Parnido

Package Leaflet: Information for the Patient

Parnido, 3 mg, prolonged-release tablets

Parnido, 6 mg, prolonged-release tablets

Parnido, 9 mg, prolonged-release tablets

Paliperidone

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

• You should 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 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 mental disorder characterized by symptoms such as hearing, seeing, or feeling things that are not there, unfounded beliefs, excessive suspiciousness, withdrawal (social isolation), disorganized speech, and flattened emotions and behavior. Patients may also experience depression, anxiety, tension, or feelings of guilt.
Parnido is also used to treat schizoaffective disorder in adults.
Schizoaffective disorder is a mental condition 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, excessive sleep or insomnia, overeating or undereating, and recurring suicidal thoughts).
Parnido helps to alleviate symptoms of the disorder 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, discuss with your doctor or pharmacist if:

• you have schizoaffective disorder, as there is a possibility of changing the phase of the disorder from manic to depressive during treatment with this medicine. Your doctor will closely monitor you for any change in the phase of the disorder 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 Parkinson's disease or dementia;
• you have ever been diagnosed with a condition characterized by high body temperature and muscle stiffness (neuroleptic malignant syndrome);
• you have ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia). You should be aware that this type of medicine may cause facial and tongue muscle disorders;
• you have had a low white blood cell count in the past (which may or may not have been caused by the use of other medicines);
• you have diabetes or are at risk of developing diabetes;
• you have heart disease or are taking medicines used to treat heart disease that may lower blood pressure;
• you have epilepsy;
• you have swallowing disorders or gastrointestinal disorders that may weaken 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 problems 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 medicines 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 monitor you periodically.
Your doctor may order a white blood cell count test, as very rare cases of dangerously low white blood cell counts have been reported in patients taking paliperidone.
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 also check for signs of high blood sugar levels, as new cases of diabetes or worsening of existing diabetes have been reported in patients taking paliperidone. In patients with existing diabetes, blood glucose levels should be regularly monitored.
During cataract surgery, the pupil (black spot in the center of the eye) may not dilate sufficiently. The iris (colored part of the eye) may also be flaccid during the procedure, which can lead to eye damage. If you are scheduled for eye surgery, you should inform your 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 disorder 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
There may be disturbances in heart rhythm when this medicine is given with certain heart medicines used to treat rhythm disorders or other types of medicines, such as antihistamines, antimalarial medicines, or other antipsychotic medicines.
Because this medicine works mainly in the brain, taking other medicines (or alcohol) that affect the brain may further disrupt its function.
This medicine may cause low 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 you take 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 taken concomitantly.
It is not recommended to take this medicine with oral risperidone, as it may lead to increased 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

Alcohol should be avoided 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 (last 3 months of pregnancy), the following symptoms may occur: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice any of these 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 (see section 4, "Possible side effects") may occur. 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 it is essentially "sodium-free".

3. How to take Parnido

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The recommended dose for adults is 6 mg once daily, taken in the morning. Your 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 your response to treatment.

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.
For adolescents weighing 51 kg or more, the dose can be increased within the range of 6 mg to 12 mg once daily.
For adolescents weighing less than 51 kg, the dose can be increased to 6 mg once daily.
Your doctor will decide what dose you should take, depending on your response to treatment.

How and when to take Parnido

Take this medicine orally, swallowing the tablet whole 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 substance, paliperidone, dissolves after swallowing the tablet, while the tablet shell is eliminated from the body.

Patients with kidney problems

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 reduced.

Overdose of Parnido

Seek immediate medical attention. You may experience drowsiness, fatigue, abnormal body movements, balance problems, dizziness due to low blood pressure, and heart rhythm disturbances.

Missed dose of Parnido

Do not take a double dose to make up for a missed dose. If you miss one dose, take the next dose the next day. If you miss two or more doses, consult your doctor.

Stopping treatment with Parnido

Do not stop taking this medicine, as you may lose its therapeutic effect. Do not stop taking this medicine unless your doctor advises you to, 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.

Seek immediate medical attention if:

• -You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, seek medical attention immediately.
• -You have dementia and experience a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, 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 neuroleptic malignant 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. Discontinuation of paliperidone may be necessary.
• -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 (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 posture), it most often affects the muscles of the face, including abnormal eye movements, mouth, tongue, or jaw
• -Dizziness
• -Dyskinesia: This condition includes involuntary muscle movements and can take the form of repetitive, spasmodic, or twisting movements or jerks
• -Tremor
• -Blurred vision
• -Abnormal heart rhythm, abnormal heart conduction, prolonged QT interval in the heart, slow heart rate, fast heart rate
• -Low blood pressure when standing up (which may cause some patients taking Parnido to faint, feel dizzy, or lose consciousness), high blood pressure
• -Sore throat, cough, stuffy nose
• -Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• -Elevated liver enzymes 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, 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 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 secretion, absence of menstruation, or other menstrual disorders
• -Development of diabetes or worsening of 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, difficulty achieving 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. Discontinuation of Parnido may be necessary.
• -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 (vertigo), ringing in the ears, ear pain
• -Irregular heartbeat, abnormal heart conduction (in ECG), feeling of palpitations
• -Low blood pressure
• -Shortness of breath, wheezing, nosebleeds
• -Tongue swelling, stomach or intestinal infection, difficulty swallowing, intense gas passage
• -Elevated liver enzyme levels in the blood, elevated gamma-glutamyltransferase (GGTP) levels in the blood
• -Hives, hair loss, rash, acne
• -Elevated creatine phosphokinase (CPK) levels 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 swelling, milk secretion, sexual disorders, breast discomfort, breast tenderness
• -Face, lip, eye, or limb swelling, body swelling
• -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)
• Akinetic crisis (a condition in which a person is unable to move or respond to stimuli and is not asleep)
• Lack of emotions
• Malignant neuroleptic syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness)
• Loss of consciousness, balance disorders, coordination disorders
• Cerebrovascular disorders, diabetic coma, unresponsiveness, decreased level of consciousness, nodding
• Glaucoma (increased pressure in the eyeball), increased tearing, eye redness, eye movement disorders, rotational eye movements
• Atrial fibrillation (abnormal heart rhythm), fast heart rate when standing up
• Blood clots in the veins, especially in the legs (see above "Seek immediate medical attention if:")
• Decreased oxygen supply to various parts of the body (due to decreased blood flow), heatstroke
• Breathing difficulties during sleep (sleep apnea), rapid, shallow breathing
• Pneumonia caused by food aspiration, congestion of the airways, voice disorders
• Bowel obstruction, fecal incontinence, very hard stools, lack of bowel movement leading to obstruction
• Jaundice (yellowing of the skin and eyes)
• Pancreatitis
• Severe allergic reaction with swelling that can involve the throat and lead to breathing difficulties
• Thickening of the skin, dry skin, skin redness, 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 swelling, milk secretion, vaginal discharge
• Menstrual irregularities (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 (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, lung crackling, and severe or life-threatening skin 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).
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 you are taking or have taken paliperidone. If you are scheduled for cataract surgery, you should inform your 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 seen 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
• Milk secretion 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 you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Parnido

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Parnido contains

• The active substance 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
For more information, 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