Orizon

Package Leaflet: 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

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

• 1. What is Orizon and what is it used for
• 2. Before you take Orizon
• 3. How to take Orizon
• 4. Possible side effects
• 5. How to store Orizon
• 6. Contents of the pack 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 to treat:

• schizophrenia - a condition where you may see, hear, or feel things that are not there, believe things that are not true, or feel unusually suspicious or confused
• manic episodes - a condition where you may feel very excited, elated, agitated, or hyperactive. Manic episodes occur in bipolar disorder
• short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who are harming themselves or others. Before taking the medicine, non-pharmacological treatment methods should be used
• short-term treatment (up to 6 weeks) of persistent aggression in mentally retarded children (over 5 years) and adolescents with behavioral disorders

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

2. Before you take Orizon

When not to take Orizon

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

If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Orizon.

Warnings and precautions

Before starting treatment with Orizon, discuss with your doctor or pharmacist if:

• you have heart problems, such as an irregular heartbeat or a tendency to low blood pressure, or if you are taking blood pressure-lowering medicines. Orizon may cause a decrease in blood pressure. It may be necessary to adjust the dose of the medicine.
• you know of any factors that may predispose you to stroke, such as high blood pressure, cardiovascular disease, or cerebral vascular disorders
• you have ever had involuntary rhythmic movements of the tongue, lips, or face
• you have ever had a condition characterized by fever, stiff muscles, sweating, or decreased consciousness (also known as neuroleptic malignant syndrome)
• you have Parkinson's disease or dementia
• you have had a low white blood cell count in the past (which may or may not have been caused by other medicines)
• you have diabetes
• you have epilepsy
• you are a man and have had a prolonged or painful erection
• you have problems with body temperature regulation or are overheating
• you have kidney problems
• you have liver problems
• you have been found to have a high level of the hormone prolactin in your blood or have a prolactin-dependent tumor
• you or a family member have had blood clots in the past, as antipsychotic medicines have been associated with the formation of blood clots.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Orizon.
Your doctor may order a white blood cell count test, as very rarely, patients taking antipsychotic medicines have had a dangerously low white blood cell count.
Orizon may cause weight gain. Significant weight gain can affect your health. Your doctor will regularly check your weight.
Your doctor should check if you have symptoms of high blood sugar, as diabetes has been reported in patients taking Orizon, and worsening of existing diabetes has been observed in patients with diabetes.
For 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 have a blood test for prolactin levels.
During cataract surgery, the pupil of the eye of a patient taking risperidone may not dilate sufficiently. The iris of the eye may also become floppy during the procedure, which can result in eye damage. If you are scheduled for eye surgery, tell your eye doctor 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 with the doctor.
Seek medical help immediately if the patient or caregiver notices a sudden change in the patient's mental state or sudden weakness or numbness of the face, arms, or legs, especially if it occurs on one side, or speech disorders, even if they only last 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, 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 regularly monitored for weight during treatment.
In a small study, an increase in growth was observed in children taking risperidone, but it is not known if this is due to the effect of the medicine or other factors.

Orizon and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you 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, or certain antidepressants
• 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 heart disease or to relieve swelling in areas where there is excessive fluid accumulation, such as furosemide or chlorothiazide). 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 (medicines for epilepsy)
• phenobarbital. If you start or stop 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 psychosis 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 arrhythmias
• sertraline and fluvoxamine, used to treat depression and other mental disorders. If you start or stop taking these medicines, it may be necessary to change the dose of risperidone.

If you are not sure if any of the above situations apply to you, talk to your 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, you should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take this medicine.
In newborns whose mothers took Orizon during the last trimester of pregnancy (the last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice such symptoms in your baby, contact your 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, dizziness, fatigue, or vision disturbances may occur. Therefore, do not drive or operate machinery without consulting your doctor.

Orizon contains lactose

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 you have been diagnosed with an intolerance to some sugars, contact your 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, i.e., the medicine is considered "sodium-free".

3. How to take Orizon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet 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 given below:
In the treatment of schizophrenia
Adults

• Usually, the initial dose is 2 mg on the first 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.
• This total daily dose may be given as a single dose or divided into two doses. The doctor will inform you which method of taking the medicine is best for you.

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 you which method of taking the medicine is best for you.

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

Use in children and adolescents

Orizon should not be used in children under 18 years of age for the treatment of schizophrenia or for the treatment of mania in bipolar 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 below 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 patient group.

Overdose

Seek medical help immediately. Take the medicine package with you.
After an overdose, the patient may experience drowsiness or fatigue, or may have abnormal movements, difficulty standing and walking, dizziness due to low blood pressure, or an abnormal heart rhythm, or may have a seizure.

Missed dose

If you miss a dose, take the next dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose as scheduled. If you miss two or more doses, contact your doctor.

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

Stopping treatment

Do not stop taking the medicine unless your doctor tells you to. The symptoms of your illness may return.
If your doctor decides to stop treatment, the dose of the medicine may be gradually reduced over several days.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Orizon can cause side effects, although not everybody gets them.

Seek medical help immediately if you experience any of the following

less common side effects( may affect up to 1 in 100 people):

• in patients with dementia, a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially if it occurs on one side, or speech disorders, even if they only last for a short time. These symptoms may indicate a stroke.
• late dyskinesia (involuntary, repetitive body movements). You should immediately inform your doctor if you experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue Orizon.

Seek medical help immediately if you experience any of the following

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

• 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 you experience such symptoms, seek medical help immediately.
• fever, stiff muscles, sweating, or decreased consciousness (a condition known as neuroleptic malignant syndrome). Immediate treatment may be necessary.
• a prolonged or painful erection in men. This condition is known as priapism. Immediate treatment may be necessary.
• a severe allergic reaction with 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 affect 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 uneven, jerky movements), and sometimes even a feeling of "freezing" of movements, followed by a release. Other symptoms of parkinsonism include a slow, shuffling gait, tremors, increased saliva production, and a mask-like face.
• feeling drowsy or less alert
• headache.

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

• respiratory tract infections, bronchitis, common cold symptoms, sinusitis, urinary tract infections, ear infections, flu-like symptoms
• Orizon may increase the level of the hormone "prolactin" in the blood (with or without symptoms). Symptoms of high 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, absence of menstrual periods, or other menstrual disorders or fertility disorders.
• weight gain, increased appetite, decreased appetite
• sleep disturbances, irritability, depression, anxiety, restlessness
• dystonia: This condition includes slow or sustained involuntary muscle contractions. It 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: This condition includes involuntary muscle movements, including repetitive, spasmodic, or twisting movements or jerks
• tremors
• blurred vision, eye infection, or conjunctivitis
• rapid heartbeat, high blood pressure, shortness of breath
• sore throat, cough, nosebleed, 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, psoriasis-like skin condition
• increased CPK (creatine phosphokinase) levels in the blood, an enzyme that is sometimes released from damaged muscles
• abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• urinary frequency, urinary incontinence, painful urination
• erectile dysfunction, ejaculation disorder
• loss of menstrual periods, menstrual disorders, and other menstrual disorders (in women)
• breast enlargement in men, milk secretion, sexual disorders, breast discomfort, vaginal discharge
• facial swelling, lip swelling, eye swelling, or mouth swelling
• chills, increased body temperature
• change in gait
• thirst, malaise, chest discomfort, feeling unwell, discomfort
• increased liver enzyme levels in the blood, increased GGTP enzyme levels in the blood, increased liver enzyme levels in the blood
• procedural pain.

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

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

infections of the skin and subcutaneous tissue

• decreased white blood cell count (including those that help protect against infections), decreased platelet count (blood cells that help stop bleeding), anemia, decreased red blood cell count, increased eosinophil count (a type of white blood cell)
• allergic reaction
• development of diabetes or worsening of existing diabetes, high blood sugar, excessive thirst
• weight loss, loss of appetite leading to malnutrition and low body weight
• high cholesterol levels in the blood
• elevated mood (mania), confusion, decreased libido, nervousness, nightmares
• decreased physical activity and lack of response in a patient with preserved consciousness (catatonia)
• disorders related to blood vessels in the brain
• diabetic coma due to uncontrolled diabetes
• shaking or nodding movements of the head
• glaucoma (increased pressure in the eyeball), eye movement disorders, rotational eye movements, eyelid margin ulcers
• surgical complications during cataract surgery. During this procedure, a condition known as intraoperative floppy iris syndrome (IFIS) may occur if the patient is taking or has taken Orizon. If you are scheduled for cataract surgery, tell your eye doctor about taking this medicine in the past or present.
• dangerously low white blood cell count
• dangerously excessive water drinking
• irregular heartbeat
• sleep apnea (breathing difficulties during sleep), rapid, shallow breathing
• pancreatitis, intestinal obstruction
• tongue swelling, lip swelling, angioedema, skin rash
• dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• delayed menstrual periods, breast enlargement, breast engorgement, milk secretion
• 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).

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

• life-threatening complications due 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 skin rash with blistering and peeling of the skin, which can affect the mouth, nose, eyes, and genitals, and can spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

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

Additional side effects in children and adolescents

Generally, side effects in children are expected to be similar to those in adults. The following side effects have been reported more frequently in children and adolescents (aged 5-17) than in adults: drowsiness or decreased alertness, fatigue, headache, increased appetite, vomiting, common cold symptoms, runny nose, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and urinary incontinence.

Reporting side effects

If you experience any side effects, talk to your 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, you can help provide more information on the safety of this medicine.

5. How to store Orizon

Keep this medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
• The other ingredients are:

Tablet core:
lactose monohydrate, cornstarch, microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), hypromellose 2910 (5 cps), sodium lauryl sulfate, colloidal anhydrous silica, 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 tablet with a score line on one side. The tablet can be divided into equal doses.
Orizon 2 mg:pale orange, biconvex, oval tablet with a score line on one side. The tablet can be divided into equal doses.
Orizon 3 mg:light yellow, biconvex, oval tablet with a score line on one side. The tablet can be divided into equal doses.
Orizon 4 mg:green, biconvex, oval 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).
Blisters:
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 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 on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

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 package leaflet:29.09.2023