Poltraxin

Patient Information Leaflet

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Poltraxin is and what it is used for
2. What you need to know 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 called 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, your doctor may consider initiating Poltraxin without prior stabilisation with paliperidone or risperidone.
Schizophrenia is a disorder characterised by both "positive" and "negative" symptoms. Positive symptoms refer to the presence of symptoms that are not normally experienced. For example, a person with schizophrenia may hear voices or see things that are not there (hallucinations), believe things that are not true (delusions), or be excessively suspicious of others. Negative symptoms refer to the absence of behaviours or emotions that are normally present. For example, a person with schizophrenia may appear withdrawn, emotionally flat, or have difficulty speaking clearly and logically. People with this condition may also experience depression, anxiety, feelings of guilt, or tension.
Poltraxin helps to reduce the symptoms of the illness and helps 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 types of medicines, there may be an increased risk of stroke or death (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, discuss with your doctor if any of the following conditions apply:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition characterized by symptoms such as 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 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 tumor
• 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 standing or sitting position
• if the patient has epilepsy
• if the patient has kidney function disorders
• if the patient has liver function disorders
• 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 prolactin hormone in the blood or suspected prolactin-dependent tumor
• 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, dangerously low levels of certain types of white blood cells necessary to fight infections have been observed in patients taking this medicine.
Even if the patient previously tolerated oral paliperidone or risperidone well, 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 negatively 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.
Since this medicine may suppress vomiting, it may mask the body's normal response to ingested toxic substances or other medical conditions.
During cataract removal surgery from the eye, the pupil may not dilate sufficiently. Also, the iris of the eye may be flaccid during the procedure, which may result in eye damage. If the patient has planned eye surgery, inform the ophthalmologist about 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 stabilizer) 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 intensify 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 prolonged conduction of electrical impulses 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 antipsychotic medicines.
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 antipsychotic medicines.
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 baby, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless discussed with the 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 breast milk and harm the child. Therefore, breastfeeding should not be performed while taking this medicine.

Driving and operating machinery
During treatment with this medicine, dizziness, extreme fatigue, and visual disturbances may occur (see section 4). This should be taken into account in situations requiring full alertness, such as driving vehicles 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 should contact your doctor immediately to arrange another appointment as soon as possible.
The first (150 mg) and second (100 mg) injections of this medicine will be given into the upper arm, approximately one week apart. After that, monthly injections (in doses ranging from 25 mg to 150 mg) will be administered into the upper arm or buttock.
If your doctor decides to switch from long-acting risperidone injections to this medicine, the first injection (in doses ranging from 25 mg to 150 mg) will be given into the upper arm or buttock on the day of your next scheduled injection. After that, monthly injections (in doses ranging from 25 mg to 150 mg) will be administered into the upper arm or buttock.
Depending on the patient's symptoms, the doctor may increase or decrease the dose by one level during the scheduled monthly injection.

Patients with kidney function disorders
The doctor will adjust the dose of the medicine according to kidney function. If the patient has mild kidney function impairment, the doctor may reduce the dose. This medicine should not be used in cases of moderate or severe kidney function 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 overdose is unlikely.
In patients who have received an excessive dose of paliperidone, the following symptoms may occur:
drowsiness and sedation, increased heart rate, low blood pressure, abnormal ECG (electrocardiogram) findings, or slowed or abnormal movements of the face, body, arms, or legs.

Discontinuation of 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 in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, seek immediate medical help
• the patient with dementia experiences sudden change in mental state or sudden weakness or numbness of the face, arms or legs, especially 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 man experiences prolonged or painful erection. This condition is known as "priapism". Immediate treatment may be required
• involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of paliperidone treatment may be necessary
• the patient experiences a severe allergic reaction characterized by: fever, swelling of the lips, face, tongue or throat, shortness of breath, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or oral paliperidone, 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, flaccid 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, feeling 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 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 blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue
• reaction at the injection site, 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 (fats) 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). You should immediately inform your doctor 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 standing up, difficulty concentrating, difficulty speaking, 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
• feeling of dizziness, ringing in the ears, ear pain
• heart conduction block, abnormal conduction of electrical impulses in the heart, QT interval prolongation in the heart, rapid heartbeat upon standing, slow heart rate, abnormal electrocardiogram (ECG), palpitations (awareness of heart beating)
• 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 or rising quickly)
• shortness of breath, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas
• increased activity of the enzyme GGTP (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• skin rash, itching, rash, hair loss, 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 mouth, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, malaise
• skin induration
• 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 cells) in blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• tremulous head movements
• abnormal secretion of the hormone regulating urine production
• sugar 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
• lack of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (disorientation, decreased or loss of consciousness, high fever and severe muscle rigidity), cerebrovascular disorders including sudden interruption of blood flow to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, decreased 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, redness of the eyes
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• blood clot in the lungs causing chest pain and difficulty breathing. If such symptoms occur, seek immediate medical help
• blood clots in the veins, especially 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)
• blood congestion in the lungs, congestion of the airways
• crackling sounds in the lungs, wheezing
• pancreatitis, tongue swelling, faecal incontinence, very hard stool
• intestinal obstruction
• chapped lips
• drug-related skin rash, skin thickening, dandruff
• breakdown of muscle fibres and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, breast gland enlargement, breast enlargement
• vaginal discharge
• priapism (prolonged erection which may require surgical intervention)
• very low body temperature, chills, feeling 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 available data)

• dangerously low levels of certain white blood cells responsible for fighting infections;
• severe allergic reaction characterized by fever, swelling of lips, face, eyelids or tongue, shortness of breath, itching, skin rash, and sometimes low blood pressure
• dangerously excessive water drinking - water intoxication
• feeding disorders related to sleep
• coma due to uncontrolled diabetes
• reduced oxygenation of various body parts (due to reduced blood flow)
• rapid, shallow breathing, pneumonia caused by food aspiration, 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 and genital areas and around these sites 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 drug effects 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 the injection site and ulceration at the injection site

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, you should inform 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization 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 carton. 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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.

Starting regimen set
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: polysorbate 20, macrogol 4000, monohydrate citric acid, disodium phosphate, monosodium 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 type I glass) with a plunger, lock, and a "tip-cap" safety needle 22G 1½ inch and a safety needle 23G 1 inch. All packed in a cardboard box.
Each starting regimen multipack 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 European Economic Area countries under the following names:
Bulgaria: Полтраксин

Information intended exclusively for medical personnel or healthcare professionals 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. If foreign particles are visible in the prefilled syringe, do not use the medicinal product.

The package contains a prefilled syringe and 2 safety-protected needles (one 22G 1½ inch [38.1 mm x 0.72 mm] needle and one 23G 1 inch [25.4 mm x 0.64 mm] needle) for intramuscular administration. The starter pack for initiating treatment 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) must 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) must 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 ranging from 25 mg to 150 mg) may be administered on the day of the next scheduled injection into either the DELTOID MUSCLE or the GLUTEAL MUSCLE, using the appropriate needle.

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

For injections into the DELTOID MUSCLE in patients with body weight <90 kg, use the 1 inch, 23G (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 (38.1 mm x 0.72 mm) needle (with gray hub).

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

3. Hold the syringe with the tip pointing upward and remove the rubber cap with a gentle twisting motion.

4. Peel off the safety-protected needle blister. Hold the base of the needle, not the safety shield. Attach the safety-protected needle to the syringe tip by pressing and turning it gently clockwise.

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. Hold the prefilled syringe with attached needle in an upright vertical position to expel air. Expel air from the prefilled syringe by gently pushing the plunger forward.

8. Administer the entire contents 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 the fingers of one hand (9a) or a flat surface (9b) to activate the needle safety system. The system is fully activated when you hear a "click." Dispose of the prefilled syringe with the needle properly.

9a

9b

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