PALMEUX 25 mg Пролонгированная Инъекционная Суспензия В Преднаполненном Шприце

Содержание инструкции

1. What is Palmeux® and what is it 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. Content of the pack and other information

Palmeux® 25 mg prolonged-release injectable suspension in pre-filled syringe
Palmeux® 50 mg prolonged-release injectable suspension in pre-filled syringe
Palmeux® 75 mg prolonged-release injectable suspension in pre-filled syringe
Palmeux® 100 mg prolonged-release injectable suspension in pre-filled syringe
Palmeux® 150 mg prolonged-release injectable suspensionin pre-filled syringe
Paliperidone
Generic medicine

Read this leaflet carefully before using this medicine as 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 get any side effects, see section 4, and speak to your doctor, pharmacist or nurse.

Contents of 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 is Palmeux® and what is it used for

Palmeux® contains the active ingredient paliperidone, which belongs to the class of medicines
antipsychotics and is used as maintenance treatment for the symptoms of schizophrenia in
adult patients stabilized with paliperidone or risperidone.
If you have shown to respond to paliperidone or risperidone in the past and have mild to
moderate symptoms, your doctor may start treatment with Palmeux® without prior stabilization with
paliperidone or risperidone.
Schizophrenia is an illness characterized by “positive” and “negative” symptoms. Positive symptoms refer
to an excess of symptoms that are not normally present. For example, a person with schizophrenia
may hear voices or see things that do not actually exist (called hallucinations), believe things that are not
true (called delusions) or be unusually suspicious of others. Negative symptoms refer to a lack of
behaviours or sensations that are normally present. For example, a person with schizophrenia may have a
tendency to isolate themselves and may not react emotionally or may have difficulty speaking clearly and
logically. People with this illness may also feel depressed, anxious, guilty or tense.
Palmeux® can help relieve the symptoms of your illness and prevent them from recurring.

2. What you need to know before you use Palmeux®

Do not use Palmeux®:

• 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 another antipsychotic medicine, including risperidone.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Palmeux®.
This medicine has not been studied in elderly patients with dementia. However, elderly patients
with dementia, treated with other 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
can worsen the symptoms of other medical conditions. For this reason, it is important that you discuss
with your doctor any of the following conditions, which may potentially worsen during the
treatment with this medicine:

• if you have Parkinson’s disease
• if you have ever been diagnosed with an illness whose symptoms include high temperature and muscle rigidity (also known as Neuroleptic Malignant Syndrome)
• if you have ever had abnormal movements of the tongue or face (Tardive Dyskinesia)
• if you are aware of having had low levels of white blood cells in the blood in the past (which may or may not have been caused by other medicines)
• if you are diabetic or predisposed to diabetes
• if you have been diagnosed with breast cancer or a tumor of the pituitary gland (hypophysis) in the brain
• if you have a heart condition or if you are undergoing treatment for a heart condition that tends to lower your blood pressure
• if you have low blood pressure when you stand up or move from a lying position to a sitting position suddenly
• if you suffer from epilepsy
• if you have kidney problems
• if you have liver problems
• if you have a prolonged and/or painful erection
• if you have difficulty controlling your internal body temperature or conditions of excessive heat
• if you have an abnormally high level of the prolactin hormone in the blood or if you have a possible prolactin-dependent tumor
• if you or someone in your family has a history of blood clot formation (thrombosis), as antipsychotics have been associated with the formation of blood clots. If you have any of these conditions, talk to your doctor so that they can assess whether it is necessary to adjust the dose or monitor you closely for a certain period.

Because a dangerously low number of a certain type of white blood cells needed to fight infections in the
blood has been observed in patients taking this medicine, your doctor may check the white blood cell count.
Even if you have previously tolerated oral paliperidone or oral risperidone, allergic reactions rarely occur
after receiving injections of Palmeux®. Contact your doctor immediately if
you experience skin rash, swelling of the throat, itching or breathing problems as
these may be signs of a serious allergic reaction.
This medicine can cause an increase in body weight. Significant weight gain
can negatively affect your health. Your doctor should weigh you regularly.
Since diabetes mellitus or a worsening of pre-existing diabetes mellitus has been observed in patients taking this medicine, the doctor should check for high levels
of sugar in the blood. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.
Since this medicine may reduce the urge to vomit, there is a possibility that
it may mask the body's normal response to the ingestion of toxic substances or other medical conditions.
During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the
center of your eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery and this can cause damage
to the eye. If you are planning to have an eye operation, be sure to inform
your ophthalmologist that you are taking this medicine.

Children and adolescents
This medicine should not be used in people under the age of 18 years.

Other medicines and Palmeux®
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Taking this medicine with carbamazepine (antiepileptic and mood stabilizer) may
require adjustment of the dose of this medicine.
Because this medicine acts predominantly on the brain, interference with other medicines that
act on the brain, such as other psychiatric drugs, opioids, antihistamines and sleep disorder medications, can cause an exaggeration of side effects such as drowsiness or other effects on the
brain.
Because this medicine can lower blood pressure, be careful when this
medicine is used with other medicines that lower blood pressure.
This medicine can reduce the effect of medicines used to treat Parkinson’s disease and
restless legs syndrome (e.g. levodopa).
This medicine can cause an abnormality in the electrocardiogram (ECG), characterized by a
longer period for the progression of an electrical impulse through a certain part of the
heart (known as “QT prolongation”). Other medicines that have this effect
include some medicines used to treat heart rhythm or to treat infections and other
antipsychotics.
If you are prone to developing seizures, this medicine may increase the possibility of
experiencing them. Other medicines that have this effect include some medicines used
to treat depression or infections and other antipsychotics.
Palmeux® must be used with caution in association with medicines that increase the activity of the
central nervous system (stimulants, such as methylphenidate).

Palmeux® and alcohol
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Do not
use this medicine during pregnancy unless you have already discussed this with your
doctor. The following symptoms may occur in newborns whose mothers have used paliperidone
in the last trimester (last three months of pregnancy): tremor, muscle rigidity and/or weakness,
drowsiness, agitation, breathing problems, and difficulty feeding. If the baby presents one
of these symptoms, you may need to contact your doctor.
This medicine can pass from the mother to the baby through breast milk and may harm
the baby. Therefore, do not breastfeed while using this medicine.

Driving and using machines
Dizziness, extreme fatigue and
vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account in cases where complete
vigilance is required, e.g. when driving vehicles or using machines.

Palmeux® contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to use Palmeux®

This medicine is administered by a doctor or another healthcare professional. The doctor will decide when you need your next injection. It is important not to miss your scheduled dose. If you believe you will not be able to attend your appointment with the doctor, contact them immediately to arrange a new appointment as soon as possible.
You will be given a first injection (150 mg) and a second injection (100 mg) of this medicine in the upper arm approximately one week apart. Afterwards, you will receive an injection (which may vary from 25 mg to 150 mg) either in the upper arm or in the buttock once a month.
If your doctor switches you from long-acting injectable risperidone to this medicine, you will receive the first injection of this medicine (which may vary from 25 mg to 150 mg) either in the upper arm or in the buttock on the date already scheduled for your next injection.
Afterwards, you will receive an injection (which may vary from 25 mg to 150 mg) either in the upper arm or in the buttock once a month.
Depending on your symptoms, your doctor may increase or decrease the dose by one level of the amount of medicine you receive at the time of the scheduled monthly injection.
Patients with kidney problems
The doctor may adjust the dose of this medicine based on kidney function. If you have mild kidney problems, your doctor may prescribe a lower dose. If you have moderate to severe kidney problems, this medicine should not be used.
Elderly
The doctor may reduce the dose of this medicine if kidney function is reduced.

If you take more Palmeux® than you should
This medicine will be administered under medical supervision; it is therefore unlikely that you will be given an overdose.
In patients who have received an overdose of paliperidone, the following symptoms may occur: drowsiness or sedation, increased heart rate, decreased blood pressure, abnormal electrocardiogram (tracing of the heart's electrical activity), or slow or abnormal movements of the face, body, arms, or legs.

If you stop taking Palmeux®
If you stop receiving your injections, you will lose the effects of the medicine. Do not stop treatment with this medicine unless your doctor tells you to, as your symptoms may return.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention immediately if:

• you develop blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can move along the blood vessels

to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult a doctor immediately

• you suffer from dementia and notice a sudden change in your mental state or a sudden weakness or numbness in your face, arms or legs, especially on one side, or if your speech is unintelligible, even for a short period. These may be signs of a stroke
• you have a fever, muscle rigidity, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary
• you are a male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary
• you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue paliperidone
• you experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes a drop in blood pressure (corresponding to an ‘anaphylactic reaction’). Even if you have previously tolerated oral risperidone or oral paliperidone, allergic reactions rarely occur after receiving paliperidone injections
• you are planning to undergo eye surgery, be sure to inform your ophthalmologist that you are taking this medicine. During eye surgery for cataract (clouding of the lens), the iris (the colored part of the eye) may become flaccid during the procedure (“iris flaccidity syndrome”), which can cause damage to the eye
• you know you have a dangerously low number of a certain type of white blood cells in your blood needed to fight infections. The following side effects may occur:
• difficulty falling asleep or staying asleep.

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

• common cold symptoms, urinary tract infection, feeling as if you have the flu
• Palmeux® may increase the levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). When symptoms due to a high level of prolactin occur, these may include (in men) breast enlargement, difficulty having or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk leakage from the breasts, loss of menstrual periods or other problems with the cycle
• high blood sugar, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slowness or impairment of movement, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of movement that stops and then restarts. Other signs of Parkinsonism include a slow walk dragging the feet, a tremor at rest, increased saliva and/or loss of saliva, and a loss of facial expression
• restlessness, feeling sleepy or drowsy
• dystonia: this is a condition involving a slow or prolonged involuntary muscle contraction. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw
• dizziness
• dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or contorted movements, or spasms
• tremor
• headache
• rapid heart rate
• high blood pressure
• cough, stuffy nose
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in the blood
• bone or muscle pain, back pain, joint pain
• loss of menstrual period
• milk leakage from the breasts
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain or swelling.

Uncommon side effects: may affect up to 1 in 100 people

• pneumonia, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased white blood cell count, decreased of a certain type of white blood cells in the blood that help protect the body from infections, decreased platelets (blood cells that help stop bleeding), anemia
• allergic reaction
• diabetes or worsening of diabetes, increased insulin in the blood (a hormone that controls blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• increased triglycerides (a fat) in the blood, increased cholesterol in the blood
• sleep disorders, elevated mood (mania), decreased sexual drive, nervousness, nightmares
• tardive dyskinesia (spasms or jerky movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. Discontinuation of this medicine may be necessary
• fainting, an urgent need to move a part of the body, dizziness when standing up, attention disorders, speech problems, loss or abnormal sense of taste, reduced sensitivity of the skin to pain and touch, a sensation of tingling, prickling or numbness of the skin
• blurred vision, eye infection or “slightly reddened”, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• interruption of the conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, rapid heartbeat when getting up, slowed heart rate, abnormal heart tracing (electrocardiogram or ECG), a feeling of a fast or pounding heartbeat (palpitations)
• low blood pressure, decreased blood pressure when getting up (as a result, some people taking this medicine may feel faint, dizzy or may faint when getting up or sitting down suddenly)
• shortness of breath, congestion of the airways, wheezing, sore throat, nosebleeds
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas or air
• increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood
• urticaria, itching, rash, hair loss, eczema, dry skin, reddened skin, acne
• an increase in CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle breakdown
• muscle spasms, joint stiffness, muscle weakness, neck pain
• incontinence (loss of control) of urine, frequent urination, pain during urination
• erectile dysfunction, ejaculation disorders, absence of menstruation or other problems with the cycle (females), development of breasts in men, sexual dysfunction, breast pain
• swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
• increased body temperature
• a change in the way you walk
• chest pain, chest discomfort, feeling unwell
• hardening of the skin
• falls.

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

• eye infection
• skin inflammation caused by mites, abscess under the skin
• increased eosinophils (a type of white blood cells) in your blood
• inappropriate secretion of a hormone that controls urine volume
• sugar in the urine
• complications of uncontrolled diabetes leading to life-threatening conditions
• low blood sugar
• excessive intake of water
• absence of movements or responses when awake (catatonia)
• confusion
• sleepwalking
• lack of emotion
• inability to reach orgasm
• neuroleptic malignant syndrome (confusion, reduction or loss of consciousness, high fever and severe muscle rigidity), cerebrovascular problems including sudden loss of blood supply to the brain (stroke or “mini” stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures (convulsions) balance disorders
• abnormal coordination
• glaucoma (increased pressure inside the eyeball)
• problems with eye movements, rotation of the eyes to the back of the head, hypersensitivity of the eyes to light, increased tearing, redness of the eyes
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs). If you notice any of these symptoms, consult a doctor immediately
• hot flashes
• sleep apnea (breathing problems during sleep)
• congestion of the lungs
• crepitant rales (lung sounds)
• inflammation of the pancreas, swelling of the tongue, fecal incontinence, very hard stools
• chapped lips
• drug-related rash, thickening of the skin, dandruff
• breakdown of muscle fibers and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, breast enlargement, enlarged breasts
• vaginal discharge
• very low body temperature, chills, thirst
• drug withdrawal symptoms
• accumulation of pus caused by an infection at the injection site, deep skin infection, a cyst at the injection site, bruising at the injection site.

Not known: frequency cannot be estimated based on available data

• dangerous decrease of a certain type of white blood cells in the blood needed to fight infections in the blood
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes a drop in blood pressure
• dangerous and excessive consumption of water
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• head tremor
• blood clots in the lungs that can cause chest pain and difficulty breathing. If you notice such symptoms, seek immediate medical attention
• decreased oxygen in parts of your body (due to reduced blood flow)
• fast and shallow breathing, pneumonia caused by inhalation of food, voice disorder
• blockage of the intestine, lack of intestinal muscle movement causing blockage
• yellowing of the skin and eyes (jaundice)
• a severe and life-threatening rash with blisters and peeling skin that can start in the mouth, nose, eyes and genitals or near them and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling that can affect the throat causing difficulty breathing
• alteration of skin color, scaling and itching of the scalp or skin
• abnormal posture
• babies born to mothers who have taken Palmeux® during pregnancy may have experienced drug-related adverse events or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems
• priapism (a prolonged erection of the penis that may require surgical treatment)
• a decrease in body temperature
• death of skin cells at the injection site and ulceration at the injection site.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at http://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects, you can help provide more information
about the safety of this medicine.

5. How to store Palmeux®

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the pre-filled syringe after EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Palmeux® contains
The active ingredient is paliperidone.
Each pre-filled syringe of Palmeux® 25 mg contains 25 mg of paliperidone (as paliperidone
palmitate).
Each pre-filled syringe of Palmeux® 50 mg contains 50 mg of paliperidone (as paliperidone
palmitate).
Each pre-filled syringe of Palmeux® 75 mg contains 75 mg of paliperidone (as paliperidone
palmitate).
Each pre-filled syringe of Palmeux® 100 mg contains 100 mg of paliperidone (as paliperidone
palmitate).
Each pre-filled syringe of Palmeux® 150 mg contains 150 mg of paliperidone (as paliperidone
palmitate).
The other ingredients are:
Polysorbate 20
Macrogol
Citric acid monohydrate
Disodium phosphate
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (for pH adjustment)
Water for injections

Description of the appearance of Palmeux® and content of the pack
Palmeux® is a prolonged-release injectable suspension, white to off-white in colour, in a
pre-filled syringe.
Each pack contains 1 pre-filled syringe and 2 needles.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amdipharm Limited
3 Burlington Road
D04 RD68 Dublin 4
Ireland
Manufacturer
Pharmathen S.A
Dervenakion 6,
Pallini Attiki, 15351,
Greece
Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Belgium, Greece, Ireland, Netherlands, Spain, Germany: Palmeux 25 mg/50 mg/75 mg/100 mg/150 mg
prolonged-release injectable suspension in pre-filled syringe
Denmark, Norway, Finland, Sweden, Italy: Palmeux
---------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for physicians or healthcare professionals and
must be read by physicians or healthcare professionals together with the complete prescribing
information (Summary of Product Characteristics).
The injectable suspension is for single use only. A visual inspection should be performed to
exclude the presence of particulate matter before administration. Do not use if the
syringe does not appear visually free of particulate matter.
The pack contains a pre-filled syringe and 2 safety needles (one 1 ½ inch, 22 G needle and
one 1 inch, 23 G needle) for intramuscular injection.

Pre-filled syringe
23 G x 1”
(Blue connector)
22 G x 1 ½ ”
(Grey connector)
Closure cap
Connector

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

2. Select the appropriate needle.
The first initial dose of Palmeux® (150) mg must be administered on Day 1 into the
DELTOID muscle using the needle for injection into the DELTOID. The second initial dose of Palmeux® (100
mg) must also be administered into the DELTOID muscle one week later (Day 8)
using the needle for injection into the DELTOID.
If the patient is switching from long-acting risperidone injection to Palmeux®, the first
injection of Palmeux® (which may range from 25 mg to 150 mg) may be administered either into the
DELTOID or the GLUTEO muscle at the time of the next scheduled injection using the
appropriate needle for the injection site.
Subsequently, monthly maintenance injections may be administered either into the
DELTOID or the GLUTEO muscle using the appropriate needle for the injection site.
For DELTOID injection, if the patient weighs < 90 kg, use the 1 inch, 23G (25.4
mm x 0.64 mm) needle (the needle with the bluecoloured connector); if the patient weighs  90 kg, use the 1 ½ inch, 22G (38.1 mm x 0.72 mm) needle (the needle with the greycoloured connector).
For GLUTEO injection, use the 1½ inch, 22G (38.1 mm x 0.72 mm) needle (the needle with the
greycoloured connector).

3. Keeping the syringe in the vertical position, remove the rubber closure cap with a
rotational movement.

4. Open the safety needle blister pack halfway. Grasp the needle hub using
the open plastic packaging. Connect the safety needle to the luer connector of the syringe with a
simple clockwise rotational movement.

• 5.Pull off the needle protection cap with a straight-line movement. Do not rotate the cap as the needle may loosen from the syringe.

6. Hold the syringe with the needle connected in a vertical position to expel air. Remove the air
from the syringe by carefully pushing the plunger forward.

7. Inject the entire contents intramuscularly slowly and deeply into the selected deltoid or
gluteal muscle of the patient. Do not administer intravenously or subcutaneously.

8. Once the injection is complete, use your thumb or another finger (8a, 8b) or a flat surface
(8c) to activate the needle safety system. The system is fully activated when a clicking sound is heard. Dispose of the syringe with the needle appropriately.

8a
8b
8c