Orizon

Package Leaflet: Information for the User

ORIZON, 1 mg/ml, Oral Solution

Risperidone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects not mentioned in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 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 in:

• treatment of schizophrenia - a condition where the patient may see, hear, or feel things that do not exist, believe in untrue things, or experience unusual suspiciousness or disorientation.
• treatment of manic episodes - a condition where the patient may feel strong excitement, agitation, irritability, 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 patients with Alzheimer's disease, who may 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 symptoms of the disease and prevent recurrence of 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 unsure whether the above information applies to them, they should consult their doctor or pharmacist before taking Orizon.

Warnings and precautions

Before starting treatment with Orizon, the patient should discuss the following with their doctor or pharmacist:

• if the patient has heart rhythm disorders, such as an irregular heartbeat, or if the patient has a tendency to low blood pressure, or if the patient is taking blood pressure-lowering medications. Orizon 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 increase the risk of stroke, such as high blood pressure, cardiovascular disease, or cerebral vascular disorders,
• if the patient has ever experienced involuntary rhythmic movements of the tongue, lips, or face,
• if 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),
• in patients with Parkinson's disease or dementia,
• if 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),
• in patients with diabetes,
• in patients with epilepsy,
• if the patient is a man and has experienced prolonged or painful erections,
• 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 an abnormally high level of the hormone prolactin in the blood or if there is a suspicion of a prolactin-dependent tumor,
• if the patient or any of their relatives have had blood clots in the past, as the use of antipsychotic medicines is associated with the formation of blood clots.

If the patient is unsure whether any of the above conditions apply to them, they should consult their doctor or pharmacist before taking Orizon.
The doctor may order a white blood cell count test, as very rarely, patients taking Orizon have been observed to have 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 monitor the patient's weight.
The doctor should check if the patient has symptoms of high blood sugar levels, as patients taking Orizon have been observed 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 swelling in men (see "Possible side effects"). If such side effects occur, it is recommended to perform a prolactin level test in the blood.
During cataract surgery, the pupil may not dilate sufficiently. The iris may also be flaccid during the procedure, which can result in eye damage. If the patient has scheduled eye surgery, they should inform their 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 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 if it is one-sided, or speech disorders, even if they occur 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 during treatment, changing the time of taking risperidone may improve concentration. Before starting treatment in both adult and child patients, it may be necessary to measure body weight and regularly monitor body weight during treatment.
In a small study, an increase in growth was observed 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 may cause a change in heart electrical activity, such as malaria medicines, anti-arrhythmic medicines, antihistamines, or certain antidepressants or other medicines used to treat mental disorders,
• medicines that slow down heart rate,
• medicines that lower blood potassium levels (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, e.g., furosemide or chlorthiazide). Orizon taken alone or in combination 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 (anti-epileptic medicines),
• phenobarbital. If these medicines are started or stopped, 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 blocking agents (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 these medicines are started or stopped, 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 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. The liquid can be swallowed directly or mixed with mineral water, orange juice, or black coffee. If the liquid is mixed in this way, the drink should be consumed immediately after preparation.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
The doctor will decide whether the patient can take Orizon.
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 such symptoms are observed in the patient's child, they should contact their doctor.
Orizon may increase the level of a hormone called "prolactin", which may affect fertility (see "Possible side effects").

Driving and using machines

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

Orizon contains benzoes acid (E 210)

This medicine contains 1.5 mg of benzoes acid in each 1 ml of oral solution. Benzoes acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

3. How to take Orizon

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Recommended doses are given below:
In the treatment of schizophrenia
Adults

• Usually, the 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.
• 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 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.

Use in children and adolescents

In children and adolescents under 18 years of age, Orizon should not be used to treat schizophrenia or mania.
In the case of behavioral disorder therapy
The dose depends on the child's body weight:
In the case of 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 the case of 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 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 to treat behavioral disorders in children under 5 years of age.

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.

Method of administration

Oral administration.

Instructions for using the pipette for Orizon oral solution:

• 1. Remove the child-resistant cap from the bottle by pressing the cap down and turning it counterclockwise (Figure 1).
• 2. Place the bottle on a flat surface.
• 3. Insert the pipette into the solution in the bottle.
• 4. Holding the lower ring, pull the upper ring up until the mark indicating the required amount of mg or ml appears (Figure 2).
• 5. Holding the lower ring, remove the pipette from the bottle (Figure 3).
• 6. To empty the pipette, press the upper ring down while still holding the lower ring.

• 7. The contents of the pipette can be emptied directly into the mouth or into a drink - mineral water, orange juice, or black coffee.
• 8. Rinse the pipette with water.
• 9. Close the bottle again with the child-resistant cap by turning it clockwise until it clicks.

Remember - each milliliter (ml) of solution corresponds to 1 mg.

Overdose of Orizon

The patient should go to their doctor immediately. They should take the medicine packaging with them.
In the event of an overdose of the medicine, the patient may experience drowsiness or fatigue, or they may experience abnormal movements of the body, difficulty standing or walking, dizziness due to low blood pressure, or 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, they should skip the missed dose and take the next dose as directed. If the patient forgets to take 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 treatment with Orizon

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 medicine, the dose of the medicine may be gradually reduced over several days.
If the patient has any further questions about taking this medicine, they 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 they experience any of the following, not very common side effects (may affect up to 1 in 100 people):

including( may affect up to 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 occur for a short time. These symptoms may signal a stroke.
• Late dyskinesia (twitching or jerking uncontrolled 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 affect up to 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 travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, the patient should seek medical help immediately.
• The patient experiences fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary.
• A man experiences prolonged or painful erections. This condition is known as priapism. Immediate treatment may be necessary.
• The patient experiences a severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching of the skin, rash, or low blood pressure.

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

• Difficulty sleeping or waking up.
• Parkinsonism: This condition may include slow or abnormal movements, 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 release. Other symptoms of parkinsonism include a slow, shuffling gait, tremors, increased salivation/drooling, and a face without expression.
• Feeling of drowsiness or decreased alertness.
• Headache.

Common ( may affect up to 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 increased prolactin levels occur not very commonly and may include in men breast swelling, difficulty achieving or maintaining an erection, decreased sex drive, or other sexual disorders. In women, they may include breast discomfort, milk leakage from the breasts, absence of menstrual periods, or other menstrual 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. Although it can affect any part of the body (which can result in an abnormal posture), dystonia most commonly affects the muscles of the face, including abnormal movements of the eyes, lips, tongue, or jaw.
• Dizziness.
• Dyskinesia: In this condition, there are involuntary muscle movements, including repetitive, spasmodic, or twisting movements or jerks.
• Tremors. Blurred vision, eye infection, or conjunctivitis.
• Fast heartbeat, high blood pressure, shortness of breath (dyspnea).
• Sore throat, cough, nosebleeds, stuffy nose.
• Abdominal pain, discomfort in the abdomen, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Rash, redness of the skin.
• Muscle spasm, bone or muscle pain, back pain, joint pain.
• Urinary incontinence.
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue, pain.
• Falls.

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

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, skin infection limited to one area or part of the body, viral infection, flu-like symptoms.
• 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 levels, excessive thirst.
• Weight loss, loss of appetite leading to malnutrition and low body weight.
• Increased cholesterol levels in the blood.
• Elevated mood (mania), confusion, decreased libido, nervousness, nightmares.
• Lack of reaction to stimuli, loss of consciousness, low level of consciousness.
• Seizures, fainting.
• Need to move body parts, balance disorders, coordination disorders, dizziness when changing position to standing, concentration disorders, speech difficulties, loss of taste, decreased sensation of pain and touch on the skin, feeling of tingling, pricking, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eye, increased tearing, redness of the eyes.
• Feeling of dizziness, ringing in the ears, ear pain.
• Atrial fibrillation (irregular heart rhythm), conduction disorder between the heart chambers, abnormal conduction of electrical impulses in the heart, prolonged QT interval in the heart, slow heartbeat, abnormal electrocardiogram (ECG), feeling of palpitations.
• Low blood pressure, low blood pressure when changing position to standing (which may cause some patients taking Orizon to faint, feel dizzy, or lose consciousness when standing up suddenly), flushing.
• Aspiration pneumonia (caused by food entering the airways), fluid accumulation in the lungs, congestion of the airways, wheezing, breathing difficulties.
• Stomach or intestinal infection, diarrhea, very hard stools, difficulty swallowing, excessive gas.
• Hives, itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, flaky, itchy skin on the head and rest of the body, skin disorders, skin damage.
• Increased activity of creatine phosphokinase (CPK) in the blood, an enzyme that is sometimes released from damaged muscles.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, urinary incontinence, painful urination.
• Erectile dysfunction, ejaculation disorders.
• Absence of menstrual periods, menstrual disorders, and other menstrual disorders (in women).
• Breast swelling in men, milk leakage from the breasts, sexual disorders, breast pain, discomfort in the breasts, vaginal discharge.
• Swelling of the face, lips, eyes, or tongue.
• Chills, increased body temperature.
• Change in gait.
• Thirst, malaise, discomfort in the chest, 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.

Rare ( may affect up to 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 levels, high triglyceride levels (fats) in the blood.
• Lack of emotions, inability to achieve orgasm.
• Decreased motor activity and lack of response in a patient with preserved consciousness (catatonia).
• Cerebrovascular disorders.
• 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 during cataract 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 scheduled cataract surgery, they should inform their eye doctor about taking this medicine in the past or present.
• Dangerously low number of certain white blood cells responsible for fighting infections.
• Dangerously excessive thirst.
• Irregular heartbeat.
• Sleep apnea (breathing difficulties during sleep), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Swelling of the tongue, dry lips, rash.
• Dandruff.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, breast swelling, breast enlargement, milk leakage from the breasts.
• Increased insulin levels in the blood (a hormone that regulates blood sugar levels).
• Skin hardening.
• Low body temperature, cooling of the hands and feet.
• Withdrawal symptoms.
• Jaundice (yellowing of the skin and eyes).

Very rare ( may affect up to 1 in 10,000 people)

• Life-threatening complications related to uncontrolled diabetes.
• A severe allergic reaction with swelling, which can affect the throat and lead to breathing difficulties.
• Intestinal obstruction leading to bowel obstruction.

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

• A severe or life-threatening rash with blisters and peeling of the skin, which may start on the lips, face, tongue, or eyes and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis). Side effects observed during the use of another medicine - paliperidone, very similar to risperidone, which may also occur during the use of 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 observed 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 urinary incontinence (loss of bladder control).

Reporting side effects

If the patient experiences any side effects, including those not mentioned in this leaflet, they should tell their doctor, pharmacist, or nurse. 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Orizon

Store in a place out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month stated.
Shelf life after opening the bottle – 4 months.
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 pack and other information

What Orizon oral solution contains

• The active substance of the medicine is risperidone. 1 ml of the medicine contains 1 mg of risperidone.
• The other ingredients are: benzoes acid (E 210), tartaric acid, hydrochloric acid, concentrated (to adjust pH 1.60-1.95), purified water.

What Orizon oral solution looks like and contents of the pack

The solution is clear and colorless.
Orizon is available in an orange glass bottle (type III) with a child-resistant cap (PP/LDPE) with a tamper-evident closure, with a dosing pipette (PS/LDPE), in a cardboard box.
Package sizes: 30 ml and 100 ml. Not all package sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

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

Czech Republic, Finland, Slovakia:
Risperidon Orion
Poland:
Orizon

Date of last revision of the package leaflet: 07.10.2024