Poltraxin

Package leaflet: information for the patient

Poltraxin, 25 mg, prolonged-release injection suspension in prefilled syringe
Poltraxin, 50 mg, prolonged-release injection suspension in prefilled syringe
Poltraxin, 75 mg, prolonged-release injection suspension in prefilled syringe
Poltraxin, 100 mg, prolonged-release injection suspension in prefilled syringe
Poltraxin, 150 mg, prolonged-release injection suspension in prefilled syringe
Initiation pack
Poltraxin, 100 mg/150 mg, prolonged-release injection suspension in prefilled syringe
Paliperidone
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Poltraxin is and what it is used for

Poltraxin contains the active substance paliperidone, which belongs to a group of medicines known as antipsychotics. It is used for the maintenance treatment of symptoms of schizophrenia in stable adult patients previously treated with paliperidone or risperidone.
For patients who previously responded to oral paliperidone or risperidone and whose psychotic symptoms are mild to moderate, the physician may initiate treatment with Poltraxin without prior stabilization with paliperidone or risperidone.
Schizophrenia is a disorder with both "positive" and "negative" symptoms. Positive symptoms refer to the presence of abnormal experiences that usually do not occur. For example, a person with schizophrenia may hear voices or see things that do not exist (hallucinations), believe in things that are not true (delusions), or be excessively suspicious of others. Negative symptoms refer to the absence or reduction of normal behaviors or emotions. A person with schizophrenia may appear withdrawn, emotionally unresponsive, or have difficulty speaking clearly and logically. Individuals affected by this disorder may also experience depression, anxiety, feelings of guilt, or tension.
Poltraxin helps to reduce the symptoms of the illness and prevent their recurrence.

2. Important information before using Poltraxin

When not to use Poltraxin

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

Warnings and precautions
Before starting treatment with Poltraxin, discuss this with your doctor, pharmacist, or
nurse.
The use of this medicine in elderly patients with dementia has not been studied. However, in such
patients treated with other similar medicines, an increased risk of stroke or death may occur (see section 4, "Possible side effects").
All medicines have side effects. Some of the side effects of this medicine may worsen symptoms of other conditions. For this reason, during treatment with this medicine, please discuss with your doctor any of the following conditions:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition characterised by high fever and muscle stiffness (also known as neuroleptic malignant syndrome)
• if the patient has ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia)
• if the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines)
• if the patient has diabetes or is predisposed to developing diabetes
• if the patient has breast cancer or a pituitary gland tumour
• if the patient has heart disease or is being treated for heart disease that predisposes to hypotension
• if the patient has low blood pressure upon sudden change to a standing or sitting position
• if the patient has epilepsy
• if the patient has impaired kidney function
• if the patient has impaired liver function
• if the patient experiences prolonged and/or painful erection
• if the patient has problems with body temperature regulation or overheating
• if the patient has abnormally high levels of the hormone prolactin in the blood or suspicion of a prolactin-dependent tumour
• if the patient or their family members have a history of blood clots in blood vessels, as antipsychotic medicines are associated with their development.

If the patient meets any of the above criteria, they should consult their doctor,
who may adjust the dose or monitor the patient periodically.
The treating doctor may order a white blood cell count test, as very rarely, this medicine has been associated with dangerously low levels of certain types of white blood cells essential for fighting infections.
Even if the patient previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after Poltraxin injections. Seek immediate medical help if the patient develops rash, throat swelling, itching, or difficulty breathing, as these may be symptoms of a severe allergic reaction.
This medicine may cause weight gain. Significant weight gain may adversely affect the patient's health. The treating doctor will regularly monitor the patient's body weight.
The treating doctor will check for symptoms of elevated blood sugar levels, as new-onset diabetes or worsening of pre-existing diabetes has been observed in patients taking this medicine. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Because this medicine may suppress vomiting, it may mask the body's normal response to ingesting toxic substances or other medical conditions.
During cataract removal surgery, the pupil may not dilate sufficiently.
Also, the iris of the eye may be floppy during surgery, which may result in eye damage.
If the patient has planned eye surgery, inform the ophthalmologist that they are taking this medicine.
Children and adolescents
This medicine is not used in children and adolescents under 18 years of age.
Poltraxin with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking this medicine together with carbamazepine (an anticonvulsant and mood stabiliser) may require adjustment of the dose of this medicine.
Since this medicine acts primarily in the brain, combining it with other medicines that act in the brain, such as other psychotropic medicines, opioids, antihistamines, and sedatives, may increase side effects such as drowsiness or other effects on the brain.
This medicine may lower blood pressure; therefore, caution is advised when using it together with other medicines that lower blood pressure.
This medicine may reduce the effectiveness of medicines used in Parkinson's disease and restless legs syndrome (e.g. levodopa).
This medicine may cause abnormalities in the electrocardiogram (ECG), manifesting as prolongation of the electrical impulse through a specific part of the heart (known as "QT interval prolongation"). Other medicines with this effect include those used to regulate heart rhythm or treat infections, as well as other antipsychotics.
If the patient is prone to seizures, this medicine may increase the risk of their occurrence. Other medicines with this effect include certain antidepressants or medicines used to treat infections, as well as other antipsychotics.
Caution is advised when using Poltraxin together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).
Poltraxin and alcohol
Alcohol consumption should be avoided.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless discussed with a doctor.
Newborns whose mothers used paliperidone during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in your child, contact your doctor.
This medicine may pass from the mother's body into her breast milk and harm the child.
Therefore, breastfeeding must not be undertaken during treatment with this medicine.
Driving and operating machinery
During treatment with this medicine, dizziness, extreme fatigue, and vision disturbances (see section 4) may occur. This should be taken into account in situations requiring full alertness, such as driving or operating machinery.
Poltraxin contains sodium and polysorbate 20
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".
This medicine contains 12 mg of polysorbate per ml, equivalent to 12 mg/ml. Polysorbates may cause allergic reactions. Inform the doctor if the patient has known allergic reactions.

3. How to use Poltraxin

The medicine will be administered by a doctor or other healthcare professional. The medicine will be injected into the muscle.
Your doctor will inform you when the next injection is due. It is important not to miss a scheduled dose. If you are unable to keep the scheduled appointment, you must inform your doctor immediately so that a new appointment can be arranged as soon as possible.
The first (150 mg) and second (100 mg) injections of this medicine will be given in the upper arm, approximately one week apart. Afterwards, an injection (at a dose ranging from 25 mg to 150 mg) will be administered once a month in the upper arm or buttock.
If your doctor decides to switch from long-acting risperidone injections to this medicine, the first injection of this medicine (at a dose ranging from 25 mg to 150 mg) will be given in the upper arm or buttock on the day of your next scheduled injection. Afterwards, an injection (at a dose ranging from 25 mg to 150 mg) will be administered once a month in the upper arm or buttock.
Depending on the symptoms experienced by the patient, the doctor may increase or decrease the administered dose by one level during the scheduled monthly injection.

Patients with impaired kidney function
The doctor will adjust the dose of the medicine based on kidney function. If the patient has mild kidney impairment, the doctor may reduce the dose. This medicine should not be used in cases of moderate or severe kidney impairment.

Elderly patients
The doctor may reduce the dose if the patient has impaired kidney function.

Use of a higher than recommended dose of Poltraxin
This medicine will be administered under medical supervision, so an overdose is unlikely.
In patients who have received too high a dose of paliperidone, the following symptoms may occur:
drowsiness and sedation, increased heart rate, low blood pressure, abnormal ECG (electrocardiogram) reading, or slowed or abnormal movements of the face, body, arms, or legs.

Stopping treatment with Poltraxin
If the patient stops receiving injections, the medicine will stop working. Do not discontinue treatment unless instructed by the doctor, as symptoms of the illness may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You should immediately inform your doctor if:

• the patient develops blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help
• in a patient with dementia, there is a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, particularly on one side, or speech disturbances, even if brief. These symptoms may indicate a stroke
• the patient develops fever, muscle stiffness, sweating or decreased level of consciousness (a condition called neuroleptic malignant syndrome). Immediate treatment may be necessary
• the male patient experiences prolonged or painful erection. This condition is known as "priapism". Immediate treatment may be necessary
• involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of paliperidone treatment may be necessary
• the patient develops a severe allergic reaction characterised by: fever, swelling of the lips, face, eyelids or tongue, shortness of breath, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or paliperidone taken orally, allergic reactions may rarely occur after paliperidone injections
• the patient has planned eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract removal, floppy iris syndrome may occur, which may lead to eye damage
• the patient has dangerously low levels of certain white blood cells essential for fighting infections

The following side effects may occur:
Very common side effects (may affect more than 1 in 10 patients)

• difficulty falling asleep or waking up

Common side effects (may affect up to 1 in 10 patients)

• cold-like symptoms, urinary tract infection, flu-like symptoms

• the medicine Poltraxin may increase the level of the hormone prolactin in the blood (which may, but does not necessarily, cause symptoms). If symptoms of increased prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erection or other sexual disturbances. In women, they may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding or other menstrual cycle disturbances

• high blood sugar levels, weight gain, weight loss, decreased appetite

• irritability, depression, anxiety

• parkinsonism: this condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a feeling of "freezing" of movements, followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation/drooling, and expressionless face

• psychomotor restlessness, drowsiness or reduced alertness

• dystonia: this condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (which may result in abnormal body posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements

• dizziness

• dyskinesia: this condition involves involuntary muscle movements and may present as repetitive, spasmodic or twisting movements or jerks

• tremor

• headache

• rapid heartbeat

• high blood pressure

• cough, stuffy nose

• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache

• increased liver enzyme activity in the blood

• bone or muscle pain, back pain, joint pain

• absence of menstruation

• fever, weakness, fatigue

• injection site reaction, including itching, pain or swelling

Uncommon side effects (may affect up to 1 in 100 patients)

• pneumonia, bronchitis, respiratory tract infections, sinus infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased number of white blood cells, decreased number of certain white blood cells protecting against infections, anaemia
• allergic reaction
• onset of diabetes and worsening of pre-existing diabetes, increased blood insulin levels (hormone regulating blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high blood triglyceride (fat) levels, increased blood cholesterol levels
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• tardive dyskinesia (twitching or jerking uncontrolled movements of the face, tongue or other body parts). Inform your doctor immediately if rhythmic involuntary movements of the tongue, lips or face occur. Discontinuation of this medicine may be necessary
• fainting, need to move body parts, dizziness upon changing to upright position, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness of the skin
• blurred vision, eye infection or conjunctivitis, dry eyes
• sensation of dizziness, ringing in the ears, ear pain
• conduction block between heart chambers, abnormal conduction of electrical impulses in the heart, QT interval prolongation on ECG, rapid heartbeat upon standing, slow heart rate, abnormal ECG reading, sensation of heart palpitations
• low blood pressure, low blood pressure upon standing (as a result of which some patients taking this medicine may faint, feel dizzy or lose consciousness when standing up suddenly)
• shortness of breath, sore throat, nosebleeds
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas
• increased GGTP enzyme activity (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• hives, itching, rash, hair loss, skin eruption, dry skin, skin redness, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) enzyme activity in blood, an enzyme sometimes released from damaged muscles
• muscle cramps, joint stiffness, muscle weakness
• urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstruation and other menstrual cycle disturbances (in women), breast enlargement in men, sexual disturbances, breast pain, galactorrhea
• swelling of the face, lips, eyes or eyelids, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in gait
• chest pain, chest discomfort, malaise
• skin hardening
• fall

Rare side effects (may affect up to 1 in 1,000 patients)

• eye infection
• skin inflammation caused by mites, scaly, itchy scalp or other body parts
• increased number of eosinophils (a type of white blood cell) in blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• head tremors
• abnormal secretion of the hormone regulating urine production
• glucose in urine
• life-threatening complications of untreated diabetes
• low blood sugar levels
• excessive water drinking
• lack of movement and response to stimuli in a patient who is not asleep (catatonia)
• disorientation
• sleepwalking (somnambulism)
• lack of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (disorientation, decreased or loss of consciousness, high fever and severe muscle rigidity), cerebral vascular disorders including sudden interruption of blood flow to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures, balance disturbances
• abnormal motor coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, rotational eye movements, light sensitivity, increased tearing, eye redness
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• blood clot in the lungs causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help
• blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, seek immediate medical help
• flushing attacks
• breathing disturbances during sleep (sleep apnoea)
• pulmonary congestion, respiratory tract hyperaemia
• crackling sounds in the lungs, wheezing
• pancreatitis, tongue swelling, faecal incontinence, very hard stool
• intestinal obstruction
• chapped lips
• drug-related skin rash, skin thickening, psoriasis
• breakdown of muscle fibres and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of breast glands, breast enlargement
• vaginal discharge
• priapism (prolonged erection which may require surgical intervention)
• very low body temperature, chills, sensation of thirst
• withdrawal symptoms
• abscess due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• dangerously low levels of certain white blood cells responsible for fighting infections;
• severe allergic reaction characterised by fever, swelling of lips, face, eyelids or tongue, shallow breathing, itching, skin rash, and sometimes low blood pressure
• dangerously excessive water drinking - water intoxication
• sleep-related eating disorders
• coma due to uncontrolled diabetes
• reduced oxygenation of various body parts (due to reduced blood flow)
• rapid, shallow breathing, aspiration pneumonia, voice disturbances
• absence of intestinal peristalsis leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening blistering rash with skin peeling, which may appear in the mouth, nose, eyes, genital organs and around these areas and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling which may involve the throat and lead to breathing difficulties
• skin depigmentation
• abnormal body posture
• in newborns whose mothers used paliperidone during pregnancy, adverse effects of the drug and (or) withdrawal symptoms may occur, such as: irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• decreased body temperature
• necrosis at injection site and ulceration at injection site

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Poltraxin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pre-filled syringe and packaging. The expiry date refers to the last day of the stated month.
The marking following the abbreviation EXP on the packaging indicates the expiry date, and the marking following the abbreviation Lot indicates the batch number.
Do not store above 30 °C. Do not freeze.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Poltraxin contains

• The active substance is paliperidone. Each 25 mg pre-filled syringe contains paliperidone palmitate equivalent to 25 mg of paliperidone. Each 50 mg pre-filled syringe contains paliperidone palmitate equivalent to 50 mg of paliperidone. Each 75 mg pre-filled syringe contains paliperidone palmitate equivalent to 75 mg of paliperidone. Each 100 mg pre-filled syringe contains paliperidone palmitate equivalent to 100 mg of paliperidone. Each 150 mg pre-filled syringe contains paliperidone palmitate equivalent to 150 mg of paliperidone.

Initiation regimen
Each 100 mg pre-filled syringe contains paliperidone palmitate equivalent to
100 mg of paliperidone.
Each 150 mg pre-filled syringe contains paliperidone palmitate equivalent to
150 mg of paliperidone.

• Other ingredients are: polysorbate 20, macrogol 4000, citric acid monohydrate, disodium phosphate, sodium dihydrogen phosphate monohydrate, sodium hydroxide (for pH adjustment), water for injections.

What Poltraxin looks like and contents of the pack
Poltraxin is a white or almost white suspension for injection in a pre-filled syringe (suspension for injection).
Each single pack contains:
1 pre-filled syringe (clear glass, type I) with a plunger, lock, and a "tip-cap" needle shield, safety needle 22G 1½ inch and safety needle 23G 1 inch. All in a cardboard box.
Each initiation pack contains:

• 1 pack of Poltraxin 150 mg, 1 pre-filled syringe and 2 needles (administered on day 1 of treatment).
• 1 pack of Poltraxin 100 mg, 1 pre-filled syringe and 2 needles (administered on day 8 of treatment).

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer/Importer
Universal Farma S.L.
Polígono Industrial Miralcampo
C/ El Tejido 2
19200 Azuqueca de Henares – Guadalajara
Spain
Pharmascience International Limited
1st Floor Jacovides Tower
81-83 Griva Digeni Avenue
1090 Nicosia
Cyprus
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria: Полтраксин

Information intended solely for healthcare professionals or healthcare workers and must be read together with the full product information (Summary of Product Characteristics).

The injection suspension is for single use only. Before administration, inspect visually for foreign particles. Do not use the medicinal product if foreign particles are observed in the prefilled syringe.

The package contains a prefilled syringe and 2 needles with safety device (one 22G 1½ inch needle [38.1 mm x 0.72 mm] and one 23G 1 inch needle [25.4 mm x 0.64 mm]) for intramuscular administration. The treatment initiation pack contains two prefilled syringes (150 mg + 100 mg) and a total of 4 needles.

1. Shake the prefilled syringe vigorously for at least 10 seconds to ensure homogeneity of the suspension.

2. Select the appropriate needle.

The first initiating dose of Poltraxin (150 mg) should be administered on day 1 of treatment into the DELTOID MUSCLE using the needle for DELTOID MUSCLE injection. The second initiating dose of Poltraxin (100 mg) should be administered one week later (day 8) also into the DELTOID MUSCLE using the needle for DELTOID MUSCLE injection.

If switching from long-acting risperidone injections to Poltraxin, the first injection of Poltraxin (at a dose between 25 mg and 150 mg) may be administered into the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle on the day of the next scheduled injection.

Subsequently, monthly maintenance doses may be administered into either the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle.

For injections into the DELTOID MUSCLE in patients with body weight <90 kg, use the 1 inch, 23G needle (25.4 mm x 0.64 mm) (needle with blue hub). If the patient's body weight is ≥90 kg, use the 1½ inch, 22G needle (38.1 mm x 0.72 mm) (needle with grey hub).

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

3. Hold the syringe with the tip pointing upwards. Remove the rubber cap with a gentle twisting motion.

4. Peel off the blister containing the safety needle. Hold the base of the needle, not the safety shield. Attach the safety needle to the syringe tip by firmly pressing and turning clockwise with a slight twisting motion.

5. Remove the protective needle shield by pulling it away from the needle at the angle shown, directing it toward the syringe barrel.

6. Remove the needle cap with a straight pull. Do not twist the cap, as this may loosen the needle from the prefilled syringe.

7. Position the prefilled syringe with attached needle vertically to expel air. Expel air from the prefilled syringe by gently pushing the plunger forward.

8. Administer the entire content of the prefilled syringe slowly and deeply by intramuscular injection into the selected muscle—deltoid or gluteal. Do not administer intravenously or subcutaneously.

9. After completing the injection, use either the fingers of one hand (9a) or a flat surface (9b) to activate the needle safety device. The safety system is fully activated when you hear a "click". Dispose of the prefilled syringe with needle appropriately.

9a

9b

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.