Prospect: information for the user

BYANNLI 700 mg prolonged-release injectable suspension in pre-filled syringe

BYANNLI 1 000 mg prolonged-release injectable suspension in pre-filled syringe

paliperidone

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

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist or nurse.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What BYANNLI is and for what it is used

2.What you need to know before starting to use BYANNLI

3.How to use BYANNLI

4.Possible adverse effects

5.Storage of BYANNLI

6.Contents of the package and additional information

BYANNLI contains the active ingredient paliperidone, which belongs to the class of antipsychotic medications.

BYANNLI is used as a maintenance treatment to combat the symptoms of schizophrenia in adult patients.

If you have responded well to treatment with paliperidone palmitate injections administered monthly or quarterly, your doctor may initiate treatment with BYANNLI.

Schizophrenia is a disease 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 (known as hallucinations), have false beliefs (known as delusions) or have an excessive distrust of others. Negative refers to the lack of behaviors or feelings that are normally present. For example, a person with schizophrenia may withdraw into themselves and not respond to any emotional stimuli or may have difficulty speaking in a clear and logical manner. People who suffer from this disorder may also feel depressed, anxious, guilty, or tense.

BYANNLI may alleviate the symptoms of your disease and reduce the likelihood of them recurring.

No use BYANNLI

-If you are allergic to paliperidone or any of the other ingredients in this medication (listed in section 6).

-If you are allergic to risperidone.

Warnings and precautions

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

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

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

-If you have Parkinson's disease

-If you have a type of dementia called "dementia with Lewy bodies"

-If you have been diagnosed with a condition whose symptoms include high temperature and muscle rigidity (known as Neuroleptic Malignant Syndrome)

-If you have had spasms or uncontrollable movements in the face, tongue, or other parts of the body (tardive dyskinesia)

-If you have had low white blood cell counts (which may have been caused by other medications or not)

-If you are diabetic or have a tendency to develop diabetes

-If you have had breast cancer or a tumor in the pituitary gland (a gland in the brain)

-If you have any heart disease or are receiving treatment for heart conditions that may make you more prone to a drop in blood pressure

-If you have low blood pressure when standing up or feel dizzy

-If you have a history of seizures

-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 experience excessive heat

-If you have an abnormally high blood level of the hormone prolactin or have a possible prolactin-dependent tumor

-If you or a family member have a history of blood clots, as antipsychotics have been associated with clot formation.

If you are in any of these situations, talk to your doctor, as you may need to adjust your dose or be monitored for some time.

Given that, rarely, a dangerously low count of a certain type of white blood cell responsible for fighting infections in the blood has been observed in patients receiving this medication, your doctor may decide to perform a white blood cell count.

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

This medication may cause you to gain or lose weight. Significant weight changes can be harmful to your health. Your doctor will regularly monitor your body weight.

Since diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in some patients taking this medication, your doctor should monitor for signs of hyperglycemia. In patients with pre-existing diabetes mellitus, blood glucose levels should be regularly controlled.

Since this medication can mask the normal response of the body to ingested toxic substances or other diseases, there is a possibility that it may mask the response to certain conditions.

Surgery for cataracts

If you are planning to have eye surgery, inform your ophthalmologist that you are using this medication, as during cataract surgery in the eye due to clouding of the crystalline lens:

• The pupil (the black circle in the middle of the eye) may not dilate as needed.
• The iris (the colored part of the eye) may become flaccid during surgery and may cause eye damage.

Children and adolescents

Do not use this medication in children and adolescents under 18 years old. Its safety and efficacy in these patients are unknown.

Other medications and BYANNLI

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

If you take this medication with carbamazepine (an antiepileptic and mood stabilizer), you may need to adjust your dose of this medication.

Since this medication primarily acts on the brain, the use of other medications with central nervous system activity may exacerbate side effects such as drowsiness or other effects on the brain, as well as other psychiatric medications, opioids, antihistamines, and sleep medications.

Inform your doctor if you are taking this medication and also taking risperidone or paliperidone orally for extended periods. You may need to change your BYANNLI dose.

Because this medication can lower blood pressure, caution should be exercised when combining it with other medications that lower blood pressure.

This medication may reduce the effect of medications used to treat Parkinson's disease and restless leg syndrome (e.g., levodopa).

This medication may cause an electrocardiogram (ECG) anomaly that indicates that electrical impulses take longer to reach a specific part of the heart (known as "prolongation of the QT interval"). Among the medications that cause this effect are some medications used to regulate heart rhythm or treat infections, as well as other antipsychotics.

If you have a history of seizures, this medication may increase the likelihood of them recurring. Other medications that cause this effect include some medications used to treat depression or infections and other antipsychotics.

BYANNLI should be used with caution with medications that increase central nervous system activity (psycho-stimulants such as methylphenidate).

Use of BYANNLI with alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

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

Women of childbearing age

A single dose of this medication is expected to remain in the body for up to 4 years, which may be hazardous to your child. Therefore, BYANNLI should only be used in women who plan to become pregnant if it is clearly necessary.

Pregnancy

Do not use this medication during pregnancy without discussing it with your doctor first. In newborns of mothers who received paliperidone in the last trimester (the last three months of pregnancy), the following symptoms may appear: tremors, rigidity, and/or muscle weakness, drowsiness, agitation, respiratory disturbances, and difficulty feeding. Newborns should be closely monitored, and if your child exhibits any of these symptoms, seek medical attention for your child.

Breastfeeding

This medication may pass from the mother to the child through breast milk. It may be harmful to the child even long after the last dose. For this reason, do not breastfeed while using or after using this medication for the last 4 years.

Driving and operating machinery

During treatment with this medication, dizziness, extreme fatigue, and vision problems (see section 4) may occur. These effects should be taken into account in cases where maximum attention is required, such as driving vehicles or operating machinery.

BYANNLI contains sodium

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

This medication is administered by a doctor or healthcare professional. The doctor will inform you when the next injection should be administered. It is essential that you do not miss the scheduled dose. If you cannot attend your appointment, please make sure to call immediately to schedule another appointment as soon as possible.

You will receive a BYANNLI injection in the buttock every 6 months.

Depending on your symptoms, the doctor will increase or decrease the amount of medication administered in the next scheduled injection.

Patients with kidney disorders

If you have a mild kidney disorder, the doctor will determine if BYANNLI is suitable based on the monthly or quarterly dose of paliperidone palmitate injectable that you have been receiving. The 1,000 mg dose of BYANNLI is not recommended.

If you have a severe or moderate kidney disorder, you should not use this medication.

Advanced age population

If you have reduced renal function, the doctor may adjust the dose of this medication.

If you receive more BYANNLI than you should

This medication will be administered under medical supervision; therefore, it is unlikely that you will receive more than the prescribed amount.

If a patient receives an excessive amount of paliperidone, they may experience the following symptoms: drowsiness or sedation, elevated heart rate, low blood pressure, electrocardiogram (ECG) abnormalities, or slow and abnormal movements of the face, body, arms, or legs.

If you stop using BYANNLI

If you stop receiving the injections, your schizophrenia symptoms may worsen. Do not stop using this medication unless your doctor instructs you to do so.

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.

Severe side effects

If you experience any of the following severe side effects, you may need immediate medical treatment. Inform your doctor or go to the nearest hospital if you experience:

• blood clots in the veins, especially in the legs. This is a rare side effect (can affect up to 1 in 1,000 people). Symptoms include:

• swelling, pain, and redness of the legs (deep vein thrombosis)
• chest pain and difficulty breathing due to blood clots that have traveled through the blood vessels to the lungs (pulmonary embolism).

• Signs of stroke, whose frequency is unknown (cannot be estimated from available data). Symptoms include:

• sudden change in mental state
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body; or if you have trouble speaking, even for a short time.

• Malignant neuroleptic syndrome. This is a rare side effect (can affect up to 1 in 1,000 people). Symptoms include:

• fever, muscle stiffness, sweating, or reduced level of consciousness.

• Prolonged erections, which can be painful (priapism). This is a rare side effect (can affect up to 1 in 1,000 people).
• Uncontrollable twitching or rhythmic spasmodic movements of the tongue, mouth, and face, or other parts of the body (tardive dyskinesia). This is a rare side effect (can affect up to 1 in 100 people). It may be necessary to discontinue this medication.
• Severe allergic reaction (anaphylactic reaction), whose frequency is unknown (cannot be estimated from available data). Symptoms include:

• fever,
• swelling of the mouth, face, lips, or tongue,
• difficulty breathing,
• itching, skin rash, and sometimes low blood pressure.

Even if you have previously tolerated oral risperidone or paliperidone, you may rarely experience allergic reactions after receiving paliperidone injections.

• Flaccid iris syndrome, when the iris (the colored part of the eye) becomes flaccid during cataract surgery. This can cause eye damage (see also "Cataract surgery" in section 2). The frequency of this side effect is unknown (cannot be estimated from available data).
• Stevens-Johnson syndrome or toxic epidermal necrolysis. Severe skin rash or life-threatening skin blistering that can start in the mouth, nose, eyes, and genitals and spread to other parts of the body. The frequency of these side effects is unknown (cannot be estimated from available data).

Inform your doctor or go to the nearest hospital if you experience any of the above severe side effects.

• Agranulocytosis, a dangerously low number of a type of white blood cell necessary to fight blood infections. The frequency of this side effect is unknown (cannot be estimated from available data).

Other side effects

Very common side effects: can affect more than 1 in 10 people

• Difficulty falling or staying asleep.

Common side effects: can affect up to 1 in 10 people

• Common cold symptoms, urinary tract infection, feeling of having the flu.
• BYANNLI 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, missed periods, or other menstrual cycle problems.
• High 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.
• Feeling of restlessness, drowsiness, or reduced alertness.
• Dystonia: This disorder 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 jaw.
• Dizziness.
• Dyskinesia: This disorder involves involuntary muscle movements and may include
• repetitive, spasmodic, or twisting movements, or spasms.
• Trembling (agitation).
• Headache.
• Fast heart rate.
• High blood pressure.
• Cough, nasal congestion.
• Abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache.
• Increased levels of liver enzymes in the blood.
• Pain in bones or muscles, back pain, joint pain.
• Missed periods.
• Fever, weakness, fatigue (tiredness).
• Reaction at the injection site, with itching, pain, or swelling.

Uncommon side effects: can affectup to 1 in 100 people

• Pneumonia, chest infection (bronchitis), respiratory tract infection, sinusitis, urinary tract infection, ear infection, tonsillitis, fungal nail infection,

skin infections.

• Reduced number of white blood cells.
• Anemia.
• Allergic reaction.
• Diabetes or worsening of diabetes, increased blood insulin levels (hormone that regulates blood sugar levels).
• Increased appetite.
• Loss of appetite leading to malnutrition and weight loss.
• High triglycerides (a type of fat) in the blood, high cholesterol in the blood.
• Sleep disorders, euphoria (mania), decreased libido, nervousness, nightmares.
• Fainting, urgent desire to move certain parts of the body, dizziness when standing up, attention problems, speech disorders, loss or alteration of taste, reduced skin sensitivity to pain and touch, feeling of pins and needles, numbness, or tingling of the skin.
• Blurred vision, eye infection, red eyes, dry eyes.
• Sensation of spinning (vertigo), ringing in the ears, ear pain.
• Abnormal heart rhythm, heart conduction disorders, prolonged QT interval, rapid heart rate, slow heart rate, abnormal electrocardiogram (ECG), feeling of palpitations or fluttering in the chest (palpitations).
• Low blood pressure, hypotension when standing up (due to this effect, some people treated with this medication may feel weakness, dizziness, or faint when standing up or sitting up suddenly).
• Difficulty breathing, sore throat, nasal bleeding.
• Abdominal discomfort, gastrointestinal or intestinal infection, difficulty swallowing, dry mouth, excessive gas or flatulence.
• Increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood.
• Appearance of hives (urticaria), itching, rash, hair loss, eczema, dry skin, skin redness, acne, abscess under the skin, peeling, itching of the scalp or skin.
• Increased CPK (creatine phosphokinase), a blood enzyme.
• Muscle spasms, joint stiffness, muscle weakness.
• Incontinence (loss of bladder control), frequent urination, painful urination.
• Erectile dysfunction, ejaculation disorders, missed periods or menstrual cycle problems (in women), breast development in men, sexual dysfunction, breast pain, milk leakage from the breasts.
• Swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs.
• Increased body temperature.
• Changes in gait.
• Chest pain, chest discomfort, general feeling of discomfort.
• Skin hardening.
• Falls.

Rare side effects: can affectup to 1 in 1,000 people

• Eye infection.
• Infestation of the skin caused by mites.
• Increased eosinophils (a type of white blood cell) in the blood.
• Reduced platelets (cells necessary to stop bleeding).
• Incorrect secretion of a hormone that controls urine volume.
• Sugar in the urine.
• Potentially life-threatening complications of uncontrolled diabetes.
• Low blood sugar.
• Excessive water intake.
• Confusion.
• Lack of movement or response while awake (catatonia).
• Somnambulism.
• Lack of emotions.
• Inability to achieve orgasm.
• Lack of response to stimuli, loss of consciousness, reduced level of consciousness, seizures (epileptic crises), balance disorder.
• Abnormal coordination.
• Glaucoma (increased eye pressure).
• Eye movement disorders, "eyes in the back of the head," light sensitivity, increased tear production, red eyes.
• Uncontrollable head movements.
• Atrial fibrillation (an abnormal heart rhythm), irregular heartbeats.
• Flush.
• Difficulty breathing during sleep (sleep apnea).
• Pulmonary congestion, respiratory tract congestion.
• Crackling sounds from the lungs.
• Whistling.
• Pancreatitis.
• Tongue swelling.
• Incontinence of feces, hard stools, intestinal obstruction.
• Cracked lips.
• Skin rash related to the medication, skin thickening, dandruff.
• Joint swelling.
• Muscle degradation ("rhabdomyolysis").
• Inability to urinate.
• Mammary discomfort, breast swelling, breast enlargement.
• Vaginal discharge.
• Very low body temperature, chills, feeling of thirst.
• Withdrawal symptoms from the medication.
• Accumulation of pus due to infection at the injection site, deep skin infection, abscess at the injection site, hematomas (bruises) at the injection site.

Unknown frequency: cannot be estimated from available data

• Excessive intake of water.
• Sleep-related eating disorder.
• Diabetic coma due to uncontrolled diabetes
• Shallow and agitated breathing, pneumonia caused by aspiration of food, voice changes
• Decreased oxygen levels in parts of the body (due to decreased blood flow)
• Lack of intestinal movement that causes intestinal obstruction
• Yellow skin and eyes (jaundice)
• Decoloration of the skin
• Abnormal posture
• Newborns whose mothers took BYANNLI during pregnancy may experience medication side effects and/or withdrawal symptoms, such as irritability, slow or sustained muscle contractions, tremors, insomnia, respiratory or feeding problems
• Decreased body temperature
• Accumulation of dead skin cells around the injection site, 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 thenational notification system included in theAppendix V. 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. The expiration date is the last day of the month indicated.

Transport and store in a horizontal position. Check the correct orientation with the arrows on the product box.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of BYANNLI

The active ingredient is paliperidone.

Each pre-filled syringe of BYANNLI 700 mg contains 1,092 mg of palmitate of paliperidone, equivalent to 700 mg of paliperidone.

Each pre-filled syringe of BYANNLI 1,000 mg contains 1,560 mg of palmitate of paliperidone, equivalent to 1,000 mg of paliperidone.

The other components are:

Polysorbate 20

Polyethylene glycol 4,000

Monohydrated citric acid

Dihydrogen phosphate of sodium monohydrate

Sodium hydroxide (for pH adjustment)

Water for injectable preparations

Appearance of the product and contents of the package

BYANNLI is a prolonged-release injectable suspension, white to off-white in color, presented in a pre-filled syringe. The pH is approximately 7.0. The doctor or nurse must shake the syringe quickly to homogenize the suspension before injecting it.

Each package contains 1 pre-filled syringe and 1 needle.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

For more information about this medication, please contact the local representative of the marketing authorization holder.

Last update of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

Information for healthcare professionals

This information is intended only for healthcare professionals, who must read it together with the complete product characteristics (Summary of Product Characteristics).

Important safety information

3. After the injection Protect the needle

After the injection, help yourself with your thumb or a flat surface to activate the needle safety device.

The needle will be safe when you hear a "click".

Dispose of correctly and check the injection site

Dispose of the syringe in an authorized sharp object container.

There may be a small amount of blood or liquid at the injection site. Apply pressure to the skin with a cotton ball or gauze until it stops bleeding.

Do not wipe the injection site.

If necessary, cover the injection site with a bandage.