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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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 pack 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 in on oneself), inconsistent 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 extremely excited, sad, agitated, distracted, insomnia, excessive talkativeness, loss of interest in daily activities, too long or too short sleep, overeating 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 the patient is 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, the patient should discuss it with their doctor or pharmacist if:

• the patient has schizoaffective disorder, as there is a possibility of changing the phase of the disease from manic to depressive during treatment with this medicine. The doctor will carefully monitor whether the patient experiences a change in the phase of the disease during treatment;
• the patient is 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");
• the patient has Parkinson's disease or dementia;
• the patient has ever been diagnosed with a condition characterized by high body temperature and muscle stiffness (so-called malignant neuroleptic syndrome);
• the patient has ever experienced abnormal movements of the tongue or facial muscles (late dyskinesia). The patient should be aware that this type of medicine can cause facial and tongue muscle movement disorders;
• the patient has had a low white blood cell count in the past (which may or may not have been caused by the action of other medicines);
• the patient has diabetes or is prone to developing diabetes;
• the patient has heart disease or is taking medicines used to treat heart disease that predispose to low blood pressure;
• the patient has epilepsy;
• the patient has swallowing disorders or gastrointestinal disorders that impair the ability to swallow or pass food through the intestines;
• the patient has a disease characterized by diarrhea;
• the patient has kidney function disorders;
• the patient has liver function disorders;
• the patient experiences prolonged or painful erections;
• the patient has a problem with regulating body temperature or overheating;
• the patient has elevated prolactin levels in the blood or suspected prolactin-dependent tumor;
• the patient or a family member has experienced blood clots (blood clots), as antipsychotic medicines have been associated with the formation of blood clots.

If the patient experiences any of these conditions, they should consult their doctor, who may adjust the dose or periodically monitor the patient.
The doctor may order a white blood cell count test, as very rare cases of a dangerously low number of a certain type of white blood cell necessary for fighting infections have been reported in patients taking paliperidone.
Parnido may cause weight gain. Significant weight gain can have a negative impact on the patient's health, so the doctor will regularly check the patient's weight.
The doctor will also check for symptoms of high blood sugar levels, as new cases of diabetes or worsening of pre-existing diabetes have been reported in patients taking paliperidone. 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 lead to eye damage. If the patient is scheduled for eye surgery, they should tell their ophthalmologist 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

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.
There may be disturbances in the electrical activity of the heart when this medicine is administered with certain heart medicines used to treat rhythm disorders or other types of medicines, such as antihistamines, antimalarial medicines, or other antipsychotic medicines.
Due to the fact that this medicine acts 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 caution should be exercised when taking it with other medicines that lower blood pressure.
This medicine may weaken the effect of medicines used to treat Parkinson's disease and restless legs syndrome (e.g., levodopa).
The effect of this medicine may be weakened when the patient takes medicines that affect the functioning of the digestive tract (e.g., metoclopramide).
It is recommended to reduce the dose of this medicine when valproate is administered concomitantly.
Concomitant use of this medicine with oral risperidone is not recommended, as it may lead to an increase in side effects.
Care should be taken when using Parnido with medicines that increase the activity of the central nervous system (psychostimulant medicines such as methylphenidate).

Parnido and alcohol

The patient should avoid consuming alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The patient should not take this medicine during pregnancy, unless it has been discussed with their 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, difficulty breathing, and feeding difficulties. If such symptoms are observed in the child, the patient should contact their doctor.
The patient should not breastfeed while taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur (see section 4. "Possible side effects"). This should be taken into account in situations where full alertness is required, e.g., when 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 considered "sodium-free".

3. How to take Parnido

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Administration in adults

The recommended dose in adults is 6 mg once daily, taken in the morning. The doctor may increase or decrease the dose within the range of 3 mg to 12 mg once daily for schizophrenia or 6 mg to 12 mg once daily for schizoaffective disorder, depending on the patient's 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 daily, 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 daily.
In adolescents weighing less than 51 kg, the dose can be increased to 6 mg once daily.
The doctor will decide what dose the patient will take, depending on their 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.
The tablet should not be chewed, divided, or crushed.
This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day. The patient should not take this medicine with breakfast one day and without breakfast the next day.
The active substance, paliperidone, dissolves after swallowing the tablet, while the tablet skeleton is excreted from the body.

Patients with renal impairment

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

Elderly patients

The doctor may reduce the dose of this medicine if kidney function is impaired.

Overdose of Parnido

The patient should contact their doctor immediately. Drowsiness, fatigue, abnormal body movements, balance problems, dizziness due to low blood pressure, and heart rhythm disturbances may occur.

Missed dose of Parnido

The patient should not take a double dose to make up for a missed dose. If the patient misses one dose of the medicine, they should take the next dose the next day. If the patient misses two or more doses of the medicine, they should contact their doctor.

Stopping treatment with Parnido

The patient should not stop taking this medicine, as they will lose its therapeutic effect. The patient should not stop taking the medicine unless their doctor advises them to do so, as the symptoms may recur.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor if:

• -The patient experiences 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 any of these symptoms occur, the patient should seek medical help immediately.
• -The patient with dementia experiences 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.
• -The patient experiences fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate treatment may be necessary.
• -The patient experiences a prolonged or painful erection. This condition is called priapism. Immediate treatment may be necessary.
• -The patient experiences involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue treatment with paliperidone.
• -The patient experiences 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 of stiffness or muscle tension (which makes the patient's movements uneven, jerky), and sometimes even a feeling of "freezing" of movements, followed by release. Other symptoms of parkinsonism include: slow, shuffling gait, resting tremor, increased salivation/drooling, 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 an abnormal posture), it most often affects the facial muscles, including abnormal eye movements, lip movements, tongue movements, or jaw movements
• -Dizziness
• -Dyskinesia: This condition includes involuntary muscle movements and may 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 when changing position to standing (which may cause some patients taking Parnido to faint, feel dizzy, or lose consciousness when standing up or getting up), 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
• -Bone or muscle 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, flu-like symptoms
• -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 the 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 leakage from the breasts, absence of menstruation, or other menstrual cycle disorders
• -Onset 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 sexual desire, inability to achieve orgasm, nervousness, nightmares
• -Late dyskinesia (involuntary, rhythmic movements of the face, tongue, or other body parts). 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 treatment with Parnido.
• -Seizures, fainting, compulsive movement of body parts, dizziness when changing position to standing, 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 (vertigo), ringing in the ears, ear pain
• -Irregular heartbeat, abnormal electrical impulse conduction in the heart (on the 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), milk leakage from the breasts, 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 1000 people)

• Eye infection, fungal infection of the nails, skin infection, skin rash caused by mites
• Dangerously low number of certain white blood cells responsible for fighting infections
• Decreased number of certain white blood cells that protect the body against infections, increased number 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 the amount of urine
• Life-threatening complications of untreated diabetes
• Excessive water drinking, low blood sugar levels, elevated cholesterol levels in the blood
• Sleepwalking (walking while sleeping)
• Absolute lack of movement and reaction to stimuli in a patient who is not sleeping (catatonia)
• Lack of emotions
• Malignant neuroleptic syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness)
• Loss of consciousness, balance disorders, abnormal coordination
• Cerebrovascular disorders, diabetic coma, lack of reaction to stimuli, low 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 changing position to standing
• Blood clots in the veins, especially in the legs (see above "The patient should immediately inform their doctor if:)
• Decreased oxygenation of various parts of the body (due to decreased blood flow), heat stroke
• Sleep apnea (breathing difficulties during sleep), rapid, shallow breathing
• Pneumonia caused by inhalation 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 may involve the throat and lead to breathing difficulties
• Thickening of the skin, dry skin, redness of the skin, skin discoloration, dandruff, seborrheic dermatitis
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal posture
• Priapism (prolonged erection that may require surgical intervention)
• Breast enlargement in men, breast enlargement, milk leakage from the breasts, vaginal discharge
• Menstrual disorders or other menstrual irregularities (in women), breast enlargement, breast discomfort
• Very low body temperature, drop in body temperature
• Withdrawal symptoms.

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

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

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: sleep-related eating disorders, other cerebrovascular disorders, crackling in the lungs, and severe or life-threatening rash with blisters and peeling skin, which may appear in the mouth, nose, eyes, and genitals, as well as around these areas, and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Complications related to the eye may also occur during cataract surgery. During this procedure, a condition called intraoperative floppy iris syndrome (IFIS) may occur if the patient is taking or has taken paliperidone. If the patient is scheduled for cataract surgery, they should inform their ophthalmologist 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 exception of the following, which are reported more frequently:

• Feeling drowsy or less alert
• Parkinsonism: This condition may include slow or abnormal movements, feeling of stiffness or muscle tension (which makes the patient's movements uneven, jerky), and sometimes even a feeling of "freezing" of movements, followed by release. Other symptoms of parkinsonism include: slow, shuffling gait, resting tremor, increased salivation/drooling, and a face without expression
• Weight gain
• Common cold symptoms
• Restlessness
• Tremor
• Abdominal pain
• Milk leakage from the breasts in girls
• Breast enlargement in boys
• Acne
• Speech disorders
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High levels of triglycerides (fats) in the blood
• Feeling of spinning (vertigo)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
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 to 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.
The patient should 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 stated.
The medicine should be stored in its original packaging to protect it from moisture.
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 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, and 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, with "P3" embossed on one side of the tablet. Diameter: approximately 9 mm.
6 mg: Brownish-yellow, round, biconvex tablets with possible surface irregularities, with "P6" embossed on one side of the tablet. Diameter: approximately 9 mm.
9 mg: Pink, round, biconvex tablets with possible surface irregularities, with "P9" embossed 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
To obtain more detailed information, the patient should contact their 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