Label: information for the user

Paliperidone Stada 50 mg prolonged-release injectable suspension

in pre-filled syringe EFG

Paliperidone Stada 75 mg prolonged-release injectable suspension

in pre-filled syringe EFG

Paliperidone Stada 100 mg prolonged-release injectable suspension

in pre-filled syringe EFG

Paliperidone Stada 150 mg prolonged-release injectable suspension

in pre-filled syringe EFG

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should 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, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Paliperidona Stada contains the active ingredient paliperidone, which belongs to the class of antipsychotic medicationsandisusedasmaintenancetreatmentforthesymptomsofschizophreniainadultpatientswhoarestableonpaliperidoneorrisperidone.

Ifyouhaveshownaresponsetopaliperidoneorrisperidoneinthepastandhavemildormoderatesymptoms,yourdoctormayinitiatetreatmentwithpaliperidonewithoutapreviousstabilizationwithpaliperidoneorrisperidone.

Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive means an excess of symptoms that are normally not present. For example, a person with schizophrenia may hear voices or see things that do not exist (called hallucinations), have false beliefs (called delusions), or have a distrust of others beyond what is normal.Negativereferstothelackofbehaviorsorfeelingsthatarenormallypresent. For example, a person with schizophrenia may withdraw into themselves and not respond to any emotional stimulus or may have difficulty speaking in a clear and logical way. People who suffer from this disorder may also feel depressed, anxious, guilty, or tense.

Paliperidonemayhelptoalleviatethesymptomsofyourdiseaseandpreventthemfromrecurring.

No use Paliperidona Stada

Advertencias y precauciones

Consult with your doctor, pharmacist, or nurse before starting to use paliperidona.

This medication has not been studied in elderly patients with dementia. However, elderly patients with dementia who are being treated with similar medications may have an increased risk of stroke or death (see section 4, Possible side effects).

All medications have side effects and some of the side effects of this medication may worsen symptoms of other conditions. For this reason, it is essential to discuss with your doctor any of the following diseases, which may worsen during treatment with this medication:

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

Niños y adolescentes

Do not use this medication in children under 18 years old.

Otros medicamentos y Paliperidona Stada

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Uso de Paliperidona Stada con alcohol

Alcohol should be avoided.

Embarazo y lactancia

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult with your doctor or pharmacist before using this medication.

Embarazo

This medication should not be used during pregnancy unless discussed with your doctor. The following symptoms may occur in newborn babies of mothers who have been treated with paliperidona in the last three months of pregnancy (last trimester): tremor, rigidity, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Lactancia

This medication may pass from mother to baby through breast milk and may harm the baby. Therefore, do not breastfeed while using this medication.

Conducción y uso de máquinas

During treatment with this medication, dizziness, extreme fatigue, and vision problems (see section 4) may occur. This should be taken into account when requiring maximum attention, such as when driving or operating machines.

Paliperidona Stada contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Your doctor or other healthcare professional will administer this medication. Your doctor will inform you when to receive the next injection. It is essential that you do not miss any scheduled doses. If you cannot attend your appointment with the doctor, please make sure to call them immediately to schedule another appointment as soon as possible.

Dose and administration

You will receive the first injection (150 mg) and the second injection (100 mg) of this medication in the upper arm approximately one week apart. From then on, you will receive an injection (between 25 mg and 150 mg) in the upper arm or buttocks once a month.

If your doctor is switching you from long-acting risperidone injectable to this medication, you will receive the first injection of this medication (between 25 mg and 150 mg) in the upper arm or buttocks at the next scheduled injection. From then on, you will receive an injection (between 25 mg and 150 mg) in the upper arm or buttocks once a month.

Your doctor may increase or decrease the amount of medication you receive at the time of the scheduled monthly injection based on your symptoms.

Patients with kidney problems

Your doctor may adjust the dose of this medication according to your renal function. If you have mild kidney problems, your doctor may give you a lower dose. You should not use this medication if you have moderate or severe kidney problems.

Older patients

Your doctor may reduce the dose of this medication if your kidney function is decreased.

If you receive more Paliperidona Stada than you should

You will receive this medication under medical supervision, so it is unlikely that you will receive an excessive dose.

Patients who have received an excessive amount of paliperidone may experience the following symptoms: drowsiness or sedation, rapid heart rate, low blood pressure, electrocardiogram abnormalities (heart tracing) or slow or abnormal movements of the face, body, arms, or legs.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you interrupt treatment with Paliperidona Stada

If you stop receiving your injections, the effects of the medication will be lost. Do not stop using this medication unless your doctor tells you to, as your symptoms may return.

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

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

Inform your doctor immediately if:

• You develop 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 immediately.
• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or it is difficult for you to speak even for a short period of time. These may be signs of a stroke.
• You develop fever, muscle stiffness, sweating, or a decrease in level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• You experience involuntary rhythmic movements of the tongue, mouth, and face. You may need the withdrawal of paliperidone.
• You develop a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, skin rash, and sometimes a decrease in blood pressure (anaphylactic reaction). Even if you have previously tolerated oral risperidone or paliperidone, in rare cases, allergic reactions have occurred after receiving paliperidone injections.
• You are scheduled to undergo eye surgery, ensure that you tell your ophthalmologist that you are taking this medicine. During eye surgery for cataracts, it is possible that the iris (the colored part of the eye) will be flaccid during surgery (known as "floppy iris syndrome") which can cause eye damage.
• You develop a dangerously low number of a type of white blood cell necessary to fight blood infections.

The following side effects may occur:

Very common:may affect more than 1 in 10 people

• Difficulty staying or falling asleep.

Common:may affect up to 1 in 10 people

• Common cold symptoms, urinary tract infection, feeling like having the flu
• 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 having or maintaining erections, or other sexual dysfunction; (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle
• Increased blood sugar, weight gain, weight loss, decreased appetite
• Irritability, depression, anxiety
• Parkinsonism: this disease may include slow or altered movement, feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly dragging the feet, trembling while resting, increased saliva and/or drooling, and loss of facial expression
• Restlessness, feeling drowsy or less attentive
• Dystonia: this disorder involves involuntary slow or continuous muscle contraction. Although it may 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 jaw
• Dizziness
• Dyskinesia: this disorder involves involuntary muscle movements and may include repetitive, spasmodic, or writhing movements, or spasms
• Tremor (agitation)
• Headache
• Fast heart rate
• Increased blood pressure
• Cough, nasal congestion
• Abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• Increased liver transaminases in blood
• Muscle or bone pain, back pain, joint pain
• Amenorrhea
• Fever, weakness, fatigue (tiredness)
• A reaction at the injection site, including itching, pain, or swelling

Uncommon:may affect up to 1 in 100 people

• Pneumonia, chest infection (bronchitis), respiratory tract infection, urinary tract infection, ear infection, fungal nail infection, tonsillitis, skin infection
• Decreased white blood cell count, decreased type of white blood cell count that helps fight infections, anemia
• Allergic reaction
• Diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels) in blood
• Increased appetite
• Loss of appetite leading to malnutrition and weight loss
• Increased triglycerides in blood (a type of fat), increased cholesterol in blood
• Sleep disorder, euphoria (mania), decreased libido, nervousness, nightmares
• Tardive dyskinesia (involuntary, uncontrollable 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 withdraw from this medication.
• Dizziness, restlessness that causes movement of body parts, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, feeling of pins and needles, numbness, or tingling of the skin
• Blurred vision, eye infection, or "pink eye," dry eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Abnormal heart rhythm, abnormal heart activity, prolonged QT interval in the heart, fast heart rate when standing up, slow heart rate, abnormal heart tracing (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure, low blood pressure when standing up (therefore, some people taking this medication may feel weak, dizzy, or faint when standing up or sitting suddenly)
• Difficulty breathing, sore throat, nasal bleeding
• Abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• Excessive gas or flatulence
• Increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood
• Hives (urticaria), itching, rash, hair loss, eczema, dry skin, redness of the skin, acne, abscess under the skin
• Increased CPK (creatine phosphokinase) in blood, an enzyme that is sometimes released with muscle breakdown
• Muscle spasms, joint stiffness, muscle weakness
• Urinary incontinence, frequent urination, painful urination
• Sexual dysfunction, ejaculation disorder, amenorrhea or other menstrual cycle problems (women), male breast development, sexual dysfunction, breast pain, milk secretion from the breasts
• Swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs
• Increased body temperature
• Change in gait
• Chest pain, chest discomfort, feeling of discomfort
• Hardening of the skin
• Falls

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

• Eye infection
• Scabies, skin or scalp eczema with itching
• Increased eosinophils (a type of white blood cell) in blood
• Decreased platelets (a type of blood cell that helps stop bleeding)
• Head agitation
• Inadequate secretion of the hormone that controls urine volume
• Sugar in the urine
• Potentially fatal complications of uncontrolled diabetes
• Decreased blood sugar
• Excessive water intake
• Loss of movement or response while awake (catatonia)
• Confusion
• Somnambulism
• Absence of emotions
• Inability to achieve orgasm
• Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle stiffness), problems with blood vessels in the brain, including sudden loss of blood flow to the brain (stroke or "mini" stroke), no response to stimuli, loss of consciousness, decreased level of consciousness, seizures (epileptic crises), balance disorder
• Abnormal coordination
• Glaucoma (increased pressure in the eyeball)
• Eye movement problems, eye rotation, light sensitivity of the eyes, increased tear production, redness of the eyes
• Atrial fibrillation (abnormal heart rhythm), irregular heart rate
• Blood clots in the lungs, which cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg).If you experience any of these symptoms, seek medical help immediately.
• Flush
• Difficulty breathing during sleep (sleep apnea)
• Pulmonary congestion, respiratory tract congestion
• Crackling sounds from the lungs, wheezing
• Pancreatitis, tongue swelling, fecal incontinence, hard stools
• Intestinal obstruction
• Cracked lips
• Medication-related skin eruption, skin thickening, dandruff
• Muscle fiber rupture and muscle pain (rhabdomyolysis)
• Joint swelling
• Urinary incontinence
• Discomfort in the breasts, breast growth, breast enlargement
• Vaginal discharge
• Priapism (prolonged or painful erection that may require surgical treatment)
• Very low body temperature, chills, feeling of thirst
• Withdrawal symptoms from the medication
• Accumulation of pus due to skin infection at the injection site, deep skin infection, abscess at the injection site, bruising at the injection site.

Frequency not known:cannot be estimated from available data

• Low white blood cell count necessary to fight infections
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, skin rash, and sometimes a decrease in blood pressure
• Excessive water intake
• Sleep-related eating disorder
• Coma due to uncontrolled diabetes
• Decreased oxygen in parts of the body (due to decreased blood flow)
• Fast, shallow breathing, pneumonia caused by aspiration of food, voice disorder
• Intestinal movement disorder that causes obstruction
• Yellow skin and eyes (jaundice)
• Severe or potentially fatal skin eruption with blisters and peeling of the skin that may start in the mouth, nose, eyes, and genitals and spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Severe allergic reaction with swelling that may affect the throat, causing difficulty breathing
• Decoloration of the skin
• Abnormal posture
• Newborn babies of mothers who have been treated with paliperidone during pregnancy may experience adverse effects of the medication and/or withdrawal symptoms, such as irritability, weak or sustained muscle contractions, agitation, drowsiness, breathing problems, or difficulty feeding
• Decreased body temperature
• Dead skin cells at the injection site and ulcer at the injection site

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through 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 box and on the pre-filled syringe after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Paliperidone Stada

The active ingredient is paliperidone.

Each pre-filled syringe of Paliperidone Stada 50 mg contains palmitate of paliperidone equivalent to 50 mg.

Each pre-filled syringe of Paliperidone Stada 75 mg contains palmitate of paliperidone equivalent to 75 mg.

Each pre-filled syringe of Paliperidone Stada 100 mg contains palmitate of paliperidone equivalent to 100 mg.

Each pre-filled syringe of Paliperidone Stada 150 mg contains palmitate of paliperidone equivalent to 150 mg.

The other components are:

Polysorbate 20 (E 432)

Macrogol

Citric acid monohydrate (E 330)

Anhydrous sodium hydrogen phosphate(E 339)

Dihydrogen phosphate monohydrate

Sodium hydroxide (E 542) (for pH adjustment)

Water for injection preparations

Appearance of the product and contents of the package

Paliperidone Stada is a prolonged-release injectable suspension of white to off-white color in a pre-filled syringe.

Pre-filled syringe of a cyclic olefin copolymer with a type of piston plug, rear stop and a tip protector (bromobutyl rubber).

Each package contains 1 pre-filled syringe and 2 safety needles.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastraße, 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

Last review date of this leaflet: March 2024.

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

This information is intended solely for doctors or healthcare professionals and should be read along with the complete prescription information (Summary of Product Characteristics).

The injectable suspension is for single use. It should be visually inspected to detect any foreign particles before administration. Do not use the product if the syringe is not visually free of foreign particles.

The pack contains a pre-filled syringe and 2 safety needles (a 22 gauge 1½ inch [38 mm x 0.7 mm] needle and a 23 gauge 1 inch [25 mm x 0.6 mm] needle) for intramuscular injection.

1. Shake the syringe vigorously for at least 10 seconds to ensure a homogeneous suspension.

1. Select the appropriate needle.

The initial dose of Paliperidone Stada (150 mg) is administered on Day 1 in the DELTOIDES muscle using the DELTOIDES injection needle. The second initial dose of Paliperidone Stada (100 mg) is also administered in the DELTOIDES muscle one week later (Day 8) using the DELTOIDES injection needle.

If a patient is switched from risperidone prolonged-release injectable to Paliperidone Stada, the first Paliperidone Stada injection (dose range of 25 mg to 150 mg) can be administered in the DELTOIDES muscle or in the GLUTEAL muscle, using the appropriate needle for the injection site, at the time of the next scheduled injection.

Subsequent monthly maintenance injections can be administered in both the DELTOIDES and GLUTEAL muscles using the appropriate needle for the injection site.

In the case of DELTOIDES injection, if the patient weighs <90>use the 23 gauge 1 inch (25 mm x 0.6 mm) needle (needle with blue hub); if the patient weighs ≥ 90 kg, use the 22 gauge 1½ inch (38 mm x 0.7 mm) needle (needle with grey hub).

In the case of GLUTEAL injection, use the 22 gauge 1½ inch (38 mm x 0.7 mm) needle (needle with grey hub).

1. While holding the syringe in a vertical position, remove the rubber tip protector with a smooth rotational movement.

1. Open the safety needle blister pack to the middle. Hold the needle cover using the plastic of the blister pack. Attach the safety needle to the Luer connector of the syringe with a smooth rotational movement in a clockwise direction.

1. Separate the needle cover from the needle by pulling the cover in a straight line. Do not rotate the cover, as the needle may become detached from the syringe.

1. Place the syringe with the needle in a vertical position to proceed with the air elimination. Eliminate the air from the syringe by carefully pushing the plunger forward.

1. Inject the entire contents slowly and deeply into the selected deltoid or gluteal muscle of the patient. Do not administer by intravascular or subcutaneous route.

1. Once the injection is complete, use the finger or another finger (8a, 8b) or a flat surface (8c) to activate the needle protection system. The system is fully activated when a "click" sound is heard. Dispose of the syringe with the needle properly.

8a

8b

8c

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.