PALIPERIDONE TEVA

Patient Information Leaflet

Paliperidone Teva 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets

Paliperidone
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Paliperidone Teva is and what it is used for
2. What you need to know before taking Paliperidone Teva
3. How to take Paliperidone Teva
4. Possible side effects
5. How to store Paliperidone Teva
6. Contents of the pack and other information

1. What Paliperidone Teva is and what it is used for

Paliperidone Teva contains the active substance paliperidone, which belongs to a class of medicines called antipsychotics.
Paliperidone Teva is used for the treatment of schizophrenia in adults and adolescents from the age of 15.
Schizophrenia is a disorder whose symptoms include hearing, seeing or perceiving things that are not present, having false beliefs or being unusually suspicious, tendency towards social withdrawal, disorganized speech, and showing behavioral and emotional apathy. People with this disorder may also feel depressed, anxious, guilty or tense.
Paliperidone Teva is also used to treat schizoaffective disorder in adults.
Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as described above) together with mood disorder symptoms (such as excitement, sadness, agitation, distractibility, insomnia, talkativeness, loss of interest in daily activities, sleeping too much or too little, eating too much or too little, and recurrent suicidal thoughts).
Paliperidone Teva may help relieve the symptoms of the illness and prevent their recurrence.

2. What you should know before taking Paliperidone Teva

Do not take Paliperidone Teva

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Paliperidone Teva.

• Patients with schizoaffective disorder treated with this medicine should be closely monitored for a potential shift from manic to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with other similar medicines may be at increased risk of stroke or death (see section 4, "Possible side effects").
• If you have Parkinson's disease or dementia.
• If you have ever been diagnosed with a condition whose symptoms include increased body temperature and muscle rigidity (also known as Neuroleptic Malignant Syndrome).
• If you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia). You should be aware that both of these conditions may be caused by this type of medicine.
• If you know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
• If you have diabetes or are predisposed to diabetes.
• If you have heart disease or are being treated for a heart condition that tends to lower your blood pressure.
• If you have epilepsy.
• If you have swallowing difficulties, or stomach or intestinal disorders that reduce your ability to swallow or move food through the intestines normally.
• If you have conditions associated with diarrhoea.
• If you have kidney problems.
• If you have liver problems.
• If you experience a prolonged and/or painful erection.
• If you have difficulty controlling your internal body temperature or are exposed to excessive heat.
• If you have abnormally high levels of prolactin hormone in your blood or if you may have a prolactin-dependent tumour.
• If you or someone in your family has a history of blood clots (thrombosis), as antipsychotic medicines have been associated with blood clot formation.

If any of these conditions apply to you, talk to your doctor so they can determine whether your dose needs adjusting or whether you need monitoring for a certain period.
Since a dangerously low number of a certain type of white blood cells needed to fight infections in the blood has been observed very rarely in patients taking paliperidone, your doctor may monitor your white blood cell count.
Paliperidone Teva may cause weight gain. Significant weight gain can negatively affect your health. Your doctor should regularly monitor your body weight.
Since diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking paliperidone, your doctor should check for high blood sugar levels. Blood glucose levels should be regularly monitored in patients with pre-existing diabetes mellitus.
During cataract surgery (surgery for clouding of the lens), the pupil (the black circle in the center of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become flaccid during surgery, which could cause eye damage. If you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents
Paliperidone Teva must not be used in children and adolescents under 15 years of age for the treatment of schizophrenia.
Paliperidone Teva must not be used in children and adolescents under 18 years of age for the treatment of schizoaffective disorder.
This is because it is not known whether paliperidone is safe or effective in these age groups.

Other medicines and Paliperidone Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When this medicine is taken together with certain heart medications that regulate heart rhythm or other medicines such as antihistamines, antimalarials, or other antipsychotics, abnormalities in the heart's electrical function may occur.
Since this medicine acts primarily on the brain, interactions may occur with other medicines (or alcohol) that also act on the brain, due to additive effects on brain function.
Since this medicine may lower blood pressure, be cautious when taking it together with other medicines that also lower blood pressure.
This medicine may reduce the effect of medicines used to treat Parkinson’s disease and restless legs syndrome (e.g. levodopa).
The effects of this medicine may be influenced if you are taking medicines that affect the speed of intestinal movements (e.g. metoclopramide).
A dose reduction should be considered when this medicine is administered concomitantly with valproate.
Concomitant use of oral risperidone with this medicine is not recommended, as the combination of these two medicines could lead to increased side effects.
Paliperidone Teva should be used with caution together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Paliperidone Teva and alcohol
Avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy unless your doctor has specifically advised you to do so. The following symptoms may occur in newborn babies whose mothers have used paliperidone during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
Avoid breastfeeding while taking this medicine.

Driving and using machines
While being treated with this medicine, dizziness and vision problems may occur (see section 4, Possible side effects). This should be taken into account in situations requiring full alertness, such as driving a car or operating machinery.

Paliperidone Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Paliperidone Teva

Take this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, 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 your dose within the range of 3 mg to 12 mg once daily for schizophrenia, or from 6 mg to 12 mg once daily for schizoaffective disorder, depending on your response to the medicine.

Use in adolescents
The recommended starting 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 may be increased within the range of 6 mg to 12 mg once daily.
For adolescents weighing less than 51 kg, the dose may be increased up to 6 mg once daily.
Your doctor will decide the appropriate dose for you, depending on your response to the medicine.

How and when to take Paliperidone Teva
This medicine is taken orally. The tablet must be swallowed whole with water or other liquid. It must not be chewed, divided, or crushed.
Take this medicine every morning with breakfast or on an empty stomach, but always in the same way each day. Do not alternate between taking the medicine on an empty stomach one day and with food the next.

The active substance, paliperidone, dissolves after swallowing, and the tablet shell is eliminated from the body as waste.

Patients with kidney problems
Depending on your kidney function, your doctor may adjust the dose of this medicine.

Elderly patients
Your doctor may reduce the dose if you have reduced kidney function.

If you take more Paliperidone Teva than you should
Contact your doctor immediately. Symptoms may include drowsiness, fatigue, abnormal body movements, difficulty maintaining posture and walking, dizziness due to low blood pressure, and abnormal heartbeats.

If you forget to take Paliperidone Teva
Do not take a double dose to make up for a missed dose. If you miss one tablet, take the next dose the following day. If you miss two or more doses, contact your doctor.

If you stop taking Paliperidone Teva
Do not stop taking this medicine, as you may lose its benefits. Do not discontinue the medicine unless instructed by your doctor, as symptoms may return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if:

• You suspect you have blood clots in your veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
• You have dementia and notice a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech becomes slurred or incomprehensible, even briefly. These may be signs of a stroke.
• You have fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• You are a man and have a prolonged or painful erection. This condition is called

priapism. Immediate medical treatment may be necessary.

• You experience involuntary rhythmic movements of the tongue, mouth or face. It may be necessary to discontinue paliperidone.
• You develop a severe allergic reaction, characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes a sudden drop in blood pressure (corresponding to an “anaphylactic reaction”).

Very common: may affect more than 1 in 10 people

• Difficulty falling asleep or staying asleep
• Parkinsonism. This condition may include: slow or impaired body movements, feeling of stiffness or muscle tension (resulting in jerky movements), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include slow walking with shuffling feet, resting tremor, increased saliva and/or drooling, and loss of facial expression
• Restlessness
• Drowsiness or reduced alertness
• Headache

Common: may affect up to 1 in 10 people

• Chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, feeling as if you have the flu
• Weight gain, increased appetite, weight loss, decreased appetite
• Elevated mood (mania), irritability, depression, anxiety
• Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. Although it can affect any part of the body (resulting in abnormal posture), dystonia often affects facial muscles, including abnormal eye, mouth, tongue or jaw movements.
• Dizziness
• Dyskinesia: this is a condition involving involuntary muscle movements and may consist of repetitive, jerky or twisting movements or spasms.
• Tremors (shaking)
• Blurred vision
• Interruption of cardiac conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the heart's QT interval, slow heart rate, fast heart rate
• Low blood pressure when standing up (as a result, some patients taking Paliperidone Teva may feel faint, lightheaded or may faint when standing up or sitting down suddenly), high blood pressure
• Sore throat, cough, stuffy nose
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Increased liver transaminases in blood
• Itching, rash
• Bone or muscle pain, back pain, joint pain
• Loss of menstrual period
• Fever, weakness, fatigue (tiredness)

Uncommon: may affect up to 1 in 100 people

• Pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis
• Decreased white blood cell count, decreased platelets (blood cells that help stop bleeding), anemia, decreased red blood cells in blood
• Paliperidone may increase levels of a hormone called "prolactin" detected in a blood test (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, they may include: (in men) breast swelling, difficulty in achieving or maintaining erection or other sexual dysfunction, (in women) breast tenderness, milk discharge from the breasts, loss of menstrual period or other menstrual problems
• Diabetes or worsening of diabetes, high blood sugar levels, increased abdominal circumference, loss of appetite resulting in malnutrition and low body weight, elevated triglyceride levels (a type of fat)
• Sleep disturbances, confusion, reduced sexual drive, inability to reach orgasm, nervousness, nightmares
• Tardive dyskinesia (involuntary spasms or jerky movements of the face, tongue or other body parts that cannot be controlled). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop taking Paliperidone Teva.
• Seizures (epileptic fits), fainting, an urgent need to move a part of the body, dizziness when standing up, attention disturbance, speech problems, loss or alteration of taste sensation, reduced skin sensitivity to pain and touch, a tingling, prickling or numbness sensation of the skin
• Light sensitivity of the eyes, eye infection or "mild redness", dry eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, abnormal heart electrical tracing (electrocardiogram or ECG), a sensation of rapid heartbeat or chest pulsations (palpitations)
• Low blood pressure
• Shortness of breath, wheezing, nosebleeds
• Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excessive passage of gas or air
• Increased GGT in blood (a liver enzyme called gamma-glutamyl transferase), increased liver enzymes in blood
• Rash (or hives), hair loss, eczema, acne
• Increased CPK (creatine phosphokinase) in blood, an enzyme that is sometimes released when there is muscle damage, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• Urinary incontinence (lack of control), frequent urination, inability to urinate, pain during urination
• Erectile dysfunction, ejaculation disorders
• Loss of menstrual period or menstrual problems (females), milk discharge from breasts, sexual dysfunction, breast pain, breast discomfort
• Swelling of the face, mouth, eyes or lips, body swelling, swelling of arms or legs
• Chills, increased body temperature
• Change in walking pattern
• Feeling of thirst
• Chest pain, chest discomfort, feeling of uneasiness
• Falls

Rare: may affect up to 1 in 1,000 people

• Eye infection, fungal nail infection, skin infection, skin inflammation caused by mites
• Dangerously low number of a certain type of white blood cells in the blood needed to fight infections
• Decrease in blood of a type of white blood cells that protects the body from infections, increase in eosinophils (a type of white blood cell)
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, rash and sometimes drop in blood pressure, allergic reaction
• Sugar in urine
• Inappropriate secretion of the hormone that controls urine volume
• Complications leading to life-threatening danger due to uncontrolled diabetes
• Dangerously excessive water intake, decreased blood sugar, excessive water drinking, increased cholesterol in blood
• Sleepwalking
• Not moving or responding while awake (catatonia)
• Lack of emotions
• Neuroleptic Malignant Syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle stiffness)
• Loss of consciousness, balance disturbances, abnormal coordination
• Problems with brain blood vessels, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, low level of consciousness, head tremor
• Glaucoma (increased pressure inside the eyeball), increased tearing, eye redness, eye movement problems, eye rotation
• Atrial fibrillation (an abnormal heart rhythm), rapid heartbeat when standing up
• Blood clots in veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
• Decreased oxygen levels in parts of the body (due to reduced blood flow), hot flushes
• Breathing problems during sleep (sleep apnea), fast and shallow breathing
• Pneumonia caused by inhalation of food, respiratory congestion, voice problems
• Intestinal obstruction, fecal incontinence, hard stools, lack of intestinal muscle movement causing blockage
• Yellowing of the skin and eyes (jaundice)
• Inflammation of the pancreas
• Severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
• Skin thickening, dry skin, skin redness, skin color changes, scaly and itchy scalp or skin, dandruff
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), abnormal posture
• Priapism (a prolonged erection of the penis that may require surgical treatment)
• Breast development in men, enlargement of mammary glands, milk discharge, vaginal discharge
• Delayed menstrual cycle, breast enlargement
• Very low body temperature, decreased body temperature
• Medication withdrawal symptoms

Frequency not known: frequency cannot be estimated from the available data

• Pulmonary congestion
• Increased insulin levels (a hormone that controls blood sugar levels)

The following side effects have been observed with the use of another medicine called
risperidone, which is very similar to paliperidone, so these effects may also be expected with
Paliperidone Teva: sleep-related eating disorders, other types of brain blood vessel problems and
crackling lung sounds. Eye problems may also occur during cataract surgery. During cataract
surgery, 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, make sure to inform your
ophthalmologist if you are taking or have taken this medicine.
Other side effects in adolescents
Side effects generally experienced by adolescents are similar to those observed in adults, except
for the following which have been observed more commonly:

• Drowsiness or reduced alertness
• Parkinsonism. This condition may include: slow or impaired body movements, feeling of stiffness or muscle tension (resulting in jerky movements), and sometimes also a sensation of movement starting and stopping. Other signs of parkinsonism include slow walking with shuffling feet, resting tremor, increased saliva and/or drooling, and loss of facial expression
• Weight gain
• Common cold symptoms
• Restlessness
• Tremors (shaking)
• Stomach pain
• Milk discharge from breasts in girls
• Breast swelling in boys
• Acne
• Speech problems
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High levels of triglycerides (a fat) in blood
• Dizziness (vertigo)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paliperidone Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after
the word "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Paliperidone Teva 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, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E172), hydroxypropylcellulose, and cellulose acetate in the tablet core; hypromellose, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172) (for 6 mg tablets only), and red iron oxide (E172) (for 9 mg tablets only) in the coating; and shellac gum, black iron oxide (E172), and propylene glycol in the printing ink. See section 2 "Paliperidone Teva contains sodium".

Description of the Appearance of Paliperidone Teva and Contents of the Pack

3 mg: Film-coated, biconvex, round tablets, white to greyish in colour, with possible uneven surface, marked with "P3" on one side.
Diameter: approximately 9 mm.

6 mg: Film-coated, biconvex, round tablets, brownish-yellow in colour, with possible uneven surface, marked with "P6" on one side.
Diameter: approximately 9 mm.

9 mg: Film-coated, biconvex, round tablets, pinkish in colour, with possible uneven surface, marked with "P9" on one side.
Diameter: approximately 9 mm.

Paliperidone Teva is available in cartons containing:

• 14x1, 28x1, 30x1, 56x1, 98x1, 112x1 or 196x1 prolonged-release tablets in single-dose perforated blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands

Manufacturer
KRKA d.d., Novo mesto
Šmarješka cesta 6, Novo mesto, 8501, Slovenia
Laboratoria Qualiphar NV (Qualiphar NV)
Rijksweg 9, 2880 Bornem, Belgium
Teva Pharma, S.L.U.
S.L.U. C/ C, nº 4. Polígono Industrial Malpica, 50016 Zaragoza, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names: