Orizon

Leaflet accompanying the packaging: information for the user

Orizon, 0.5 mg, coated tablets

Orizon, 1 mg, coated tablets

Orizon, 2 mg, coated tablets

Orizon, 3 mg, coated tablets

Orizon, 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.
• In case of 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.
• 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 Orizon and what is it used for
• 2. Important information before taking Orizon
• 3. How to take Orizon
• 4. Possible side effects
• 5. How to store Orizon
• 6. Contents of the packaging and other information

1. What is Orizon and what is it used for

Orizon belongs to a group of medicines called antipsychotics.
Orizon 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, stimulation, 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 people with Alzheimer's disease 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.

Orizon may help alleviate the symptoms of the disease and prevent the recurrence of its symptoms.

2. Important information before taking Orizon

When not to take Orizon

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

If the patient is not sure whether the above information applies to them, they should consult a doctor or pharmacist before taking Orizon.

Warnings and precautions

Before starting to take Orizon, the patient should discuss it with their doctor or pharmacist if:

• the patient has heart rhythm disorders, such as irregular heartbeat or a tendency to low blood pressure, or if the patient is taking blood pressure medications. Orizon may cause a decrease in blood pressure. It may be necessary to adjust the dose of the medicine.
• the patient knows of any factors that may predispose them to stroke, such as high blood pressure, cardiovascular disorders, or cerebral vessel disorders
• the patient has ever experienced involuntary rhythmic movements of the tongue, lips, or face
• the patient has ever experienced a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as malignant neuroleptic syndrome)
• the patient has Parkinson's disease or dementia
• 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 has diabetes
• the patient has epilepsy
• the patient is a man and has ever experienced a prolonged or painful erection
• the patient has body temperature regulation disorders or overheats
• the patient has kidney function disorders
• the patient has liver function disorders
• the patient has been found to have an abnormally high level of the hormone prolactin in the blood or suspected prolactin-dependent tumor
• the patient or their family members have had blood clots in the past, as the use of antipsychotic medicines has been associated with the formation of blood clots.

If the patient is not sure whether any of the above conditions apply to them, they should consult a doctor or pharmacist before taking Orizon.
The doctor may order a white blood cell count test, as very rarely, antipsychotic medicines have been found to cause a dangerously low number of a certain type of white blood cell necessary for fighting infections.
Orizon may cause weight gain. Significant weight gain can have a negative impact on health. The doctor will regularly check the patient's weight.
The doctor should check if the patient does not have symptoms of high blood sugar levels, as patients taking Orizon have been found to develop diabetes and worsening of existing diabetes. In patients with existing diabetes, blood sugar levels should be regularly monitored.
Orizon often increases the level of a hormone called "prolactin". This can cause side effects such as menstrual disorders, fertility problems in women, breast enlargement in men (see "Possible side effects"). If such side effects occur, it is recommended to perform a blood prolactin level test.
During cataract surgery, the patient's pupil may not dilate sufficiently. The iris may also become flaccid during the procedure, which can result in eye damage. If the patient has a planned eye surgery, they should tell 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 Orizon, the patient should frequently consult their doctor.
Medical help should be sought immediately if the patient or their caregiver notices a sudden change in their mental state or sudden weakness or numbness of the face, arms, or legs, especially if it is one-sided, or speech disorders, even if they only last for a short time. These symptoms may signal 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 or concentration problems during treatment, changing the time of risperidone administration may improve it. Before starting treatment, the patient, both adult and child, should be weighed, and then their weight should be regularly monitored during treatment.
In a small study, an increase in growth was found in children taking risperidone, but it is not known whether this is due to the action of the medicine or other factors.

Orizon 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 can change the electrical activity of the heart, such as malaria medicines, anti-arrhythmic medicines, antihistamines, certain antidepressants, or other medicines used to treat mental disorders
• medicines that slow down the heart rate
• medicines that lower potassium levels in the blood (e.g., certain diuretics)
• medicines used to treat high blood pressure. Orizon may lower blood pressure
• medicines used to treat Parkinson's disease, such as levodopa
• medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)
• diuretics, used in patients with heart disease or to relieve swelling in areas where there is excessive fluid accumulation (such as furosemide or chlorthiazide). Orizon taken alone or 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 (anti-epileptic medicines)
• phenobarbital. If the patient starts or stops taking these medicines, it may be necessary to change 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)
• itraconazole or 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 mental disorders. If the patient starts or stops taking these medicines, it may be necessary to change the dose of risperidone.

If the patient is not sure whether any of the above situations apply to them, they should consult a doctor or pharmacist before taking Orizon.

Orizon with food, drink, and alcohol

This medicine can be taken with or without food.
During treatment with Orizon, 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 a doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take this medicine.
In newborns whose mothers took Orizon in the last trimester of pregnancy (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If such symptoms are observed in the patient's child, they should contact a doctor.
Orizon may increase the level of a hormone called "prolactin", which can affect fertility (see "Possible side effects").

Driving and using machines

During treatment with Orizon, the patient may experience dizziness, drowsiness, and/or vision disturbances.
Therefore, without consulting a doctor, the patient should not drive vehicles or operate machines.

Orizon contains lactose monohydrate

Orizon tablets contain lactose (in the form of monohydrate): 22.5 mg (in a 0.5 mg tablet), 45.2 mg (in a 1 mg tablet), 90.3 mg (in a 2 mg tablet), 135.4 mg (in a 3 mg tablet), 180.5 mg (in a 4 mg tablet). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Orizon 2 mg tablets contain orange yellow FCF (E 110)

Orizon 2 mg tablets contain a coloring agent, orange yellow FCF (E 110), which may cause allergic reactions.

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Orizon

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
The tablet should be swallowed with water. The 1 mg, 2 mg, 3 mg, and 4 mg tablets can be divided into equal doses. The 0.5 mg tablets cannot be divided. To administer a dose of 0.25 mg or to increase the dose by 0.25 mg, other medicines should be used.
The recommended doses are listed below:
In the treatment of schizophrenia
Adults

• Usually, the initial dose is 2 mg on the first day, and the dose 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 may be given in a single dose 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 1-2 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 1-2 mg twice a day, depending on the patient's response to treatment.

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.

Administration in children and adolescents

Children and adolescents under the age of 18 should not be treated with Orizon for schizophrenia or manic episodes in bipolar affective disorder.
In the treatment of behavioral disorders in children and adolescents
The dose depends on the child's body weight:
In children with a body weight of less than 50 kg

• The initial dose is usually 0.25 mg once a day.
• The dose may be increased every other day (gradually) by 0.25 mg per day.
• Usually, the maintenance dose is between 0.25 mg and 0.75 mg once a day.

In children with a body weight of 50 kg or more

• The initial dose is usually 0.5 mg once a day.
• The dose may be increased every other day (gradually) by 0.5 mg per day.
• Usually, the maintenance dose is between 0.5 mg and 1.5 mg once a day.

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

Patients with renal or hepatic impairment

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.

Overdose of Orizon

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

Missed dose of Orizon

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 directed. If the patient forgets to take two or more doses, they should consult a doctor.

Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping treatment with Orizon

The patient should not stop taking the medicine unless their doctor tells them to. The symptoms of the disease may return.
If the doctor decides to stop the treatment, the dose of the medicine may be gradually reduced over several days.
If the patient has any further doubts about taking this medicine, they should consult a 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 they experience any of the following

less common side effects( may occur in less than 1 in 100 people):

• in a patient with dementia, a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially if it is one-sided, or speech disorders, even if they only last for a short time. These symptoms may signal a stroke.
• late dyskinesia (involuntary, repetitive, spasmodic, or twitching movements of the face, tongue, or other parts of the body). 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 Orizon.

The patient should immediately inform their doctor if they experience any of the following

rare side effects( may occur in less than 1 in 1,000 people):

• the patient develops 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 attention.
• the patient develops fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary.
• the patient, a man, experiences a prolonged or painful erection. This condition is called priapism. Immediate treatment may be necessary.
• the patient develops a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, rash, or low blood pressure.

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

• difficulty sleeping or waking up
• parkinsonism: This condition may include slowed or abnormal movements, a feeling of stiffness or tension in the muscles (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 salivation, and a mask-like face.
• feeling of drowsiness or decreased alertness
• headache.

Common side effects ( may occur in 1 in 10 people):

• pneumonia, respiratory tract infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infection, flu-like symptoms
• Orizon may increase the level of the hormone "prolactin" in the blood (with or without symptoms). Symptoms of elevated prolactin levels may include in men: breast enlargement, difficulty achieving or maintaining an erection, decreased sex drive, or other sexual disorders. In women, symptoms include breast discomfort, milk secretion from the breasts, absence of menstrual periods, or other menstrual cycle disorders or fertility disorders.
• weight gain, increased appetite, decreased appetite
• sleep disturbances, irritability, depression, anxiety, restlessness
• dystonia: In this condition, there are slow or sustained involuntary muscle contractions. This can affect any part of the body (which can result in an abnormal posture), but dystonia most commonly affects the face (abnormal movements of the eyes, lips, tongue, or jaw).
• dizziness
• dyskinesia: In this condition, there are involuntary muscle movements, including repetitive, spasmodic, or twitching movements.
• tremors
• blurred vision, eye infection, or conjunctivitis
• rapid heartbeat, high blood pressure, shallow breathing
• throat pain, cough, nosebleeds, stuffy nose
• abdominal pain, discomfort in the abdomen, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• rash, itching, hair loss, skin thickening, urticaria, dry skin, skin discoloration, acne, flaky, itchy scalp and body
• increased CPK (creatine phosphokinase) activity in the blood, an enzyme that is sometimes released from damaged muscles
• abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• frequent urination, incontinence, painful urination
• erectile dysfunction, ejaculation disorders
• loss of menstrual bleeding, absence of menstruation, and other menstrual cycle disorders (in women)
• breast enlargement in men, milk secretion from the breasts, sexual disorders, breast pain, discomfort in the breasts, vaginal discharge
• 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 aminotransferases in the blood, increased activity of the enzyme GGTP (liver enzyme - gamma-glutamyltransferase) in the blood, increased activity of liver enzymes in the blood
• pain related to medical procedures.

Uncommon side effects ( may occur in 1 in 100 people):

• respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal nail infection, skin infection, skin infection limited to one area or part of the body, viral infection, allergic skin reaction

Rare side effects ( may occur in 1 in 1,000 people):

• infection
• abnormal secretion of the hormone that regulates the amount of urine
• sleepwalking (sleepwalking)
• eating disorders related to sleep
• sugar in the urine, low blood sugar, high triglyceride levels (fats) in the blood
• lack of emotions, inability to achieve orgasm
• reduced motor activity and lack of response in a patient with preserved consciousness (catatonia)
• disorders related to cerebral vessels
• coma due to uncontrolled diabetes
• tremors, nodding movements of the head
• glaucoma (increased pressure in the eyeball), eye movement disorders, rotational eye movements, ulcers on the edges of the eyelids
• complications related to eye surgery. During this procedure, a condition called intraoperative floppy iris syndrome (IFIS) may occur if the patient is taking or has taken Orizon. If the patient has a planned cataract surgery, they should tell their ophthalmologist about taking this medicine in the past or present.
• dangerously low number of white blood cells responsible for fighting infections
• dangerously excessive water drinking
• irregular heartbeat
• sleep apnea (breathing difficulties during sleep), rapid, shallow breathing
• pancreatitis, intestinal obstruction
• tongue swelling, lip swelling, allergic rash
• dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• delayed menstrual bleeding, breast enlargement, breast engorgement, milk secretion from the breasts
• increased insulin levels in the blood (a hormone that regulates blood sugar levels)
• skin thickening
• low body temperature, cold hands and feet
• withdrawal symptoms
• jaundice (yellowing of the skin and eyes).

Very rare side effects ( may occur in 1 in 10,000 people)

• life-threatening complications related to uncontrolled diabetes
• severe allergic reaction with swelling, which can affect the throat and lead to breathing difficulties
• lack of bowel movement, which can cause bowel obstruction.

Frequency not known ( frequency cannot be estimated from the available data):

• a severe, life-threatening rash with blistering and peeling of the skin may occur in or around the mouth, nose, eyes, and genitals, and may spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Side effects that have been reported in patients taking another medicine - paliperidone, which is very similar to risperidone, and which may also occur in patients taking Orizon: rapid heartbeat when changing position to standing.

Additional side effects in children and adolescents

Generally, it can be expected that 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 alertness, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, runny nose, abdominal pain, dizziness, cough, fever, tremors (shaking), diarrhea, and incontinence (loss of bladder control).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell 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, tel.: 22 49 21 301, fax: 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 Orizon

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
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 Orizon contains

• The active substance of the medicine is risperidone. Each coated tablet contains: 0.5 mg, 1 mg, 2 mg, 3 mg, or 4 mg of risperidone.
• The other ingredients of the medicine are:

Tablet core:
lactose monohydrate, cornstarch, microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), hypromellose 2910 (5 cps), sodium lauryl sulfate, colloidal silicon dioxide, and magnesium stearate.
Coating:
hypromellose 2910 (5 cps), hypromellose 2910 (15 cps), propylene glycol, titanium dioxide (E 171), talc.
In addition, the coating contains:
0.5 mg tablet:
iron oxide red (E 172).
2 mg tablet:
orange yellow FCF (E 110).
3 mg tablet:
quinoline yellow (E 104).
4 mg tablet:
indigo carmine (E 132),
quinoline yellow (E 104).

What Orizon looks like and contents of the pack

Orizon 0.5 mg:brown-red, round, coated tablet. The tablets cannot be divided.
Orizon 1 mg:white, biconvex, oval-shaped tablet with a score line on one side. The tablet can be divided into equal doses.
Orizon 2 mg: pale orange, biconvex, oval-shaped tablet with a score line on one side. The tablet can be divided into equal doses.
Orizon 3 mg:light yellow, biconvex, oval-shaped tablet with a score line on one side. The tablet can be divided into equal doses.
Orizon 4 mg:green, biconvex, oval-shaped tablet with a score line on one side. The tablet can be divided into equal doses.
Orizon coated tablets are available in blisters or in an HDPE container with a child-resistant closure and a desiccant plug. The HDPE container contains a desiccant (silica gel).

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Importer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland, Sweden: Risperidon Orion
Poland: Orizon
Date of last revision of the leaflet:29.09.2023