Parnido

Leaflet accompanying the packaging: patient information

Parnido, 3 mg, prolonged-release tablets

Parnido, 6 mg, prolonged-release tablets

Parnido, 9 mg, prolonged-release tablets

Paliperidone

You should carefully read the contents of this leaflet before taking this 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 experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Parnido and what is it used for

Parnido contains the active substance paliperidone, which belongs to a class of medicines called antipsychotics.
Parnido is used to treat schizophrenia in adults and adolescents aged 15 years and older. Schizophrenia is a disease with symptoms such as hearing, seeing, or feeling things that do not exist, unfounded beliefs, excessive suspicion, withdrawal (closing oneself off), incoherent speech, and flattening of emotions and behavior. Patients may also experience depression, anxiety, tension, or feelings of guilt.
Parnido is also used to treat schizoaffective disorders in adults.
Schizoaffective disorder is a mental state in which a person experiences both symptoms of schizophrenia (described above) and mood disorders (feeling strongly excited, sad, agitated, distracted, insomnia, excessive talkativeness, loss of interest in daily activities, excessive eating or undereating, and recurring suicidal thoughts).
Parnido helps to alleviate the symptoms of the disease and prevent their recurrence.

2. Important information before taking Parnido

When not to take Parnido

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

Warnings and precautions

Before starting to take Parnido, you should discuss it with your doctor or pharmacist if:

• you have schizoaffective disorder, as there is a possibility of changing the phase of the disease from manic to depressive during treatment with this medicine. Your doctor will carefully monitor whether you experience a change in the phase of the disease during treatment;
• you are elderly. The use of this medicine has not been studied in elderly patients with dementia. In elderly patients with dementia treated with other similar medicines, there is an increased risk of stroke and death (see section 4. "Possible side effects");
• you have been diagnosed with Parkinson's disease or dementia;
• you have ever been diagnosed with a condition whose symptoms included high body temperature and muscle stiffness (so-called malignant neuroleptic syndrome);
• you have ever experienced abnormal movements of the tongue or facial muscles (late dyskinesia). You should be aware that this type of medicine can cause facial and tongue muscle movement disorders;
• you have had a low white blood cell count in the past (which may or may not have been caused by the action of other medicines);
• you have diabetes or are prone to developing diabetes;
• you have heart disease or are taking medications used in heart disease that predispose to low blood pressure;
• you have epilepsy;
• you have swallowing disorders or gastrointestinal disorders that impair your ability to swallow or pass food through the intestines;
• you have a disease characterized by diarrhea;
• you have kidney function disorders;
• you have liver function disorders;
• you experience prolonged or painful erections;
• you have a problem with regulating your body temperature or overheating;
• you have elevated prolactin levels in your blood or suspected prolactin-dependent tumors;
• you or a family member have had blood clots (blood clots), as antipsychotic medications have been associated with the formation of blood clots.

If you experience any of these conditions, you should consult your doctor, who may adjust the dose or periodically monitor you.
Your doctor may order a white blood cell count test, as very rarely, patients taking paliperidone have had dangerously low levels of a certain type of white blood cell necessary to fight infections in their blood.
Parnido may cause weight gain. Significant weight gain can have a negative impact on your health, so your doctor will regularly check your weight.
Your doctor will check if you experience symptoms of high blood sugar levels, as patients taking paliperidone have had new cases of diabetes or worsening of pre-existing diabetes. In patients with pre-existing diabetes, blood glucose levels should be regularly checked.
During cataract surgery, the pupil (the black spot in the center of the eye) may not dilate sufficiently. The iris (the colored part of the eye) may also be flaccid during the procedure, which can result in eye damage. If you are scheduled for eye surgery, you should tell your eye doctor about taking this medicine.

Children and adolescents

Parnido is not intended for the treatment of schizophrenia in children and adolescents under 15 years of age.
Parnido is not intended for the treatment of schizoaffective disorders in children and adolescents under 18 years of age.
It is not known whether paliperidone is safe and effective in these age groups.

Parnido and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
There may be disturbances in the electrical activity of the heart when this medicine is administered with certain heart medications used to treat rhythm disorders or other types of medications, such as antihistamines, antimalarials, or other antipsychotic medications.
Since this medicine works primarily in the brain, taking other medicines (or alcohol) that affect the brain may further disrupt its function.
This medicine may cause a decrease in blood pressure, so you should be cautious when taking it with other medicines that lower blood pressure.
This medicine may weaken the effect of medications used in Parkinson's disease and restless legs syndrome (such as levodopa).
The effect of this medicine may be weakened if you take medicines that affect the functioning of the digestive tract (such as metoclopramide).
You should consider reducing the dose of this medicine when taking valproate.
It is not recommended to take this medicine with oral risperidone, as it may lead to increased side effects.
You should be cautious when taking Parnido with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).

Parnido and alcohol

You should avoid consuming alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine during pregnancy unless it has been discussed with your doctor. In newborns whose mothers took paliperidone 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 child, you should contact your doctor.
While taking this medicine, you should not breastfeed.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur (see section 4. "Possible side effects"). You should take this into account in situations where full alertness is required, such as driving vehicles or operating machines.

Parnido contains sodium

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

3. How to take Parnido

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Administration in adults

The recommended dose in adults is 6 mg once a day, taken in the morning. Your doctor may increase or decrease the dose within the range of 3 mg to 12 mg once a day for schizophrenia or 6 mg to 12 mg once a day for schizoaffective disorder, depending on your response to treatment.

Administration in adolescents

The recommended initial dose for the treatment of schizophrenia in adolescents aged 15 years and older is 3 mg once a day, taken in the morning.
In adolescents weighing 51 kg or more, the dose can be increased within the range of 6 mg to 12 mg once a day.
In adolescents weighing less than 51 kg, the dose can be increased to 6 mg once a day.
Your doctor will decide what dose you will take. This will depend on your response to treatment.

How and when to take Parnido

This medicine should be taken orally, swallowing the tablet whole and washing it down with water or another liquid.
Do not chew, divide, or crush the tablets.
This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day. Do not take this medicine with breakfast one day and without breakfast the next day.
The active ingredient, paliperidone, dissolves after swallowing the tablet, while the tablet skeleton is excreted from the body.

Patients with kidney disorders

Your doctor may adjust the dose of this medicine depending on your kidney function.

Elderly patients

Your doctor may reduce the dose of this medicine if your kidney function is decreased.

Overdose of Parnido

You should immediately contact your doctor. You may experience drowsiness, fatigue, abnormal body movements, problems standing and walking, dizziness due to low blood pressure, and heart rhythm disturbances.

Missing a dose of Parnido

You should not take a double dose to make up for a missed dose. If you miss a dose of this medicine, you should take the next dose the next day. If you miss two or more doses, you should contact your doctor.

Stopping treatment with Parnido

You should not stop taking this medicine, as you may lose its therapeutic effect. You should not stop taking this medicine unless your doctor advises you to do so, as your symptoms may recur.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

You should immediately inform your doctor if:

• -You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, you should seek medical help immediately.
• -You experience a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially one-sided, or speech disturbances, even for a short time. These symptoms may indicate a stroke.
• -You experience fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate treatment may be necessary.
• -You experience a prolonged or painful erection. This condition is called priapism. Immediate treatment may be necessary.
• -You experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue treatment with paliperidone.
• -You experience a severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure (called anaphylactic reaction).

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

• -Difficulty sleeping or waking up
• -Parkinsonism: This condition may include slow or abnormal movements, feeling stiff or tense muscles (which can cause uneven, jerky movements), and sometimes even a feeling of "freezing" of movements, followed by release. Other symptoms of parkinsonism include a slow, shuffling gait, resting tremor, increased saliva production, and a face without expression
• -Anxiety
• -Feeling drowsy or less alert
• -Headache

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

• -Bronchitis, common cold symptoms, sinus infection, urinary tract infection, flu-like symptoms
• -Weight gain, increased appetite, weight loss, decreased appetite
• -Elevated mood (mania), irritability, depression, anxiety
• -Dystonia: This condition includes slow or sustained involuntary muscle contractions. Although dystonia can affect any part of the body (and result in abnormal body posture), it most often affects the facial muscles, including abnormal eye movements, lip, tongue, or jaw movements
• -Dizziness
• -Dyskinesia: This condition includes involuntary muscle movements and can take the form of repetitive, spasmodic, or twisting movements or jerks
• -Tremor
• -Blurred vision
• -Blockage of the electrical impulse conduction between the atria and ventricles (chambers of the heart), abnormal electrical impulse conduction in the heart, prolonged QT interval in the heart, slow heart rate, fast heart rate
• -Low blood pressure, high blood pressure
• -Sore throat, cough, stuffy nose
• -Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• -Elevated liver enzyme activity in the blood
• -Itching, rash
• -Muscle or bone pain, back pain, joint pain
• -Absence of menstruation
• -Fever, weakness, fatigue

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

• -Pneumonia, respiratory tract infections, urinary tract infections, ear infections, tonsillitis
• -Decreased white blood cell count, decreased platelet count (blood cells responsible for stopping bleeding), anemia, decreased red blood cell count
• -Paliperidone may increase the level of a hormone called prolactin in your blood (which may or may not cause symptoms). Symptoms of elevated prolactin levels include: (in men) breast swelling, difficulty achieving or maintaining an erection, or other sexual disorders; in women, symptoms may include breast discomfort, milk secretion from the breasts, absence of menstruation, or other menstrual cycle disorders
• -Development of diabetes or worsening of pre-existing diabetes, high blood sugar levels, increased waist circumference, loss of appetite leading to malnutrition and low body weight, high levels of triglycerides (fats) in the blood
• -Sleep disturbances, confusion, decreased sex drive, inability to achieve orgasm, nervousness, nightmares
• -Late dyskinesia (involuntary, rhythmic movements of the face, tongue, or other body parts). You should immediately inform your doctor if you experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue treatment with Parnido.
• -Seizures, fainting, compulsive movement of body parts, dizziness when standing up, concentration disorders, speech difficulties, loss of taste, impaired sensation of pain and touch on the skin, feeling of tingling, pricking, or numbness of the skin
• -Increased sensitivity of the eyes to light, eye infection or conjunctivitis, dry eye
• -Feeling of spinning (dizziness), ringing in the ears, ear pain
• -Irregular heartbeat, abnormal electrical impulse conduction in the heart (on an ECG), feeling of palpitations
• -Low blood pressure
• -Shortness of breath, wheezing, nosebleeds
• -Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, intense gas passage
• -Elevated activity of the liver enzyme gamma-glutamyltransferase (GGTP) in the blood, elevated liver enzyme activity in the blood
• -Hives, hair loss, rash, acne
• -Elevated activity of the enzyme creatine phosphokinase (CPK) in the blood (an enzyme that is sometimes released from damaged muscles), muscle cramps, joint stiffness, joint swelling, muscle weakness, neck pain
• -Urinary incontinence, frequent urination, inability to urinate, painful urination
• -Erectile dysfunction, ejaculation disorders
• -Absence of menstruation or other menstrual disorders (in women), breast milk secretion, sexual disorders, breast pain, breast discomfort
• -Swelling of the face, lips, eyes, or tongue, swelling of the body, arms, or legs
• -Chills, elevated body temperature
• -Change in gait
• -Feeling of thirst
• -Chest pain, chest discomfort, malaise
• -Fall

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

• Eye infection, fungal infection of the nails, skin infection, skin rash caused by mites
• Dangerously low levels of certain white blood cells responsible for fighting infections
• Decreased levels of certain white blood cells that protect against infection, elevated levels of eosinophils (a type of white blood cell) in the blood
• Severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure (anaphylactic reaction), allergic reaction
• Presence of sugar in the urine
• Abnormal secretion of the hormone that regulates urine production
• Life-threatening complications of untreated diabetes
• Excessive water drinking, low blood sugar levels, elevated cholesterol levels in the blood
• Sleepwalking (sleepwalking)
• Lack of movement and reaction to stimuli in a patient who is not asleep (catatonia)
• Lack of emotions
• Malignant neuroleptic syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness)
• Loss of consciousness, balance disorders, impaired coordination
• Cerebrovascular disorders, diabetic coma, lack of response to stimuli, decreased level of consciousness, head shaking
• Glaucoma (increased pressure in the eyeball), increased tearing, eye redness, eye movement disorders, rotational eye movements
• Atrial fibrillation (abnormal heart rhythm), fast heartbeat when standing up
• Blood clots in the veins, especially in the legs (see above "You should immediately inform your doctor if:")
• Decreased oxygenation of various body parts (due to decreased blood flow), heatstroke
• Breathing difficulties during sleep (sleep apnea), rapid, shallow breathing
• Pneumonia caused by aspiration of food, congestion of the airways, voice disorders
• Intestinal obstruction, fecal incontinence, very hard stools, lack of intestinal peristalsis leading to obstruction
• Jaundice (yellowing of the skin and eyes)
• Pancreatitis
• Severe allergic reaction with swelling that can affect the throat and lead to breathing difficulties
• Thickening of the skin, dry skin, redness of the skin, skin discoloration, dandruff, seborrheic dermatitis of the scalp
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal body posture
• Priapism (prolonged erection that may require surgical intervention)
• Breast enlargement in men, breast enlargement, milk secretion from the breasts, vaginal discharge
• Menstrual irregularities or other menstrual disorders (in women), breast enlargement
• Very low body temperature, decreased body temperature
• Withdrawal symptoms.

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

• Pulmonary embolism
• Elevated insulin levels in the blood (a hormone that regulates blood sugar levels).

The following side effects have been reported with the use of another medicine, risperidone, which is very similar to paliperidone, so they may also occur with Parnido: eating disorders related to sleep, other cerebrovascular disorders, crackling in the lungs, and severe or life-threatening rash with blisters and peeling skin, which can occur in the mouth, nose, eyes, and genitals, as well as around these areas, and can also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Eye complications may also occur during cataract surgery. During this procedure, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken paliperidone. If you are scheduled for cataract surgery, you should tell your eye doctor about taking this medicine in the past or present.

Additional side effects reported in adolescents

In adolescents, side effects are generally similar to those in adults, with the following exceptions, which are reported more frequently:

• Feeling drowsy or less alert
• Parkinsonism: This condition may include slow or abnormal movements, feeling stiff or tense muscles (which can cause uneven, jerky movements), and sometimes even a feeling of "freezing" of movements, followed by release. Other symptoms of parkinsonism include a slow, shuffling gait, resting tremor, increased saliva production, and a face without expression
• Weight gain
• Common cold symptoms
• Restlessness
• Tremor
• Abdominal pain
• Breast milk secretion in girls
• Breast enlargement in boys
• Acne
• Speech disorders
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High levels of triglycerides in the blood (fats)
• Feeling of spinning (dizziness)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Parnido

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Parnido contains

• The active substance of Parnido is paliperidone. Each prolonged-release tablet contains 3 mg, 6 mg, or 9 mg of paliperidone.
• The other ingredients are: macrogol, butylhydroxytoluene (E 321), povidone (K 30), sodium chloride, microcrystalline cellulose, magnesium stearate, iron oxide red (E 172), hydroxypropylcellulose, and cellulose acetate in the tablet core, as well as hypromellose, titanium dioxide (E 171), talc, propylene glycol (E 1520), iron oxide yellow (E 172) (only for 6 mg tablets), and iron oxide red (E 172) (only for 9 mg tablets) in the tablet coating, as well as shellac, iron oxide black (E 172), and propylene glycol (E 1520) in the ink. See section 2 "Parnido contains sodium".

What Parnido looks like and contents of the pack

3 mg: White to off-white, round, biconvex tablets with possible surface irregularities and the inscription "P3" on one side of the tablet. Diameter: approximately 9 mm.
6 mg: Brownish-yellow, round, biconvex tablets with possible surface irregularities and the inscription "P6" on one side of the tablet. Diameter: approximately 9 mm.
9 mg: Pink, round, biconvex tablets with possible surface irregularities and the inscription "P9" on one side of the tablet. Diameter: approximately 9 mm.
Parnido is available in cartons containing 30 prolonged-release tablets in blisters.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
For more detailed information, please contact your local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: +48 22 573 75 00
Date of last revision of the leaflet:1.09.2021