Package Insert: Information for the Patient

Paliperidona ratiopharm 3 mg prolonged-release tablets EFG

Paliperidona ratiopharm 6 mg prolonged-release tablets EFG

Paliperidona ratiopharm 9 mg prolonged-release tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Paliperidone Ratiopharm contains the active ingredient paliperidone which belongs to the class ofmedicamentosantipsicóticos.

Paliperidone is used to treat schizophrenia in adults and adolescents aged 15 years and older.

Schizophrenia is a disorder that causes symptoms that include hearing, seeing or feeling things thatdonotexist, holding false beliefs, having an abnormal distrust, withdrawing into oneself,speaking incoherently and flattening of behavior and emotion. People with this disorder may also feeldepressed, anxious, guilty ortense.

Paliperidone is also used to treat schizoaffective disorder inadults.

Schizoaffective disorder is a mental condition where the person experiences several of the symptoms ofschizophrenia (listed in the previous paragraph) in addition to symptoms of mood disorder (feeling ofeuphoria, sadness, agitation, being distracted, insomnia, loquacity, loss of interest in dailyactivities, excessive or insufficient sleep, excessive or insufficient food intake, and recurring thoughts ofsuicidio).

Paliperidone may help alleviate the symptoms of your illness and prevent it fromreoccurringagain.

Do not takepaliperidone

-if you are allergic to paliperidone, risperidone, or any of the other ingredients in thismedicine(listed in section6).

Warnings andprecautions

Consult your doctor or pharmacist before starting to take paliperidone.

• Patients with schizoaffective disorder treated with this medicine should be closely monitored for a possible change from manic symptoms to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are treated with similar medicines, may have an 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 are high 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 know that these two conditions may be caused by this type of medicine.
• if you have had low white blood cell counts in the past (which may or may not have been caused by other medicines)
• if you are diabetic or have a tendency to develop diabetes.
• if you have any heart disease or if you are receiving treatment for heart diseases that may make you more prone to a drop in blood pressure.
• if you have epilepsy.
• if you have any disorders of swallowing, stomach, or intestines that reduce your ability to swallow food or digest it normally.
• if you have diseases associated with diarrhea.
• if you have kidney problems.
• if you have liver problems.
• if you have a prolonged and painful erection.
• if you have difficulty controlling your body temperature or are overheated.
• if you have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• if you or a family member has a history of blood clots, as antipsychotics are associated with the formation of blood clots.

If you have any of these conditions, please consult your doctor as it may be necessary to adjust your dose or keep you under observation for a while.

Because very rarely, patients treated with paliperidone have been observed to have a dangerously low number of a type of white blood cells necessary to fight infections in the blood, your doctor may check the number of white blood cells.

Paliperidone may cause you to gain weight. A significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

In patients treated with paliperidone, diabetes mellitus or worsening of existing diabetes mellitus has been observed. Your doctor should check for signs of increased blood sugar.In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

During cataract surgery in the eye, the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause damage to the eye.Make sure to inform your eye surgeon that you are taking this medicine.

Children andadolescents

Paliperidone should not be administered to children and adolescents under 15 years of age for the treatment of schizophrenia.

Paliperidone should not be administered to children and adolescents under 18 years of age for the treatment of schizoaffective disorder.

This is because it is unknown whether paliperidone is safe or effective in this age group.

Other medicines and paliperidone

Inform your doctor or pharmacist if you are using, have used recently, or may take other medicines.

Abnormalities in heart function may occur when this medicine is taken with other medicines for controlling heart rhythm or other medicines such as antihistamines, antimalarials, or antipsychotics.

Since this medicine primarily acts on the brain, this medicine may interfere with other medicines (or alcohol) that also act on it, due to the sum of effects on brain function.

This medicine may lower blood pressure, so you should be careful if you take this medicine with other medicines that also lower blood pressure.

This medicine may reduce the effect of medicines for Parkinson's disease and restless legs syndrome (e.g., levodopa).

The effects of this medicine may be affected if you take medicines that influence the speed of movement of the intestines (e.g., metoclopramide).

Reduction of the dose of this medicine should be considered when this medicine is administered with valproate.

The use of oral risperidone with this medicine is not recommended as this combination may cause an increase in adverse effects.

Paliperidone should be used with caution with medicines that increase the activity of the central nervous system (psycho-stimulants such as methylphenidate).

Paliperidone and alcohol

You should avoid consuming alcohol during treatment with this medicine.

Pregnancy andlactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

You should not take this medicine during pregnancy unless you have discussed it with your doctor.

The following symptoms may occur in newborn babies of mothers who have been treated with paliperidone in the last three months of pregnancy (last three months of your pregnancy): tremor, rigidity, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

You should not breastfeed your child while taking this medicine.

Driving and use ofmachines

During treatment with this medicine, dizziness and vision problems may occur (see section 4, Possible side effects). This should be taken into account when requiring high concentration, for example, when driving or operating machinery.

Paliperidone ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which may be considered "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor, pharmacist.

Use in adults

The recommended dose in adults is 6 mg once a day in the morning. Your doctor may increase or decrease it within the dosing interval of 3 mg to 12 mg once a day in case of schizophrenia or 6 mg to 12 mg once a day in case of schizoaffective disorder. This depends on how well the medication works for you.

Use in adolescents and children

The recommended starting dose for the treatment of schizophrenia in adolescents from 15 years of age is 3 mg once a day taken in the morning.

For adolescents weighing 51 kg or more, the dose can be increased within the interval of 6 mg to 12 mg once a day.

For adolescents weighing less than 51 kg, the dose can be increased to 6 mg once a day.

Your doctor will decide how much to administer to you. The amount you take depends on how well the medication works for you.

How and when to take paliperidone

This medication should be taken by mouth, swallowed whole with water or other liquids. It should not be chewed, broken, or crushed.

This medication should be taken in the mornings with breakfast or on an empty stomach, but in the same way every day. Do not alternate between taking the medication with breakfast and on an empty stomach the next day.

The active ingredient, paliperidone, dissolves once swallowed, and the coating of the tablet is eliminated from the body by the kidneys.

Patients with kidney problems

Your doctor may adjust your dose of this medication according to your kidney function.

Patients of advanced age

Your doctor may reduce your medication dose if your kidney function is reduced.

If you take more paliperidone than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicological Information Service. Telephone: 91 562 04 20 indicating the medication and the amount ingested. You may experience drowsiness, dizziness, abnormal body movements, difficulty staying upright and walking, dizziness due to reduced blood pressure, and cardiac rhythm alterations.

If you forgot to take paliperidone

Do not take a double dose to compensate for the missed doses. If you forget a dose, take the next dose the next day. If you forget two or more doses, contact your doctor.

If you interrupt the treatment with paliperidone

Do not stop taking this medication as you will lose the effects of the medication. Do not stop taking this medication unless your doctor tells you to, as the symptoms may reappear.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Inform your doctor immediately if you experience any of the following:

• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice.

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in your face, arms, or legs, especially on one side, or you have difficulty speaking even for a short period of time. These may be signs of a stroke.

• You experience fever, muscle stiffness, sweating, or a decrease in your level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need medical treatment.

• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need medical treatment.

• You experience involuntary rhythmic movements of the tongue, mouth, or face. You may need to discontinue treatment.

• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, and sometimes a decrease in blood pressure (anaphylactic reaction).

Very common (may affect more than 1 in 10 patients):

• Difficulty staying or remaining asleep
• Parkinsonism: This disease may include slow or altered movement, a feeling of stiffness or tension in the muscles (causing abrupt movements) and sometimes a feeling of "freezing" of movement that is later reinitiated. Other signs of parkinsonism include walking slowly dragging the feet, trembling while descending stairs, increased saliva and/or drooling, and loss of facial expression.
• Insomnia
• Feeling drowsy or less alert
• Abdominal pain

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

• Chest infection (bronchitis), common cold symptoms, nasal infection, urinary tract infection, feeling like you have a lump in your throat
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety
• Dystonia: This disease involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible.
• Dizziness
• Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms
• Tremor (akathisia)
• Blurred vision
• Abnormal heart rhythm, anomalies in heart electrical conduction, prolonged QT interval in the heart, irregular heartbeat, rapid heartbeat
• Decreased blood pressure when standing (resulting in some people who take paliperidone feeling weakness, dizziness, or loss of consciousness when standing or sitting suddenly), increased blood pressure
• Sore throat, cough, congestion
• Abdominal pain, nausea, vomiting, constipation, diarrhea, indigestion, dry mouth, jaw pain
• Increased liver enzymes in the blood
• Itching, skin rash
• Muscle or bone pain, back pain, joint pain
• Loss of menstrual periods
• Fever, weakness, fatigue (cansancio)

Rare side effects (may affect up to 1 in 100 patients):

• Pneumonia, respiratory tract infection, urinary tract infection, ear infection, angina
• Decreased white blood cell count, decreased platelet count (cells that help stop bleeding), anemia, decreased red blood cell count
• Paliperidone may increase levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). When symptoms of increased prolactin appear, they may include: (in men) breast swelling, difficulty getting or maintaining erections, or other sexual dysfunction, (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems.
• Diabetes or worsening of diabetes, increased blood sugar, increased blood circumference, loss of appetite causing malnutrition and weight loss, increased triglycerides in the blood (a type of fat)
• Sleep disorder, confusion, decreased sex drive, inability to achieve orgasm, nervousness, anxiety
• Tardive dyskinesia (spasms or involuntary movements that cannot be controlled in the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. You may need to discontinue paliperidone.
• Convulsions (epileptic seizures), fainting, restlessness causing movement of parts of the body, dizziness when standing, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of pins and needles, numbness, or tingling of the skin
• Increased sensitivity of the eyes to light, eye infection, or "red eye," dry eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, anomaly in heart electrical activity (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure
• Labored breathing, gasping, nosebleeds
• Swollen tongue, stomach or intestinal infection, difficulty swallowing, excessive gas or flatulence
• Increased GGT (a liver enzyme called gamma-glutamiltransferase) in the blood, increased liver enzymes in the blood
• Hives (urticaria), hair loss, eczema
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that sometimes is associated with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, muscle pain
• Urinary incontinence, frequent urination, inability to urinate, painful urination
• Erectile dysfunction, sexual dysfunction
• Loss of menstrual periods or other menstrual cycle problems (women), milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort
• Swollen face, mouth, eyes, or lips, swollen body, arms, or legs
• Chills, increased body temperature
• Change in the way you walk
• Sensation of sedation
• Chest pain, chest discomfort, sensation of malaise
• Falls

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

• Eye infection, fungal infection of the nails, skin infection, skin inflammation caused by bacteria
• Pelviclymphopenia (dangerously low count of a type of white blood cell necessary for combat infections)
• Decreased count of a type of white blood cell that helps fight infections, increased eosinophils (a type of white blood cell) in the blood
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, and sometimes decreased blood pressure, anaphylactic reaction
• Increased sugar in the urine
• Incorrect secretion of a hormone that controls urine volume
• Complications of uncontrolled diabetes with risk to life
• Excessive water intake, dangerously low blood sugar, excessive water intake, increased cholesterol in the blood
• Somnambulism
• Lack of movement or response while awake (catatonia)
• Absence of emotions
• Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle rigidity)
• Loss of consciousness, balance disorder, coordination abnormality
• Problems in blood vessels of the brain, coma due to uncontrolled diabetes, decreased response to stimuli, decreased level of consciousness, agitation of the brain
• Glaucoma (increased pressure of the eyeball), increased tear production, eye redness, eye movement problems, eye rotation
• Atrial fibrillation (abnormal heart rhythm), rapid heartbeat when standing
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice.
• Decreased oxygen in parts of the body (due to decreased blood flow), flushing
• Respiratory problems during sleep (sleep apnea), rapid breathing, superficial breathing
• Pneumonia caused by aspiration of food, respiratory tract congestion, voice disorder
• Intestinal obstruction, fecal incontinence, hard stools, absence of intestinal movement causing obstruction
• Yellow skin and eyes (ictericia)
• Inflammation of the pancreas
• Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing
• Thickening of the skin, dry skin, skin redness, skin or scalp eczema, and itching
• Muscle fiber rupture and muscle pain (rhabdomyolysis), abnormal muscle postures
• Priapism (prolonged erection that may require surgical treatment)
• Development of breasts in men, increased breast gland size, milk secretion from the breasts, vaginal secretion
• Delayed menstrual periods, increased breast size
• Low body temperature, decreased body temperature
• Withdrawal symptoms from the medication

Unknown (frequency cannot be estimated from available data):

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

The following side effects have appeared with the use of another medication called risperidone, which is very similar to paliperidone, so it is also expected to appear with paliperidone:

Other types of blood vessel problems in the brain, crepitant sounds from the lungs, and severe or potentially fatal skin rash with blisters and peeling of the skin that may start in the mouth, nose, eyes, and genitals and spread to other areas of the body (Stevens-Johnson syndrome/toxic epidermal necrolysis).

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 need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication.

Additional side effects in adolescents:

Adolescents generally experienced side effects similar to those found in adults, except for the following side effects that were detected more frequently:

Reporting of side effects:

If you experience side effects, consult your doctor, pharmacist, or nurse, even if the side effects do not appear in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require special temperature conditions for its conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paliperidone ratiopharm

• The active ingredient is paliperidone. Each prolonged-release tablet contains 3 mg, 6 mg or 9 mg of paliperidone.
• The other components are macrogol, butylhydroxytoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate,red iron oxide (E172), hydroxypropylcellulose and cellulose acetate in the tablet core and hypromellose, titanium dioxide (E171), talc and propylene glycol in the coating and lacquer, black iron oxide (E172) and propylene glycol in the printing ink.

Appearance of the product and content of the container

3 mg: Film-coated, round, biconvex, white to off-white tablets with possible uneven surface and printed with the mark P3 on one side of the tablet. Diameter: approximately 9mm.

6 mg:Film-coated, round, biconvex, yellowish-brown tablets with possible uneven surface and printed with the mark P6 on one side of the tablet. Diameter: approximately 9mm.

9 mg:Film-coated, round, biconvex, pale pink tablets with possible uneven surface and printed with the mark P3 on one side of the tablet. Diameter: approximately 9mm.

Paliperidone ratiopharm is available in boxes containing:

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

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

ratiopharm España, S.A.

c/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer:

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501

Slovenia

Last review date of thisleaflet: November 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/