Orizon: detailed information

Patient Information Leaflet: Information for the User

Orizon, 0.5 mg, film-coated tablets
Orizon, 1 mg, film-coated tablets
Orizon, 2 mg, film-coated tablets
Orizon, 3 mg, film-coated tablets
Orizon, 4 mg, film-coated tablets
Risperidone
Please read this leaflet carefully before taking 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 other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Orizon is and what it is used for
What you need to know before taking Orizon
How to take Orizon
Possible side effects
How to store Orizon
Contents of the pack and other information

1. What Orizon is and what it is used for

Orizon belongs to a group of medicines known as antipsychotics.
Orizon is used for:

Treating schizophrenia – a condition in which patients may see, hear, or feel things that are not real, believe in untrue things, or experience unusual suspicion or confusion.
Treating manic episodes – a condition in which patients may experience intense excitement, agitation, hyperactivity, or excessive enthusiasm. Manic episodes occur in bipolar affective disorder.
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. Before starting treatment, non-pharmacological alternative approaches should be considered.
Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (over 5 years of age) and adolescents with behavioral disorders.

Orizon may help relieve the symptoms of the illness and prevent recurrence of symptoms.

2. Important information before using Orizon

When not to use 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 unsure whether the above information applies to them, they should consult a doctor or
pharmacist before taking Orizon.
Warnings and precautions
Before starting treatment with Orizon, discuss with a doctor or pharmacist if:

the patient has heart function disorders, for example irregular heartbeat or a tendency to low blood pressure, or if the patient is taking medicines that regulate blood pressure. Orizon may cause a decrease in blood pressure. Dose adjustment may be necessary.
the patient has any risk factors that may predispose them to stroke, such as high blood pressure, cardiovascular disorders or cerebral vascular disorders
the patient has ever experienced involuntary rhythmic movements of the tongue, mouth or face
the patient has ever had a condition characterised by fever, severe muscle stiffness, sweating or decreased level of consciousness (also known as neuroleptic malignant syndrome)
the patient suffers from Parkinson's disease or dementia
the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines)
the patient has diabetes
the patient has epilepsy
the patient is a man who has ever experienced prolonged or painful erection
the patient has disorders of body temperature regulation or is overheating
the patient has kidney function disorders
the patient has liver function disorders
the patient has been diagnosed with abnormally high levels of the hormone prolactin in the blood or suspected prolactin-dependent tumour
the patient or members of their family have previously had blood clots, as the use of antipsychotic medicines has been associated with the formation of blood clots.

If the patient is unsure whether any of the symptoms described above apply to them, they should
consult a doctor or pharmacist before taking Orizon.
The treating doctor may order a white blood cell count test, as very rarely, a dangerously low number of a certain type of white blood cells essential for fighting infections has been observed in patients taking antipsychotic medicines.
Orizon may cause weight gain. Significant weight gain may adversely affect health. The treating doctor will regularly monitor the patient's body weight.
The doctor should check whether the patient shows symptoms of high blood glucose levels, as diabetes and worsening of pre-existing diabetes have been observed in patients taking Orizon. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Orizon often increases the level of a hormone called "prolactin". This may cause adverse effects such as: menstrual disorders, fertility problems in women, breast swelling in men (see "Possible side effects"). If such adverse effects occur, measurement of prolactin levels in the blood is recommended.
During cataract surgery in patients taking risperidone, the pupil may not dilate sufficiently. Also, the iris may become floppy during the procedure, which may lead to eye damage. If the patient has eye surgery planned, they should inform the 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.
Seek immediate medical help if the patient or caregiver observes sudden change in mental status or sudden weakness or numbness of facial muscles, arms or legs, especially on one side, or speech disturbances, even if they last only briefly. 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 the patient experiences fatigue or concentration problems during treatment, changing the time of risperidone administration may help. Before starting treatment, both adult and child patients should have their body weight assessed, and body weight should be monitored 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 effect of the drug or other causes.
Orizon with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 sedatives (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect
medicines that may alter 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 slowing of the heart rate
medicines that reduce potassium levels in the blood (e.g. certain diuretics)
medicines used for hypertension. Orizon may lower blood pressure
medicines used for Parkinson's disease, e.g. levodopa
medicines that increase central nervous system activity (psychostimulants, such as methylphenidate)
diuretics (diuretics) used in patients with heart disease or to relieve oedema in areas with excessive fluid accumulation (such as furosemide or hydrochlorothiazide). Orizon 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 (a medicine used to treat certain infections)
carbamazepine, phenytoin (medicines for epilepsy)
phenobarbital. When starting or stopping these medicines, a change in risperidone dose 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
medicines known as beta-blockers (used to treat hypertension)
phenothiazines (used to treat psychosis or for sedation)
cimetidine, ranitidine (reducing gastric acid)
itraconazole or ketoconazole (used for fungal infections)
certain medicines used to treat HIV/AIDS, such as ritonavir
verapamil, used to treat hypertension and (or) heart rhythm disorders
sertraline and fluvoxamine, used to treat depression and other psychiatric disorders. When starting or stopping these medicines, a change in risperidone dose may be necessary.

If the patient is unsure whether any of the situations described above 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, alcohol consumption should be avoided.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether the patient can take this medicine.
Newborns whose mothers used Orizon during the third trimester of pregnancy (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 child, contact a doctor.
Orizon may increase the level of a hormone called "prolactin", which may affect fertility (see "Possible side effects").
Driving and operating machinery
During treatment, dizziness, fatigue and vision disturbances may occur. Therefore, without consulting a doctor, patients should not drive or operate machinery.
Orizon contains monohydrate lactose
Orizon tablets contain lactose (in monohydrate form): 22.5 mg (in 0.5 mg tablet), 45.2 mg (in 1 mg tablet), 90.3 mg (in 2 mg tablet), 135.4 mg (in 3 mg tablet), 180.5 mg (in 4 mg tablet). If the patient has previously been diagnosed with intolerance to certain sugars, they should contact a doctor before taking the medicine.
Orizon 2 mg tablets contain Sunset Yellow FCF (E 110)
Orizon 2 mg tablets contain a colouring agent, Sunset Yellow FCF (E 110), which may cause allergic reactions.
Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Orizon

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The tablet should be swallowed with water. The 1 mg, 2 mg, 3 mg, and 4 mg tablets may be divided into equal
doses. The 0.5 mg tablet cannot be divided. To administer a 0.25 mg dose or to increase the dose by 0.25 mg,
alternative medicines should be used.

The recommended doses are given below:

Treatment of schizophrenia
Adults

The usual starting dose is 2 mg on the first day; this dose may be increased to 4 mg on the second day.
Depending on the patient's response to treatment, the doctor may adjust the dose.
For most patients, the most appropriate daily dose ranges from 4 mg to 6 mg.
This total daily dose may be given as a single dose or divided into two doses. Your doctor will advise which dosing regimen is best for you.

Elderly patients

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

Treatment of manic episodes
Adults

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

Elderly patients

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

Treatment of long-term 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 most appropriate daily dose is 0.5 mg twice daily. Some patients may require 1 mg twice daily.
The duration of treatment in patients with Alzheimer's type dementia should not exceed 6 weeks.

Use in children and adolescents
Orizon should not be used in children and adolescents under 18 years of age for the treatment of schizophrenia
or for the treatment of mania in bipolar affective disorder.
In the treatment of behavioural disorders in children and adolescents
The dose depends on the child's body weight:
In 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 typically between 0.25 mg and 0.75 mg once daily.

In 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 (gradually) by 0.5 mg per day.
The usual maintenance dose is typically between 0.5 mg and 1.5 mg once daily.

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

Patients with kidney or liver impairment
Regardless of the condition being treated, all initial and subsequent doses should be reduced by half.
Doses should be increased more slowly in these patients.
Risperidone should be used with caution in this patient group.

Use of a higher than recommended dose of Orizon
Seek medical advice immediately. Take the medicine packaging 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 seizures may occur.

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 missed dose should be skipped and the next dose taken at the usual time. If the patient forgets 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 Orizon
Do not stop taking this medicine unless advised 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 they do not occur in everyone.
Immediately inform the doctor if the patient experiences any of the following
uncommon adverse reactions ( may occur in less than 1 out of 100 people ):

sudden change in mental state or sudden weakness or numbness of the face or limbs, particularly on one side of the body, 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 parts of the body). Immediately inform the doctor if rhythmic involuntary movements of the tongue, mouth or face occur. Discontinuation of Orizon may be necessary.

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

blood clots in the veins, especially in the legs (symptoms include leg pain and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. In such cases, seek immediate medical help.
fever, muscle stiffness, sweating or decreased 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 with symptoms such as fever, swelling of the mouth, face, lips or tongue, breathing difficulties, itching, skin rash or low blood pressure.

The following adverse reactions may occur:
Very common adverse reactions ( may occur in more than 1 out of 10 patients ):

difficulty falling asleep or waking up
parkinsonism: This condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing jerky, uneven movements), and sometimes even a sensation of "freezing" of movement followed by sudden release. Other symptoms of parkinsonism include shuffling gait, resting tremor, increased salivation/drooling, and expressionless face.
feeling of drowsiness or reduced alertness
headache.

Common adverse reactions ( may occur in 1 out of 10 patients ):

pneumonia, respiratory tract infection (bronchitis), cold symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms
Orizon may increase blood levels of the hormone "prolactin" (with or without symptoms). Symptoms of increased prolactin levels may include in men: breast swelling, difficulty achieving or maintaining erection, decreased libido or other sexual disturbances. In women, symptoms 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: This condition involves slow or sustained involuntary muscle contractions. It may affect any part of the body (possibly resulting in abnormal posture), but dystonia most commonly affects facial muscles (abnormal eye, mouth, tongue or jaw movements).
dizziness
dyskinesia: This condition involves involuntary muscle movements, 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, diarrhea, 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
fall.

Uncommon adverse reactions ( may occur in 1 out of 100 patients ):

respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection limited to one area or one part of the body, viral infection, skin inflammation caused by mites
decreased number of white blood cells (including those that help protect against infections), decreased number of platelets (blood cells that help stop bleeding), anemia, decreased number of red blood cells, increased eosinophilia (a type of white blood cell)
allergic reaction
development 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, decreased libido, nervousness, nightmares
lack of response to stimuli, loss of consciousness, low level of consciousness
seizures, fainting
irresistible urge to move body parts, balance disturbances, abnormal coordination, dizziness upon standing, concentration difficulties, 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 eye, increased tearing, eye redness
dizziness, ringing in the ears, ear pain
atrial fibrillation (irregular heartbeat), impaired conduction of impulses between the atria and ventricles of the heart, abnormal conduction of electrical impulses in the heart, QT interval prolongation in the heart, slow heartbeat, abnormal electrocardiogram (ECG), palpitations
low blood pressure, low blood pressure upon standing (as a result of which some patients taking Orizon may faint, feel dizzy or lose consciousness when standing up suddenly), sudden flushing
aspiration pneumonia (caused by food entering the airways), blood congestion in the lungs, hyperemia of the respiratory tract, crackles, rales, voice disturbances, respiratory tract disturbances
stomach or intestinal infection, fecal incontinence, very hard stool, difficulty swallowing, excessive gas
urticaria, itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, scaly and itchy scalp and body, 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, urinary incontinere, painful urination
erectile dysfunction, ejaculation disorders
absence of menstrual bleeding, amenorrhea and 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, discomfort
increased aminotransferase activity in blood, increased GGTP enzyme activity (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
pain related to medical procedures.

Rare adverse reactions ( may occur in 1 out of 1,000 patients ):

infection
abnormal secretion of the hormone regulating urine production
sleepwalking (somnambulism)
eating disorders related to sleep
glucose in urine, low blood sugar, high triglyceride (fat) levels in blood
lack of emotion, inability to achieve orgasm
reduced motor activity and lack of response in a patient with preserved consciousness (catatonia)
disturbances related to cerebral blood vessels
coma due to uncontrolled diabetes
tremulous, nodding head movements
glaucoma (increased intraocular pressure), eye movement disorders, rotational eye movements, eyelid margin ulcers
eye complications during cataract surgery. During this procedure, intraoperative floppy iris syndrome (IFIS) may occur if the patient is currently or previously taking Orizon. If the patient is scheduled for cataract surgery, inform the ophthalmologist about current or past use of this medicine.
dangerously low number of white blood cells responsible for fighting infections
dangerous excessive water drinking
irregular heartbeat
breathing disturbances during sleep (sleep apnea), rapid, shallow breathing
pancreatitis, intestinal obstruction
tongue swelling, chapped lips, drug rash
pityriasis
muscle fiber breakdown and muscle pain (rhabdomyolysis)
delayed menstrual periods, 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 occur in 1 out of 10,000 patients ):

life-threatening complications related to uncontrolled diabetes
severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties
lack of intestinal muscle movement, leading to obstruction.

Frequency unknown ( frequency cannot be determined from available data ):

severe, life-threatening rash with blistering and skin peeling 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).

Adverse reactions observed during use of another medicine – paliperidone, very similar to risperidone – which may also occur during use of Orizon: rapid heartbeat upon standing.
Additional adverse reactions in children and adolescents
Generally, adverse reactions in children are expected to 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, feeling of fatigue (tiredness), headache, increased appetite, vomiting, cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhea, and urinary incontinence (lack of bladder control).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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.: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Orizon

Keep this medicine 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 cardboard box. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Orizon contains

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

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

What Orizon looks like and contents of the pack

Orizon 0.5 mg: brownish-red, round coated tablet. The tablet cannot be divided.
Orizon 1 mg: white, biconvex, elongated coated tablet with a division line on one side. The tablet can be divided into equal doses.
Orizon 2 mg: light orange, biconvex, elongated coated tablet with a division line on one side. The tablet can be divided into equal doses.
Orizon 3 mg: light yellow, biconvex, elongated coated tablet with a division line on one side. The tablet can be divided into equal doses.
Orizon 4 mg: green, biconvex, elongated coated tablet with a division line on one side. The tablet can be divided into equal doses.

Orizon, coated tablets, are available in blister packs or in HDPE containers with a child-resistant cap and a sealing protective insert. The HDPE container contains a moisture-absorbing agent (silica gel desiccant).

Blister packs:
0.5 mg: 20 tablets
1 mg: 20 and 60 tablets
2 mg: 60 tablets
3 mg: 60 tablets
4 mg: 60 tablets

HDPE container:
0.5 mg: 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Finland, Sweden: Risperidon Orion
Poland: Orizon