Paliperidone Stada 50 mg prolonged-release injectable suspension in pre-filled syringe EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Paliperidona Stada 50 mg prolonged-release injectable suspension

in pre-filled syringeEPAR

Paliperidona Stada 75 mg prolonged-release injectable suspension

in pre-filled syringeEPAR

Paliperidona Stada 100 mg prolonged-release injectable suspension

in pre-filled syringeEPAR

Paliperidona Stada 150 mg prolonged-release injectable suspension

in pre-filled syringeEPAR

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Paliperidona Stada is and what it is used for
2. What you need to know before using Paliperidona Stada
3. How to use Paliperidona Stada
4. Possible side effects
5. How to store Paliperidona Stada
6. Contents of the pack and other information

1. What Paliperidona Stada is and what it is used for

Paliperidona Stada contains the active substance paliperidona, which belongs to the class of antipsychotic medicines. It is used for maintenance treatment of the symptoms of schizophrenia in adult patients who have been stabilized with paliperidona or risperidone.

If you have previously responded to paliperidona or risperidone and have mild to moderate symptoms, your doctor may start treatment with paliperidona without prior stabilization with paliperidona or risperidona.

Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive means an excess of symptoms that are not normally 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 excessive mistrust of others. Negative refers to the absence of behaviours or emotions that are normally present. For example, a person with schizophrenia may become withdrawn and unresponsive to emotional stimuli, or may have difficulty speaking in a clear and logical manner. People with this disorder may also feel depressed, anxious, guilty, or tense.

Paliperidona may help relieve the symptoms of your illness and prevent them from returning.

2. What you need to know before starting to use Paliperidone Stada

Do not use Paliperidona Stada

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use paliperidone.

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).

All medicines have side effects, and some of the side effects of this medicine may worsen symptoms of other conditions. For this reason, it is important that you discuss with your doctor if you have any of the following conditions, which could worsen during treatment with this medicine:

• if you have Parkinson's disease
• if you have ever been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome)
• if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia)
• if you have previously had low levels of white blood cells in the blood (which may or may not have been caused by other medicines)
• if you have diabetes or are prone to diabetes
• if you have had breast cancer or a tumor in the pituitary gland of the brain
• if you have heart disease or are receiving treatment for heart conditions that may make you more susceptible to a drop in blood pressure
• if you have low blood pressure when standing up or getting up suddenly
• if you have epilepsy
• if you have kidney problems
• if you have liver problems
• if you have a prolonged and/or painful erection
• if you have difficulty regulating body temperature or feel overheated
• if you have abnormally high levels of the hormone prolactin in your blood or have a tumor that may be prolactin-dependent
• if you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, please consult your doctor, as a dose adjustment or monitoring may be necessary.

• Since, very rarely, a dangerously low number of a type of white blood cells needed to fight infections has been observed in patients treated with this medicine, your doctor may check your white blood cell count.

• Even if you have previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after receiving paliperidone injections. Seek immediate medical help if you experience a skin rash, swelling of the throat, itching, or breathing difficulties, as these may be signs of a serious allergic reaction.

• This medicine may cause weight gain. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

• Diabetes mellitus has been observed or pre-existing diabetes mellitus has worsened in patients treated with this medicine. Your doctor should check for signs of increased blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

• Since this medicine may reduce the urge to vomit, it may mask the body's normal response to ingesting toxic substances or other medical conditions.

• During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents

Do not use this medicine in individuals under 18 years of age.

Other medicines and Paliperidona Stada

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

• Taking this medicine together with carbamazepine (an antiepileptic and mood stabilizer) may require a change in your dose of this medicine.

• Since this medicine acts mainly on the brain, interactions with other medicines that also act on the brain may increase side effects such as drowsiness or other central nervous system effects, including other psychiatric medicines, opioids, antihistamines, and sleeping medicines.

• Since this medicine may lower blood pressure, you should be cautious when using it together with other medicines that lower blood pressure.

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

• This medicine may cause an abnormality in the electrocardiogram (ECG) indicating a prolonged time for an electrical impulse to travel through a certain part of the heart (known as "QT interval prolongation"). Other medicines that have this effect include some medicines used to treat heart rhythm disorders or infections, and other antipsychotics.

• If you are prone to seizures, this medicine may increase your risk of experiencing them. Other medicines with this effect include some medicines used to treat depression or infections, and other antipsychotics.

• Paliperidone should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Use of Paliperidona Stada with alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not use this medicine during pregnancy unless discussed with your doctor. The following symptoms may occur in newborn babies of mothers who have been treated with paliperidone during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Breastfeeding

This medicine may pass into breast milk and may harm the baby. Therefore, you must not breastfeed while taking this medicine.

Driving and using machines

Dizziness, extreme tiredness, and vision problems may occur during treatment with this medicine (see section 4). This should be taken into account when maximum attention is required, e.g., when driving or operating machinery.

Paliperidona Stada contains sodium

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

3. How to use Paliperidona Stada

This medicine will be administered to you by your doctor or another healthcare professional. Your doctor will tell you when the next injection should be given. It is important that you do not miss any of the scheduled doses. If you are unable to attend your appointment, make sure to contact your doctor immediately to reschedule as soon as possible.

Dosage and method of administration

You will receive the first injection (150 mg) and the second injection (100 mg) of this medicine in the upper arm, approximately one week apart. After that, 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 injectable risperidone to this medicine, you will receive the first injection of this medicine (between 25 mg and 150 mg) in the upper arm or buttocks at your next scheduled injection. After that, you will receive an injection (between 25 mg and 150 mg) in the upper arm or buttocks once a month.

Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive to a different dose level at the time of your scheduled monthly injection.

Patients with kidney problems

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

Elderly patients

Your doctor may reduce the dose of this medicine if your kidney function is reduced.

If you receive more Paliperidona Stada than you should

You will receive this medicine under medical supervision, so it is unlikely that you will receive an overdose.

Patients who have received an overdose of paliperidone may experience the following symptoms: drowsiness or sedation, rapid heart rate, low blood pressure, abnormalities in the electrocardiogram (electrical tracing of the heart), 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 at 91 562 04 20, indicating the medicine and the amount ingested.

If you stop treatment with Paliperidona Stada

If you stop receiving your injections, the effects of the medicine will be lost. You must not stop using this medicine unless instructed by your doctor, as your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Tell your doctor immediately if:

• you develop 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 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 of the body, or have difficulty speaking even for a short period. These may be signs of a stroke.
• you develop fever, muscle stiffness, sweating or a decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). You may require immediate medical treatment.
• you are male and experience a prolonged or painful erection. This is known as priapism. You may require immediate medical treatment.
• you develop involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be necessary.
• you experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash and sometimes a drop in blood pressure (anaphylactic reaction). Even if you have previously tolerated oral risperidone or oral paliperidone, severe allergic reactions have occasionally occurred after receiving paliperidone injections.
• you are scheduled for eye surgery, make sure to inform your ophthalmologist that you are taking this medicine. During cataract surgery, the iris (the colored part of the eye) may become floppy during the procedure (known as "floppy iris syndrome"), which could lead to eye damage.
• you experience a dangerously low count of a type of white blood cells essential for fighting blood infections.

The following adverse effects may occur:

Very common: may affect more than 1 in 10 people

• difficulty falling asleep or staying asleep.

Common: may affect up to 1 in 10 people

• symptoms of common cold, urinary tract infection, feeling as if you have the flu
• Paliperidone may increase levels of a hormone called "prolactin" detectable in blood tests (which may or may not cause symptoms). When symptoms of elevated prolactin occur, they may include (in men) breast enlargement, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk discharge from the breasts, missed menstrual periods or other menstrual cycle problems
• increased blood sugar, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slow or altered movement, a sensation of stiffness or tightness in muscles (causing jerky movements), and sometimes a "freezing" of movement that later resumes. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/or drooling, and reduced facial expression
• restlessness, feeling drowsy or less alert
• dystonia: a disorder involving involuntary, slow or sustained muscle contractions. Although any body part may be affected (and may result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
• dizziness
• dyskinesia: this disorder involves involuntary muscle movements and may include repetitive, jerky or twisting movements, or spasms
• tremor (agitation)
• headache
• rapid heartbeat
• increased blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue (tiredness)
• injection site reaction, including itching, pain or swelling

Uncommon: may affect up to 1 in 100 people

• pneumonia, chest infection (bronchitis), respiratory tract infection, sinus infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased number of white blood cells, decreased count of a type of white blood cells that help 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 blood triglycerides (a type of fat), increased blood cholesterol
• sleep disorder, euphoria (mania), decreased sexual desire, nervousness, nightmares
• tardive dyskinesia (involuntary spasms or jerky movements of the face, tongue or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of this medicine may be necessary.
• fainting, a restlessness causing body movements, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, reduced skin sensitivity to pain or touch, tingling, prickling or numbness of the skin
• blurred vision, eye infection or "pink eye", dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• conduction block between upper and lower parts of the heart, abnormal heart electrical activity, QT interval prolongation on ECG, rapid heartbeat upon standing, slow heartbeat, abnormalities in the heart's electrical tracing (electrocardiogram or ECG), fluttering or pounding sensation in the chest (palpitations)
• decreased blood pressure, low blood pressure upon standing (thus, some people taking this medicine may feel weak, dizzy or may faint when standing or sitting up suddenly)
• difficulty breathing, sore throat, nosebleeds
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excess gas or flatulence
• increased GGT (an enzyme called gamma-glutamyl transferase) in blood, increased liver enzymes in blood
• hives (or "urticaria"), itching, rash, hair loss, eczema, dry skin, skin redness, acne, skin abscess
• increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown
• muscle spasms, joint stiffness, muscle weakness
• urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorder, absence of menstrual periods or other cycle problems (women), breast development in men, sexual dysfunction, breast pain, milk discharge from breasts
• swelling of the face, mouth, eyes or lips, body swelling, swelling of arms or legs
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, feeling unwell
• hardening of the skin
• falls

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

• eye infection
• skin inflammation caused by mites, scaly and itchy skin or scalp
• increased eosinophils (a type of white blood cell) in blood
• decreased platelets (blood cells that help stop bleeding)
• head agitation
• inappropriate secretion of the hormone controlling urine volume
• sugar in urine
• potentially life-threatening complications of uncontrolled diabetes
• decreased blood sugar
• excessive water intake
• lack of movement or response while awake (catatonia)
• confusion
• sleepwalking
• absence of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever and severe muscle rigidity), brain blood vessel problems including sudden loss of blood supply to the brain (stroke or "mini" stroke), unresponsiveness to stimuli, loss of consciousness, decreased level of consciousness, seizures (epileptic fits), balance disorder
• abnormal coordination
• glaucoma (increased pressure inside the eyeball)
• eye movement problems, eye rolling, light sensitivity of the eyes, increased tearing, eye redness
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clots in the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical help.
• blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness). If you experience any of these symptoms, seek immediate medical help.
• flushing
• difficulty breathing during sleep (sleep apnea)
• pulmonary congestion, respiratory congestion
• crackling lung sounds, wheezing
• pancreatitis (inflammation of the pancreas), swollen tongue, fecal incontinence, very hard stools
• intestinal obstruction
• cracked lips
• drug-related skin rash, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of breast glands, breast growth
• vaginal discharge
• priapism (a prolonged penile erection that may require surgical treatment)
• very low body temperature, chills, feeling thirsty
• medication withdrawal symptoms
• pus accumulation due to infection at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site.

Frequency not known: cannot be estimated from available data

• dangerously low count of a type of white blood cells essential for fighting infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash and sometimes low blood pressure
• dangerously excessive water intake
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• decreased oxygen supply to body parts (due to reduced blood flow)
• rapid, shallow breathing, aspiration pneumonia (caused by inhaling food), voice disorder
• absence of intestinal movement leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or potentially life-threatening skin rash with blisters and skin peeling, which may start inside and around the mouth, nose, eyes and genitals and spread to other body areas (Stevens-Johnson Syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling that may affect the throat, causing breathing difficulty
• skin discoloration
• postural abnormality
• newborn babies of mothers treated with paliperidone during pregnancy may experience adverse effects from the medicine and/or withdrawal symptoms such as irritability, weak or sustained muscle contractions, restlessness, drowsiness, breathing problems or feeding difficulties
• decreased body temperature
• dead skin cells at the injection site and ulceration at the injection site

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paliperidone Stada

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

Do not use this medicine after the expiry date stated on the carton and on the prefilled syringe after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Paliperidona Stada

The active substance is paliperidone.

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

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

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

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

The other components are:

Polysorbate 20 (E 432)
Macrogol
Monohydrate citric acid (E 330)
Anhydrous sodium hydrogen phosphate (E 339)
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (E 542) (for pH adjustment)
Water for injections

Appearance of the product and contents of the pack

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

Pre-filled syringe made of cyclic olefin copolymer, with a plunger stopper, a plunger rod, and a needle shield (bromobutyl rubber).

Each pack contains 1 pre-filled syringe and 2 needles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastraße, 2-18
61118 Bad Vilbel
Germany

or

STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Wien
Austria

or

Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands

Date of the most recent revision of this leaflet: March 2024.

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

This information is intended exclusively for physicians or healthcare professionals and should be read together with the full prescribing information (Summary of Product Characteristics).

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

The pack contains one pre-filled syringe and 2 safety needles (one 22-gauge 1½ inch [38 mm x 0.7 mm] needle and one 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 first initiation dose of Paliperidona Stada (150 mg) is administered on Day 1 into the DELTOID muscle using the needle intended for DELTOID injection. The second initiation dose of Paliperidona Stada (100 mg) is also administered into the DELTOID muscle one week later (Day 8) using the needle intended for DELTOID injection.

If a patient is being switched from long-acting risperidone injection to Paliperidona Stada, the first injection of Paliperidona Stada (dose range 25 mg to 150 mg) may be administered into either the DELTOID or GLUTEAL muscle, using the appropriate needle for the injection site, at the time of the next scheduled injection.

Subsequently, monthly maintenance injections can be administered either into the DELTOID or GLUTEAL muscle, using the appropriate needle for the injection site.

For DELTOID injection: if the patient weighs < 90 kg, use the 23-gauge 1 inch needle (25 mm x 0.6 mm) (needle with blue hub); if the patient weighs ≥ 90 kg, use the 22-gauge 1½ inch needle (38 mm x 0.7 mm) (needle with gray hub).

For GLUTEAL injection, use the 22-gauge 1½ inch needle (38 mm x 0.7 mm) (needle with gray hub).

1. While holding the syringe vertically, remove the rubber needle shield with a gentle twisting motion.

1. Open the safety needle blister pack halfway. Hold the needle cover using the plastic of the blister. Attach the safety needle to the luer-lock connection of the syringe with a gentle clockwise twisting motion.

1. Pull the tab straight off to remove the cover from the needle. Do not twist the tab, as the needle may detach from the syringe.

1. Hold the syringe with the needle attached vertically to expel air. Carefully push the plunger forward to remove air from the syringe.

1. Inject the entire contents slowly and deeply by intramuscular route into the selected deltoid or gluteal muscle. The product must not be administered intravenously or subcutaneously.

2. After completing the injection, use the thumb or another finger (8a, 8b) or a flat surface (8c) to activate the needle safety device. The safety mechanism is fully activated when a “click” is heard. Dispose of the syringe with the needle properly.

8a

8b

8c

Any unused medicine and materials that have come into contact with it must be disposed of in accordance with local regulations.