolit is risperidone. Each coated tablet of Ryspolit contains 1 mg, 2 mg, 3 mg, or 4 mg of risperidone.
• The other ingredients of Ryspolit are: lactose anhydrous, microcrystalline cellulose, maize starch, magnesium stearate, and the coating contains 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, scored tablet, 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, scored tablet, 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, scored tablet, 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, scored tablet, 14 mm x 7.5 mm in size, with the inscription "T4". The tablet can be divided into equal doses.
The pack 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: