Rispolept

Package leaflet: Information for the patient

Rispolept, 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

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

1. What Rispolept is and what it is used for

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

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

Rispolept helps to reduce the symptoms of the illness and prevent their recurrence.

2. Important information before taking Rispolept

When not to take Rispolept

• if the patient is allergic to the active substance or to 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 Rispolept.

Warnings and precautions

Before starting treatment with Rispolept, discuss the following with your doctor or pharmacist:

• if the patient has heart function disorders, such as irregular heartbeat, or if the patient is prone to low blood pressure, or is taking medicines to regulate blood pressure. Rispolept 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 cerebrovascular disorders
• if the patient has ever experienced involuntary movements of the tongue, mouth, or face
• if the patient has ever had a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as 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 is a man who has experienced prolonged or painful erection
• if the patient has disorders in body temperature regulation or is overheating
• if the patient has kidney function disorders
• if the patient has liver function disorders
• if the patient has abnormally high levels of the hormone prolactin in the blood or suspected prolactin-dependent tumor
• if the patient or a family member has a history of blood clots, as treatment with medicines like Rispolept has been associated with blood clot formation.

If the patient is unsure whether any of the symptoms described above apply to them, they should consult their doctor or pharmacist before taking Rispolept.

The treating doctor may order a white blood cell count, as a dangerously low number of certain types of white blood cells necessary to fight infections has been observed very rarely in patients taking Rispolept.

Rispolept 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 onset or worsening of pre-existing diabetes has been observed in patients taking Rispolept. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.

Rispolept often increases the level of a hormone called prolactin. This may cause adverse effects such as menstrual disorders, fertility problems in women, or breast enlargement in men (see: Possible side effects). If such adverse effects occur, blood prolactin level testing is recommended.

During cataract removal surgery, the pupil may not dilate sufficiently. Also, the iris may be flaccid during the procedure, which could lead to eye damage. If the patient has planned eye surgery, they should inform the ophthalmologist that they are 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 risperidone, the patient should consult their doctor frequently.

Seek immediate medical help if the patient or caregiver observes sudden changes in mental status, sudden muscle weakness or numbness, especially on one side of the body, or speech disturbances, even if they are brief. 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 fatigue occurs during treatment, changing the time of risperidone administration may improve concentration.

Body weight may 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.

Rispolept and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Patients should especially inform their doctor or pharmacist if they are taking any of the following medicines:

• sedatives acting on the brain (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, antihistamines, certain antidepressants, or other medicines used to treat psychiatric disorders
• medicines that cause slow heart rate
• medicines that reduce potassium levels in the blood (e.g. certain diuretics)
• medicines used for high blood pressure. Rispolept may lower blood pressure
• medicines used to treat 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 reduce swelling in areas with excessive fluid accumulation (e.g. furosemide or chlorothiazide). Rispolept, 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 (used to treat certain infections)
• carbamazepine, phenytoin (antiepileptic medicines)
• phenobarbital. When starting or stopping these medicines, a dose adjustment of risperidone 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
• beta-blockers (used to treat high blood pressure)
• phenothiazines (e.g. used to treat psychosis or for sedation)
• cimetidine, ranitidine (reducing stomach acid)
• itraconazole and ketoconazole (used in fungal infections)
• certain medicines used to treat HIV/AIDS, such as ritonavir
• verapamil, used to treat high blood pressure and (or) heart rhythm disorders
• sertraline and fluvoxamine, used to treat depression and other psychiatric disorders. When starting or stopping these medicines, a dose adjustment of risperidone may be necessary.

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

Rispolept, food, drink, and alcohol

This medicine can be taken with or without food. During treatment with Rispolept, alcohol consumption should be avoided.

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 her doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take Rispolept
• newborns whose mothers took Rispolept during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the baby, contact a doctor
• Rispolept may increase prolactin levels in the blood – a hormone that may affect fertility (see section: "Possible side effects").

Driving and operating machinery

While taking Rispolept, dizziness, fatigue, and vision disturbances may occur. Therefore, without consulting a doctor, the patient should not drive, use tools, or operate machinery.

Rispolept oral solution contains benzoic acid (E 210) and sodium

This medicine contains 2 mg of benzoic acid per 1 ml of oral solution. Benzoic acid may worsen jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains less than 1 mmol of sodium (23 mg) per dose and is essentially "sodium-free".

3. How to take Rispolept

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Recommended doses are given below:
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 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 dosing schedule 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 to 2 mg twice daily
• your doctor will advise which dosing schedule is best for you.

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 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 to 2 mg twice daily, depending on the patient's response to treatment.

In the treatment of persistent aggression associated with dementia in Alzheimer's disease
Adults (including elderly patients)

• the usual starting dose is 0.25 mg (0.25 ml of Rispolept oral solution 1 mg/ml) twice daily
• depending on the patient's response to treatment, the doctor may gradually adjust the dose
• for most patients, the 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 dementia in Alzheimer's disease should not exceed 6 weeks.

Use in children and adolescents

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

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

• the usual starting dose is 0.25 mg (0.25 ml of Rispolept oral solution 1 mg/ml) once daily
• the dose may be increased every other day (gradually) by 0.25 mg per day
• the usual maintenance dose is 0.25 mg to 0.75 mg (0.25 ml to 0.75 ml of Rispolept oral solution 1 mg/ml) once daily.

In children weighing 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 0.5 mg to 1.5 mg once daily.

The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.
Rispolept should not be used in children under 5 years of age for the treatment of behavioural disorders.
Patients with renal or hepatic impairment
Regardless of the disease being treated, all initial and subsequent doses of risperidone 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.
Rispolept oral solution
A dosing pipette is supplied with the package, allowing accurate measurement of the required amount of medicine.
Follow these steps:

1. remove the child-resistant cap. To do this, press down on the plastic cap and unscrew it counterclockwise (Figure 1)

2. insert the pipette into the bottle (Figure 2)

3. holding the pipette body by the collar, pull the plunger up to the mark on the pipette corresponding to the number of millilitres or milligrams to be taken (Figure 3)

4. holding the pipette by the collar of the body, remove it from the bottle (Figure 4)

5. press the plunger to empty the pipette, squeezing the contents into any non-alcoholic drink (except tea)
6. close the bottle
7. rinse the pipette with a small amount of water.

If you take more Rispolept than you should

• seek medical advice immediately. Take the medicine package with you.
• after an overdose, the patient may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, irregular heartbeat, or a seizure may occur.

If you forget to take Rispolept

• 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 misses 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 Rispolept
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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Immediately inform the doctor if the patient experiences any of the following uncommon adverse reactions (may affect less than 1 in 100 people):

• sudden change in mental state or sudden weakness or numbness of the face, limbs—particularly on one side—or speech disturbances, even if brief. These symptoms may indicate a stroke
• tardive dyskinesia (involuntary, jerking or twitching movements of the face, tongue or other body parts). Promptly inform the doctor if rhythmic involuntary movements of the tongue, lips or face occur. Discontinuation of Rispolept may be necessary.

Immediately inform the doctor if the patient experiences any of the following rare adverse reactions (may affect less than 1 in 1,000 people):

• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help
• fever, muscle rigidity, sweating or reduced level of consciousness (a condition called neuroleptic malignant syndrome). Immediate treatment may be required
• prolonged or painful erection in men. This condition is known as priapism. Immediate treatment may be necessary
• severe allergic reaction characterised by fever, swelling of the lips, face, tongue or throat, difficulty breathing, skin itching, rash or drop in blood pressure.

Other adverse reactions may also occur:

Very common adverse reactions (may affect more than 1 in 10 people):

• difficulty falling asleep or waking up
• parkinsonism: this condition may include slow or abnormal movements, feeling of stiffness or muscle tension (causing uneven movements), 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 and/or drooling, and expressionless face
• drowsiness or reduced alertness
• headache.

Common adverse reactions (may affect less than 1 in 10 people):

• pneumonia, respiratory tract infection (bronchitis), cold symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms
• increased blood levels of prolactin hormone (with or without symptoms). Symptoms of elevated prolactin occur uncommonly and may include in men: breast swelling, difficulty achieving or maintaining erection, reduced sexual drive 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, or fertility problems
• weight gain, increased appetite, decreased appetite
• sleep disturbances, irritability, depression, anxiety, restlessness
• dystonia: in this condition, slow or sustained involuntary muscle contractions occur. They may affect any part of the body (possibly resulting in abnormal posture), but 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 jerks
• tremor
• blurred vision, eye infection or conjunctivitis
• rapid heartbeat, high blood pressure, shortness of breath (dyspnea)
• 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, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• fall.

Uncommon adverse reactions (may affect less than 1 in 100 people):

• respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection, viral infection, dermatitis caused by mites
• decreased number of white blood cells (including those that help protect against infections), decreased platelet count (blood cells that help stop bleeding), anaemia, decreased number of red blood cells, increased number of eosinophils (a type of white blood cell) in the blood
• allergic reaction
• onset of diabetes or worsening of existing diabetes, high blood sugar levels, excessive thirst
• weight loss, loss of appetite leading to malnutrition and low body weight
• increased blood cholesterol levels
• elevated mood (mania), confusion, reduced libido, nervousness, nightmares
• lack of response to stimuli, loss of consciousness, low level of consciousness
• seizures, fainting
• urge to move body parts, balance disturbances, abnormal coordination, dizziness upon standing, difficulty concentrating, 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 eyes, excessive tearing, eye redness
• dizziness, ringing in the ears, ear pain
• atrial fibrillation (irregular heartbeat), heart conduction block between chambers, abnormal electrical conduction in the heart, QT interval prolongation on ECG, slow heartbeat, abnormal ECG readings, palpitations
• low blood pressure, low blood pressure upon standing (which may cause some patients taking Rispolept to faint, feel dizzy or lose consciousness when standing up suddenly), sudden flushing
• aspiration pneumonia (caused by food entering the airways), pulmonary congestion, respiratory congestion, crackles, rales, speech difficulties, respiratory disturbances
• stomach or intestinal infection, faecal incontinence, very hard stool, difficulty swallowing, excessive flatulence
• urticaria, itching, hair loss, skin thickening, rash, dry skin, skin discolouration, acne, scaly and itchy scalp or other body parts, skin disorders, skin lesions
• increased CPK (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, painful urination
• erectile dysfunction, ejaculation disorders
• absence of menstruation, missed periods or 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 mouth
• chills, increased body temperature
• change in gait
• thirst, malaise, chest discomfort, feeling unwell, general discomfort
• increased aminotransferase activity in blood, increased GGT (gamma-glutamyl transferase) enzyme activity in blood, increased liver enzyme activity in blood
• pain related to medical procedures.

Rare adverse reactions (may affect less than 1 in 1,000 people):

• infection
• abnormal secretion of the hormone regulating urine production
• sleepwalking (somnambulism)
• sleep-related eating disorders
• glucose in urine, low blood sugar, high blood triglyceride levels
• lack of emotion, inability to achieve orgasm
• reduced motor activity and unresponsiveness in a conscious patient (catatonia)
• cerebral vascular disorders
• coma due to uncontrolled diabetes
• tremulous, nodding head movements
• glaucoma (increased pressure in the eyeball), eye movement disorders, rotary eye movements, eyelid margin ulcers (with crust formation)
• eye complications during cataract surgery. During this procedure, Intraoperative Floppy Iris Syndrome (IFIS) may occur if the patient is currently or previously taking Rispolept. If cataract surgery is planned, inform the ophthalmologist about current or past use of this medicine
• dangerously low number of specific white blood cells responsible for fighting infections
• dangerous excessive water drinking
• irregular heartbeat
• breathing disturbances during sleep (sleep apnoea), rapid, shallow breathing
• pancreatitis, intestinal obstruction
• tongue swelling, dry lips, drug eruption
• seborrhoea
• muscle fibre breakdown and muscle pain (rhabdomyolysis)
• delayed menstruation, breast gland enlargement, breast enlargement, breast discharge
• increased insulin levels in blood (hormone regulating blood sugar)
• skin sclerosis
• low body temperature, cold hands and feet
• withdrawal symptoms
• yellowing of the skin and eyes (jaundice).

Very rare adverse reactions (may affect less than 1 in 10,000 people):

• life-threatening complications associated with uncontrolled diabetes
• severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
• loss of intestinal function leading to obstruction.

Adverse reactions with unknown frequency: frequency cannot be estimated from the available data

• severe or life-threatening rash with blisters and skin peeling, which may 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).

Adverse reactions observed during use of another medicine—paliperidone, very similar to risperidone—which may also occur during use of Rispolept: rapid heartbeat upon standing.

Additional adverse reactions in children and adolescents

In general, adverse reactions in children will be similar to those in adults.

The following adverse reactions have been reported more frequently in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or reduced alertness, fatigue (tiredness), headache, increased appetite, vomiting, frequent cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhoea and urinary incontinence.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can also 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 reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Rispolept

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and bottle. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Do not store in a refrigerator or freeze.
Shelf life after first opening the bottle: 3 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Rispolept contains

• The active substance is risperidone. 1 ml of oral solution contains 1 mg of risperidone.
• The other ingredients (excipients) are: tartaric acid, benzoic acid (E 210), sodium hydroxide, purified water.

What Rispolept looks like and contents of the pack
Rispolept oral solution is supplied in an amber glass bottle with a PP/LDPE screw cap, featuring a tamper-evident seal and child-resistant closure, packed in a cardboard box. Bottles contain 30 ml or 100 ml of a clear, colourless liquid.
An oral dosing pipette made of PS/LDPE is supplied with the bottle.
The pipette supplied with the bottle is graduated in milligrams and millilitres, with a minimum volume of 0.25 ml and a maximum volume of 3 ml. The graduations on the pipette are marked every 0.25 ml (corresponding to 0.25 mg of oral solution) up to a volume of 3 ml (corresponding to 3 mg of oral solution).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Lusomedicamenta Sociedade Técnica Farmacêutica S.A.
Estrada Consiglieri Pedroso 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal

For further information, contact the local representative of the Marketing Authorisation Holder:
Janssen-Cilag Polska sp. z o.o.
tel. +48 22 237 60 00

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:
Austria: Risperdal
Belgium/Cyprus/Czech Republic/Denmark/Finland/France/Greece/Spain/Netherlands/Ireland/Iceland/Luxembourg/Malta/Germany/Norway/Portugal/Slovenia/Sweden/Hungary/United Kingdom (Northern Ireland)/Italy: RISPERDAL
Estonia/Lithuania/Latvia/Poland/Romania: RISPOLEPT