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
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else 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.

Contents of the leaflet

1. What Parnido is and what it is used for
2. What you need to know 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 Parnido is and what it is 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 at least 15 years. Schizophrenia is a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, having unfounded beliefs, excessive suspiciousness, social withdrawal (isolation), disorganized speech, and blunted 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 (such as intense excitement, sadness, agitation, difficulty concentrating, insomnia, excessive talkativeness, loss of interest in everyday activities, sleeping too much or too little, overeating or undereating, and recurring suicidal thoughts).
Parnido helps to relieve the symptoms of the illness and helps prevent their recurrence.

2. Important information before using Parnido

When not to use 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, discuss with your doctor or pharmacist if:

• the patient has schizoaffective disorders, as there is a possibility of a shift in disease phase from manic to depressive during treatment with this medicine. The doctor will closely monitor whether such a phase change occurs 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 neuroleptic malignant syndrome);
• the patient has ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia). The patient should be aware that this type of medicine may cause movement disorders of the face and tongue;
• the patient has previously had low white blood cell count (which may or may not have been caused by other medicines);
• the patient has diabetes or is predisposed to developing diabetes;
• the patient has heart disease or is taking medicines used for heart conditions that predispose to low blood pressure;
• the patient has epilepsy;
• the patient has swallowing disorders or gastrointestinal disorders that impair swallowing or the passage of food through the intestines;
• the patient suffers from a condition associated with diarrhoea;
• the patient has kidney function disorders;
• the patient has liver function disorders;
• the patient experiences prolonged and (or) painful erection;
• the patient has problems regulating core body temperature or overheating of the body;
• the patient has abnormally increased blood levels of prolactin hormone or suspicion of a prolactin-dependent tumour;
• the patient or someone in their family has had thrombosis (blood clots), as blood clots have been reported during treatment with antipsychotic medicines.

If any of these conditions apply to the patient, consult a doctor, who may adjust the dose or monitor the patient periodically.
The treating doctor may order a white blood cell count test, as very rarely, dangerously low levels of a certain type of white blood cells necessary to fight infections have been observed in patients taking paliperidone.
Parnido may cause weight gain. Significant weight gain may negatively affect the patient's health; therefore, the treating doctor will regularly monitor the patient's body weight.
The treating doctor will monitor for symptoms of elevated blood sugar levels, as new-onset diabetes or worsening of pre-existing diabetes has been observed in patients taking paliperidone. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
During cataract surgery, the pupil (black spot in the center of the eye) may not dilate sufficiently. Also, the iris of the eye (coloured part of the eye) may be flaccid during the procedure, which could lead to eye damage. If the patient is scheduled for eye surgery, inform the ophthalmologist that they are 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 with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Cardiac electrical function disturbances may occur when this medicine is taken concomitantly with certain heart medications used to treat arrhythmias, or with other types of medicines such as antihistamines, antimalarials, or other antipsychotics.
Since this medicine acts primarily in the brain, taking other medicines (or alcohol) that affect the brain may further impair its function.
This medicine may lower blood pressure; therefore, caution is advised when taking it together with other medicines that lower blood pressure.
This medicine may reduce the effectiveness of medicines used in Parkinson's disease and restless legs syndrome (e.g., levodopa).
The effect of this medicine may be reduced if the patient takes medicines affecting gastrointestinal motility (e.g., metoclopramide).
Consider reducing the dose of this medicine when used concomitantly with valproate.
Concomitant use of this medicine with oral risperidone is not recommended, as it may lead to increased side effects.
Exercise caution when using Parnido together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Parnido and alcohol
Alcohol consumption should be avoided during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The patient should not take this medicine during pregnancy unless discussed with the doctor. Newborns whose mothers took paliperidone during the third trimester of pregnancy (last 3 months) may experience the following symptoms: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If such symptoms are observed in the baby, contact a doctor immediately.
The patient should not breastfeed while taking this medicine.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4. "Possible side effects"). This should be taken into account in situations requiring full alertness, such as driving or operating machinery.

Parnido contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Parnido

This medicine should always be taken as instructed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.

Use in 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 in the case of schizophrenia, or from 6 mg to
12 mg once daily in the case of schizoaffective disorders. This will depend on the patient's response
to treatment.

Use in adolescents
The recommended starting dose for treating schizophrenia in adolescents aged at least 15 years is 3 mg
once daily, taken in the morning.

In adolescents with body weight of at least 51 kg, the dose may be increased to a range of 6 mg to 12 mg
once daily.

In adolescents with body weight less than 51 kg, the dose may be increased up to 6 mg once daily.

The treating physician will decide the appropriate dose for the patient. This will depend on the patient's
response to treatment.

How and when to take Parnido
This medicine should be taken orally by 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 manner
each day. Do not take this medicine with breakfast one day and without breakfast the next day.

The active ingredient, paliperidone, dissolves after the tablet is swallowed, whereas the tablet shell is
excreted from the body.

Patients with kidney disorders
Your doctor may adjust the dose of this medicine depending on kidney function.

Elderly patients
Your doctor may reduce the dose of this medicine if kidney function is impaired.

Taking more Parnido than recommended
Seek medical advice immediately. Symptoms may include drowsiness, feeling tired, abnormal body
movements, difficulty standing and walking, dizziness due to low blood pressure, and heart rhythm
disturbances.

If you miss a 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
following day. If you miss two or more doses, contact your doctor.

Stopping Parnido
Do not stop taking this medicine, as you will lose the therapeutic effect. Do not discontinue treatment
unless instructed by your doctor, as symptoms may return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor if:

• The patient develops blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, seek immediate medical help.
• The patient with dementia experiences a sudden change in mental state or sudden weakness or numbness of the face, hands or feet, particularly on one side, or speech disturbances, even if brief. These symptoms may indicate a stroke.
• Fever, muscle stiffness, sweating or decreased level of consciousness occurs (a condition called neuroleptic malignant syndrome). Immediate treatment may be necessary.
• A man experiences prolonged or painful erection. This condition is known as priapism. Immediate treatment may be necessary.
• Involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of paliperidone treatment may be necessary.
• A severe allergic reaction occurs characterized by: fever, swelling of the lips, face, tongue or throat, breathing difficulties, itching, skin rash and sometimes a drop in blood pressure (known as "anaphylactic reaction").

Very common adverse reactions (may occur in more than 1 in 10 patients)

• Difficulty falling asleep or waking up
• Parkinsonism: This condition may involve slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a sensation of "freezing" of movement followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation/drooling, and expressionless face
• Restlessness
• Drowsiness or reduced alertness
• Headache

Common adverse reactions (may occur in less than 1 in 10 patients)

• Bronchitis, 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 involves slow or sustained involuntary muscle contractions. Although dystonia may affect any part of the body (and result in abnormal posture), it usually involves facial muscles, including abnormal eye, lip, tongue or jaw movements
• Dizziness
• Dyskinesia: This condition involves involuntary muscle movements and may present as repetitive, spasmodic or twisting movements or jerks
• Tremor
• Blurred vision
• Heart block (impaired electrical conduction between the atria and ventricles), abnormal electrical conduction in the heart, QT interval prolongation in the heart, slow heart rate, fast heart rate
• Low blood pressure upon standing (as a result, some patients taking Parnido may faint, feel dizzy or lose consciousness when they stand up suddenly), high blood pressure
• Sore throat, cough, stuffy nose
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Increased liver aminotransferase activity in blood
• Itching, rash
• Bone or muscle pain, back pain, joint pain
• Absence of menstruation
• Fever, weakness, fatigue

Uncommon adverse reactions (may occur in less than 1 in 100 patients)

• Pneumonia, respiratory tract infections, bladder infection, ear infection, tonsillitis
• Decreased white blood cell count, decreased platelet count (blood cells responsible for stopping bleeding), anaemia, decreased red blood cell count
• Paliperidone may increase blood levels of a hormone called prolactin (which may, but does not necessarily, cause symptoms). Symptoms of increased prolactin include: (in men) breast swelling, difficulty achieving or maintaining erection or other sexual disturbances; in women symptoms may include: breast discomfort, milk discharge from the breasts, absence of menstrual bleeding or other menstrual cycle disturbances
• 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 blood triglyceride (fat) levels
• Sleep disturbances, confusion, decreased libido, inability to achieve orgasm, nervousness, nightmares
• Late dyskinesias (twitching or jerking uncontrolled movements of the face, tongue or other body parts). You should immediately inform your doctor if involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of Parnido may be necessary.
• Seizures, fainting, restless urge to move parts of the body, dizziness upon standing, difficulty concentrating, difficulty speaking, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, prickling or numbness of the skin
• Light sensitivity, eye or conjunctival infection, dry eyes
• Sensation of spinning (dizziness), ringing in the ears, ear pain
• Irregular heartbeat, abnormal electrical conduction in the heart (on ECG), palpitations
• Low blood pressure
• Shortness of breath, wheezing, nosebleeds
• Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excessive passing of gas
• Increased GGTP enzyme activity (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• Urticaria, hair loss, rash, acne
• Increased CPK (creatine phosphokinase) activity in blood (an enzyme 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 disturbances (in women), milk discharge from the breasts, sexual disturbances, breast pain, breast discomfort
• Swelling of the face, lips, eyes or mouth, body swelling, swelling of upper or lower limbs
• Chills, increased body temperature
• Change in walking pattern
• Feeling of thirst
• Chest pain, chest discomfort, malaise
• Fall

Rare adverse reactions (may occur in less than 1 in 1000 patients)

• Eye infection, fungal nail infection, skin infection, mite-induced skin inflammation
• Dangerously low count of certain white blood cells responsible for fighting infections
• Decreased count of certain white blood cells protecting the body against infections, increased blood eosinophil count (a type of white blood cell)
• Severe allergic reaction characterized by fever, swelling of lips, face, tongue or throat, breathing difficulties, itching, skin rash and sometimes drop in blood pressure, allergic reaction
• Presence of sugar in urine
• Abnormal secretion of a hormone regulating urine output
• Life-threatening complications of untreated diabetes
• Dangerously excessive water drinking, low blood sugar, increased blood cholesterol levels
• Sleepwalking (somnambulism)
• Lack of movement and response to stimuli in a patient who is not asleep (catatonia)
• Lack of emotion
• Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever and severe muscle rigidity)
• Loss of consciousness, imbalance, abnormal coordination
• Cerebrovascular disorders, coma due to uncontrolled diabetes, lack of response to stimuli, head shaking
• Glaucoma (increased intraocular pressure), excessive tearing, eye redness, eye movement disorders, rotational eye movements
• Atrial fibrillation (irregular heartbeat), rapid heartbeat upon standing
• Blood clots in veins, especially in limbs (see section above "You should immediately inform your doctor if:")
• Reduced oxygenation of various body parts (due to reduced blood flow), hot flushes
• Breathing disturbances during sleep (sleep apnoea), rapid, shallow breathing
• Aspiration pneumonia (pneumonia caused by food inhalation), hyperaemia of the respiratory tract, voice disturbances
• Intestinal obstruction, faecal incontinence, very hard stool, lack of intestinal peristalsis leading to obstruction
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis
• Severe allergic reaction with swelling which may involve the throat and lead to breathing difficulties
• Skin thickening, dry skin, skin redness, skin depigmentation, seborrhoeic dermatitis of the scalp, dandruff
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal body posture
• Priapism (prolonged erection which may require surgical intervention)
• Breast enlargement in men, enlargement of glands in the nipples, nipple discharge, vaginal discharge
• Delayed menstruation, breast enlargement
• Very low body temperature, decreased body temperature
• Withdrawal symptoms

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

• Pulmonary congestion
• Increased insulin concentration (hormone regulating blood sugar levels) in blood.

The following adverse reactions have been reported during use of another medicine – risperidone – which is very similar to paliperidone, so they may also occur during use of Parnido:
sleep-related eating disorders, other cerebrovascular disorders, crackles in the lungs, and severe or life-threatening blistering rash with skin peeling, which may appear in the mouth, nose, eyes and genital areas and around these sites and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Ocular complications may also occur during cataract surgery. During this procedure, floppy iris syndrome (IFIS) may occur if the patient is taking or has taken paliperidone. If a patient has planned cataract surgery, the ophthalmologist should be informed about current or past use of this medicine.

Additional adverse reactions observed in adolescents
Adolescents generally experience similar adverse reactions to those observed in adults, except for the following, which are reported more frequently:

• Drowsiness or reduced alertness
• Parkinsonism: This condition may involve slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a sensation of "freezing" of movement followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation/drooling, and expressionless face
• Weight gain
• General cold symptoms
• Motor restlessness
• Tremor
• Stomach pain
• Galactorrhoea in girls
• Breast enlargement in boys
• Acne
• Speech disturbances
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High blood triglyceride levels (fats)
• Sensation of spinning (dizziness)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Parnido

Keep this medicine out of 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 the stated 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 no longer required. Such practices 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, butylated hydroxytoluene (E 321), povidone (K 30), sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E 172), hydroxypropylcellulose, and cellulose acetate in the tablet core; hypromellose, titanium dioxide (E 171), talc, propylene glycol (E 1520), yellow iron oxide (E 172) (for 6 mg tablets only), and red iron oxide (E 172) (for 9 mg tablets only) in the tablet coating; and shellac, black iron oxide (E 172), and propylene glycol (E 1520) in the printing 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, marked with "P3" on one side. Diameter: approximately 9 mm.
6 mg: brownish-yellow, round, biconvex tablets with possible surface irregularities, marked with "P6" on one side. Diameter: approximately 9 mm.
9 mg: pinkish, round, biconvex tablets with possible surface irregularities, marked with "P9" on one side. Diameter: approximately 9 mm.
Parnido is available in cardboard boxes containing 30 prolonged-release tablets in blister packs.

Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00