Risperidon Vipharm

Leaflet accompanying the packaging: patient information

Risperidon Vipharm, 1 mg, coated tablets

Risperidon Vipharm, 2 mg, coated tablets

Risperidon Vipharm, 3 mg, coated tablets

Risperidon Vipharm, 4 mg, coated tablets

Risperidone

You should carefully read the contents of the 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 another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Risperidon Vipharm and what is it used for
• 2. Important information before taking Risperidon Vipharm
• 3. How to take Risperidon Vipharm
• 4. Possible side effects
• 5. How to store Risperidon Vipharm
• 6. Contents of the packaging and other information

1. What is Risperidon Vipharm and what is it used for

Risperidon Vipharm belongs to a group of medicines called antipsychotics.
Risperidon Vipharm is used in:

• treatment of schizophrenia - a condition in which the patient may see, hear, or feel things that do not exist, believe in untrue things, or experience unusual suspicion or disorientation.
• treatment of manic episodes - a condition in which the patient may feel strong excitement, agitation, irritation, enthusiasm, or be overly active. Manic episodes occur in the course of bipolar affective disorder.
• short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia who harm 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.

2. Important information before taking Risperidon Vipharm

When not to take Risperidon Vipharm:

• if the patient is allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Risperidon Vipharm, you should discuss it with your doctor or
pharmacist:

• if the patient has heart rhythm disorders, such as irregular heartbeat, or if the patient has a tendency to low blood pressure, or if the patient is taking blood pressure-lowering medicines. Risperidon Vipharm may cause a decrease in blood pressure.
  It may be necessary to adjust the dose of the medicine.

regulating blood pressure. Risperidon Vipharm 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 their risk of stroke, such as high blood pressure, cardiovascular disease, or cerebral vascular disorders.
• if the patient has ever experienced uncontrolled movements, mainly of the face and tongue.
• if the patient has ever experienced symptoms including high fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder called "malignant neuroleptic syndrome").
• in patients with Parkinson's disease or dementia.
• if the patient has a history of low white blood cell count (which may have been related to, but not necessarily, the use of other medicines).
• 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 while taking Risperidon Vipharm, the patient should immediately contact their doctor.
• if the patient has disorders of body temperature regulation or overheats.
• if the patient has kidney function disorders.
• if the patient has liver function disorders.
• if the patient has been found to have abnormally high levels of the hormone 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 Risperidon Vipharm is associated with the formation of blood clots.

The doctor may order a test to check the white blood cell count, as very rarely, patients taking
Risperidon Vipharm have developed a dangerously low level of a certain type of white blood cell
needed to fight infections in the blood.
Risperidon Vipharm may cause weight gain. Significant weight gain can have a negative impact on health. The doctor should regularly measure the patient's weight.
As diabetes or worsening of existing diabetes has been observed in patients taking Risperidon Vipharm, the doctor should order a blood sugar test.
In patients with existing diabetes, blood glucose levels should be regularly monitored.
During eye surgery to remove cataracts, the pupil (the black circle in the center of the eye) may not
dilate as required. The iris (the colored part of the eye) may also become floppy during surgery, which
can lead to vision damage. If the patient knows that they will undergo eye surgery in the future, 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 Risperidon Vipharm, the patient should frequently consult their doctor.
Medical help should be sought 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
on one side, 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 risperidone administration
may improve concentration.
Before starting treatment, the patient's weight (also in the case of a child patient) may be measured
and regularly monitored during treatment.

Risperidon Vipharm and other medicines

The patient should tell 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 may cause changes in heart electrical activity, such as malaria medicines, anti-arrhythmic medicines (e.g., quinidine, propafenone), antihistamines, or certain antidepressants or other medicines used to treat mental disorders,
• medicines that slow down heart activity,
• medicines that lower potassium levels in the blood (e.g., certain diuretics),
• medicines used to treat high blood pressure. Risperidon Vipharm may lower blood pressure,
• medicines used to treat Parkinson's disease, such as levodopa,
• diuretics (used in heart disease or to relieve swelling in areas where there is excessive fluid accumulation, e.g., furosemide or chlorothiazide). Risperidon Vipharm taken alone or together with furosemide may increase the risk of stroke or death in elderly patients with dementia,
• medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)

The following medicines may reduce the effect of risperidone:

• rifampicin (a medicine used to treat certain infections),
• carbamazepine, phenytoin (anti-epileptic medicines),
• phenobarbital. If the patient starts or stops taking these medicines, it may be necessary 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 the patient starts or stops taking these medicines, it may be necessary to adjust the dose of risperidone.

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 Risperidon Vipharm.

Taking Risperidon Vipharm with food and drink

This medicine can be taken with or without food. While taking Risperidon Vipharm, 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 child, they
should consult their doctor or pharmacist before taking this medicine.
In newborns whose mothers took Risperidon Vipharm during 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, feeding difficulties. If the child experiences any
of these symptoms, the patient should contact their doctor.
Risperidon Vipharm may increase the level of a hormone called "prolactin", which may affect fertility (see:
Possible side effects).

Driving and using machines

While taking Risperidon Vipharm, the patient may experience dizziness, fatigue, and vision disturbances.
Therefore, without consulting their doctor, the patient should not drive vehicles or operate any machines.

Important information about some ingredients of Risperidon Vipharm

Risperidon Vipharm contains lactose monohydrate. If the patient has been diagnosed with intolerance to
some sugars, they should consult their doctor before taking the medicine.
Risperidon Vipharm contains less than 1 mmol (23 mg) of sodium per tablet, which means that the
medicine is considered "sodium-free".
Risperidon Vipharm 2 mg contains orange yellow S (E 110), which may cause allergic reactions.

3. How to take Risperidon Vipharm

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of
any doubts, the patient should consult their doctor or pharmacist.
The doctor will determine the dose of the medicine and the duration of treatment. This depends on the
individual patient's condition.
The tablet should be taken with a glass of water.
There are other medicinal products from other pharmaceutical companies available on the market that
contain risperidone in smaller strengths in the form of an oral solution 1 mg/ml, allowing for dosing with
a 0.25 mg increment. In case of doubts, the patient should consult their doctor.

In the treatment of schizophrenia

Adults

• The recommended 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.
• Risperidon Vipharm may increase the level of a hormone called "prolactin", which may affect fertility (see:
  Possible side effects).
• This total daily dose may 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.

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.

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

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 treatment duration in patients with Alzheimer's dementia should not exceed 6 weeks.

Use in children and adolescents

Risperidon Vipharm 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 behavioral disorders in children and adolescents

The dose depends on the child's weight:
In the case of children weighing 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.
• The usual maintenance dose is between 0.25 mg and 0.75 mg once a day.

In the case of children weighing 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.
• The usual maintenance dose is between 0.5 mg and 1.5 mg once a day.

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

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.

Taking a higher dose of Risperidon Vipharm than recommended

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

Missing a dose of Risperidon Vipharm

If the patient forgets to take a dose of the medicine, 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 prescribed. If the patient forgets to take two or more doses, they should consult
their doctor.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Risperidon Vipharm

The patient should not stop taking the medicine unless it is in agreement with their doctor. It is possible
that the symptoms of the disease will recur. If the doctor decides to stop the treatment, the dose of the
medicine may be gradually reduced over several days.
In case of any further doubts about the use of the medicine, the patient should consult their doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should immediately inform their doctor if:

• The patient experiences blood clots in the veins, especially in the legs (symptoms include 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 help.
• In patients with dementia, there is a sudden change in their mental state or sudden weakness or
  numbness of the face, arms, or legs, especially on one side, or speech disorders, even if they occur
  for a short time. These symptoms may indicate a stroke.
• The patient experiences fever, severe muscle stiffness, sweating, or decreased level of consciousness
  (a disorder called "malignant neuroleptic syndrome"). Immediate medical help may be necessary.
• The patient experiences prolonged or painful erections. This is called priapism. Immediate medical help
  may be necessary.
• The patient experiences involuntary rhythmic movements of the tongue, lips, and face. It may be
  necessary to discontinue Risperidon Vipharm.

The following side effects may occur.

Very common side effects (may affect more than 1 in 10 people)

• Difficulty falling or staying asleep or excessive sleepiness
• Parkinsonism: a condition that may include slow or impaired body movements, feeling of stiffness or
  tension in the muscles (which can cause jerky movements) and sometimes even a feeling of "freezing"
  of movement, and then restarting it. Other symptoms of parkinsonism include slow, shuffling gait,
  trembling at rest, increased saliva production and/or drooling, and a face without expression.
• Feeling of drowsiness or decreased attention.
• Headache.

Common side effects (may affect up to 1 in 10 people)

• Pneumonia, chest infection (bronchitis), common cold symptoms, sinus infections, urinary tract
  infections, ear infections, flu-like symptoms
• Risperidone may increase the level of a hormone called "prolactin" in the blood (which may, but not
  necessarily, cause symptoms). If symptoms of high prolactin levels occur, they may cause men to
  experience breast swelling, difficulty getting or maintaining an erection, or other sexual disorders. In
  women, they may cause breast discomfort, milk leakage from the breasts, absence of menstruation, or
  other problems related to the menstrual cycle.
• Weight gain, increased appetite, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, restlessness.
• Dystonia: a condition that includes slow or sustained involuntary muscle contractions. Although it can
  affect any part of the body (and may cause abnormal posture), dystonia most often affects the facial
  muscles, including abnormal movements of the eyes, lips, tongue, and jaw.
• Dizziness.
• Dyskinesia: a condition that includes involuntary muscle movements, and may include repetitive,
  spastic, or writhing movements or muscle stiffness.
• Tremor (shaking).
• Blurred vision, eye infections, or "red eye".
• Rapid heartbeat, high blood pressure, shortness of breath.
• Sore throat, cough, nosebleeds, stuffy nose.
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry
  mouth, toothache.
• Rash, skin redness.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence (loss of bladder control).
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue, pain.
• Falls.

Uncommon side effects (may affect up to 1 in 100 people)

• Respiratory tract infections, urinary tract infections, eye infections, tonsillitis, fungal infections of the
  nails, skin infections, localized skin infections, viral infections, chickenpox.
• Decreased white blood cell count, which helps protect against infection, decreased white blood cell
  count, decreased platelet count (blood cells that help stop bleeding), anemia, decreased red blood cell
  count, increased eosinophil count (a type of white blood cell) in the blood.
• Allergic reaction.
• Diabetes or worsening of existing diabetes, high blood sugar levels, excessive thirst.
• Weight loss, loss of appetite due to malnutrition and low body weight.
• Increased cholesterol levels in the blood.
• Mood elevation (mania), confusion, decreased sex drive, nightmares.
• Tardive dyskinesia (involuntary, rhythmic movements of the tongue, lips, and face, which may be
  permanent). The patient should immediately inform their doctor if they experience involuntary rhythmic
  movements of the tongue, lips, and face. It may be necessary to discontinue Risperidon Vipharm.
• Sudden loss of blood supply to the brain (stroke or "mini" stroke)
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
• Seizures (seizure attacks), fainting.
• Uncontrollable need to move a part of the body, balance disorders, coordination disorders, dizziness
  when standing up, attention disorders, speech disorders, loss or disturbance of taste, decreased skin
  sensitivity to pain and touch, feeling of tingling, numbness, or prickling of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tearing, red eyes.
• Feeling of spinning (dizziness), ringing in the ears, ear pain.
• Arrhythmia (irregular heartbeat), conduction disorders between the upper and lower parts of the
  heart, heart conduction disorders, prolonged QT interval, slow heartbeat, heart rhythm disorders
  (electrocardiogram or EKG), feeling of pounding or palpitations in the chest (palpitations).
• Low blood pressure, low blood pressure when standing up (which may cause fainting, dizziness, or
  sudden redness of the face in some patients taking Risperidon Vipharm).
• Pneumonia caused by food entering the airways, fluid accumulation in the lungs, fluid accumulation
  in the airways, crackling in the lungs, wheezing, breathing difficulties.
• Gastrointestinal infection, intestinal obstruction, abdominal pain during procedures.
• Swelling of the tongue, cracked lips, skin rash related to taking the medicine.
• Dandruff.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Delayed menstruation, breast enlargement, breast engorgement, milk leakage from the breasts.
• Increased insulin levels (a hormone that regulates blood sugar levels) in the blood.
• Priapism (prolonged erection of the penis, which may require surgical treatment).
• Skin hardening.
• Low body temperature, decreased body temperature, feeling of cold hands and feet.
• Withdrawal symptoms.
• Yellowing of the skin and eyes (jaundice).

Rare side effects (may affect up to 1 in 1,000 people)

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

The following side effects have been observed with the use of another medicine called paliperidone,
which is very similar to risperidone, so they may also occur with the use of Risperidon Vipharm: rapid
heart rate after withdrawal.

Additional side effects in children and adolescents

It is expected that the side effects in children will be similar to those in adults.
The following side effects have been reported more frequently in children and adolescents (aged 5 to 17
years) than in adults: drowsiness or decreased attention, fatigue (tiredness), headache, increased
appetite, vomiting, common cold symptoms, runny nose, abdominal pain, dizziness, cough, fever,
trembling (shaking), diarrhea, and urinary incontinence (loss of bladder control).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should
tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of
Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych
i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides):
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more
information can be collected on the safety of the medicine.

5. How to store Risperidon Vipharm

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the
  last day of the month.
• 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 packaging and other information

What Risperidon Vipharm contains

Risperidon Vipharm, 1 mg, coated tablets.
The active substance of Risperidon Vipharm 1 mg is risperidone in a dose of 1 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Coating
Opadry White 02H28525:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, talc.
Risperidon Vipharm, 2 mg, coated tablets.
The active substance of Risperidon Vipharm 2 mg is risperidone in a dose of 2 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Coating
Opadry Orange 02H23363:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, orange yellow S (E110), talc.
Risperidon Vipharm, 3 mg, coated tablets.
The active substance of Risperidon Vipharm 3 mg is risperidone in a dose of 3 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Coating
Opadry Yellow 02H22051:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, quinoline yellow (E104), talc.
Risperidon Vipharm, 4 mg, coated tablets.
The active substance of Risperidon Vipharm 4 mg is risperidone in a dose of 4 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Coating
Opadry Green 02H21429:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, indigo carmine (E132), quinoline
yellow (E104), talc.

What Risperidon Vipharm looks like and contents of the pack

Coated tablets
1 mg: White, oblong tablet with a coating, 11 x 5.5 mm in size, with a score line on both sides.
2 mg: Orange, oblong tablet with a coating, 11 x 5.5 mm in size, with a score line on both sides.
3 mg: Yellow, oblong tablet with a coating, 11 x 5.5 mm in size, with a score line on both sides.
4 mg: Green, oblong tablet with a coating, 11 x 5.5 mm in size, with a score line on both sides.
The tablets are packaged in PVC/PE/PVDC//Al blisters containing 10 tablets, in a cardboard box.
Pack sizes:
1 mg:
6, 20, 50, 60, or 100 coated tablets
2 mg:
20, 50, 60, or 100 coated tablets
3 mg:
20, 50, 60, or 100 coated tablets
4 mg:
6, 20, 28, 30, 50, 60, or 100 coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
phone: (+48 22) 679 5135
fax: (+48 22) 678 92 87
e-mail: [email protected]
Manufacturer
PharmaPath S.A.
1, 28 Octovriou str., Ag. Varvara
123 51 Athens
Greece
Date of last revision of the leaflet:01.03.2022