NIAPELF 25 mg Prolonged-Release Injectable Suspension In Pre-Filled Syringe

Зміст інструкції

1. Niapelf 25 mg prolonged-release injectable suspension, 50 mg prolonged-release injectable suspension, 75 mg prolonged-release injectable suspension, 100 mg prolonged-release injectable
2. Niapelf 150 mg injectable suspension with
   1. What is Niapelf and what it is used for
   2. What you need to know before you use Niapelf
   3. How to use Niapelf
   4. Possible side effects
   5. How to store Niapelf
   6. Contents of the pack and other information

Niapelf 25 mg prolonged-release injectable suspension, 50 mg prolonged-release injectable suspension, 75 mg prolonged-release injectable suspension, 100 mg prolonged-release injectable

prolonged-release

Niapelf 150 mg injectable suspension with

prolonged-release
paliperidone

Read this leaflet carefully before you start to use 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, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
• 1. What Niapelf is and what it is used for
• 2. What you need to know before you use Niapelf
• 3. How to use Niapelf
• 4. Possible side effects
• 5. How to store Niapelf
• 6. Contents of the pack and other information

1. What is Niapelf and what it is used for

Niapelf 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 previously shown to respond to paliperidone or risperidone and have mild to
moderate symptoms, your doctor may start treatment with Niapelf without prior stabilization with
paliperidone or risperidone.
Schizophrenia is an illness characterized by “positive” and “negative” symptoms. Positive refers 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
behaviors 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.
Paliperidone can help relieve the symptoms of the illness and prevent them from recurring.

2. What you need to know before you use Niapelf

Do not use Niapelf

• if you are allergic to paliperidone or 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 Niapelf.
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 may 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 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 in the brain
• if you have heart disease or are being treated for heart disease that tends to lower blood pressure
• if you have low blood pressure when you get up or go 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 hormone prolactin in the blood or if you have a possible prolactin-dependent tumor
• if you or someone in your family has a history of blood clots (thrombi), because antipsychotics have been associated with the formation of blood clots.

If you have any of these conditions, talk to your doctor so they can assess whether it is
necessary to adjust the dose or monitor you carefully 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 very rarely in patients taking this medicine, your doctor may check your white blood cell count.
Even if you have previously tolerated oral paliperidone or oral risperidone, allergic reactions rarely occur after receiving paliperidone injections. Contact your
doctor immediately if you develop a rash, swelling of the throat, itching or breathing problems as
these may be signs of a serious allergic reaction.
This medicine can cause weight gain. Significant weight gain can negatively affect your health. Your doctor should weigh you regularly.
Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking this medicine, your doctor should check for signs of increased
blood sugar levels. 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 the eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become flaccid during surgery and this may cause
damage to the eye. If you are planning to have an eye operation, be sure to
tell your ophthalmologist that you are taking this medicine.

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

Other medicines and Niapelf
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 mainly on the brain, interference with other medicines that
act on the brain, such as other psychiatric medicines, opioids, antihistamines and medicines for
sleep disorders, 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 "prolongation of the QT interval"). Other medicines that have this
effect include some medicines used to treat heart rhythm or to treat
infections and other antipsychotics.
If you are predisposed to developing seizures, this medicine may increase the possibility of
developing them. Other medicines that have this effect include some medicines used
to treat depression or infections and other antipsychotics.
Niapelf should be used with caution with medicines that increase the activity of the central nervous
system (stimulants such as methylphenidate).

Niapelf 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 of mothers who have used paliperidone
in the last trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness,
drowsiness, agitation, breathing problems, and difficulty feeding. If the baby presents
any 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 a car or using machines.

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

3. How to use Niapelf

This medicine is administered by a doctor or another healthcare professional. The doctor will determine when you will need the next injection. It is important not to miss the 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 once a month (at a dose that may vary from 25 mg to 150 mg) either in the upper arm or in the gluteus muscle.
If your doctor switches you from risperidone extended-release to this medicine, you will receive the first injection of this medicine (at a dose that may vary from 25 mg to 150 mg) either in the upper arm or in the gluteus muscle on the date already scheduled for your next injection.
Afterwards, you will receive an injection (at a dose that may vary from 25 mg to 150 mg) either in the upper arm or in the gluteus muscle once a month.
Depending on your symptoms, the doctor may increase or decrease by one dose level 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 the 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 Niapelf 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 excessive dose 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 using Niapelf
If you stop receiving the injections, you will lose the effects of the medicine. Do not stop using this medicine unless it is established by your doctor, as your symptoms may return.
If you have any further questions about taking 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.

Tell your doctor immediately if:

• you think you have 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, see your doctor immediately.
• you have dementia and notice a sudden change in your mental state or sudden weakness or numbness of the 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 stiffness, 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 have involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop 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, make sure to inform the ophthalmologist that you are taking this medicine. During eye surgery for lens opacity (cataract), the iris (the colored part of the eye) may become flaccid during the procedure (“iris floppy syndrome”), which can cause eye damage.
• you are aware that you have a dangerously low number of a certain type of white blood cells in the blood needed to fight infections.

The following side 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

• common cold symptoms, urinary tract infection, feeling as if you have the flu
• paliperidone may increase the levels of a hormone called “prolactin” found with a blood test (which may or may not cause symptoms). When symptoms due to an increase in prolactin levels occur, these may include (in men) breast enlargement, difficulty having or maintaining an erection or other sexual dysfunction; (in women) breast discomfort, leakage of milk from the breasts, loss of menstrual periods or other problems with the cycle
• elevated blood sugar levels, weight gain, weight loss, decreased appetite
• agitation, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, 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 walking slowly dragging the feet, resting tremor, increased saliva and/or loss of saliva, and a loss of facial expression
• restlessness, feeling sleepy or drowsy
• dystonia: this is a condition that consists of 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 that involves involuntary muscle movements and may include repetitive, spastic or contorted movements, or spasms.
• tremor
• headache
• rapid heart rate
• high blood pressure
• cough, nasal congestion
• 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 periods
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain or swelling.

Uncommon: may affect up to 1 in 100 people

• lung infection, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased white blood cell count, decreased number of a certain type of white blood cells in the blood that serve to protect the body from infections, 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), reduced sexual drive, nervousness, nightmares
• tardive dyskinesia (spasms or jerking movements of the face, tongue or other parts of the body that you cannot control). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue this medicine.
• fainting, an urgent need to move a part of the body, dizziness when getting 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 red” eye, 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 heartbeat, abnormal heart tracing (electrocardiogram or ECG), a feeling of a fast or pounding heartbeat (palpitations)
• low blood pressure, decrease in 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, 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, subcutaneous abscess
• an increase in CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage, muscle spasms, joint stiffness, muscle weakness
• urinary incontinence (loss of control) of urine, frequent urination, pain during urination
• erectile dysfunction, ejaculation disorders, absence of menstruation or other problems with the cycle (women), development of breasts in men, sexual dysfunction, breast pain, leakage of milk from the breasts
• swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
• increased body temperature
• a change in the way of walking
• 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, scaling and itching of the scalp or skin
• increased eosinophils (a type of white blood cells) in the blood
• decreased platelets (blood cells that help stop bleeding)
• head tremor
• inappropriate secretion of a hormone that controls urine volume
• sugar in the urine
• complications leading to life-threatening uncontrolled diabetes
• low blood sugar levels
• excessive intake of water
• absence of movement or response 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 stiffness), 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, rolling of the eyes backwards, hypersensitivity of the eyes to light, increased tearing, redness of the eyes
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clots in the lungs that can cause chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately
• 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, see your doctor immediately.
• hot flashes
• sleep breathing problems (sleep apnea)
• congestion of the lungs, congestion of the airways
• crackling in the lungs, wheezing
• inflammation of the pancreas, swelling of the tongue, fecal incontinence, very hard stools
• intestinal blockage
• chapped lips
• severe or life-threatening rash with blisters and peeling of the skin that can start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis)
• severe allergic reaction with swelling that can affect the throat causing difficulty breathing
• change in skin color
• abnormal posture
• babies born to mothers who have taken paliperidone during pregnancy may experience adverse drug events or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, sleepiness, breathing or feeding problems
• a decrease in body temperature
• death of skin cells at the injection site and ulcer at the injection site.

Not known: frequency cannot be estimated from available data

• dangerous decrease in a certain type of white blood cells in the blood that serve to protect the body from infections
• 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
• decreased oxygen in parts of the body (due to reduced blood flow)
• fast and shallow breathing, infection caused by inhalation of food, difficulty speaking
• lack of intestinal muscle movement causing blockage
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening rash with blisters and peeling of the skin that can start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis)
• severe allergic reaction with swelling that can affect the throat causing difficulty breathing
• change in skin color
• abnormal posture
• babies born to mothers who have taken paliperidone during pregnancy may experience adverse drug events or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, sleepiness, breathing or feeding problems
• a reduction in body temperature
• death of skin cells at the injection site and ulcer 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 listed in Annex V.
By reporting side effects you can help provide more information on the
safety of this medicine

5. How to store Niapelf

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cardboard packaging. The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Niapelf contains
The active ingredient is paliperidone.
Each pre-filled syringe of Niapelf 25 mg contains 39 mg of paliperidone palmitate
Each pre-filled syringe of Niapelf 50 mg contains 78 mg of paliperidone palmitate
Each pre-filled syringe of Niapelf 75 mg contains 117 mg of paliperidone palmitate.
Each pre-filled syringe of Niapelf 100 mg contains 156 mg of paliperidone palmitate.
Each pre-filled syringe of Niapelf 150 mg contains 234 mg of paliperidone palmitate.
The other ingredients are:
Polysorbate 20
Macrogol
Citric acid monohydrate (E-330)Dibasium sodium phosphate
Monobasic sodium phosphate monohydrate
Sodium hydroxide (E-524) (for pH adjustment)
Water for injections

Description of the appearance of Niapelf and contents of the pack
Niapelf is an injectable suspension for prolonged release in a pre-filled syringe of white-
whitish color.
Each pack contains 1 pre-filled syringe and 2 needles.
Starter pack:
each pack contains 1 pack of Niapelf 150 mg and 1 pack of Niapelf 100 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí
Barcelona – Spain

Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí
Barcelona – Spain
Neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Strasse 23
Richrath, Langenfeld (Rheinland)
40764, Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/

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
[38.1 mm x 0.72 mm ] and one 1 inch, 23 G [25.4 mm x 0.64 mm ]) for intramuscular
injection. Niapelf is also available in a starter pack for treatment containing two pre-filled
syringes (150 mg + 100 mg) and 2 additional safety needles.

1. 22 G x 1 1/2 ” (Grey hub)

2. 23 G x 1” (Blue hub)

3. Hub

4. Tip cap

5. Pre-filled syringe

• 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 Niapelf (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 Niapelf
(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 Niapelf, the
first Niapelf injection (which may range from 25 mg to 150 mg) may be administered either into the
DELTOID or the GLUTEAL 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 GLUTEAL muscle using the appropriate needle for the injection site.
For injection into the DELTOID, if the patient weighs <90 kg, use the 1 inch, 23G
(25.4 mm x 0.64 mm ) needle (the needle with the bluecolored hub); if the patient weighs ≥ 90 kg,
use the 1 ½ inch, 22G (38.1 mm x 0.72 mm ) needle (the needle with the colored hub in

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

• 3. Holding the syringe with the tip cap facing upwards, remove the rubber tip cap with a slight twisting motion.

• 4. Open the blister of the safety needle halfway. Grip the needle hub using the open plastic packaging. Hold the syringe facing upwards. Connect the safety needle to the syringe using a slight twisting motion to avoid breakage or damage to the needle connection.

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

• 6. Hold the syringe with the needle attached vertically to eliminate air. Remove 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 orsubcutaneously.
• 8. Once the injection is complete, use your thumb or another finger (8a, 8b) or a flat surface (8c) to activate the needle protection system. The system is fully activated when a clicking sound is heard. Dispose of the syringe with the needle appropriately.

Unused medicinal product and waste materials derived from such medicinal product should be disposed of in
accordance with local regulations.