Palmeux 100 mg prolonged-release injectable suspension in pre-filled syringe EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Palmeux 25 mg prolonged-release injectable suspension in pre-filled syringe EFG

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

Palmeux 75 mg prolonged-release injectable suspension in pre-filled syringe EFG

Palmeux 100 mg prolonged-release injectable suspension in pre-filled syringe EFG

Palmeux 150 mg prolonged-release injectable suspension in pre-filled syringe EFG

Paliperidone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Palmeux is and what it is used for

This medicine contains the active substance paliperidone, which belongs to the class of antipsychotic medicines. It is used as maintenance treatment for the symptoms of schizophrenia in stabilized adult patients who have previously been treated with paliperidone or risperidone.

If you have previously responded to paliperidone or risperidone and have mild or moderate symptoms, your doctor may initiate treatment with Palmeux without prior stabilization with paliperidone 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 abnormally high levels of distrust toward others. Negative refers to the absence of behaviors or feelings that are normally present. For example, a person with schizophrenia may withdraw into themselves and fail to respond 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.

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

2. What you need to know before using Palmeux

Do not use Palmeux:

• if you are allergic to paliperidone or to any of the other components 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 Palmeux.

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 any of the following medical 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 are diabetic or have a tendency towards 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 prone to low 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 are 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 you may require a dose adjustment or need to be monitored for a period of time.

Because, in very rare cases, 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 Palmeux 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 or worsening of pre-existing diabetes mellitus has been observed in patients treated with this medicine. Your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar levels should be monitored regularly.

Because this medicine may reduce the urge to vomit, it may mask the body's normal response to ingesting toxic substances or other illnesses.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the middle of the eye) may not dilate as required. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medicine.

Children and adolescents

Do not use this medicine in children or adolescents under 18 years of age.

Other medicines and Palmeux

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.

Because this medicine acts mainly in 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.

Because this medicine may lower blood pressure, you should be cautious if taking it together with other medicines that also 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 certain medicines used to treat heart rhythm disorders or infections, as well as other antipsychotics.

If you are prone to seizures, this medicine may increase your risk of experiencing them. Other medicines that have this effect include certain antidepressants and antibiotics, as well as other antipsychotics.

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

Palmeux and alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should not use 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 during the third 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.

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

Driving and using machines

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

Palmeux contains sodium

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

3. How to use Palmeux.

Your doctor or another healthcare professional will administer this medicine to you. Your doctor will tell you when the next injection should be given. It is important not to miss any of the scheduled doses. If you are unable to attend your appointment, make sure to call your doctor immediately to schedule another appointment as soon as possible.

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 your 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 Palmeux than you should

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

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 pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you stop treatment with Palmeux

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 can cause adverse effects, although not everyone will experience 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.
• 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 have difficulty speaking, even for a short period of time. These may be signs of a stroke.
• develop fever, muscle stiffness, sweating or a decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• are male and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be necessary.
• develop a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, rash and sometimes a drop in blood pressure (i.e., an "anaphylactic reaction"). Even if you have previously tolerated oral risperidone or oral paliperidone, allergic reactions have rarely occurred after receiving paliperidone injections.
• 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 surgery (known as "intraoperative floppy iris syndrome"), which may cause eye damage.
• experience a dangerously low number of a type of white blood cell necessary to fight blood infections.

The following adverse effects may occur:

Very common adverse effects: may affect more than 1 in 10 patients

• difficulty falling or staying asleep.

Common adverse effects: may affect up to 1 in 10 patients

• symptoms of common cold, urinary tract infection, feeling as if you have the flu
• Palmeux may increase levels of a hormone called "prolactin" which can be detected in blood tests (this may or may not cause symptoms). When symptoms of increased prolactin occur, they may include (in men) breast swelling, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk discharge from the breasts, loss of 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 feeling of stiffness or tightness in the muscles (causing jerky movements), and sometimes a sensation of "freezing" of movement that then restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• restlessness, feeling drowsy or less alert
• dystonia: This is a disorder involving involuntary, slow or sustained muscle contractions. Although any part of the body may be affected (and may lead to 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, spasmodic or twisting movements, or spasms.
• tremor (shakiness)
• 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
• milk discharge from the breasts
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain or swelling.

Uncommon adverse effects: may affect up to 1 in 100 patients

• pneumonia, chest infection (bronchitis), respiratory tract infection, nasal infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decrease in the number of white blood cells, decrease in a type of white blood cell that helps fight infections, decrease in platelets (blood cells that help stop bleeding), 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 decreased body weight
• increased triglycerides in blood (fat), increased cholesterol in blood
• sleep disorder, euphoria (mania), decreased sexual desire, nervousness, nightmares
• tardive dyskinesia (spasms or spasmodic movements that cannot be controlled in 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 movement of body parts, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling or numbness of the skin
• blurred vision, eye infection or "red eye", dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation in the heart, rapid heartbeat upon standing, slow heartbeat, abnormalities in the heart's electrical trace (electrocardiogram or ECG), sensation of fluttering or pounding 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 up or sitting down suddenly)
• shortness of breath, respiratory congestion, wheezing, sore throat, nosebleeds
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excess gas or flatulence
• increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood
• hives (or "urticaria"), itching, rash, hair loss, eczema, dry skin, skin redness, acne
• increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown
• muscle spasms, joint stiffness, muscle weakness, neck pain
• urinary incontinence (loss of control), frequent urination, pain during urination
• erectile dysfunction, ejaculation disorder, absence of menstrual periods or other cycle problems (women), breast development in men, sexual dysfunction, breast pain
• swelling of the face, mouth, eyes or lips, body swelling, arms or legs
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, feeling of discomfort
• hardening of the skin
• falls.

Rare adverse effects: may affect up to 1 in 1,000 patients

• eye infection
• skin inflammation caused by mites, subcutaneous abscess
• increased eosinophils (a type of white blood cell) in blood
• 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), problems in brain blood vessels, 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 in 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 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
• flushing
• difficulty breathing during sleep (sleep apnea)
• pulmonary congestion
• crackling lung sounds
• pancreatitis, tongue swelling, fecal incontinence, very hard stools
• cracked lips
• drug-related skin rash, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, growth of breast glands, breast enlargement
• vaginal discharge
• very low body temperature, chills, sensation of thirst
• 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 number of a type of white blood cell necessary to fight infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash and sometimes drop in blood pressure
• dangerously excessive water intake
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• head agitation
• blood clots in the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, see a doctor immediately.
• decreased oxygen in parts of the body (due to reduced blood flow)
• rapid, shallow breathing, pneumonia caused by aspiration of food, voice disorder
• intestinal obstruction, absence of intestinal movement causing obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening rash with blisters and skin peeling that 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, scaly and itchy skin or scalp
• postural abnormality
• newborn babies of mothers who have been treated with Palmeux during pregnancy may experience adverse effects from the medicine and/or withdrawal symptoms, such as irritability, weak or sustained muscle contractions, agitation, drowsiness, breathing problems or feeding difficulties
• priapism (a prolonged erection that may require surgical treatment)
• 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. This includes any possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Palmeux

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 pre-filled syringe after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Palmeux

The active substance is paliperidone.

Each prefilled syringe of Palmeux 25 mg contains 25 mg of paliperidone (as paliperidone palmitate).

Each prefilled syringe of Palmeux 50 mg contains 50 mg of paliperidone (as paliperidone palmitate).

Each prefilled syringe of Palmeux 75 mg contains 75 mg of paliperidone (as paliperidone palmitate).

Each prefilled syringe of Palmeux 100 mg contains 100 mg of paliperidone (as paliperidone palmitate).

Each prefilled syringe of Palmeux 150 mg contains 150 mg of paliperidone (as paliperidone palmitate).

The other components are:

Polysorbate 20
Macrogol
Monohydrate citric acid
Anhydrous sodium hydrogen phosphate
Monohydrate sodium dihydrogen phosphate
Sodium hydroxide (for pH adjustment)
Water for injections

Appearance of the Product and Contents of the Package

Palmeux is a white to off-white injectable suspension for prolonged release, supplied in a prefilled syringe.

Each package contains 1 prefilled syringe and 2 needles.

Marketing Authorization Holder

Amdipharm Limited
Unit 17
Northwood House
Northwood Crescent
Northwood
Dublin 9
D09 V504
Ireland

Manufacturer

Pharmathen S.A
Dervenakion 6,
Pallini Attiki, 15351,
Greece

OR

Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece

Local Representative:

Advanz Pharma Spain S.L.U.
Paseo de la Castellana 135, 7th floor
28046 Madrid (Spain)
Tel: +34 900 834 889
[email protected]

Date of Most Recent Review of This Summary: September 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for 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 complete prescribing information (Summary of Product Characteristics).

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

The package contains one prefilled syringe and two safety needles (one 22-gauge 1½-inch needle and one 23-gauge 1-inch needle) for intramuscular injection.

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

2. Select the appropriate needle.

The first initiation dose of Palmeux (150 mg) is administered on Day 1 into the DELTOID muscle using the needle intended for DELTOID injection. The second initiation dose of Palmeux (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 injectable risperidone to Palmeux, the first injection of Palmeux (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 may be administered into either 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 (25.4 mm x 0.64 mm) (needle with blue hub); if the patient weighs ≥ 90 kg, use the 22-gauge 1½-inch needle (38.1 mm x 0.72 mm) (needle with grey hub).

For GLUTEAL injection, use the 22-gauge 1½-inch needle (38.1 mm x 0.72 mm) (needle with grey hub).

1. While holding the syringe in an upright position, remove the rubber cap from the tip with a twisting motion.

2. Open the safety needle blister pack halfway. Hold the needle cover using the plastic film of the opened blister. Attach the safety needle to the luer connection of the syringe with a simple clockwise twisting motion.

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

1. Position the syringe with the attached needle upright to proceed with air removal. Carefully expel air from the syringe by gently pushing the plunger forward.

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

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

8a

8b

8c