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
Please read this leaflet carefully before using this medicine, as 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 adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Ryspolit is and what it is used for
Important information before taking Ryspolit
How to take Ryspolit
Possible side effects
How to store Ryspolit
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 in things that are not true, or experience unusual suspiciousness or disorientation.
In the treatment of manic episodes – a condition in which the patient may experience intense excitement, agitation, elation, or excessive activity. Manic episodes occur in bipolar affective disorders.
In 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. Non-pharmacological treatment options should be considered before initiating therapy.
In 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 to relieve disease symptoms and prevent their recurrence.

2. Important 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 a doctor or pharmacist before using Ryspolit.

Warnings and precautions
Before starting treatment with Ryspolit, discuss the following with a doctor:

if the patient has heart problems, such as irregular heartbeat, or if they are prone to low blood pressure, or if they are taking medicines for blood pressure. Ryspolit may cause a drop in blood pressure. A dose adjustment may be necessary.
if the patient has any risk factors for stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disease.
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 erection. If this occurs during treatment with Ryspolit, medical advice should be sought immediately.
if the patient has problems with body temperature regulation or is overheating.
if the patient has kidney problems.
if the patient has liver problems.
if the patient has abnormally high levels of the hormone prolactin in the blood or a tumour likely to be prolactin-dependent.
if the patient or a family member has previously had blood clots, as treatment with medicines like Ryspolit may increase the risk of thrombosis.
if the patient has previously had a low white blood cell count (whether or not caused by other medicines).

Immediately inform the doctor if the patient experiences:

involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of Ryspolit may be necessary.
fever, severe muscle stiffness, sweating or decreased level of consciousness (a condition called neuroleptic malignant syndrome). Immediate medical treatment may be required. If the patient is unsure whether any of the symptoms described above apply to them, they should consult a doctor or pharmacist before using Ryspolit.

The treating doctor may order a white blood cell count, as very rarely, patients taking Ryspolit have developed a dangerously low number of certain white blood cells essential for fighting infections.
Ryspolit may cause weight gain. Significant weight gain may negatively affect health. The treating doctor will regularly monitor the patient's body weight.
The doctor should check for symptoms of high blood glucose levels, as diabetes has been observed in patients taking Ryspolit, and pre-existing diabetes may worsen. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
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 has eye surgery planned, they must inform the ophthalmologist about taking this medicine.

Elderly patients with dementia
Elderly patients with dementia have an increased risk of stroke. Patients with dementia caused by stroke should not take risperidone. During treatment with Ryspolit, the patient should have regular medical check-ups. Seek immediate medical help if the patient or caregiver notices a sudden change in mental status, sudden weakness or numbness in the face, arms or legs (especially on one side), or speech disturbances, even if brief. These symptoms may indicate a stroke.

Children and adolescents
Before starting treatment for behavioural disorders, other causes of aggressive behaviour should be ruled out.
If fatigue occurs during treatment, changing the time of administration of risperidone may improve concentration.
The doctor may recommend measuring body weight before treatment and regular monitoring during treatment.

Ryspolit and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Patients should especially inform the doctor or pharmacist if they are taking any of the following medicines:

medicines acting on the brain, such as those used to calm down (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effects,
medicines that may cause changes in the electrical activity of the heart, such as antimalarial drugs, antiarrhythmics (e.g. quinidine), antihistamines, certain antidepressants or other medicines used to treat psychiatric disorders,
medicines that slow down heart rate,
medicines that reduce potassium levels in the blood (e.g. certain diuretics),
medicines used for high blood pressure. Ryspolit may lower blood pressure.
medicines used in Parkinson's disease, e.g. levodopa,
diuretics, used in patients with heart disease or to reduce fluid accumulation (e.g. furosemide or chlorothiazide). Ryspolit, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

rifampicin (used to treat certain infections),
carbamazepine, phenytoin (antiepileptic medicines),
phenobarbital. Dose adjustment of risperidone may be necessary when starting or stopping these medicines.

The following medicines may increase the effect of risperidone:

quinidine (used in certain heart conditions),
antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants,
medicines known as beta-blockers (used to treat high blood pressure),
phenothiazines (used to treat psychosis or for sedation),
cimetidine, ranitidine (reducing stomach acid). Dose adjustment of risperidone may be necessary when starting or stopping these medicines.

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

Ryspolit with food, drink and alcohol
This medicine may be taken with or without food. Alcohol should be avoided during treatment with Ryspolit.

Pregnancy, breastfeeding and fertility

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

Driving and operating machinery
Dizziness, fatigue and visual disturbances may occur during treatment with Ryspolit. Therefore, driving, using tools or operating machinery should not be undertaken without consulting a doctor.

Ryspolit contains lactose
If the patient has previously 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 directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose:

In the treatment of schizophrenia

Adults

The usual starting dose is 2 mg per day. This dose may be increased on the second day to 4 mg per day.
Depending on the patient's response to treatment, the doctor may adjust the dose.
For most patients, the optimal daily dose ranges from 4 mg to 6 mg.
This total daily dose may be taken once daily or divided into two doses. Your doctor will advise which method of administration is best for you.

Elderly patients

The usual starting dose is 0.5 mg twice daily.
The doctor may then gradually increase the dose to 1 mg – 2 mg twice daily.
Your doctor will advise which method of administration is best for you.

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 usual starting dose is 2 mg once daily.
Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
For most patients, the optimal dose ranges from 1 mg to 6 mg once daily.

Elderly patients

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

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 disorder.

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

Adults (including elderly patients)

The usual starting dose is 0.25 mg twice daily.
Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
For most patients, the optimal 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.

In the treatment of behavioural disorders in children and adolescents

The dose depends on the child's body weight:

Children with body weight below 50 kg

The usual starting dose is 0.25 mg once daily.
The dose may be increased every other day (gradually) by 0.25 mg per day.
The usual maintenance dose is generally between 0.25 mg and 0.75 mg once daily.

Children with body weight of 50 kg or more

The usual starting dose is 0.5 mg once daily.
The dose may be increased every other day by 0.5 mg per day.
The usual maintenance dose is generally between 0.5 mg and 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.

Important:
The necessity of using a 0.25 mg dose should be discussed with the doctor. The doctor may prescribe another medicine with an appropriate strength.

Patients with renal or hepatic impairment
Regardless of the condition being treated, all starting 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 patient group.

How to take Ryspolit
Swallow the tablet with a glass of water.

Taking more Ryspolit than prescribed
Seek medical advice immediately. Take the medicine package with you.
In case of overdose, the patient may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, irregular heartbeat, or seizures 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 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 recur. 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.
You should contact a doctor immediately if:

Blood clots in the veins occur, 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 difficulty breathing. If such symptoms occur, seek immediate medical help.
A sudden change in mental state, sudden weakness or numbness of the face, hands or feet (especially on one side), or speech disturbances occur in a patient with dementia, even if they are short-lived. These symptoms may indicate a stroke.
Fever, muscle stiffness, sweating or decreased level of consciousness occurs (a condition known as neuroleptic malignant syndrome). Immediate treatment may be necessary.
A prolonged or painful erection occurs in men. This condition is known as priapism. Immediate treatment may be necessary.
Involuntary, rhythmic movements of the tongue or face occur. Discontinuation of risperidone treatment may be necessary.
A severe allergic reaction occurs, characterised by: fever, swelling of the lips, face, tongue or throat, shortness of breath, skin itching, rash or drop in blood pressure.

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

Difficulty falling asleep or inability to sleep,
Parkinsonism: This condition may involve slow or abnormal movements, feelings of stiffness or muscle tension (causing movements to be jerky or uneven), and sometimes even a sensation of "freezing" of movement 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 (occurring in 1 to 10 in 100 patients)

Pneumonia, bronchitis, cold symptoms,
Influenza,
Sinus infection,
Urinary tract infection,
Ear infection,
Ryspolit medicine may increase the level of the hormone prolactin in the blood (with or without symptoms). If symptoms of increased prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erection, or other sexual disturbances. In women, they may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding, or other menstrual cycle disturbances,
Weight gain, increased appetite, decreased appetite,
Sleep disturbances, irritability, depression, anxiety, akathisia (inability to sit still or remain motionless),
Dystonia: In this condition, slow or sustained involuntary muscle contractions occur. 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: In this condition, involuntary muscle movements occur, including repetitive, spasmodic or twisting movements, or jerking,
Tremor,
Blurred vision, eye infection or conjunctival congestion,
Rapid heartbeat, high blood pressure,
Difficulty breathing,
Sore throat, cough,
Nosebleeds, 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,
Falls.

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

Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin or body part infection, viral infection, dermatitis caused by mites,
Decreased number of certain white blood cells that protect the body against bacterial infection, decreased number of white blood cells, decreased number of platelets (blood cells involved in stopping bleeding), anaemia (anaemia), decreased number of red blood cells, increased eosinophilia (a type of white blood cell),
Allergic reaction,
Diabetes or worsening of existing diabetes, high blood sugar levels, excessive water drinking,
Weight loss, reduced appetite leading to malnutrition and low body weight,
Increased cholesterol levels in the blood,
Elevated mood (mania), confusion, decreased libido, restlessness, nightmares,
Tardive dyskinesia (twitching or jerking uncontrolled movements of the face, tongue or other body parts). You should inform your doctor immediately if rhythmic involuntary movements of the tongue, lips or face occur. Discontinuation of Ryspolit medicine may be necessary,
Sudden interruption 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 upon standing, concentration difficulties, speech difficulties, loss or abnormal sensation of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness of the skin,
Light sensitivity, dry eye, increased tearing, eye redness,
Dizziness, ringing in the ears, ear pain,
Atrial fibrillation (irregular heartbeat), conduction block between upper and lower heart chambers, abnormal electrical conduction in the heart, QT interval prolongation on ECG, slow heart rate, abnormal ECG readings, palpitations (awareness of heartbeats),
Low blood pressure, low blood pressure upon standing (as a result, some patients taking Ryspolit may faint, feel dizzy or lose consciousness when standing up suddenly),
Facial flushing,
Lung infection due to food entering the airways, pulmonary congestion, congestion of the airways, breathing disturbances, crackles in the lungs, rattling/wheezing, voice disturbances,
Difficulty swallowing, stomach and intestinal inflammation, faecal incontinence, very hard stools, excessive passing of gas,
Urticaria, severe skin itching, hair loss, skin thickening, eczema, dry skin, skin discolouration, acne, scaly and itchy scalp and body skin, skin disorders, skin changes,
Increased creatine phosphokinase activity in blood, 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, breast pain, breast discomfort, vaginal discharge, sexual disturbances,
Swelling of the face, lips, eyes or lips, chills, increased body temperature,
Change in gait,
Thirst, malaise, chest discomfort, feeling "unwell", discomfort,
Increased activity of aminotransferases and gamma-glutamyl transferase in blood, increased liver enzyme activity in blood,
Pain associated with medical procedures.

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

Infection,
Abnormal secretion of the hormone regulating urine volume,
Glucose in urine, low blood sugar levels, increased blood triglyceride levels,
Increased insulin levels in blood (a hormone regulating blood sugar levels),
Lack of emotion, inability to achieve orgasm,
Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever and severe muscle rigidity),
Cerebrovascular disorders,
Coma due to uncontrolled diabetes,
Head tremor,
Glaucoma (increased pressure in the eyeball), eye movement disorders, rotary eye movements, eyelid margin ulcers. Complications involving the eye may also occur during cataract surgery. During this procedure, intraoperative floppy iris syndrome (IFIS) may occur if the patient is currently or previously taking Ryspolit medicine. 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,
Severe allergic reaction characterised by fever, swelling of lips, face, tongue or throat, shallow breathing (dyspnoea), itching, skin rash, and sometimes drop in blood pressure,
Dangerous, excessive water drinking,
Irregular heartbeat,
Blood clots in legs; blood clot in lungs,
Breathing problems during sleep, rapid, shallow breathing,
Pancreatitis, intestinal obstruction,
Tongue swelling, lip inflammation,
Drug hypersensitivity (skin rash), pityriasis,
Muscle fibre breakdown and muscle pain (rhabdomyolysis),
Delayed menstruation, breast gland enlargement, breast enlargement, breast discharge,
Priapism (prolonged erection which may require surgical intervention),
Skin thickening,
Decreased body temperature, cold hands and feet,
Withdrawal symptoms,
Yellowing of the skin and eyes (jaundice).

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

Life-threatening complications associated with uncontrolled diabetes,
Severe allergic reaction with swelling which may involve the larynx 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 symptoms, nasal mucosal 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, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website:
Adverse effects can also be reported to the marketing authorisation 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer carton. The expiry date refers to the last day of the specified month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and the abbreviation Lot/LOT indicates the batch number.
No special precautions regarding storage are required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Ryspolit contains

The active substance is risperidone. Each Ryspolit coated tablet contains 1 mg, 2 mg, 3 mg, or 4 mg of risperidone, respectively.
Other ingredients are: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, magnesium stearate, and for the tablet coating Opadry White 03F28470: hypromellose 6 cP, polyethylene glycol 6000, and titanium dioxide (E171).

What Ryspolit looks like and contents of the pack
1 mg tablet: white, coated, round, biconvex tablet with a dividing groove,
measuring 8 mm x 5 mm, imprinted with the code "T1". The tablet can be divided into equal doses.
2 mg tablet: white, coated, round, biconvex tablet with a dividing groove,
measuring 10 mm x 5 mm, imprinted with the code "T2". The tablet can be divided into equal doses.
3 mg tablet: white, coated, round, biconvex tablet with a dividing groove,
measuring 11 mm x 6.5 mm, imprinted with the code "T3". The tablet can be divided into equal doses.
4 mg tablet: white, coated, round, biconvex tablet with a dividing groove,
measuring 14 mm x 7.5 mm, imprinted with the code "T4". The tablet can be divided into equal doses.
Pack contents: 20, 28, 30, 60, or 100 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +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.
Dupnitsa 2600
Bulgaria